Geographic differences in approach to advanced gastric cancer: Is there a standard approach?

Kim, Richard; Tan, Ann; Choi, Minsig; El‐Rayes, Bassel F.

doi:10.1016/j.critrevonc.2013.05.007

Cited by 39 publications

(34 citation statements)

References 62 publications

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“…Differences in survival outcome between Japanese and Western patients with gastric cancer are well known, and the reasons have been widely speculated upon and include tumor biology, ethnicity, health care, insurance or reimbursement systems, and use of subsequent therapy [8,9]. In this article, we compare the outcomes of Japanese versus Western patients in the RAINBOW trial.…”

Section: Introductionmentioning

confidence: 99%

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

et al. 2015

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Background We evaluated the safety and efficacy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients previously treated for advanced gastric or gastroesophageal junction adenocarcinoma in Japanese and Western subgroups from the RAINBOW trial. Methods Patients received ramucirumab at 8 mg/kg or placebo (days 1 and 15) plus paclitaxel at 80 mg/m 2 (days 1, 8, and 15 of a 28-day cycle). End points were compared between treatment arms within Japanese (N = 140) and Western (N = 398) populations. Results The incidence of adverse events of grade 3 or higher was higher for ramucirumab plus paclitaxel in both populations (Japanese population, 83.8 % vs 52.1 %; Western population, 79.1 % vs 61.9 %). Neutropenia was the commonest adverse event of grade 3 or higher, with a higher incidence for ramucirumab plus paclitaxel (Japanese population, 66.2 % vs 25.4 %; Western population, 32.1 % vs 14.7 %). The incidence of febrile neutropenia was low and was similar between treatment arms in both populations. The overall survival hazard ratio was 0.88 (95 % Conclusions Safety profiles of the ramucirumab plus paclitaxel arm were similar between populations, though there was a higher incidence of neutropenia in Japanese patients. Progression-free survival and objective response rate improvements were observed for ramucirumab plus paclitaxel in both populations. ClinicalTrials.gov identifier: NCT01170663This

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Section: Introductionmentioning

confidence: 99%

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

et al. 2015

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“…Nevertheless, we are aware that such indirect comparisons might be further confounded by ethnic factors. Consistently, microRNA expression profiling and next-generation sequencing studies are beginning to unveil the existence of different sets of deregulated genes potentially associated with ethnicity, and differentiation type-related differences exist in dihydropyrimidine dehydrogenase levels [27][28][29].…”

Section: Discussionmentioning

confidence: 99%

Docetaxel, oxaliplatin, and capecitabine combination chemotherapy for metastatic gastric cancer

Lauro¹,

Vici²,

Belli³

et al. 2013

Gastric Cancer

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Background The incorporation of docetaxel into the cisplatin and fluorouracil backbone has been demonstrated to be an active combination in metastatic gastric cancer. Nevertheless, this regimen is burdened by nonnegligible toxicity. We hypothesized that replacing cisplatin and fluorouracil with oxaliplatin and capecitabine should be an active and safe option for metastatic gastric cancer patients. Methods In this phase II study, we tested the activity of docetaxel in combination with oxaliplatin and capecitabine (DOC) as a first-line treatment. DOC was administered as follows: docetaxel (60 mg/m 2 ) and oxaliplatin (100 mg/ m 2 ) on day 1, and capecitabine (500 mg/m 2 ) was administered orally twice daily given continuously, with cycles repeated every 3 weeks. The primary endpoint was the overall response rate. Results Forty-eight patients entered the study. All patients had metastatic disease (stage IV). None of the patients had previously received chemotherapy for advanced disease. Performance status was 0, 1, and 2 in 25, 58, and 17 % of patients, respectively; 13 patients (27 %) had adenocarcinoma of the gastroesophageal junction, and 29 patients (60.5 %) had two or more metastatic sites. The overall response rate was 52.1 %. Progression-free survival and overall survival were 6.9 and 12.6 months, respectively. The treatment was well tolerated with no treatmentrelated deaths. The most common grade 3-4 toxicity was neutropenia (41 %). Conclusions DOC is an effective and tolerated first-line treatment, and the lower dose of docetaxel and oxaliplatin used in this study compared with other similar regimens does not seem to hamper the antitumor activity.

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“…Geographical differences are evident in gastric cancer between Asian and Western countries in incidence rates, tumor location, stage presentation, treatment patterns, prognosis, and survival [10-14]. The RAINBOW trial reported efficacy by geographic region, with those from Asian countries showing longer median PFS (5.5 months, 95% CI: 4.2–5.7) and OS (12.1 months, 95% CI: 10–13.3).…”

Section: Discussion/conclusionmentioning

confidence: 99%

“…The authors speculated that the geographic region difference in treatment effect was a result from the higher use of subsequent therapy in Asia than in Western countries. The role of second-line therapy has traditionally been a state of debate in Western countries, with reports of only 50% of patients in Western countries offered second-line therapy; conversely, almost all patients in Japan receive second-line therapy, and more than half receive third-line therapy [10-14]. Concerns with performance status and toxicity of therapy have limited the use of second-line therapy in Western countries.…”

Section: Discussion/conclusionmentioning

confidence: 99%

Ramucirumab and Paclitaxel Administered Every 2 Weeks (mRAINBOW Regimen) in Advanced Gastroesophageal Adenocarcinoma

et al. 2019

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Background: The RAINBOW trial established ramucirumab combined with paclitaxel as a second-line option in metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Ramucirumab was given on days 1 and 15 with paclitaxel on days 1, 8, and 15 of a 28-day cycle. The median overall survival (OS) was significantly longer with ramucirumab plus paclitaxel (p = 0.017), and it led to 41% grade 3 or higher neutropenia. We review our experience with both ramucirumab plus paclitaxel given biweekly (mRAINBOW) to assess efficacy and safety. Objectives: The primary objective was to assess OS. Secondary end points were progression-free survival (PFS), overall response, and safety. Methods: We identified 129 patients retrospectively from our database between November 2014 and May 2017. Patients were included if they were followed up at our institution. Results: Median doses given were ramucirumab 8 mg/kg i.v. plus paclitaxel 110 mg/m² i.v. given once every 2 weeks. The median performance status was 1, and ∼60% had poorly differentiated histology; 55.8% had progression in < 6 months on first-line therapy, and the majority had measurable cancer. Median overall OS and PFS for the entire cohort was 9.4 months (95% CI: 8.05–10.74) and 3.68 months (95% CI: 2.73–4.5), respectively. Median OS was 9.46 months (95% CI: 8.05–14.95) and median PFS was 4.14 months (95% CI: 2.96–5.29) in those patients that received ramucirumab plus paclitaxel in the second-line setting. Conclusion: Biweekly administration of ramucirumab plus paclitaxel did not compromise efficacy. Delays, adjustments, or doses held were similar to the RAINBOW trial, with 31% requiring a dose or schedule modification.

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Geographic differences in approach to advanced gastric cancer: Is there a standard approach?

Cited by 39 publications

References 62 publications

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

Docetaxel, oxaliplatin, and capecitabine combination chemotherapy for metastatic gastric cancer

Ramucirumab and Paclitaxel Administered Every 2 Weeks (mRAINBOW Regimen) in Advanced Gastroesophageal Adenocarcinoma

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