Secuencia en cáncer gástrico metastásico
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Key trials in metastatic gastric cancer (1st-Line) - Platinum + fluoropyrimidine (e.g. cisplatin or oxaliplatin + 5-FU or capecitabine) form the backbone of 1st-line treatment. - Trastuzumab is added for HER2-positive cancers. - Consider adding an anthracycline or taxane for younger fit patients. - Immuno-oncology such as nivolumab shows promise when available, improving PFS and OS in some patients. - Consider monotherapy with a fluoropyrimidine for those who cannot tolerate polychemotherapy.
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Secuencia en cáncer gástrico metastásico
- 1. Secuenciación en cáncer gástrico metastásico Mauricio Lema Medina Clínica de Oncología Astorga / Clínica SOMA, Medellín
- 2. 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 AIO2 Cisplatin vs Oxaliplatin 2009 ML170323 FU vs Capecitabine 2010 Yun4 CX vs ECX (P2T) 2008 Dank6 Irinotecan FULV vs Cisplatin FULV 2010 ToGA7 Trastuzumab + CF 2013 EXPAND9 Cetuximab + Chemotherapy 2011 AVAGAST8 Bevacizumab + Chemotherap y 2020 CheckMate 64910 Nivolumab + CT 1. REAL2 - Cunningham D. N Engl J Med. 2008;358(1):36–46. 2. AIO - Al-Batran SE, J Clin Oncol. 2008;26(9):1435–42. 3. ML17032 - Kang YK. Ann Oncol. 2009;20(4):666–73. 4. Yun J. Eur J Cancer. 2010;46(5):885–91. 5. TAX-325 - Van Cutsem E. J Clin Oncol. 2006;24(31):4991–7. 6. Dank M, Ann Oncol. 2008;19(8):1450–7. 7. ToGA - Bang YJ. Lancet. 2010;376(9742):687–97 8. AVAGAST - Ohtsu A. J Clin Oncol. 2011;29(30):3968–76. 9. EXPAND - Lordick F. Lancet Oncol. 2013;14(6):490–9 10. CheckMate 649 - Moehler M. ESMO Virtual Congress 2020. Abstract LBA6 PR. 11. ATTRACTION-4. Boku N. ESMO Virtual Congress 2020. Abstract LBA7 PR. 2006 TAX 3255 DCF vs CF 2020 ATTRACTION-411 Nivolumab + CT Key trials in metastatic gastric cancer (1st-Line) Cisplatin vs Oxaliplatin Oxaliplatin, non-inferior Different toxicity profile Oxaliplatin, less toxic Oxaliplatin, probably, superior ≥ 65 yo
- 3. 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 AIO2 Cisplatin vs Oxaliplatin 2009 ML170323 FU vs Capecitabine 2010 Yun4 CX vs ECX (P2T) 2008 Dank6 Irinotecan FULV vs Cisplatin FULV 2010 ToGA7 Trastuzumab + CF 2013 EXPAND9 Cetuximab + Chemotherapy 2011 AVAGAST8 Bevacizumab + Chemotherap y 2020 CheckMate 64910 Nivolumab + CT 1. REAL2 - Cunningham D. N Engl J Med. 2008;358(1):36–46. 2. AIO - Al-Batran SE, J Clin Oncol. 2008;26(9):1435–42. 3. ML17032 - Kang YK. Ann Oncol. 2009;20(4):666–73. 4. Yun J. Eur J Cancer. 2010;46(5):885–91. 5. TAX-325 - Van Cutsem E. J Clin Oncol. 2006;24(31):4991–7. 6. Dank M, Ann Oncol. 2008;19(8):1450–7. 7. ToGA - Bang YJ. Lancet. 2010;376(9742):687–97 8. AVAGAST - Ohtsu A. J Clin Oncol. 2011;29(30):3968–76. 9. EXPAND - Lordick F. Lancet Oncol. 2013;14(6):490–9 10. CheckMate 649 - Moehler M. ESMO Virtual Congress 2020. Abstract LBA6 PR. 11. ATTRACTION-4. Boku N. ESMO Virtual Congress 2020. Abstract LBA7 PR. 2006 TAX 3255 DCF vs CF 2020 ATTRACTION-411 Nivolumab + CT Key trials in metastatic gastric cancer (1st-Line) FU vs Capecitabine Capecitabine non inferior to FU (or slightly superior) Capecitabine: High occurrence of hand-foot syndrome 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 ML170323 FU vs Capecitabine
- 4. 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 AIO2 Cisplatin vs Oxaliplatin 2009 ML170323 FU vs Capecitabine 2010 Yun4 CX vs ECX (P2T) 2008 Dank6 Irinotecan FULV vs Cisplatin FULV 2010 ToGA7 Trastuzumab + CF 2013 EXPAND9 Cetuximab + Chemotherapy 2011 AVAGAST8 Bevacizumab + Chemotherap y 2020 CheckMate 64910 Nivolumab + CT 1. REAL2 - Cunningham D. N Engl J Med. 2008;358(1):36–46. 2. AIO - Al-Batran SE, J Clin Oncol. 2008;26(9):1435–42. 3. ML17032 - Kang YK. Ann Oncol. 2009;20(4):666–73. 4. Yun J. Eur J Cancer. 2010;46(5):885–91. 5. TAX-325 - Van Cutsem E. J Clin Oncol. 2006;24(31):4991–7. 6. Dank M, Ann Oncol. 2008;19(8):1450–7. 7. ToGA - Bang YJ. Lancet. 2010;376(9742):687–97 8. AVAGAST - Ohtsu A. J Clin Oncol. 2011;29(30):3968–76. 9. EXPAND - Lordick F. Lancet Oncol. 2013;14(6):490–9 10. CheckMate 649 - Moehler M. ESMO Virtual Congress 2020. Abstract LBA6 PR. 11. ATTRACTION-4. Boku N. ESMO Virtual Congress 2020. Abstract LBA7 PR. 2006 TAX 3255 DCF vs CF 2020 ATTRACTION-411 Nivolumab + CT Key trials in metastatic gastric cancer (1st-Line) Triplets vs Doublets Higher response with triplets Higher toxicity with triplets Conflicting OS results Consider triplets in < 55 yo AND PS 0/1 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 ML170323 FU vs Capecitabine 2010 Yun4 CX vs ECX (P2T) 2006 TAX 3255 DCF vs CF
- 5. 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 AIO2 Cisplatin vs Oxaliplatin 2009 ML170323 FU vs Capecitabine 2010 Yun4 CX vs ECX (P2T) 2008 Dank6 Irinotecan FULV vs Cisplatin FULV 2010 ToGA7 Trastuzumab + CF 2013 EXPAND9 Cetuximab + Chemotherapy 2011 AVAGAST8 Bevacizumab + Chemotherap y 2020 CheckMate 64910 Nivolumab + CT 1. REAL2 - Cunningham D. N Engl J Med. 2008;358(1):36–46. 2. AIO - Al-Batran SE, J Clin Oncol. 2008;26(9):1435–42. 3. ML17032 - Kang YK. Ann Oncol. 2009;20(4):666–73. 4. Yun J. Eur J Cancer. 2010;46(5):885–91. 5. TAX-325 - Van Cutsem E. J Clin Oncol. 2006;24(31):4991–7. 6. Dank M, Ann Oncol. 2008;19(8):1450–7. 7. ToGA - Bang YJ. Lancet. 2010;376(9742):687–97 8. AVAGAST - Ohtsu A. J Clin Oncol. 2011;29(30):3968–76. 9. EXPAND - Lordick F. Lancet Oncol. 2013;14(6):490–9 10. CheckMate 649 - Moehler M. ESMO Virtual Congress 2020. Abstract LBA6 PR. 11. ATTRACTION-4. Boku N. ESMO Virtual Congress 2020. Abstract LBA7 PR. 2006 TAX 3255 DCF vs CF 2020 ATTRACTION-411 Nivolumab + CT Key trials in metastatic gastric cancer (1st-Line) Biologics Cetuximab and Bevacizumab: no rôle Trastuzumab improves OS in HER2+ 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 ML170323 FU vs Capecitabine 2010 Yun4 CX vs ECX (P2T) 2006 TAX 3255 DCF vs CF 2010 ToGA7 Trastuzumab + CF 2013 EXPAND9 Cetuximab + Chemotherapy 2011 AVAGAST8 Bevacizumab + Chemotherap y
- 6. 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 AIO2 Cisplatin vs Oxaliplatin 2009 ML170323 FU vs Capecitabine 2010 Yun4 CX vs ECX (P2T) 2008 Dank6 Irinotecan FULV vs Cisplatin FULV 2010 ToGA7 Trastuzumab + CF 2013 EXPAND9 Cetuximab + Chemotherapy 2011 AVAGAST8 Bevacizumab + Chemotherap y 2020 CheckMate 64910 Nivolumab + CT 1. REAL2 - Cunningham D. N Engl J Med. 2008;358(1):36–46. 2. AIO - Al-Batran SE, J Clin Oncol. 2008;26(9):1435–42. 3. ML17032 - Kang YK. Ann Oncol. 2009;20(4):666–73. 4. Yun J. Eur J Cancer. 2010;46(5):885–91. 5. TAX-325 - Van Cutsem E. J Clin Oncol. 2006;24(31):4991–7. 6. Dank M, Ann Oncol. 2008;19(8):1450–7. 7. ToGA - Bang YJ. Lancet. 2010;376(9742):687–97 8. AVAGAST - Ohtsu A. J Clin Oncol. 2011;29(30):3968–76. 9. EXPAND - Lordick F. Lancet Oncol. 2013;14(6):490–9 10. CheckMate 649 - Moehler M. ESMO Virtual Congress 2020. Abstract LBA6 PR. 11. ATTRACTION-4. Boku N. ESMO Virtual Congress 2020. Abstract LBA7 PR. 2006 TAX 3255 DCF vs CF 2020 ATTRACTION-411 Nivolumab + CT Key trials in metastatic gastric cancer (1st-Line) Immuno-oncology Nivolumab improves PFS Nivolumab improves OS (mainly, in PD-L1 ≥ 5%) No peer-reviewed publication (as of 02.2021) No regulatory approval (Colombia) 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 ML170323 FU vs Capecitabine 2020 CheckMate 64910 Nivolumab + CT 2020 ATTRACTION-411 Nivolumab + CT
- 7. 2008 REAL21 Cisplatin vs Oxaliplatin FU vs Capecitabine 2009 AIO2 Cisplatin vs Oxaliplatin 2009 ML170323 FU vs Capecitabine 2010 Yun4 CX vs ECX (P2T) 2008 Dank6 Irinotecan FULV vs Cisplatin FULV 2010 ToGA7 Trastuzumab + CF 2013 EXPAND9 Cetuximab + Chemotherapy 2011 AVAGAST8 Bevacizumab + Chemotherap y 2020 CheckMate 64910 Nivolumab + CT 1. REAL2 - Cunningham D. N Engl J Med. 2008;358(1):36–46. 2. AIO - Al-Batran SE, J Clin Oncol. 2008;26(9):1435–42. 3. ML17032 - Kang YK. Ann Oncol. 2009;20(4):666–73. 4. Yun J. Eur J Cancer. 2010;46(5):885–91. 5. TAX-325 - Van Cutsem E. J Clin Oncol. 2006;24(31):4991–7. 6. Dank M, Ann Oncol. 2008;19(8):1450–7. 7. ToGA - Bang YJ. Lancet. 2010;376(9742):687–97 8. AVAGAST - Ohtsu A. J Clin Oncol. 2011;29(30):3968–76. 9. EXPAND - Lordick F. Lancet Oncol. 2013;14(6):490–9 10. CheckMate 649 - Moehler M. ESMO Virtual Congress 2020. Abstract LBA6 PR. 11. ATTRACTION-4. Boku N. ESMO Virtual Congress 2020. Abstract LBA7 PR. 2006 TAX 3255 DCF vs CF 2020 ATTRACTION-411 Nivolumab + CT Key trials in metastatic gastric cancer (1st-Line)
- 8. Primera línea en cáncer gástrico Platino + Fluoropirimidina (Backbone) Cisplatino u oxaliplatino FU o capecitabina Adicionar Trastuzumab si HER2+ Considerar adición de antraciclina o taxano en jóvenes, buen PS Considerar IO, cuando esté disponible Considerar monoagente (FU-like) si no tolera poliquimio Matices
- 9. 2LMETASTATICGASTRIC CANCER Key Trials Iri or Docetaxel vs BSC 2012 Kang2 Ramucirumab + Paclitaxel vs Paclitaxel 2014 RAINBOW4 Irinotecan vs BSC 2011 AIO1 Docetaxel vs BSC 2013 Ford3 1. AIO - Thuss-Patience PC. Eur J Cancer. 2011;47(15):2306–14. 2. Kang JH. J Clin Oncol. 2012;30(13):1513–8. 3. Ford H. J Clin Oncol. 2013; 30. suppl 34 (abstr LBA4). 4. RAINBOW - Wilke H. Lancet Oncol. 2014 Oct;15(11):1224-35. CT in 2L 2L improves OS in PS0/1 2L improves symptom control Irinotecan or taxane-based Ramucirumab + paclitaxel one SoC
- 10. Propuesta de secuencia en cáncer gástrico metastásico Platino + Fluoropirimidina (Backbone) Cisplatino u oxaliplatino FU o capecitabina Adicionar Trastuzumab si HER2+ Considerar adición de antraciclina o taxano en jóvenes, buen PS Considerar adicionar IO, cuando esté disponible Considerar monoagente (FU-like) si no tolera poliquimio Progresión (2L)– Considerar Ramucirumab + Paclitaxel Progresión (3L)– Considerar Irinotecán Mauricio Lema Medina, 2021 IO: anti PD1 (ie, nivolumab / pembrolizumab) PS: Desempeño Joven: ≤ 55 años, y cambiando.
- 11. Propuesta de secuencia en cáncer gástrico metastásico Platino + Fluoropirimidina (Backbone) Cisplatino u oxaliplatino1 FU o capecitabina1 Adicionar Trastuzumab si HER2+3 Considerar adición de antraciclina o taxano en jóvenes, buen PS2 Considerar adicionar IO, cuando esté disponible4,5 Considerar monoagente (FU-like) si no tolera poliquimio Progresión (2L)– Considerar Ramucirumab + Paclitaxel7 Progresión (3L)– Considerar Irinotecán6 Mauricio Lema Medina, 2021 IO: anti PD1 (ie, nivolumab / pembrolizumab) PS: Desempeño Joven: ≤ 55 años, y cambiando. 1. REAL2 - Cunningham D. N Engl J Med. 2008;358(1):36–46. 2. TAX-325 - Van Cutsem E. J Clin Oncol. 2006;24(31):4991–7. 3. ToGA - Bang YJ. Lancet. 2010;376(9742):687–97 4. CheckMate 649 - Moehler M. ESMO Virtual Congress 2020. Abstract LBA6 PR. 5. ATTRACTION-4. Boku N. ESMO Virtual Congress 2020. Abstract LBA7 PR. 6. AIO - Thuss-Patience PC. Eur J Cancer. 2011;47(15):2306–14. 7. RAINBOW - Wilke H. Lancet Oncol. 2014 Oct;15(11):1224-35.
Editor's Notes
- REAL2 - Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358(1):36–46. Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008;26(9):1435–42. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. 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;20(4):666–73. Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46(5):885–91. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006;24(31):4991–7. Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19(8):1450–7. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. 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;376(9742):687–97 Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2011;29(30):3968–76. Lordick F, Kang YK, Chung HC, Salman P, Oh SC, Bodoky G, et al. 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;14(6):490–9 Moehler M, Shitara K, Garrido M, et al: Nivolumab plus chemotherapy vs chemo as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: First results of the CheckMate 649 study. ESMO Virtual Congress 2020. Abstract LBA6 PR. Boku N, Ryu M, Oh D, et al: Nivolumab plus chemotherapy vs chemotherapy alone in patients with previously untreated advanced or recurrent gastric/gastroesophageal junction cancer: ATTRACTION-4 (ONO-4538-37) study. ESMO Virtual Congress 2020. Abstract LBA7 PR.
- REAL2 - Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358(1):36–46. Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008;26(9):1435–42. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. 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;20(4):666–73. Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46(5):885–91. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006;24(31):4991–7. Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19(8):1450–7. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. 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;376(9742):687–97 Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2011;29(30):3968–76. Lordick F, Kang YK, Chung HC, Salman P, Oh SC, Bodoky G, et al. 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;14(6):490–9 Moehler M, Shitara K, Garrido M, et al: Nivolumab plus chemotherapy vs chemo as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: First results of the CheckMate 649 study. ESMO Virtual Congress 2020. Abstract LBA6 PR. Boku N, Ryu M, Oh D, et al: Nivolumab plus chemotherapy vs chemotherapy alone in patients with previously untreated advanced or recurrent gastric/gastroesophageal junction cancer: ATTRACTION-4 (ONO-4538-37) study. ESMO Virtual Congress 2020. Abstract LBA7 PR.
- REAL2 - Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358(1):36–46. Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008;26(9):1435–42. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. 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;20(4):666–73. Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46(5):885–91. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006;24(31):4991–7. Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19(8):1450–7. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. 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;376(9742):687–97 Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2011;29(30):3968–76. Lordick F, Kang YK, Chung HC, Salman P, Oh SC, Bodoky G, et al. 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;14(6):490–9 Moehler M, Shitara K, Garrido M, et al: Nivolumab plus chemotherapy vs chemo as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: First results of the CheckMate 649 study. ESMO Virtual Congress 2020. Abstract LBA6 PR. Boku N, Ryu M, Oh D, et al: Nivolumab plus chemotherapy vs chemotherapy alone in patients with previously untreated advanced or recurrent gastric/gastroesophageal junction cancer: ATTRACTION-4 (ONO-4538-37) study. ESMO Virtual Congress 2020. Abstract LBA7 PR.
- REAL2 - Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358(1):36–46. Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008;26(9):1435–42. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. 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;20(4):666–73. Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46(5):885–91. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006;24(31):4991–7. Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19(8):1450–7. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. 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;376(9742):687–97 Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2011;29(30):3968–76. Lordick F, Kang YK, Chung HC, Salman P, Oh SC, Bodoky G, et al. 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;14(6):490–9 Moehler M, Shitara K, Garrido M, et al: Nivolumab plus chemotherapy vs chemo as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: First results of the CheckMate 649 study. ESMO Virtual Congress 2020. Abstract LBA6 PR. Boku N, Ryu M, Oh D, et al: Nivolumab plus chemotherapy vs chemotherapy alone in patients with previously untreated advanced or recurrent gastric/gastroesophageal junction cancer: ATTRACTION-4 (ONO-4538-37) study. ESMO Virtual Congress 2020. Abstract LBA7 PR.
- REAL2 - Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358(1):36–46. Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008;26(9):1435–42. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. 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;20(4):666–73. Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46(5):885–91. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006;24(31):4991–7. Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19(8):1450–7. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. 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;376(9742):687–97 Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2011;29(30):3968–76. Lordick F, Kang YK, Chung HC, Salman P, Oh SC, Bodoky G, et al. 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;14(6):490–9 Moehler M, Shitara K, Garrido M, et al: Nivolumab plus chemotherapy vs chemo as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: First results of the CheckMate 649 study. ESMO Virtual Congress 2020. Abstract LBA6 PR. Boku N, Ryu M, Oh D, et al: Nivolumab plus chemotherapy vs chemotherapy alone in patients with previously untreated advanced or recurrent gastric/gastroesophageal junction cancer: ATTRACTION-4 (ONO-4538-37) study. ESMO Virtual Congress 2020. Abstract LBA7 PR.
- REAL2 - Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358(1):36–46. Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008;26(9):1435–42. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. 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;20(4):666–73. Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46(5):885–91. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006;24(31):4991–7. Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19(8):1450–7. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. 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;376(9742):687–97 Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2011;29(30):3968–76. Lordick F, Kang YK, Chung HC, Salman P, Oh SC, Bodoky G, et al. 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;14(6):490–9 Moehler M, Shitara K, Garrido M, et al: Nivolumab plus chemotherapy vs chemo as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: First results of the CheckMate 649 study. ESMO Virtual Congress 2020. Abstract LBA6 PR. Boku N, Ryu M, Oh D, et al: Nivolumab plus chemotherapy vs chemotherapy alone in patients with previously untreated advanced or recurrent gastric/gastroesophageal junction cancer: ATTRACTION-4 (ONO-4538-37) study. ESMO Virtual Congress 2020. Abstract LBA7 PR.
- Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, et al. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer—a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011;47(15):2306–14. Kang JH, Lee SI, Lim do H, Park KW, Oh SY, Kwon HC, et al. Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol. 2012;30(13):1513–8. Ford H, Marshall A, Wadsley J. Cougar-02: a randomized phase III study of docetaxel versus active symptom control in advanced esophagogastric adenocarcinoma. J Clin Oncol. 2013; 30. suppl 34 (abstr LBA4). 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. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17. PMID: 25240821.