Difference between revisions of "Gallbladder cancer"

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(Migrating appropriate regimens from cholangiocarcinoma page for metastatic disease and adding information on subset of patients with primary GBC. (Still more regimens to go through, just saving my progress).)
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| style="background-color:#F0F0F0; width:15%" |[[File:Seifter.jpg|frameless|upright=0.3|center]]
 
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|-
 
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| rowspan="2" |[https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 Sharma et al. 2010]
 
| rowspan="2" |[https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 Sharma et al. 2010]
−
| rowspan="2" style="background-color:#1a9851" |Randomized (C)
+
| style="background-color:#1a9851" rowspan="2" |Randomized (C)
 
|1. FUFA
 
|1. FUFA
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
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|-
 
|-
 
|}
 
|}
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''3 of 37 patients (8%) had primary gallbladder cancer.''
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====Chemotherapy====
 
====Chemotherapy====
  
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#'''Retrospective:''' Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15274071 PubMed]
 
#'''Retrospective:''' Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15274071 PubMed]
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 +
==Capecitabine & Mitomycin {{#subobject:6a9270|Regimen=1}}==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[Cholangiocarcinoma#top|back to top]]
 +
|}
 +
===Regimen {{#subobject:a46bbd|Variant=1}}===
 +
{| class="wikitable" style="width: 100%; text-align:center;"
 +
! style="width: 25%" |Study
 +
! style="width: 25%" |[[Levels of Evidence#Evidence|Evidence]]
 +
! style="width: 25%" |Comparator
 +
! style="width: 25%" |[[Levels of Evidence#Efficacy|Efficacy]]
 +
|-
 +
|[http://annonc.oxfordjournals.org/content/15/3/478.long Kornek et al. 2004]
 +
| style="background-color:#1a9851" |Randomized Phase II (E-switch-ic)
 +
|[[Cholangiocarcinoma#Gemcitabine .26 Mitomycin|Gemcitabine & Mitomycin]]
 +
| style="background-color:#d9ef8b" |Might have superior ORR
 +
|-
 +
|}
 +
''14 of 51 enrolled patients (27%) had primary gallbladder cancer.''
 +
 +
====Chemotherapy====
 +
 +
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup><font size="2">2</font></sup> PO twice per day on days 1 to 14
 +
*[[Mitomycin (Mutamycin)]] 8 mg/m<sup><font size="2">2</font></sup> IV bolus once on day 1
 +
 +
====Supportive medications====
 +
 +
*[[Dexamethasone (Decadron)]] and [[:Category:Serotonin 5-HT3 antagonists|5-HT3 antagonists]] on the day of IV chemotherapy
 +
 +
'''28-day cycles'''
 +
===References===
 +
 +
#Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. [http://annonc.oxfordjournals.org/content/15/3/478.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14998852 PubMed]
  
 
==CapeOx {{#subobject:cf9acc|Regimen=1}}==
 
==CapeOx {{#subobject:cf9acc|Regimen=1}}==
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! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://academic.oup.com/annonc/article/30/5/788/5345557 Kim et al. 2019 (SMC 2011-05-070)]
+
|[https://academic.oup.com/annonc/article/30/5/788/5345557 ''Kim et al. 2019 (SMC 2011-05-070)'']
−
| style="background-color:#1a9851" |Phase III (E-switch-ic)
+
| style="background-color:#1a9851" |''Phase III (E-switch-ic)''
−
|[[#GemOx_2|GEMOX]]
+
|[[#GemOx_2|''GEMOX'']]
−
| style="background-color:#eeee01" |Non-inferior PFS
+
| style="background-color:#eeee01" |''Non-inferior PFS''
 
|-
 
|-
 
|}
 
|}
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''61 of 222 enrolled patients (22%) had primary gallbladder cancer.''
 +
 
====Chemotherapy====
 
====Chemotherapy====
  
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#'''SMC 2011-05-070:''' Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. [https://academic.oup.com/annonc/article/30/5/788/5345557 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30785198 PubMed]
 
#'''SMC 2011-05-070:''' Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. [https://academic.oup.com/annonc/article/30/5/788/5345557 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30785198 PubMed]
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==Cisplatin & Gemcitabine {{#subobject:af0357|Regimen=1}}==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[Cholangiocarcinoma#top|back to top]]
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|}GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin
 +
===Regimen {{#subobject:cb3c9d|Variant=1}}===
 +
{| class="wikitable" style="width: 100%; text-align:center;"
 +
! style="width: 20%" |Study
 +
! style="width: 20%" |[[Levels of Evidence#Evidence|Evidence]]
 +
! style="width: 20%" |Comparator
 +
! style="width: 20%" |[[Levels of Evidence#Comparative efficacy|Comparative Efficacy]]
 +
! style="width: 20%" |Years of study
 +
|-
 +
|[https://www.nejm.org/doi/full/10.1056/NEJMoa0908721 Valle et al. 2010 (ABC-02)]
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| style="background-color:#1a9851" |Phase III (E-esc)
 +
|[[Cholangiocarcinoma#Gemcitabine monotherapy 2|Gemcitabine]]
 +
| style="background-color:#1a9850" |Superior OS
 +
|2002-2008
 +
|-
 +
|[https://academic.oup.com/annonc/article-abstract/30/12/1950/5578479 Morizane et al. 2019 (FUGA-BT)]
 +
| style="background-color:#1a9851" |Phase III (C)
 +
|[[Cholangiocarcinoma#Gemcitabine .26 S-1|Gemcitabine & S-1]]
 +
| style="background-color:#eeee01" |Seems to have non-inferior OS
 +
|2013-2016
 +
|-
 +
|}
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''In the Valle et al. study, 149 of 410 enrolled patients (36%) had primary gallbladder cancer.''
 +
 +
''In the Morizne et al. study, 137 of 354 enrolled patients (39%) had primary gallbladder cancer''
 +
 +
====Chemotherapy====
 +
 +
*[[Cisplatin (Platinol)]] 25 mg/m<sup><font size="2">2</font></sup> IV over 60 minutes once per day on days 1 & 8, '''given first'''
 +
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup><font size="2">2</font></sup> IV over 30 minutes once per day on days 1 & 8, '''given second'''
 +
 +
====Supportive medications====
 +
 +
*Cisplatin is mixed in a solution of 1 liter of normal saline with 20 mmol potassium chloride, 8 mmol magnesium sulfate
 +
*After cisplatin, 500 mL normal saline given over 30 minutes
 +
 +
'''21-day cycle for 4 to 8 cycles depending on response'''
 +
===References===
 +
 +
#'''ABC-02:''' Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. [https://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20375404 PubMed]
 +
#'''FUGA-BT:''' Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, Ozaka M, Okano N, Sugimori K, Fukutomi A, Hara H, Mizuno N, Yanagimoto H, Wada K, Tobimatsu K, Yane K, Nakamori S, Yamaguchi H, Asagi A, Yukisawa S, Kojima Y, Kawabe K, Kawamoto Y, Sugimoto R, Iwai T, Nakamura K, Miyakawa H, Yamashita T, Hosokawa A, Ioka T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019 Dec 1;30(12):1950-1958. [https://academic.oup.com/annonc/article-abstract/30/12/1950/5578479 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/31566666 PubMed]
  
 
==GemOx {{#subobject:c7cmar|Regimen=1}}==
 
==GemOx {{#subobject:c7cmar|Regimen=1}}==
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|-
 
|-
 
| rowspan="2" |[https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 Sharma et al. 2010]
 
| rowspan="2" |[https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 Sharma et al. 2010]
−
| rowspan="2" style="background-color:#1a9851" |Randomized (E-esc)
+
| style="background-color:#1a9851" rowspan="2" |Randomized (E-esc)
 
|1. [[#Best_supportive_care|Best supportive care]]
 
|1. [[#Best_supportive_care|Best supportive care]]
 
| style="background-color:#91cf60" |Seems to have superior OS
 
| style="background-color:#91cf60" |Seems to have superior OS

Revision as of 22:03, 15 January 2020

Page editor Section editor
Seifter.jpg
 Ari Seifter, MD
University of Illinois at Chicago
Chicago, IL
Nkv.jpg
 Neeta K. Venepalli, MD, MBA
University of Illinois at Chicago
Chicago, IL
21 regimens on this page
26 variants on this page

Note: there is some overlap, especially in the earlier literature, between treatment regimens for gallbladder cancer and those for pancreatic adenocarcinoma, periampullary adenocarcinoma, and cholangiocarcinoma; please see those pages for additional regimens.


Guidelines

ESMO

NCCN

Adjuvant therapy

Capecitabine monotherapy

back to top

Regimen

Study Evidence Comparator Efficacy
Primrose et al. 2019 (BILCAP) Phase III (E-esc) Observation Might have superior OS

79 of 447 enrolled patients (17.7%) had primary gallbladder cancer.

Preceding treatment

  • Surgical resection with macroscopically curative resection
  • Chemotherapy start date 8-16 weeks after surgery

Chemotherapy

21-day cycle for 8 cycles

References

  1. BILCAP: Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. link to original article PubMed

Capecitabine & Gemcitabine

back to top

GemCap: Gemcitabine & Capecitabine

Regimen

Study Evidence
Ben-Josef et al. 2015 (SWOG S0809) Phase II

25 of 79 enrolled patients (32%) had primary gallbladder cancer.

Preceding treatment

Chemotherapy

21-day cycle for 4 cycles

Subsequent treatment

  • Capecitabine & RT

References

  1. SWOG S0809: Ben-Josef E, Guthrie KA, El-Khoueiry AB, Corless CL, Zalupski MM, Lowy AM, Thomas CR Jr, Alberts SR, Dawson LA, Micetich KC, Thomas MB, Siegel AB, Blanke CD. SWOG S0809: A phase II intergroup trial of adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine in extrahepatic cholangiocarcinoma and gallbladder carcinoma. J Clin Oncol. 2015 Aug 20;33(24):2617-22. Epub 2015 May 11. link to original article link to PMC article contains verified protocol PubMed

GemOx

back to top

GemOx: Gemcitabine & Oxaliplatin

Regimen

Study Evidence Comparator Efficacy
Edeline et al. 2019 (PRODIGE 12-ACCORD 18-UNICANCER GI) Phase III (E-esc) Observation Did not meet primary endpoint of RFS

38 of 194 enrolled patients (20%) had primary gallbladder cancer.

Preceding treatment

Chemotherapy

14-day cycle for 12 cycles

References

  1. PRODIGE 12-ACCORD 18-UNICANCER GI: Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. link to original article PubMed

Metastatic or unresectable disease, all lines of therapy

Best supportive care

back to top

Regimen

Study Evidence Comparator Comparative Efficacy
Sharma et al. 2010 Randomized (C) 1. FUFA Did not meet primary endpoint of OS
2. mGEMOX Seems to have inferior OS

No active antineoplastic treatment.

References

  1. Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. link to original article contains protocol PubMed

Capecitabine monotherapy

back to top

Regimen

Study Evidence
Patt et al. 2004 Retrospective

3 of 37 patients (8%) had primary gallbladder cancer.

Chemotherapy

21-day cycles

References

  1. Retrospective: Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. link to original article PubMed

Capecitabine & Mitomycin

back to top

Regimen

Study Evidence Comparator Efficacy
Kornek et al. 2004 Randomized Phase II (E-switch-ic) Gemcitabine & Mitomycin Might have superior ORR

14 of 51 enrolled patients (27%) had primary gallbladder cancer.

Chemotherapy

Supportive medications

28-day cycles

References

  1. Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. link to original article contains verified protocol PubMed

CapeOx

back to top

CapeOx: Capecitabine & Oxaliplatin
XELOX: XELoda (Capecitabine) & OXaliplatin

Regimen

Study Evidence Comparator Comparative Efficacy
Kim et al. 2019 (SMC 2011-05-070) Phase III (E-switch-ic) GEMOX Non-inferior PFS

61 of 222 enrolled patients (22%) had primary gallbladder cancer.

Chemotherapy

21-day cycle for 8 cycles

References

  1. SMC 2011-05-070: Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. link to original article contains protocol PubMed

Cisplatin & Gemcitabine

back to top

GC: Gemcitabine & Cisplatin

Regimen

Study Evidence Comparator Comparative Efficacy Years of study
Valle et al. 2010 (ABC-02) Phase III (E-esc) Gemcitabine Superior OS 2002-2008
Morizane et al. 2019 (FUGA-BT) Phase III (C) Gemcitabine & S-1 Seems to have non-inferior OS 2013-2016

In the Valle et al. study, 149 of 410 enrolled patients (36%) had primary gallbladder cancer.

In the Morizne et al. study, 137 of 354 enrolled patients (39%) had primary gallbladder cancer

Chemotherapy

Supportive medications

  • Cisplatin is mixed in a solution of 1 liter of normal saline with 20 mmol potassium chloride, 8 mmol magnesium sulfate
  • After cisplatin, 500 mL normal saline given over 30 minutes

21-day cycle for 4 to 8 cycles depending on response

References

  1. ABC-02: Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. link to original article contains verified protocol PubMed
  2. FUGA-BT: Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, Ozaka M, Okano N, Sugimori K, Fukutomi A, Hara H, Mizuno N, Yanagimoto H, Wada K, Tobimatsu K, Yane K, Nakamori S, Yamaguchi H, Asagi A, Yukisawa S, Kojima Y, Kawabe K, Kawamoto Y, Sugimoto R, Iwai T, Nakamura K, Miyakawa H, Yamashita T, Hosokawa A, Ioka T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019 Dec 1;30(12):1950-1958. link to original article PubMed

GemOx

back to top

GemOx: Gemcitabine & Oxaliplatin
mGEMOX: modified GEMcitabine & OXaliplatin

Variant #1, 900/80 ("mGEMOX")

Study Evidence Comparator Comparative Efficacy
Sharma et al. 2010 Randomized (E-esc) 1. Best supportive care Seems to have superior OS
2. FUFA Not reported

Chemotherapy

21-day cycle for up to 6 cycles

Variant #2, 1000/100, bi-weekly

Study Evidence Comparator Comparative Efficacy
Lee et al. 2011 (SMC 2008-12-024) Phase III (C) E-GEMOX Might have inferior PFS

Chemotherapy

14-day cycles

Variant #3, 1000/100, 2 weeks out of 3

Study Evidence Comparator Comparative Efficacy
Kim et al. 2019 (SMC 2011-05-070) Phase III (C) XELOX Non-inferior PFS

Chemotherapy

21-day cycle for 8 cycles

References

  1. Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. link to original article contains protocol PubMed
  2. SMC 2008-12-024: Lee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA, Jang JS, Jeung HC, Kang JH, Lee HW, Shin DB, Kang HJ, Sun JM, Park JO, Park YS, Kang WK, Lim HY. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13(2):181-8. Epub 2011 Dec 20. link to original article contains protocol PubMed
  3. SMC 2011-05-070: Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. link to original article contains protocol PubMed
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