Gastric cancer

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***Since there is significant overlap between regimens for gastric cancer and esophageal cancer, please check that page to see if there is a suitable reference listed in esophageal cancer for your desired regimen.***

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12 regimens on this page
13 variants on this page

Contents


Guidelines

CAP/ASCP/ASCO

ESMO

ESMO/ESSO/ESTRO

NCCN

Neoadjuvant chemotherapy

ECF

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ECF: Epirubicin, Cisplatin, Fluorouracil

Regimen

Study Evidence Comparator Efficacy
Cunningham et al. 2006 (MAGIC) Phase III Surgery alone Superior OS

This is the neoadjuvant portion of pre-planned "perioperative" therapy.

Chemotherapy

Supportive medications

21-day cycle for 3 cycles

Surgical resection is performed 3 to 6 weeks after the completion of cycle 3, followed in 6 to 12 weeks by adjuvant ECF.

References

  1. Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. link to original article contains protocol PubMed

Cisplatin & Fluorouracil

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Regimen

Study Evidence Comparator Efficacy
Ychou et al. 2011 Phase III Surgery alone Seems to have superior OS

This is the neoadjuvant portion of pre-planned "perioperative" therapy.

Chemotherapy

28-day cycle for 2 to 3 cycles

Treatment followed by surgical resection, then adjuvant cisplatin & 5-FU.

References

  1. Ychou M, Boige V, Pignon JP, Conroy T, Bouché O, Lebreton G, Ducourtieux M, Bedenne L, Fabre JM, Saint-Aubert B, Genève J, Lasser P, Rougier P. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol. 2011 May 1;29(13):1715-21. link to original article contains protocol PubMed

Adjuvant therapy

5-FU & Leucovorin, then 5-FU, Leucovorin, RT, then 5-FU & Leucovorin

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RT: Radiation Therapy

Regimen

Study Evidence Comparator Efficacy
Macdonald et al. 2001 Phase III Surgery alone Superior OS

Treatment is to start 20 to 40 days after surgery.

Chemotherapy, part 1

28-day cycle for 1 cycle, followed by:

Chemoradiotherapy

  • Fluorouracil (5-FU) 400mg/m2 IV bolus once per day on days 1 to 4 and the last 3 days of radiation therapy
  • Folinic acid (Leucovorin) 20 mg/m2 IV bolus once per day on days 1 to 4 and the last 3 days of radiation therapy
  • Concurrent radiation therapy starting on day 1 with 180 cGy, 5 days per week; 25 fractions given over 5 weeks for a total of 4500 cGy

35-day course, followed by:

Chemotherapy, part 2

28-day cycle for 2 cycles

References

  1. Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. link to original article contains protocol PubMed

Cisplatin & Fluorouracil

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Regimen

Study Evidence Comparator Efficacy
Ychou et al. 2011 Phase III Surgery alone Seems to have superior OS

This is the adjuvant portion of pre-planned "perioperative" therapy.

Preceding treatment

Chemotherapy

28-day cycle for 3 to 4 cycles, for a total of 6 cycles

References

  1. Ychou M, Boige V, Pignon JP, Conroy T, Bouché O, Lebreton G, Ducourtieux M, Bedenne L, Fabre JM, Saint-Aubert B, Genève J, Lasser P, Rougier P. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol. 2011 May 1;29(13):1715-21. link to original article contains protocol PubMed

CX

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CX: Cisplatin, Xeloda (Capecitabine)
XP: Xeloda (Capecitabine), Platinol (Cisplatin)

Regimen

Study Evidence Comparator Efficacy
Lee et al. 2012 (ARTIST) Phase III XP, then RT, then XP Might have inferior DFS

Chemotherapy

21-day cycle for 6 cycles

References

  1. Lee J, Lim DH, Kim S, Park SH, Park JO, Park YS, Lim HY, Choi MG, Sohn TS, Noh JH, Bae JM, Ahn YC, Sohn I, Jung SH, Park CK, Kim KM, Kang WK. Phase III trial comparing capecitabine plus cisplatin versus capecitabine plus cisplatin with concurrent capecitabine radiotherapy in completely resected gastric cancer with D2 lymph node dissection: the ARTIST trial. J Clin Oncol. 2012 Jan 20;30(3):268-73. Epub 2011 Dec 19. link to original article contains verified protocol PubMed
    1. Update: Park SH, Sohn TS, Lee J, Lim DH, Hong ME, Kim KM, Sohn I, Jung SH, Choi MG, Lee JH, Bae JM, Kim S, Kim ST, Park JO, Park YS, Lim HY, Kang WK. Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses. J Clin Oncol. 2015 Oct 1;33(28):3130-6. Epub 2015 Jan 5. link to original article PubMed

ECF

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ECF: Epirubicin, Cisplatin, Fluorouracil

Regimen

Study Evidence Comparator Efficacy
Cunningham et al. 2006 (MAGIC) Phase III Surgery alone Superior OS

This is the adjuvant portion of pre-planned "perioperative" therapy.

Preceding treatment

Chemotherapy

Supportive medications

21-day cycle for 3 cycles

References

  1. Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. link to original article contains protocol PubMed

Chemotherapy for metastatic or locally advanced disease (non-radiation/surgery candidate)

CX

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CX: Cisplatin, Xeloda (Capecitabine)
XP: Xeloda (Capecitabine), Platinol (Cisplatin)

Regimen

Study Evidence Comparator Efficacy
Kang et al. 2009 Phase III Cisplatin & Fluorouracil Noninferior PFS
Lordick et al. 2013 (EXPAND) Phase III Capecitabine, Cetuximab, Cisplatin Seems not superior
Kim et al. 2014 Phase III Capecitabine, Cisplatin, Simvastatin Seems not superior

Chemotherapy

Supportive medications

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

References

  1. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. Epub 2009 Jan 19. link to original article contains verified protocol PubMed content property of HemOnc.org
  2. Lordick F, Kang YK, Chung HC, Salman P, Oh SC, Bodoky G, Kurteva G, Volovat C, Moiseyenko VM, Gorbunova V, Park JO, Sawaki A, Celik I, Götte H, Melezínková H, Moehler M; Arbeitsgemeinschaft Internistische Onkologie (AIO) and EXPAND Investigators. Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND): a randomised, open-label phase 3 trial. Lancet Oncol. 2013 May;14(6):490-9. Epub 2013 Apr 15. link to original article contains verified protocol PubMed
  3. Kim ST, Kang JH, Lee J, Park SH, Park JO, Park YS, Lim HY, Hwang IG, Lee SC, Park KW, Lee HR, Kang WK. Simvastatin plus capecitabine-cisplatin versus placebo plus capecitabine-cisplatin in patients with previously untreated advanced gastric cancer: a double-blind randomised phase 3 study. Eur J Cancer. 2014 Nov;50(16):2822-30. Epub 2014 Sep 15. link to original article contains verified protocol PubMed

CX & Trastuzumab

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CX: Cisplatin, Xeloda (Capecitabine)

Regimen #1

Study Evidence Comparator Efficacy
Shah et al. 2017 (HELOISE) Phase IIIb CX & HD-Trastuzumab Seems not superior

Patients had overexpression of HER2 protein by immunohistochemistry AND gene amplification by in-situ hybridisation.

Chemotherapy

21-day cycle for up to 6 cycles; trastuzumab alone continued until progression of disease or unacceptable toxicity

Regimen #2

Study Evidence Comparator Efficacy
Bang et al. 2010 (ToGA) Phase III CX Superior OS

Patients had overexpression of HER2 protein by immunohistochemistry OR gene amplification by fluorescence in-situ hybridisation.

Chemotherapy

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

References

  1. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. link to original article contains verified protocol PubMed
  2. Shah MA, Xu RH, Bang YJ, Hoff PM, Liu T, Herráez-Baranda LA, Xia F, Garg A, Shing M, Tabernero J. HELOISE: Phase IIIb randomized multicenter study comparing standard-of-care and higher-dose trastuzumab regimens combined with chemotherapy as first-line therapy in patients with human epidermal growth factor receptor 2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol. 2017 Aug 1;35(22):2558-2567. Epub 2017 Jun 2.link to original article contains verified protocol PubMed

ECC

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ECC: Epirubicin, Cisplatin, Capecitabine

Regimen

Study Evidence Comparator Efficacy
Konings et al. 2010 Randomized Phase II ECC+P Seems not superior

Chemotherapy

21-day cycle for up to 6 cycles

References

  1. Konings IR, van der Gaast A, van der Wijk LJ, de Jongh FE, Eskens FA, Sleijfer S. The addition of pravastatin to chemotherapy in advanced gastric carcinoma: a randomised phase II trial. Eur J Cancer. 2010 Dec;46(18):3200-4. Epub 2010 Aug 18. link to original article contains verified protocol PubMed

Paclitaxel monotherapy

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Regimen

Study Evidence Comparator Efficacy
Wilke et al. 2014 (RAINBOW) Phase III Ramucirumab & Paclitaxel Seems to have inferior OS

Eligibility criteria for patients in RAINBOW included: "documented objective radiological or clinical disease progression during or within 4 months of the last dose of first-line platinum and fluoropyrimidine doublet with or without anthracycline."

Chemotherapy

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

References

  1. Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. link to original article contains verified protocol PubMed

Pembrolizumab monotherapy

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Regimen

Study Evidence ORR
Fuchs et al. 2017 (KEYNOTE-059) Phase II 11% (95% CI 8-16)

Immunotherapy

21-day cycle for up to 2 years or disease progression

References

  1. Abstract: Charles S. Fuchs, Toshihiko Doi, Raymond Woo-Jun Jang, Kei Muro, Taroh Satoh, Manuela Machado, ...Weijing Sun, Shadia Ibrahim Jalal, Manish A. Shah, Jean-Philippe Metges, Marcelo Garrido, Talia Golan, Mario Mandala, Zev A. Wainberg, Daniel V.T. Catenacci, Yung-Jue Bang, Jiangdian Wang, Minori Koshiji, Rita P. Dalal, Harry H. Yoon (2017). KEYNOTE-059 cohort 1: Efficacy and safety of pembrolizumab (pembro) monotherapy in patients with previously treated advanced gastric cancer. Journal of Clinical Oncology 35, no. 15_suppl (May 2017) 4003-4003. link to abstract

Placebo

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Regimen

Study Evidence Comparator Efficacy
Fuchs et al. 2014 (REGARD) Phase III Ramucirumab Seems to have inferior OS
Pavlakis et al. 2016 (INTEGRATE) Randomized Phase II Regorafenib Inferior PFS

Patients in REGARD previously had "disease progression within 4 months of the last dose of first-line platinum-containing or fluoropyrimidine-containing chemotherapy for metastatic disease, or within 6 months of the last dose of platinum-containing or fluoropyrimidine-containing adjuvant treatment."

No active antineoplastic treatment.

Treatment

References

  1. Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-9. link to original article contains verified protocol PubMed
  2. Pavlakis N, Sjoquist KM, Martin AJ, Tsobanis E, Yip S, Kang YK, Bang YJ, Alcindor T, O'Callaghan CJ, Burnell MJ, Tebbutt NC, Rha SY, Lee J, Cho JY, Lipton LR, Wong M, Strickland A, Kim JW, Zalcberg JR, Simes J, Goldstein D. Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): A multinational placebo-controlled phase II trial. J Clin Oncol. 2016 Aug 10;34(23):2728-35. Epub 2016 Jun 20. link to original article contains verified protocol link to PMC article PubMed

Ramucirumab monotherapy

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Regimen

Study Evidence ORR Comparator Comparator ORR Efficacy Pt Population
Fuchs et al. 2014 (REGARD) Phase III 3% Placebo 3% Seems to have superior OS Chemo exposed

Patients in REGARD previously had "disease progression within 4 months of the last dose of first-line platinum-containing or fluoropyrimidine-containing chemotherapy for metastatic disease, or within 6 months of the last dose of platinum-containing or fluoropyrimidine-containing adjuvant treatment."

Chemotherapy

Given until progression of disease, unacceptable toxicity, or death

References

  1. Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-9. link to original article contains verified protocol PubMed

Ramucirumab & Paclitaxel

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Regimen

Study Evidence ORR Comparator Comparator ORR Efficacy Pt Population
Wilke et al. 2014 (RAINBOW) Phase III 28% (95% CI 23-33%) Paclitaxel 16% (95% CI 13-20%) Seems to have superior OS Chemo exposed

Eligibility criteria for patients in RAINBOW included: "documented objective radiological or clinical disease progression during or within 4 months of the last dose of first-line platinum and fluoropyrimidine doublet with or without anthracycline."

Chemotherapy

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

References

  1. Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. link to original article contains verified protocol PubMed

Regorafenib monotherapy

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Regimen

Study Evidence Comparator Efficacy
Pavlakis et al. 2016 (INTEGRATE) Randomized Phase II Placebo Superior PFS

Chemotherapy

28-day cycles

References

  1. Pavlakis N, Sjoquist KM, Martin AJ, Tsobanis E, Yip S, Kang YK, Bang YJ, Alcindor T, O'Callaghan CJ, Burnell MJ, Tebbutt NC, Rha SY, Lee J, Cho JY, Lipton LR, Wong M, Strickland A, Kim JW, Zalcberg JR, Simes J, Goldstein D. Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): A multinational placebo-controlled phase II trial. J Clin Oncol. 2016 Aug 10;34(23):2728-35. Epub 2016 Jun 20. link to original article contains verified protocol link to PMC article PubMed