Subgroup analysis of East Asians in RAINBOW

A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer

Kei Muro, Sang Cheul Oh, Yasuhiro Shimada, Keun Wook Lee, Chia Jui Yen, Yee Chao, Jae Yong Cho, Rebecca Cheng, Roberto Carlesi, Kumari Chandrawansa, Mauro Orlando, Atsushi Ohtsu

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background and Aim: East Asia has higher gastric cancer incidence and mortality rates than other regions. We present a subgroup analysis of East Asians in the positive study RAINBOW. Methods: Patients with advanced gastric or gastroesophageal junction adenocarcinoma previously treated with platinum and fluoropyrimidine received ramucirumab 8mg/kg or placebo on days 1 and 15 plus paclitaxel 80mg/m2 on days 1, 8, and 15 of a 28-day cycle. Results: Of 665 intention-to-treat patients, 223 were East Asian. Median overall survival was 12.1months for ramucirumab plus paclitaxel and 10.5months for placebo plus paclitaxel (hazard ratio: 0.986, 95% confidence interval: 0.727-1.337, P=0.929). Median progression-free survival was 5.5months for ramucirumab plus paclitaxel and 2.8months for placebo plus paclitaxel (hazard ratio: 0.628, 95% confidence interval: 0.473-0.834, P=0.001). Objective response rates were 34% for ramucirumab plus paclitaxel and 20% for placebo plus paclitaxel. Grade ≥3 neutropenia (60% vs 28%) and leukopenia (34% vs 13%) were higher for ramucirumab plus paclitaxel. The rate of febrile neutropenia was low (4% vs 4%). Special interest adverse events included any grade bleeding/hemorrhage (55% vs 25%), proteinuria (27% vs 7%), and hypertension (22% vs 2%). Conclusions: Ramucirumab plus paclitaxel significantly improves progression-free survival and response rate, with prolonged median overall survival and an acceptable safety profile in East Asians with advanced gastric cancer.

Original languageEnglish
Pages (from-to)581-589
Number of pages9
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume31
Issue number3
DOIs
Publication statusPublished - 2016 Mar 1

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Paclitaxel
Stomach Neoplasms
Placebos
Disease-Free Survival
Confidence Intervals
Hemorrhage
ramucirumab
Esophagogastric Junction
Febrile Neutropenia
Survival
Far East
Leukopenia
Neutropenia
Platinum
Proteinuria
Stomach
Adenocarcinoma
Survival Rate
Hypertension
Safety

Keywords

  • Far East
  • Gastrointestinal neoplasms
  • Paclitaxel
  • Ramucirumab
  • Vascular endothelial growth factor receptor-2

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Subgroup analysis of East Asians in RAINBOW : A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer. / Muro, Kei; Oh, Sang Cheul; Shimada, Yasuhiro; Lee, Keun Wook; Yen, Chia Jui; Chao, Yee; Cho, Jae Yong; Cheng, Rebecca; Carlesi, Roberto; Chandrawansa, Kumari; Orlando, Mauro; Ohtsu, Atsushi.

In: Journal of Gastroenterology and Hepatology (Australia), Vol. 31, No. 3, 01.03.2016, p. 581-589.

Research output: Contribution to journalArticle

Muro, K, Oh, SC, Shimada, Y, Lee, KW, Yen, CJ, Chao, Y, Cho, JY, Cheng, R, Carlesi, R, Chandrawansa, K, Orlando, M & Ohtsu, A 2016, 'Subgroup analysis of East Asians in RAINBOW: A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer', Journal of Gastroenterology and Hepatology (Australia), vol. 31, no. 3, pp. 581-589. https://doi.org/10.1111/jgh.13153
Muro, Kei ; Oh, Sang Cheul ; Shimada, Yasuhiro ; Lee, Keun Wook ; Yen, Chia Jui ; Chao, Yee ; Cho, Jae Yong ; Cheng, Rebecca ; Carlesi, Roberto ; Chandrawansa, Kumari ; Orlando, Mauro ; Ohtsu, Atsushi. / Subgroup analysis of East Asians in RAINBOW : A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer. In: Journal of Gastroenterology and Hepatology (Australia). 2016 ; Vol. 31, No. 3. pp. 581-589.
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abstract = "Background and Aim: East Asia has higher gastric cancer incidence and mortality rates than other regions. We present a subgroup analysis of East Asians in the positive study RAINBOW. Methods: Patients with advanced gastric or gastroesophageal junction adenocarcinoma previously treated with platinum and fluoropyrimidine received ramucirumab 8mg/kg or placebo on days 1 and 15 plus paclitaxel 80mg/m2 on days 1, 8, and 15 of a 28-day cycle. Results: Of 665 intention-to-treat patients, 223 were East Asian. Median overall survival was 12.1months for ramucirumab plus paclitaxel and 10.5months for placebo plus paclitaxel (hazard ratio: 0.986, 95{\%} confidence interval: 0.727-1.337, P=0.929). Median progression-free survival was 5.5months for ramucirumab plus paclitaxel and 2.8months for placebo plus paclitaxel (hazard ratio: 0.628, 95{\%} confidence interval: 0.473-0.834, P=0.001). Objective response rates were 34{\%} for ramucirumab plus paclitaxel and 20{\%} for placebo plus paclitaxel. Grade ≥3 neutropenia (60{\%} vs 28{\%}) and leukopenia (34{\%} vs 13{\%}) were higher for ramucirumab plus paclitaxel. The rate of febrile neutropenia was low (4{\%} vs 4{\%}). Special interest adverse events included any grade bleeding/hemorrhage (55{\%} vs 25{\%}), proteinuria (27{\%} vs 7{\%}), and hypertension (22{\%} vs 2{\%}). Conclusions: Ramucirumab plus paclitaxel significantly improves progression-free survival and response rate, with prolonged median overall survival and an acceptable safety profile in East Asians with advanced gastric cancer.",
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AU - Chao, Yee

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KW - Vascular endothelial growth factor receptor-2

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