Difference between revisions of "Pancreatic cancer"

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==Fluorouracil (5-FU) & Folinic acid (Leucovorin)==
 
==Fluorouracil (5-FU) & Folinic acid (Leucovorin)==
 
===Regimen===
 
===Regimen===
−
*[[Fluorouracil (5-FU)]] 425 mg/m2 IV bolus on days 1-5, given second
+
Level of Evidence:
−
*[[Folinic acid (Leucovorin)]] 20 mg/m2 IV bolus on days 1-5, given first
+
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
 +
*[[Fluorouracil (5-FU)]] 425 mg/m2 IV bolus on days 1 to 5, given second
 +
*[[Folinic acid (Leucovorin)]] 20 mg/m2 IV bolus on days 1 to 5, given first
  
 
'''28-day cycles x 6 cycles'''
 
'''28-day cycles x 6 cycles'''
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==Gemcitabine (Gemzar)==
 
==Gemcitabine (Gemzar)==
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
  
−
'''28-day cycles x 6 cycles, starting day 10-42 after surgery or after wound is healed'''
+
'''28-day cycles x 6 cycles, starting day 10 to 42 after surgery or after wound is healed'''
  
 
===References===
 
===References===
Line 27: Line 43:
 
# P. Neuhaus, H. Riess, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zuelke, J. Fahlke, J. Langrehr, H. Oettle. CONKO-001: Final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). 2008 ASCO Annual Meeting abstract LBA4504. [http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=34749 link to abstract]
 
# P. Neuhaus, H. Riess, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zuelke, J. Fahlke, J. Langrehr, H. Oettle. CONKO-001: Final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). 2008 ASCO Annual Meeting abstract LBA4504. [http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=34749 link to abstract]
 
# Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. [http://jama.ama-assn.org/content/304/10/1073.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20823433 PubMed]
 
# Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. [http://jama.ama-assn.org/content/304/10/1073.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20823433 PubMed]
 +
 +
==Placebo (Observation)==
 +
 +
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 +
''No treatment.  Placed here because one or more randomized clinical trials included a placebo arm in this disease context.''
 +
 +
===References===
 +
# Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007 Jan 17;297(3):267-77. [http://jama.ama-assn.org/content/297/3/267.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17227978 PubMed]
 +
# P. Neuhaus, H. Riess, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zuelke, J. Fahlke, J. Langrehr, H. Oettle. CONKO-001: Final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). 2008 ASCO Annual Meeting abstract LBA4504. [http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=34749 link to abstract]
  
 
=Adjuvant chemoradiation=
 
=Adjuvant chemoradiation=
 
==Fluorouracil (5-FU) & RT==
 
==Fluorouracil (5-FU) & RT==
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
Prior to chemoradiation:
 
Prior to chemoradiation:
−
*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion on days 1-21
+
*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion on days 1 to 21
  
 
'''21-day course'''
 
'''21-day course'''
  
 
Chemoradiation:
 
Chemoradiation:
−
*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion daily throughout radiation therapy
+
*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion throughout radiation therapy
 
*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.  The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
 
*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.  The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
  
−
'''6-week course, to start 1-2 weeks after chemotherapy'''
+
'''6-week course, to start 1 to 2 weeks after chemotherapy'''
  
 
After chemoradiation:
 
After chemoradiation:
−
*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion on days 1-28
+
*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion on days 1 to 28
  
 
'''6-week cycles x 2 cycles, to start 3-5 weeks after completion of chemoradiation'''
 
'''6-week cycles x 2 cycles, to start 3-5 weeks after completion of chemoradiation'''
  
 
===References===
 
===References===
 +
# Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Büchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. [http://www.nejm.org/doi/full/10.1056/NEJMoa032295 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15028824 PubMed]
 
# Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. [http://jama.ama-assn.org/content/299/9/1019.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18319412 PubMed]
 
# Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. [http://jama.ama-assn.org/content/299/9/1019.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18319412 PubMed]
  
 
==Gemcitabine (Gemzar) & RT==
 
==Gemcitabine (Gemzar) & RT==
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
Chemoradiation:
 
Chemoradiation:
 
<br>''Note: Loehrer, et al. 2011's abstract and body are inconsistent about whether the number of gemcitabine doses during radiation therapy is 5 or 6.  In the abstract, gemcitabine is listed as being used from weeks 1 to 5, but then later gemcitabine is listed as being given weekly during radiation, which would be 6 weeks since radiation lasts 5.5 weeks.  The 2008 ASCO abstract also specifies 6 doses of gemcitabine, so this is what is listed below.''
 
<br>''Note: Loehrer, et al. 2011's abstract and body are inconsistent about whether the number of gemcitabine doses during radiation therapy is 5 or 6.  In the abstract, gemcitabine is listed as being used from weeks 1 to 5, but then later gemcitabine is listed as being given weekly during radiation, which would be 6 weeks since radiation lasts 5.5 weeks.  The 2008 ASCO abstract also specifies 6 doses of gemcitabine, so this is what is listed below.''
−
*[[Gemcitabine (Gemzar)]] 600 mg/m2 IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36
+
*[[Gemcitabine (Gemzar)]] 600 mg/m2 IV over 30 to 60 minutes on days 1, 8, 15, 22, 29, 36
 
*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.
 
*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.
  
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==Gemcitabine (Gemzar), Fluorouracil (5-FU), RT==
 
==Gemcitabine (Gemzar), Fluorouracil (5-FU), RT==
 
===Regimen===
 
===Regimen===
 +
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
Prior to chemoradiation:
 
Prior to chemoradiation:
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
Line 76: Line 135:
  
 
Chemoradiation:
 
Chemoradiation:
−
*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion daily throughout radiation therapy
+
*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion throughout radiation therapy
 
*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.  The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
 
*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.  The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
  
−
'''6-week course, to start 1-2 weeks after chemotherapy'''
+
'''6-week course, to start 1 to 2 weeks after chemotherapy'''
  
 
After chemoradiation:
 
After chemoradiation:
Line 90: Line 149:
  
 
=Metastatic disease=
 
=Metastatic disease=
 +
 +
==Best supportive care==
 +
 +
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 +
''Best supportive care.  Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.''
 +
 +
===References===
 +
# Pelzer U, Schwaner I, Stieler J, Adler M, Seraphin J, Dörken B, Riess H, Oettle H. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011 Jul;47(11):1676-81. Epub 2011 May 10. [http://www.ejcancer.info/article/S0959-8049%2811%2900260-7/abstract link to original article] '''contains verified protocol'''--with error as noted above [http://www.ncbi.nlm.nih.gov/pubmed/21565490 PubMed]
 +
 
==Capecitabine (Xeloda)==
 
==Capecitabine (Xeloda)==
 
===Regimen===
 
===Regimen===
−
*[[Capecitabine (Xeloda)]] 1250 mg/m2 PO BID on days 1-14
+
Level of Evidence:
 +
<span
 +
style="background:#EEEE00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase II</span>
 +
 
 +
*[[Capecitabine (Xeloda)]] 1250 mg/m2 PO BID on days 1 to 14
  
 
'''21-day cycles x up to 1 year'''
 
'''21-day cycles x up to 1 year'''
Line 101: Line 185:
 
==Capecitabine (Xeloda) & Erlotinib (Tarceva)==
 
==Capecitabine (Xeloda) & Erlotinib (Tarceva)==
 
===Regimen===
 
===Regimen===
−
*[[Capecitabine (Xeloda)]] 1000 mg/m2 (rounded to the nearest 150 mg tablet) PO BID on days 1-14
+
Level of Evidence:
−
*[[Erlotinib (Tarceva)]] 150 mg PO on days 1-21
+
<span
 +
style="background:#EEEE00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase II</span>
 +
 
 +
*[[Capecitabine (Xeloda)]] 1000 mg/m2 (rounded to the nearest 150 mg tablet) PO BID on days 1 to 14
 +
*[[Erlotinib (Tarceva)]] 150 mg PO on days 1 to 21
  
 
'''21-day cycles, given until progression of disease or unacceptable toxicity'''
 
'''21-day cycles, given until progression of disease or unacceptable toxicity'''
Line 108: Line 200:
 
===References===
 
===References===
 
# Kulke MH, Blaszkowsky LS, Ryan DP, Clark JW, Meyerhardt JA, Zhu AX, Enzinger PC, Kwak EL, Muzikansky A, Lawrence C, Fuchs CS. Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol. 2007 Oct 20;25(30):4787-92. [http://jco.ascopubs.org/content/25/30/4787.full link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17947726 PubMed]
 
# Kulke MH, Blaszkowsky LS, Ryan DP, Clark JW, Meyerhardt JA, Zhu AX, Enzinger PC, Kwak EL, Muzikansky A, Lawrence C, Fuchs CS. Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol. 2007 Oct 20;25(30):4787-92. [http://jco.ascopubs.org/content/25/30/4787.full link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17947726 PubMed]
 +
 +
==Fluorouracil (5-FU)==
 +
 +
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 +
''Inferior to gemcitabine. Here for reference purposes, only.''
 +
 +
===References===
 +
# Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. [http://jco.ascopubs.org/content/15/6/2403.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/9196156 PubMed]
  
 
==FOLFIRINOX==
 
==FOLFIRINOX==
 
FOLFIRINOX: '''<u>FOL</u>'''inic acid, '''<u>F</u>'''luorouracil, '''<u>IRIN</u>'''otecan, '''<u>OX</u>'''aliplatin
 
FOLFIRINOX: '''<u>FOL</u>'''inic acid, '''<u>F</u>'''luorouracil, '''<u>IRIN</u>'''otecan, '''<u>OX</u>'''aliplatin
 
===Regimen===
 
===Regimen===
−
*[[Fluorouracil (5-FU)]] 400 mg/m2 IV bolus, then 1200 mg/m2/day (total dose of 2400 mg/m2) IV continuous 46-hour infusion on days 1-2; given last
+
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
 +
*[[Fluorouracil (5-FU)]] 400 mg/m2 IV bolus, then 1200 mg/m2/day (total dose of 2400 mg/m2) IV continuous 46-hour infusion on days 1 to 2; given last
 
*[[Folinic acid (Leucovorin)]] 400 mg/m2 IV over 2 hours on day 1; given second
 
*[[Folinic acid (Leucovorin)]] 400 mg/m2 IV over 2 hours on day 1; given second
 
*[[Irinotecan (Camptosar)]] 180 mg/m2 IV over 90 minutes on day 1; given third together with the last 90 minutes of Folinic acid (Leucovorin); that is, irinotecan starts 30 minutes after the start of leucovorin
 
*[[Irinotecan (Camptosar)]] 180 mg/m2 IV over 90 minutes on day 1; given third together with the last 90 minutes of Folinic acid (Leucovorin); that is, irinotecan starts 30 minutes after the start of leucovorin
Line 123: Line 239:
  
 
==Gemcitabine (Gemzar)==
 
==Gemcitabine (Gemzar)==
−
===Regimen #1, Burris, et al. 1997; Moore, et al. 2007; Herrmann, et al. 2007; Poplin, et al. 2009; Cunningham, et al. 2009; Conroy, et al. 2011; Loehrer, et al. 2011===
+
===Regimen #1, Burris, et al. 1997; Moore, et al. 2007; Herrmann, et al. 2007; Poplin, et al. 2009 (E6201); Cunningham, et al. 2009; Conroy, et al. 2011; Loehrer, et al. 2011===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43
  
Line 133: Line 257:
  
 
===Regimen #2, Heinemann, et al. 2006===
 
===Regimen #2, Heinemann, et al. 2006===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
  
 
'''4-week cycles'''
 
'''4-week cycles'''
  
−
===Regimen #3, "Fixed-dose rate," Poplin, et al. 2009===
+
===Regimen #3, "Fixed-dose rate," Poplin, et al. 2009 (E6201)===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
 
*[[Gemcitabine (Gemzar)]] 1500 mg/m2 IV over 150 minutes (10 mg/m2/min) on days 1, 8, 15
 
*[[Gemcitabine (Gemzar)]] 1500 mg/m2 IV over 150 minutes (10 mg/m2/min) on days 1, 8, 15
  
Line 144: Line 284:
 
===References===
 
===References===
 
# Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. [http://jco.ascopubs.org/content/15/6/2403.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/9196156 PubMed]
 
# Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. [http://jco.ascopubs.org/content/15/6/2403.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/9196156 PubMed]
 +
# Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. [http://jco.ascopubs.org/content/23/15/3509.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15908661 PubMed]
 
# Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. [http://jco.ascopubs.org/content/24/24/3946.long link to original article] '''contains verified regimen''' [http://www.ncbi.nlm.nih.gov/pubmed/16921047 PubMed]
 
# Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. [http://jco.ascopubs.org/content/24/24/3946.long link to original article] '''contains verified regimen''' [http://www.ncbi.nlm.nih.gov/pubmed/16921047 PubMed]
 
# Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. Epub 2007 Apr 23. [http://jco.ascopubs.org/content/25/15/1960.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17452677 PubMed]
 
# Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. Epub 2007 Apr 23. [http://jco.ascopubs.org/content/25/15/1960.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17452677 PubMed]
 
# Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. [http://jco.ascopubs.org/content/25/16/2212.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17538165 PubMed]
 
# Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. [http://jco.ascopubs.org/content/25/16/2212.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17538165 PubMed]
 +
# Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. [http://jco.ascopubs.org/content/26/22/3695.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18669454 PubMed]
 
# Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. Epub 2009 Jul 6. [http://jco.ascopubs.org/content/27/23/3778.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19581537 PubMed]
 
# Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. Epub 2009 Jul 6. [http://jco.ascopubs.org/content/27/23/3778.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19581537 PubMed]
 
# Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. [http://jco.ascopubs.org/content/27/33/5513.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19858379 PubMed]
 
# Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. [http://jco.ascopubs.org/content/27/33/5513.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19858379 PubMed]
 
# Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. [http://www.nejm.org/doi/full/10.1056/NEJMoa1011923 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21561347 PubMed]
 
# Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. [http://www.nejm.org/doi/full/10.1056/NEJMoa1011923 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21561347 PubMed]
 
# Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. Epub 2011 Oct 3. [http://jco.ascopubs.org/content/29/31/4105.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21969502 PubMed]
 
# Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. Epub 2011 Oct 3. [http://jco.ascopubs.org/content/29/31/4105.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21969502 PubMed]
 +
# Daniel D. Von Hoff, Thomas J. Ervin, Francis P. Arena, E. Gabriela Chiorean, Jeffrey R. Infante, Malcolm J. Moore, Thomas E. Seay, Sergei Tjulandin, Wen Wee Ma, Mansoor N. Saleh, Marion Harris, Michele Reni, Ramesh K. Ramanathan, Josep Tabernero, Manuel Hidalgo, Eric Van Cutsem, David Goldstein, Xinyu Wei, Jose Luis Iglesias, Markus Frederic Renschler. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). 2013 ASCO Gastrointestinal Cancers Symposium abstract LBA148. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=133&abstractID=106143 link to abstract] [http://clinicaltrials.gov/show/NCT00844649 ClinicalTrials.gov NCT00844649]
  
−
==GemCap - Gemcitabine (Gemzar) & Capecitabine (Xeloda)==
+
==GemCap, GEM-CAP==
 
GemCap/GEM-CAP: '''<u>Gem</u>'''citabine, '''<u>Cap</u>'''ecitabine
 
GemCap/GEM-CAP: '''<u>Gem</u>'''citabine, '''<u>Cap</u>'''ecitabine
 
===Regimen #1, Cunningham, et al. 2009===
 
===Regimen #1, Cunningham, et al. 2009===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43
−
*[[Capecitabine (Xeloda)]] 830 mg/m2 PO BID on days 1-21, 29-49
+
*[[Capecitabine (Xeloda)]] 830 mg/m2 PO BID on days 1 to 21, 29 to 49
  
 
'''8-week course, THEN'''
 
'''8-week course, THEN'''
  
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
−
*[[Capecitabine (Xeloda)]] 830 mg/m2 PO BID on days 1-21
+
*[[Capecitabine (Xeloda)]] 830 mg/m2 PO BID on days 1 to 21
  
 
'''4-week cycles, given until progression of disease or unacceptable toxicity'''
 
'''4-week cycles, given until progression of disease or unacceptable toxicity'''
  
 
===Regimen #2, Herrmann, et al. 2007 & Bernhard, et al. 2008===
 
===Regimen #2, Herrmann, et al. 2007 & Bernhard, et al. 2008===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1 & 8
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1 & 8
−
*[[Capecitabine (Xeloda)]] 650 mg/m2 PO BID on days 1-14
+
*[[Capecitabine (Xeloda)]] 650 mg/m2 PO BID on days 1 to 14
  
 
'''21-day cycles x up to 24 weeks'''
 
'''21-day cycles x up to 24 weeks'''
Line 176: Line 335:
 
# Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. [http://jco.ascopubs.org/content/27/33/5513.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19858379 PubMed]
 
# Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. [http://jco.ascopubs.org/content/27/33/5513.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19858379 PubMed]
  
−
==Gemcitabine (Gemzar) & Cisplatin (Platinol)==
+
==Gemcitabine & Cisplatin==
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1 & 15
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1 & 15
 
*[[Cisplatin (Platinol)]] 50 mg/m2 IV over 1 hour on days 1 & 15
 
*[[Cisplatin (Platinol)]] 50 mg/m2 IV over 1 hour on days 1 & 15
Line 186: Line 353:
 
# Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. [http://jco.ascopubs.org/content/24/24/3946.long link to original article] '''contains verified regimen''' [http://www.ncbi.nlm.nih.gov/pubmed/16921047 PubMed]
 
# Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. [http://jco.ascopubs.org/content/24/24/3946.long link to original article] '''contains verified regimen''' [http://www.ncbi.nlm.nih.gov/pubmed/16921047 PubMed]
  
−
==Gemcitabine (Gemzar) & Erlotinib (Tarceva)==
+
==Gemcitabine & Erlotinib==
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43
−
*[[Erlotinib (Tarceva)]] 100 or 150 mg (100 mg dose recommended) PO daily throughout
+
*[[Erlotinib (Tarceva)]] 100 or 150 mg (100 mg dose recommended) PO once per day throughout
  
 
'''8-week course, THEN'''
 
'''8-week course, THEN'''
  
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes on days 1, 8, 15
−
*[[Erlotinib (Tarceva)]] 100 or 150 mg (100 mg dose recommended) PO daily throughout
+
*[[Erlotinib (Tarceva)]] 100 or 150 mg (100 mg dose recommended) PO once per day throughout
  
 
'''4-week cycles'''
 
'''4-week cycles'''
Line 201: Line 376:
 
# Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. Epub 2007 Apr 23. [http://jco.ascopubs.org/content/25/15/1960.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17452677 PubMed]
 
# Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. Epub 2007 Apr 23. [http://jco.ascopubs.org/content/25/15/1960.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17452677 PubMed]
  
−
==GemOx - Gemcitabine (Gemzar) & Oxaliplatin (Eloxatin)==
+
==GemOx==
 
GemOx: '''<u>Gem</u>'''citabine, '''<u>Ox</u>'''aliplatin
 
GemOx: '''<u>Gem</u>'''citabine, '''<u>Ox</u>'''aliplatin
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 100 minutes on day 1
 
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 100 minutes on day 1
 
*[[Oxaliplatin (Eloxatin)]] 100 mg/m2 IV over 2 hours on day 2
 
*[[Oxaliplatin (Eloxatin)]] 100 mg/m2 IV over 2 hours on day 2
Line 211: Line 394:
 
===References===
 
===References===
 
# Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. [http://jco.ascopubs.org/content/23/15/3509.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15908661 PubMed]
 
# Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. [http://jco.ascopubs.org/content/23/15/3509.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15908661 PubMed]
 +
# Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. Epub 2009 Jul 6. [http://jco.ascopubs.org/content/27/23/3778.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19581537 PubMed]
 +
 +
==Gemcitabine & nab-Paclitaxel==
 +
===Regimen #1, Von Hoff, et al. 2013 (MPACT)===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
  
−
==Gemcitabine (Gemzar) & nab-Paclitaxel==
+
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV once per day on days 1, 8, 15, given second
−
===Regimen #1, Von Hoff, et al. 2013 - MPACT===
+
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 125 mg/m2 IV once per day on days 1, 8, 15, given first
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV once daily on days 1, 8, 15, given second
 
−
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 125 mg/m2 IV once daily on days 1, 8, 15, given first
 
  
 
'''28-day cycles'''
 
'''28-day cycles'''
  
 
===Regimen #2, Von Hoff, et al. 2011===
 
===Regimen #2, Von Hoff, et al. 2011===
 +
Level of Evidence:
 +
<span
 +
style="background:#EEEE00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase II</span>
 +
 
''Note: The abstract and body of Von Hoff, et al. 2011 contradicted each other about which drug is given first in this regimen.''
 
''Note: The abstract and body of Von Hoff, et al. 2011 contradicted each other about which drug is given first in this regimen.''
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV once daily on days 1, 8, 15
+
*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV once per day on days 1, 8, 15
−
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 or 125 mg/m2 IV once daily on days 1, 8, 15
+
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 or 125 mg/m2 IV once per day on days 1, 8, 15
  
 
'''28-day cycles'''
 
'''28-day cycles'''
Line 230: Line 430:
 
# Daniel D. Von Hoff, Thomas J. Ervin, Francis P. Arena, E. Gabriela Chiorean, Jeffrey R. Infante, Malcolm J. Moore, Thomas E. Seay, Sergei Tjulandin, Wen Wee Ma, Mansoor N. Saleh, Marion Harris, Michele Reni, Ramesh K. Ramanathan, Josep Tabernero, Manuel Hidalgo, Eric Van Cutsem, David Goldstein, Xinyu Wei, Jose Luis Iglesias, Markus Frederic Renschler. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). 2013 ASCO Gastrointestinal Cancers Symposium abstract LBA148. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=133&abstractID=106143 link to abstract] [http://clinicaltrials.gov/show/NCT00844649 ClinicalTrials.gov NCT00844649]
 
# Daniel D. Von Hoff, Thomas J. Ervin, Francis P. Arena, E. Gabriela Chiorean, Jeffrey R. Infante, Malcolm J. Moore, Thomas E. Seay, Sergei Tjulandin, Wen Wee Ma, Mansoor N. Saleh, Marion Harris, Michele Reni, Ramesh K. Ramanathan, Josep Tabernero, Manuel Hidalgo, Eric Van Cutsem, David Goldstein, Xinyu Wei, Jose Luis Iglesias, Markus Frederic Renschler. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). 2013 ASCO Gastrointestinal Cancers Symposium abstract LBA148. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=133&abstractID=106143 link to abstract] [http://clinicaltrials.gov/show/NCT00844649 ClinicalTrials.gov NCT00844649]
  
−
==GTX - Gemcitabine (Gemzar), Docetaxel (Taxotere), Capecitabine (Xeloda)==
+
==GTX==
 
GTX: '''<u>G</u>'''emcitabine, '''<u>T</u>'''axotere, '''<u>X</u>'''eloda
 
GTX: '''<u>G</u>'''emcitabine, '''<u>T</u>'''axotere, '''<u>X</u>'''eloda
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#EEEE00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase II</span>
 +
 
''Note: De Jesus-Acosta, et al. 2012 lists the capecitabine dose as "750 mg/m2/day orally divided into two doses," but this is believed to be a typographical error since the original reference that it cites, Fine, et al. 2008, uses capecitabine at 750 mg/m2 PO BID.  The 2009 ASCO abstract by Fine also lists this 750 mg/m2 PO BID (1500 mg/m2/day) dose.''
 
''Note: De Jesus-Acosta, et al. 2012 lists the capecitabine dose as "750 mg/m2/day orally divided into two doses," but this is believed to be a typographical error since the original reference that it cites, Fine, et al. 2008, uses capecitabine at 750 mg/m2 PO BID.  The 2009 ASCO abstract by Fine also lists this 750 mg/m2 PO BID (1500 mg/m2/day) dose.''
 
*[[Gemcitabine (Gemzar)]] 750 mg/m2 IV over 75 minutes on days 4 & 11
 
*[[Gemcitabine (Gemzar)]] 750 mg/m2 IV over 75 minutes on days 4 & 11
 
*[[Docetaxel (Taxotere)]] 30 mg/m2 IV on days 4 & 11
 
*[[Docetaxel (Taxotere)]] 30 mg/m2 IV on days 4 & 11
−
*[[Capecitabine (Xeloda)]] 750 mg/m2 PO BID on days 1-14
+
*[[Capecitabine (Xeloda)]] 750 mg/m2 PO BID on days 1 to 14
  
 
'''21-day cycles, given until progression of disease or unacceptable toxicity'''
 
'''21-day cycles, given until progression of disease or unacceptable toxicity'''
Line 245: Line 453:
 
# De Jesus-Acosta A, Oliver GR, Blackford A, Kinsman K, Flores EI, Wilfong LS, Zheng L, Donehower RC, Cosgrove D, Laheru D, Le DT, Chung K, Diaz LA Jr. A multicenter analysis of GTX chemotherapy in patients with locally advanced and metastatic pancreatic adenocarcinoma. Cancer Chemother Pharmacol. 2012 Feb;69(2):415-24. Epub 2011 Jul 29. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3265723 link to original article] '''contains verified protocol'''--with error as noted above [http://www.ncbi.nlm.nih.gov/pubmed/21800112 PubMed]
 
# De Jesus-Acosta A, Oliver GR, Blackford A, Kinsman K, Flores EI, Wilfong LS, Zheng L, Donehower RC, Cosgrove D, Laheru D, Le DT, Chung K, Diaz LA Jr. A multicenter analysis of GTX chemotherapy in patients with locally advanced and metastatic pancreatic adenocarcinoma. Cancer Chemother Pharmacol. 2012 Feb;69(2):415-24. Epub 2011 Jul 29. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3265723 link to original article] '''contains verified protocol'''--with error as noted above [http://www.ncbi.nlm.nih.gov/pubmed/21800112 PubMed]
  
−
==OFF - Oxaliplatin (Eloxatin), Fluorouracil (5-FU), Folinic acid (Leucovorin)==
+
==OFF==
 
OFF: '''<u>O</u>'''xaliplatin, '''<u>F</u>'''luorouracil, '''<u>F</u>'''olinic acid  
 
OFF: '''<u>O</u>'''xaliplatin, '''<u>F</u>'''luorouracil, '''<u>F</u>'''olinic acid  
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#00CD00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase III</span>
 +
 
''Note: The treatment section of Pelzer, et al. 2011 incorrectly lists the oxaliplatin dose as "0.85 g/m2," or 850 mg/m2.''
 
''Note: The treatment section of Pelzer, et al. 2011 incorrectly lists the oxaliplatin dose as "0.85 g/m2," or 850 mg/m2.''
 
*[[Oxaliplatin (Eloxatin)]] 85 mg/m2 IV over 2-4 hours on days 8 & 22
 
*[[Oxaliplatin (Eloxatin)]] 85 mg/m2 IV over 2-4 hours on days 8 & 22
Line 261: Line 477:
 
==Paclitaxel, nanoparticle albumin-bound (Abraxane)==
 
==Paclitaxel, nanoparticle albumin-bound (Abraxane)==
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#EEEE00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase II</span>
 +
 
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m2 IV over 30 minutes on days 1, 8, 15
 
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m2 IV over 30 minutes on days 1, 8, 15
  
Line 268: Line 492:
 
# Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A Phase II Trial of nab-Paclitaxel as Second-line Therapy in Patients With Advanced Pancreatic Cancer. Am J Clin Oncol. 2012 Feb 2. [Epub ahead of print] [http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=9000&issue=00000&article=99592&type=abstract link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22307213 PubMed]
 
# Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A Phase II Trial of nab-Paclitaxel as Second-line Therapy in Patients With Advanced Pancreatic Cancer. Am J Clin Oncol. 2012 Feb 2. [Epub ahead of print] [http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=9000&issue=00000&article=99592&type=abstract link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22307213 PubMed]
  
−
==XELOX (CapeOx) - Capecitabine (Xeloda) & Oxaliplatin (Eloxatin)==
+
==XELOX, CapeOx==
 
XELOX: '''<u>XEL</u>'''oda, '''<u>OX</u>'''aliplatin
 
XELOX: '''<u>XEL</u>'''oda, '''<u>OX</u>'''aliplatin
 
CapeOX: '''<u>Cape</u>'''citabine, '''<u>OX</u>'''aliplatin
 
CapeOX: '''<u>Cape</u>'''citabine, '''<u>OX</u>'''aliplatin
 
===Regimen===
 
===Regimen===
 +
Level of Evidence:
 +
<span
 +
style="background:#EEEE00;
 +
padding:3px 6px 3px 6px;
 +
border-color:black;
 +
border-width:2px;
 +
border-style:solid;">Phase II</span>
 +
 
If age <65 years old and [[Performance status|ECOG performance status]] <2:
 
If age <65 years old and [[Performance status|ECOG performance status]] <2:
−
*[[Capecitabine (Xeloda)]] 1000 mg/m2 PO BID on days 1-14
+
*[[Capecitabine (Xeloda)]] 1000 mg/m2 PO BID on days 1 to 14
 
*[[Oxaliplatin (Eloxatin)]] 130 mg/m2 IV over 2 hours on day 1
 
*[[Oxaliplatin (Eloxatin)]] 130 mg/m2 IV over 2 hours on day 1
  
 
If age >65 years old and/or [[Performance status|ECOG performance status]] =2:
 
If age >65 years old and/or [[Performance status|ECOG performance status]] =2:
−
*[[Capecitabine (Xeloda)]] 750 mg/m2 PO BID on days 1-14
+
*[[Capecitabine (Xeloda)]] 750 mg/m2 PO BID on days 1 to 14
 
*[[Oxaliplatin (Eloxatin)]] 110 mg/m2 IV over 2 hours on day 1
 
*[[Oxaliplatin (Eloxatin)]] 110 mg/m2 IV over 2 hours on day 1
  

Revision as of 23:12, 13 July 2013

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Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.


Adjuvant chemotherapy

Fluorouracil (5-FU) & Folinic acid (Leucovorin)

Regimen

Level of Evidence: Phase III

28-day cycles x 6 cycles

References

  1. Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Büchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. link to original article contains verified protocol PubMed
  2. Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. link to original article contains verified protocol PubMed

Gemcitabine (Gemzar)

Regimen

Level of Evidence: Phase III

28-day cycles x 6 cycles, starting day 10 to 42 after surgery or after wound is healed

References

  1. Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007 Jan 17;297(3):267-77. link to original article contains verified protocol PubMed
  2. P. Neuhaus, H. Riess, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zuelke, J. Fahlke, J. Langrehr, H. Oettle. CONKO-001: Final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). 2008 ASCO Annual Meeting abstract LBA4504. link to abstract
  3. Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. link to original article contains verified protocol PubMed

Placebo (Observation)

Regimen

Level of Evidence: Phase III

No treatment. Placed here because one or more randomized clinical trials included a placebo arm in this disease context.

References

  1. Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007 Jan 17;297(3):267-77. link to original article contains verified protocol PubMed
  2. P. Neuhaus, H. Riess, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zuelke, J. Fahlke, J. Langrehr, H. Oettle. CONKO-001: Final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). 2008 ASCO Annual Meeting abstract LBA4504. link to abstract

Adjuvant chemoradiation

Fluorouracil (5-FU) & RT

Regimen

Level of Evidence: Phase III

Prior to chemoradiation:

21-day course

Chemoradiation:

  • Fluorouracil (5-FU) 250 mg/m2/day IV continuous infusion throughout radiation therapy
  • Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.

6-week course, to start 1 to 2 weeks after chemotherapy

After chemoradiation:

6-week cycles x 2 cycles, to start 3-5 weeks after completion of chemoradiation

References

  1. Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Büchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. link to original article contains verified protocol PubMed
  2. Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. link to original article contains verified protocol PubMed

Gemcitabine (Gemzar) & RT

Regimen

Level of Evidence: Phase III

Chemoradiation:
Note: Loehrer, et al. 2011's abstract and body are inconsistent about whether the number of gemcitabine doses during radiation therapy is 5 or 6. In the abstract, gemcitabine is listed as being used from weeks 1 to 5, but then later gemcitabine is listed as being given weekly during radiation, which would be 6 weeks since radiation lasts 5.5 weeks. The 2008 ASCO abstract also specifies 6 doses of gemcitabine, so this is what is listed below.

  • Gemcitabine (Gemzar) 600 mg/m2 IV over 30 to 60 minutes on days 1, 8, 15, 22, 29, 36
  • Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.

6-week course, THEN

Chemotherapy:

28-day cycles x 5 cycles, to start 4 weeks after finishing chemoradiation

References

  1. P. J. Loehrer, M. E. Powell, H. R. Cardenes, L. Wagner, J. M. Brell, R. K. Ramanathan, C. H. Crane, S. R. Alberts, A. B. Benson. A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. 2008 ASCO Annual Meeting abstract 4506. link to abstract
  2. Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. Epub 2011 Oct 3. link to original article contains verified protocol--see note above PubMed

Gemcitabine (Gemzar), Fluorouracil (5-FU), RT

Regimen

Level of Evidence: Phase III

Prior to chemoradiation:

21-day course

Chemoradiation:

  • Fluorouracil (5-FU) 250 mg/m2/day IV continuous infusion throughout radiation therapy
  • Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.

6-week course, to start 1 to 2 weeks after chemotherapy

After chemoradiation:

28-day cycles x 3 cycles, to start 3-5 weeks after completion of chemoradiation

References

  1. Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. link to original article contains verified protocol PubMed

Metastatic disease

Best supportive care

Regimen

Level of Evidence: Phase III

Best supportive care. Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.

References

  1. Pelzer U, Schwaner I, Stieler J, Adler M, Seraphin J, Dörken B, Riess H, Oettle H. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011 Jul;47(11):1676-81. Epub 2011 May 10. link to original article contains verified protocol--with error as noted above PubMed

Capecitabine (Xeloda)

Regimen

Level of Evidence: Phase II

21-day cycles x up to 1 year

References

  1. Cartwright TH, Cohn A, Varkey JA, Chen YM, Szatrowski TP, Cox JV, Schulz JJ. Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer. J Clin Oncol. 2002 Jan 1;20(1):160-4. link to original article contains verified protocol PubMed

Capecitabine (Xeloda) & Erlotinib (Tarceva)

Regimen

Level of Evidence: Phase II

21-day cycles, given until progression of disease or unacceptable toxicity

References

  1. Kulke MH, Blaszkowsky LS, Ryan DP, Clark JW, Meyerhardt JA, Zhu AX, Enzinger PC, Kwak EL, Muzikansky A, Lawrence C, Fuchs CS. Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol. 2007 Oct 20;25(30):4787-92. link to original article contains verified protocol PubMed

Fluorouracil (5-FU)

Regimen

Level of Evidence: Phase III

Inferior to gemcitabine. Here for reference purposes, only.

References

  1. Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. link to original article contains verified protocol PubMed

FOLFIRINOX

FOLFIRINOX: FOLinic acid, Fluorouracil, IRINotecan, OXaliplatin

Regimen

Level of Evidence: Phase III

  • Fluorouracil (5-FU) 400 mg/m2 IV bolus, then 1200 mg/m2/day (total dose of 2400 mg/m2) IV continuous 46-hour infusion on days 1 to 2; given last
  • Folinic acid (Leucovorin) 400 mg/m2 IV over 2 hours on day 1; given second
  • Irinotecan (Camptosar) 180 mg/m2 IV over 90 minutes on day 1; given third together with the last 90 minutes of Folinic acid (Leucovorin); that is, irinotecan starts 30 minutes after the start of leucovorin
  • Oxaliplatin (Eloxatin) 85 mg/m2 IV over 2 hours, given first

14-day cycles

References

  1. Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. link to original article contains verified protocol PubMed

Gemcitabine (Gemzar)

Regimen #1, Burris, et al. 1997; Moore, et al. 2007; Herrmann, et al. 2007; Poplin, et al. 2009 (E6201); Cunningham, et al. 2009; Conroy, et al. 2011; Loehrer, et al. 2011

Level of Evidence: Phase III

8-week course, THEN

  • Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes on days 1, 8, 15; in Burris, et al. 1997, patients with grade 2 or lower toxicities could have had doses increased to 1250 mg/m2

4-week cycles

Regimen #2, Heinemann, et al. 2006

Level of Evidence: Phase III

4-week cycles

Regimen #3, "Fixed-dose rate," Poplin, et al. 2009 (E6201)

Level of Evidence: Phase III

28-day cycles

References

  1. Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. link to original article contains verified protocol PubMed
  2. Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. link to original article contains verified protocol PubMed
  3. Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. link to original article contains verified regimen PubMed
  4. Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. Epub 2007 Apr 23. link to original article contains verified protocol PubMed
  5. Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. link to original article contains verified protocol PubMed
  6. Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. link to original article contains verified protocol PubMed
  7. Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. Epub 2009 Jul 6. link to original article contains verified protocol PubMed
  8. Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. link to original article contains verified protocol PubMed
  9. Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. link to original article contains verified protocol PubMed
  10. Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. Epub 2011 Oct 3. link to original article contains verified protocol PubMed
  11. Daniel D. Von Hoff, Thomas J. Ervin, Francis P. Arena, E. Gabriela Chiorean, Jeffrey R. Infante, Malcolm J. Moore, Thomas E. Seay, Sergei Tjulandin, Wen Wee Ma, Mansoor N. Saleh, Marion Harris, Michele Reni, Ramesh K. Ramanathan, Josep Tabernero, Manuel Hidalgo, Eric Van Cutsem, David Goldstein, Xinyu Wei, Jose Luis Iglesias, Markus Frederic Renschler. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). 2013 ASCO Gastrointestinal Cancers Symposium abstract LBA148. link to abstract ClinicalTrials.gov NCT00844649

GemCap, GEM-CAP

GemCap/GEM-CAP: Gemcitabine, Capecitabine

Regimen #1, Cunningham, et al. 2009

Level of Evidence: Phase III

8-week course, THEN

4-week cycles, given until progression of disease or unacceptable toxicity

Regimen #2, Herrmann, et al. 2007 & Bernhard, et al. 2008

Level of Evidence: Phase III

21-day cycles x up to 24 weeks

References

  1. Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. link to original article contains verified protocol PubMed
  2. Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. link to original article contains verified protocol PubMed
  3. Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. link to original article contains verified protocol PubMed

Gemcitabine & Cisplatin

Regimen

Level of Evidence: Phase III

28-day cycles

References

  1. Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. link to original article contains verified regimen PubMed

Gemcitabine & Erlotinib

Regimen

Level of Evidence: Phase III

8-week course, THEN

4-week cycles

References

  1. Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. Epub 2007 Apr 23. link to original article contains verified protocol PubMed

GemOx

GemOx: Gemcitabine, Oxaliplatin

Regimen

Level of Evidence: Phase III

14-day cycles

References

  1. Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. link to original article contains verified protocol PubMed
  2. Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. Epub 2009 Jul 6. link to original article contains verified protocol PubMed

Gemcitabine & nab-Paclitaxel

Regimen #1, Von Hoff, et al. 2013 (MPACT)

Level of Evidence: Phase III

28-day cycles

Regimen #2, Von Hoff, et al. 2011

Level of Evidence: Phase II

Note: The abstract and body of Von Hoff, et al. 2011 contradicted each other about which drug is given first in this regimen.

28-day cycles

References

  1. Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. Epub 2011 Oct 3. link to original article contains verified protocol
  2. Daniel D. Von Hoff, Thomas J. Ervin, Francis P. Arena, E. Gabriela Chiorean, Jeffrey R. Infante, Malcolm J. Moore, Thomas E. Seay, Sergei Tjulandin, Wen Wee Ma, Mansoor N. Saleh, Marion Harris, Michele Reni, Ramesh K. Ramanathan, Josep Tabernero, Manuel Hidalgo, Eric Van Cutsem, David Goldstein, Xinyu Wei, Jose Luis Iglesias, Markus Frederic Renschler. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). 2013 ASCO Gastrointestinal Cancers Symposium abstract LBA148. link to abstract ClinicalTrials.gov NCT00844649

GTX

GTX: Gemcitabine, Taxotere, Xeloda

Regimen

Level of Evidence: Phase II

Note: De Jesus-Acosta, et al. 2012 lists the capecitabine dose as "750 mg/m2/day orally divided into two doses," but this is believed to be a typographical error since the original reference that it cites, Fine, et al. 2008, uses capecitabine at 750 mg/m2 PO BID. The 2009 ASCO abstract by Fine also lists this 750 mg/m2 PO BID (1500 mg/m2/day) dose.

21-day cycles, given until progression of disease or unacceptable toxicity

References

  1. Fine RL, Fogelman DR, Schreibman SM, Desai M, Sherman W, Strauss J, Guba S, Andrade R, Chabot J. The gemcitabine, docetaxel, and capecitabine (GTX) regimen for metastatic pancreatic cancer: a retrospective analysis. Cancer Chemother Pharmacol. 2008 Jan;61(1):167-75. Epub 2007 Apr 18. link to original article contains protocol PubMed
  2. R. L. Fine, G. Moorer, W. Sherman, K. Chu, M. Maurer, J. Chabot, I. Postolov, J. Prowda, S. Schreibman, J. Levitz. Phase II trial of GTX chemotherapy in metastatic pancreatic cancer. 2009 ASCO Annual Meeting abstract 4623. link to abstract
  3. De Jesus-Acosta A, Oliver GR, Blackford A, Kinsman K, Flores EI, Wilfong LS, Zheng L, Donehower RC, Cosgrove D, Laheru D, Le DT, Chung K, Diaz LA Jr. A multicenter analysis of GTX chemotherapy in patients with locally advanced and metastatic pancreatic adenocarcinoma. Cancer Chemother Pharmacol. 2012 Feb;69(2):415-24. Epub 2011 Jul 29. link to original article contains verified protocol--with error as noted above PubMed

OFF

OFF: Oxaliplatin, Fluorouracil, Folinic acid

Regimen

Level of Evidence: Phase III

Note: The treatment section of Pelzer, et al. 2011 incorrectly lists the oxaliplatin dose as "0.85 g/m2," or 850 mg/m2.

42-day cycles

References

  1. U. Pelzer, K. Kubica, J. Stieler, I. Schwaner, G. Heil, M. Görner, M. Mölle, A. Hilbig, B. Dörken, H. Riess, H. Oettle. A randomized trial in patients with gemcitabine refractory pancreatic cancer. Final results of the CONKO 003 study. 2008 ASCO Annual Meeting abstract 4508. link to abstract
  2. Pelzer U, Schwaner I, Stieler J, Adler M, Seraphin J, Dörken B, Riess H, Oettle H. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011 Jul;47(11):1676-81. Epub 2011 May 10. link to original article contains verified protocol--with error as noted above PubMed

Paclitaxel, nanoparticle albumin-bound (Abraxane)

Regimen

Level of Evidence: Phase II

28-day cycles

References

  1. Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A Phase II Trial of nab-Paclitaxel as Second-line Therapy in Patients With Advanced Pancreatic Cancer. Am J Clin Oncol. 2012 Feb 2. [Epub ahead of print] link to original article contains protocol PubMed

XELOX, CapeOx

XELOX: XELoda, OXaliplatin CapeOX: Capecitabine, OXaliplatin

Regimen

Level of Evidence: Phase II

If age <65 years old and ECOG performance status <2:

If age >65 years old and/or ECOG performance status =2:

21-day cycles

References

  1. Xiong HQ, Varadhachary GR, Blais JC, Hess KR, Abbruzzese JL, Wolff RA. Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second-line therapy for patients with advanced pancreatic cancer. Cancer. 2008 Oct 15;113(8):2046-52. link to original article contains verified protocol PubMed
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