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Ramucirumab in Indian Patients with Advanced Gastric Cancer—Does Borderline Performance Status and Heavy Burden of Disease in Real World Practice Impact Clinical Benefit?Funding No funding received for study.
Background Ramucirumab is considered a standard of care as second-line therapy (CT2) in advanced gastric cancers (AGCs). The aim of this study was to assess practice patterns and outcomes with ramucirumab among Indian patients with AGCs.
Materials and Methods A computerized clinical data entry form was formulated by the coordinating center’s (Tata Memorial Hospital) medical oncologists and disseminated through personal contacts at academic conferences as well as via email for anonymized patient data entry. The data was analyzed for clinical characteristics, response rates, and survival outcomes.
Results A total of 26 physicians contributed data, resulting in 55 patients receiving ramucirumab and being available for analysis. Median age was 53 years (range: 26–78), 69.1% of patients had greater than two sites of disease, and baseline Eastern Cooperative Oncology Group’s performance score (ECOG PS) ≥ 2 was seen in 61.8% of patients. Ramucirumab was used as monotherapy in 10.9% of patients, while the remaining 89.1% received ramucirumab combined with chemotherapy. Median event-free survival (EFS) and median overall survival (OS) with ramucirumab were3.53 months (95% CI: 2.5–4.57) and 5.7 months (95% CI: 2.39–9.0), respectively. Common class specific grade adverse events seen with ramucirumab included gastrointestinal (GI) hemorrhage (9.1% - all grades) and uncontrolled hypertension (Grade 3/4 - 3.6%).
Conclusions Ramucirumab appears to have similar efficacy in Indian AGC patients when compared with real-world data from other countries in terms of median EFS, but OS appears inferior due to more patients having borderline ECOG PS and high metastatic disease burden. GI hemorrhages appear more common than published data, although not unequivocally related to ramucirumab.
04 September 2021 (online)
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- 1 Koizumi W, Narahara H, Hara T. et al. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 2008; 9 (03) 215-221
- 2 Guimbaud R, Louvet C, Ries P. et al. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) study. J Clin Oncol 2014; 32 (31) 3520-3526
- 3 Takahari D. Second-line chemotherapy for patients with advanced gastric cancer. Gastric Cancer 2017; 20 (03) 395-406
- 4 Muro K, Chung HC, Shankaran V. et al. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol 2016; 17 (06) 717-726
- 5 Shitara K, Özgüroğlu M, Bang Y-J. et al. KEYNOTE-061 investigators. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet 2018; 392 (10142) 123-133
- 6 Kang Y-K, Boku N, Satoh T. et al. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2017; 390 (10111) 2461-2471
- 7 Wilke H, Muro K, Van Cutsem E. et al. 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; 15 (11) 1224-1235
- 8 Zhu AX, Park JO, Ryoo B-Y. et al. REACH Trial Investigators. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol 2015; 16 (07) 859-870
- 9 Ramaswamy A, Ostwal V, Gupta K. et al. Modified 5-fluorouracil/leucovorin/irinotecan as a feasible and efficacious second-line chemotherapeutic regimen in advanced gastric cancers. South Asian J Cancer 2018; 7 (04) 219-222
- 10 Di Bartolomeo M, Niger M, Tirino G. et al. Ramucirumab as second-line therapy in metastatic gastric cancer: real-world data from the RAMoss study. Target Oncol 2018; 13 (02) 227-234
- 11 Jung M, Ryu M-H, Oh DY. et al. Efficacy and tolerability of ramucirumab monotherapy or in combination with paclitaxel in gastric cancer patients from the Expanded Access Program Cohort by the Korean Cancer Study Group (KCSG). Gastric Cancer 2018; 21 (05) 819-830
- 12 WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [Internet]. [cited 2018 Jan 25]. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Last accessed March 24, 2021
- 13 Al-Batran S-E, Homann N, Schmalenberg H. et al. Perioperative chemotherapy with docetaxel, oxaliplatin, and fluorouracil/leucovorin (FLOT) versus epirubicin, cisplatin, and fluorouracil or capecitabine (ECF/ECX) for resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma (FLOT4-AIO): A multicenter, randomized phase 3 trial. J Clin Oncol 2017; 35 (15_suppl) 4004-4004
- 14 Tabernero J, Yoshino T, Cohn AL. et al. RAISE Study Investigators. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol 2015; 16 (05) 499-508
- 15 Taghavi S, Jayarajan SN, Davey A, Willis AI. Prognostic significance of signet ring gastric cancer. J Clin Oncol 2012; 30 (28) 3493-3498
- 16 Signet-ring cell carcinoma of the stomach: Impact on prognosis and specific therapeutic challenge [Internet]. [cited 2019 Jan 22]. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4616218/. Last accessed March 24, 2021
- 17 Shitara K, Muro K, Matsuo K. et al. Chemotherapy for patients with advanced gastric cancer with performance status 2. Gastrointest Cancer Res 2009; 3 (06) 220-224
- 18 Fanotto V, Cordio S, Pasquini G. et al. Prognostic factors in 868 advanced gastric cancer patients treated with second-line chemotherapy in the real world. Gastric Cancer 2017; 20 (05) 825-833