Gastric cancer

***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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71 regimens on this page 108 variants on this page

Guidelines

CAP/ASCP/ASCO

• HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma (2017) PubMed

ESMO

• Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) PubMed

NCCN

• NCCN Guidelines - Gastric Cancer

Perioperative 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

Chemotherapy

• Epirubicin (Ellence) 50 mg/m² IV once on day 1
• Cisplatin (Platinol) 60 mg/m² IV once on day 1
• Fluorouracil (5-FU) 200 mg/m²/day IV continuous infusion on days 1 to 21

Supportive medications

• Warfarin (Coumadin) 1 mg PO once per day suggested as thrombosis prophylaxis

21-day cycle for 3 cycles prior to surgery, which is performed 3 to 6 weeks after the completion of cycle 3, then 3 more cycles to begin 6 to 12 weeks after surgery

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 & 5-FU

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Regimen

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

Chemotherapy

• Cisplatin (Platinol) 100 mg/m² IV over 1 hour once on day 28
• Fluorouracil (5-FU) 800 mg/m²/day IV continuous infusion on days 1 to 5

28-day cycle for 2 to 3 cycles prior to surgery, then 3 to 4 more cycles after surgery, 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

Adjuvant therapy

5-FU & Leucovorin -> 5-FU, Leucovorin, RT -> 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

• Fluorouracil (5-FU) 425 mg/m² IV bolus once per day on days 1 to 5
• Folinic acid (Leucovorin) 20 mg/m² IV bolus once per day on days 1 to 5

28-day cycle for 1 cycle, followed by:

Chemoradiation

• 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

• Fluorouracil (5-FU) 425 mg/m² IV bolus once per day on days 1 to 5
• Folinic acid (Leucovorin) 20 mg/m² IV bolus once per day on days 1 to 5

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

XP

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XP: Xeloda (Capecitabine), Platinol (Cisplatin)

Regimen

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

Chemotherapy

• Cisplatin (Platinol) 60 mg/m² IV once on day 1
• Capecitabine (Xeloda) 1000 mg/m² PO BID on days 1 to 14

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

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

CX; XP

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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

Chemotherapy

• Cisplatin (Platinol) 80 mg/m² IV over 2 hours once on day 1
• Capecitabine (Xeloda) 1000 mg/m² PO BID on days 1 to 14
  • Lordick et al. 2013 gave Capecitabine (Xeloda) 1000 mg/m² PO BID from the evening of day 1 to the morning of day 15 (28 doses per cycle)

Supportive medications

• (per Kang et al. 2009):
• "Hyperhydration" for Cisplatin (Platinol)

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

Paclitaxel (Taxol)

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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

• Paclitaxel (Taxol) 80 mg/m² IV once per day on days 1, 8, 15

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

Placebo

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Regimen

Study	Evidence	Comparator	Efficacy
Fuchs et al. 2014 (REGARD)	Phase III	Ramucirumab	Seems to have inferior OS

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.

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 (Cyramza)

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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

• Ramucirumab (Cyramza) 8 mg/kg IV once every 2 weeks

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

• Ramucirumab (Cyramza) 8 mg/kg IV once per day on days 1 & 15
• Paclitaxel (Taxol) 80 mg/m² IV once per day on days 1, 8, 15

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