Difference between revisions of "Pancreatic cancer - null regimens"
Jump to navigation
Jump to search
Warner-admin (talk | contribs) m (Text replacement - "https://insights.ovid.com/pubmed?pmid=17968163" to "https://doi.org/10.1097/SLA.0b013e318156eef3") |
m |
||
(19 intermediate revisions by 2 users not shown) | |||
Line 3: | Line 3: | ||
[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
− | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Pancreatic cancer|main pancreatic cancer page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
Line 9: | Line 9: | ||
=Neoadjuvant therapy= | =Neoadjuvant therapy= | ||
==No neoadjuvant therapy== | ==No neoadjuvant therapy== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 22: | Line 21: | ||
|2009-2018 | |2009-2018 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#GemOx_999|GemOx]] |
| style="background-color:#d3d3d3" |No results | | style="background-color:#d3d3d3" |No results | ||
|- | |- | ||
Line 34: | Line 33: | ||
''<sup>1</sup>Reported efficacy is based on the 2022 update.''<br> | ''<sup>1</sup>Reported efficacy is based on the 2022 update.''<br> | ||
''No treatment prior to surgery.'' | ''No treatment prior to surgery.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
*[[Surgery#Pancreatic_cancer_surgery|Surgery]] | *[[Surgery#Pancreatic_cancer_surgery|Surgery]] | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | #'''PREOPANC:''' Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. Epub 2020 Feb 27. [https://doi.org/10.1200/jco.19.02274 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32105518 PubMed] EudraCT 2012-003181-40 | + | #'''PREOPANC:''' Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. Epub 2020 Feb 27. [https://doi.org/10.1200/jco.19.02274 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32105518/ PubMed] EudraCT 2012-003181-40 |
##'''Update:''' Versteijne E, van Dam JL, Suker M, Janssen QP, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Tienhoven G, van Eijck CHJ; Dutch Pancreatic Cancer Group. Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. J Clin Oncol. 2022 Apr 10;40(11):1220-1230. Epub 2022 Jan 27. [https://doi.org/10.1200/jco.21.02233 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35084987/ PubMed] | ##'''Update:''' Versteijne E, van Dam JL, Suker M, Janssen QP, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Tienhoven G, van Eijck CHJ; Dutch Pancreatic Cancer Group. Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. J Clin Oncol. 2022 Apr 10;40(11):1220-1230. Epub 2022 Jan 27. [https://doi.org/10.1200/jco.21.02233 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35084987/ PubMed] | ||
− | #'''NEOPAC:''' NCT01314027 | + | #'''NEOPAC:''' [https://clinicaltrials.gov/study/NCT01314027 NCT01314027] |
=Adjuvant therapy= | =Adjuvant therapy= | ||
==Observation== | ==Observation== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 58: | Line 57: | ||
|1987-1995 | |1987-1995 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[#Fluorouracil_. | + | |[[#Fluorouracil_.26_RT_999|5-FU & RT]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS24 | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS24 | ||
|- | |- | ||
Line 67: | Line 66: | ||
| style="background-color:#d73027" |Inferior OS | | style="background-color:#d73027" |Inferior OS | ||
|- | |- | ||
− | |2. [[Pancreatic_cancer# | + | |2. [[Pancreatic_cancer#Fluorouracil_.26_RT|5-FU & RT]]<br> 3. [[#Fluorouracil_.26_RT_999|5-FU & RT]], then [[Pancreatic_cancer#FULV|FULV]] |
| style="background-color:#91cf60" |Seems to have superior OS | | style="background-color:#91cf60" |Seems to have superior OS | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1001/jama.297.3.267 Oettle et al. 2007 (CONKO-001)] |
|1998-2004 | |1998-2004 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
Line 84: | Line 83: | ||
|} | |} | ||
''No active antineoplastic treatment. Reported efficacy for ESPAC-1 is based on the 2004 update and efficacy for CONKO-001 is based on 2013 update.'' | ''No active antineoplastic treatment. Reported efficacy for ESPAC-1 is based on the 2004 update and efficacy for CONKO-001 is based on 2013 update.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*[[Surgery#Pancreatic_cancer_surgery|Surgery]] | *[[Surgery#Pancreatic_cancer_surgery|Surgery]] | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | #'''EORTC 40891:''' Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82. [https://doi.org/10.1097/00000658-199912000-00006 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1420941/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/10615932 PubMed] | + | #'''EORTC 40891:''' Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82. [https://doi.org/10.1097/00000658-199912000-00006 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1420941/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/10615932/ PubMed] |
− | ##'''Update:''' Smeenk HG, van Eijck CH, Hop WC, Erdmann J, Tran KC, Debois M, van Cutsem E, van Dekken H, Klinkenbijl JH, Jeekel J. Long-term survival and metastatic pattern of pancreatic and periampullary cancer after adjuvant chemoradiation or observation: long-term results of EORTC trial 40891. Ann Surg. 2007 Nov;246(5):734-40. [https://doi.org/10.1097/SLA.0b013e318156eef3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17968163 PubMed] | + | ##'''Update:''' Smeenk HG, van Eijck CH, Hop WC, Erdmann J, Tran KC, Debois M, van Cutsem E, van Dekken H, Klinkenbijl JH, Jeekel J. Long-term survival and metastatic pattern of pancreatic and periampullary cancer after adjuvant chemoradiation or observation: long-term results of EORTC trial 40891. Ann Surg. 2007 Nov;246(5):734-40. [https://doi.org/10.1097/SLA.0b013e318156eef3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17968163/ PubMed] |
− | #'''ESPAC-1:''' Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet. 2001 Nov 10;358(9293):1576-85. [https://doi.org/10.1016/S0140-6736(01)06651-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/11716884 PubMed] | + | #'''ESPAC-1:''' Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet. 2001 Nov 10;358(9293):1576-85. [https://doi.org/10.1016/S0140-6736(01)06651-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/11716884/ PubMed] |
− | ##'''Update:''' 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. [https://doi.org/10.1056/NEJMoa032295 link to original article] | + | ##'''Update:''' 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. [https://doi.org/10.1056/NEJMoa032295 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15028824/ PubMed] |
− | #'''CONKO-001:''' 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. [ | + | #'''CONKO-001:''' 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. [https://doi.org/10.1001/jama.297.3.267 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17227978/ PubMed] ISRCTN34802808 |
− | ##'''Update:''' Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zülke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. [ | + | ##'''Update:''' Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zülke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. [https://doi.org/10.1001/jama.2013.279201 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24104372/ PubMed] |
− | #'''JSAP-02:''' Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer. 2009 Sep 15;101(6):908-15. Epub 2009 Aug 18. [https://doi.org/10.1038/sj.bjc.6605256 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2743365/ link to original article] | + | #'''JSAP-02:''' Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer. 2009 Sep 15;101(6):908-15. Epub 2009 Aug 18. [https://doi.org/10.1038/sj.bjc.6605256 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2743365/ link to original article] [https://pubmed.ncbi.nlm.nih.gov/19690548/ PubMed] |
=Metastatic disease, refractory= | =Metastatic disease, refractory= | ||
==Best supportive care== | ==Best supportive care== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 113: | Line 112: | ||
|2001-2002 | |2001-2002 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#G17DT_monotherapy_999|G17DT]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
|[https://doi.org/10.1016/j.ejca.2011.04.011 Pelzer et al. 2011 (CONKO-003)] | |[https://doi.org/10.1016/j.ejca.2011.04.011 Pelzer et al. 2011 (CONKO-003)] | ||
− | |2002-2003 | + | |2002-12 to 2003-12 |
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[Pancreatic_cancer#OLF|OFF]] | |[[Pancreatic_cancer#OLF|OFF]] | ||
Line 125: | Line 124: | ||
|2004-2006 | |2004-2006 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#Glufosfamide_monotherapy_999|Glufosfamide]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
Line 131: | Line 130: | ||
''Best supportive care. Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.'' | ''Best supportive care. Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.'' | ||
+ | </div> | ||
===References=== | ===References=== | ||
− | #'''PC6:''' Gilliam AD, Broome P, Topuzov EG, Garin AM, Pulay I, Humphreys J, Whitehead A, Takhar A, Rowlands BJ, Beckingham IJ. An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas. 2012 Apr;41(3):374-9. [https://doi.org/10.1097/mpa.0b013e31822ade7e link to original article] [https://pubmed.ncbi.nlm.nih.gov/22228104/ PubMed] NCT02118077 | + | #'''PC6:''' Gilliam AD, Broome P, Topuzov EG, Garin AM, Pulay I, Humphreys J, Whitehead A, Takhar A, Rowlands BJ, Beckingham IJ. An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas. 2012 Apr;41(3):374-9. [https://doi.org/10.1097/mpa.0b013e31822ade7e link to original article] [https://pubmed.ncbi.nlm.nih.gov/22228104/ PubMed] [https://clinicaltrials.gov/study/NCT02118077 NCT02118077] |
− | #'''TH-CR-302:''' Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, Tidmarsh GT. A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer. 2009 Jun;45(9):1589-96. Epub 2009 Jan 31. [https://doi.org/10.1016/j.ejca.2008.12.022 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19188061 PubMed] NCT00099294 | + | #'''TH-CR-302:''' Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, Tidmarsh GT. A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer. 2009 Jun;45(9):1589-96. Epub 2009 Jan 31. [https://doi.org/10.1016/j.ejca.2008.12.022 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19188061/ PubMed] [https://clinicaltrials.gov/study/NCT00099294 NCT00099294] |
− | #'''CONKO-003:''' 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. [https://doi.org/10.1016/j.ejca.2011.04.011 link to original article] | + | #'''CONKO-003:''' 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. [https://doi.org/10.1016/j.ejca.2011.04.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21565490/ PubMed] [https://clinicaltrials.gov/study/NCT00786058 NCT00786058] |
[[Category:Pancreatic cancer regimens]] | [[Category:Pancreatic cancer regimens]] |
Latest revision as of 00:10, 30 June 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main pancreatic cancer page for regimens that include active anticancer treatment.
Neoadjuvant therapy
No neoadjuvant therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Terminated for low accrual (NEOPAC) | 2009-2018 | Phase 3 (C) | GemOx | No results |
Versteijne et al. 2020 (PREOPANC) | 2013-2017 | Phase 3 (C) | Gemcitabine & RT | Seems to have inferior OS1 |
1Reported efficacy is based on the 2022 update.
No treatment prior to surgery.
Subsequent treatment
References
- PREOPANC: Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. Epub 2020 Feb 27. link to original article PubMed EudraCT 2012-003181-40
- Update: Versteijne E, van Dam JL, Suker M, Janssen QP, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Tienhoven G, van Eijck CHJ; Dutch Pancreatic Cancer Group. Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. J Clin Oncol. 2022 Apr 10;40(11):1220-1230. Epub 2022 Jan 27. link to original article PubMed
- NEOPAC: NCT01314027
Adjuvant therapy
Observation
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Klinkenbijl et al. 1999 (EORTC 40891) | 1987-1995 | Phase 3 (C) | 5-FU & RT | Did not meet primary endpoint of OS24 |
Neoptolemos et al. 2001 (ESPAC-1) | 1994-2000 | Phase 3 (C) | 1. FULV | Inferior OS |
2. 5-FU & RT 3. 5-FU & RT, then FULV |
Seems to have superior OS | |||
Oettle et al. 2007 (CONKO-001) | 1998-2004 | Phase 3 (C) | Gemcitabine | Seems to have inferior OS |
Ueno et al. 2009 (JSAP-02) | 2002-2005 | Phase 3 (C) | Gemcitabine | Inferior DFS |
No active antineoplastic treatment. Reported efficacy for ESPAC-1 is based on the 2004 update and efficacy for CONKO-001 is based on 2013 update.
Preceding treatment
References
- EORTC 40891: Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82. link to original article link to PMC article PubMed
- Update: Smeenk HG, van Eijck CH, Hop WC, Erdmann J, Tran KC, Debois M, van Cutsem E, van Dekken H, Klinkenbijl JH, Jeekel J. Long-term survival and metastatic pattern of pancreatic and periampullary cancer after adjuvant chemoradiation or observation: long-term results of EORTC trial 40891. Ann Surg. 2007 Nov;246(5):734-40. link to original article PubMed
- ESPAC-1: Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet. 2001 Nov 10;358(9293):1576-85. link to original article PubMed
- Update: 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 PubMed
- CONKO-001: 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 PubMed ISRCTN34802808
- Update: Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zülke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. link to original article PubMed
- JSAP-02: Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer. 2009 Sep 15;101(6):908-15. Epub 2009 Aug 18. link to original article link to original article PubMed
Metastatic disease, refractory
Best supportive care
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gilliam et al. 2012 (PC6) | 2001-2002 | Phase 3 (C) | G17DT | Did not meet primary endpoint of OS |
Pelzer et al. 2011 (CONKO-003) | 2002-12 to 2003-12 | Phase 3 (C) | OFF | Inferior OS |
Ciuleanu et al. 2009 (TH-CR-302) | 2004-2006 | Phase 3 (C) | Glufosfamide | Did not meet primary endpoint of OS |
Best supportive care. Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.
References
- PC6: Gilliam AD, Broome P, Topuzov EG, Garin AM, Pulay I, Humphreys J, Whitehead A, Takhar A, Rowlands BJ, Beckingham IJ. An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas. 2012 Apr;41(3):374-9. link to original article PubMed NCT02118077
- TH-CR-302: Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, Tidmarsh GT. A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer. 2009 Jun;45(9):1589-96. Epub 2009 Jan 31. link to original article PubMed NCT00099294
- CONKO-003: 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 PubMed NCT00786058