Evidence map›Paper›PMID 26510663›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2016

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.

Kohei Shitara, Kei Muro, Yasuhiro Shimada, Shuichi Hironaka, Naotoshi Sugimoto, Yoshito Komatsu, Tomohiro Nishina, Kensei Yamaguchi, Yoshihiko Segawa, Yasushi Omuro and 13 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 45 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01170663 phase3completednot on this map

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

TypeinterventionalSponsorEli Lilly and CompanyRan2010 to 2017Enrolled665ConditionsGastric CancerArmsRamucirumab (IMC-1211B) DP, Placebo, Paclitaxel
NCT04770623 phase2completednot on this mapstarted 2021, after this paper: background citation

Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study

TypeinterventionalSponsorMenoufia UniversityRan2021 to 2023Enrolled32ConditionsStomach Cancer, Gastric Cancer, Chemotherapy EffectArmsDocetaxel, Irinotecan
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  8. A phase II trial of ramucirumab and docetaxel as second-line treatment for patients with advanced gastric cancer (HGCSG 1903).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Kohei ShitaraDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. kshitara@east.ncc.go.jp.
Kei MuroAichi Cancer Center, Nagoya, Japan.
Yasuhiro ShimadaNational Cancer Center Hospital, Tokyo, Japan.
Shuichi HironakaChiba Cancer Center, Chiba, Japan.
Naotoshi SugimotoOsaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
Yoshito KomatsuHokkaido University Hospital, Sapporo, Japan.
Tomohiro NishinaShikoku Cancer Center, Matsuyama, Japan.
Kensei YamaguchiSaitama Cancer Center, Kita-Adachi-Gun, Japan.
Yoshihiko SegawaSaitama Medical University International Medical Center, Hidaka, Japan.
Yasushi OmuroTokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Takao TamuraKinki University Faculty of Medicine, Sayama, Japan.
Toshihiko DoiDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Seigo YukisawaTochigi Cancer Center, Utsunomiya, Japan.
Hirofumi YasuiShizuoka Cancer Center, Sunto-gun, Japan.
Fumio NagashimaKyorin University Hospital, Tokyo, Japan.
Masahiro GotohOsaka Medical College Hospital, Takatsuki, Japan.
Taito EsakiNational Kyushu Cancer Center, Fukuoka, Japan.
Michael EmigEli Lilly and Company, Bad Homburg, Germany.
Kumari ChandrawansaEli Lilly and Company, Bridgewater, NJ, USA.
Astra M LiepaEli Lilly and Company, Indianapolis, IN, USA.
Hansjochen WilkeKliniken Essen-Mitte Center of Palliative Care, Essen, Germany.
Yukako IchimiyaEli Lilly Japan K. K., Kobe, Japan.
Atsushi OhtsuNational Cancer Center, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe 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.

methodsPatients 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.

resultsThe 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 % confidence interval, 0.60-1.28) in the Japanese population and 0.73 (95 % confidence interval, 0.58-0.91) in the Western population. The progression-free survival hazard ratio was 0.50 (95 % confidence interval, 0.35-0.73) in the Japanese population and 0.63 (95 % confidence interval, 0.51-0.79) in the Western population. The objective response rate was higher for ramucirumab plus paclitaxel in both populations (Japanese population, 41.2 % vs 19.4 %; Western population, 26.8 % vs 13.0 %), as was the 6-month survival rate (Japanese population, 94.1 % vs 71.4 %; Western population, 66.0 % vs 49.0 %).

conclusionsSafety 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: NCT01170663.

Indexed as

Quality of LifeAdenocarcinomaAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsEsophageal NeoplasmsEsophagogastric JunctionFemaleFollow-Up StudiesHumansJapanLymphatic MetastasisMaleAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsRamucirumabAdvanced gastric or gastroesophageal junction adenocarcinomaJapanese patientsPaclitaxelRamucirumabVascular endothelial growth factor receptor 2

Identifiers

PMID26510663

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.