Evidence map›Paper›PMID 37129153›Full record

ArticleJournal of gastric cancer2023

Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study.

Takatsugu Ogata, Yukiya Narita, Zev A Wainberg, Eric Van Cutsem, Kensei Yamaguchi, Yongzhe Piao, Yumin Zhao, Patrick M Peterson, Sameera R Wijayawardana, Paolo Abada and 2 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Journal of gastric cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01170663 (A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 22% of its field
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
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

Takatsugu OgataAichi Cancer Center Hospital, Nagoya, Japan.
Yukiya NaritaAichi Cancer Center Hospital, Nagoya, Japan.
Zev A WainbergUniversity of California Los Angeles, Los Angeles, CA, United States.
Eric Van CutsemUniversity Hospitals Gasthuisberg/Leuven & Katholieke Universiteit (KU) Leuven, Leuven, Belgium.
Kensei YamaguchiCancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Yongzhe PiaoEli Lilly Japan K.K., Kobe, Japan.
Yumin ZhaoEli Lilly and Company, Indianapolis, IN, United States.
Patrick M PetersonEli Lilly and Company, Indianapolis, IN, United States.
Sameera R WijayawardanaEli Lilly and Company, Indianapolis, IN, United States.
Paolo AbadaEli Lilly and Company, Indianapolis, IN, United States.
Anindya ChatterjeeEli Lilly and Company, Indianapolis, IN, United States.
Kei MuroAichi Cancer Center Hospital, Nagoya, Japan. kmuro@aichi-cc.jp.ORCID https://orcid.org/0000-0002-5572-743X
Eli Lilly (United States) · USAichi Cancer Center · JPEli Lilly (Japan) · JPJapanese Foundation For Cancer Research · JPUniversitair Ziekenhuis Leuven · BEUniversity of California, Los Angeles · US

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

purposeLiver metastasis (LM) is reported in approximately 40% of patients with advanced/metastatic gastric/gastroesophageal junction adenocarcinoma (metastatic esophagogastric adenocarcinoma; mGEA) and is associated with a worse prognosis. This post-hoc analysis from the RAINBOW trial reported the efficacy, safety, and biomarker outcomes of ramucirumab and paclitaxel combination treatment (RAM+PAC) in patients with (LM+) and without (LM-) LM at baseline. MATERIALS AND

methodsPatients (n=665) were randomly assigned on a 1:1 basis to receive either RAM+PAC (LM+: 150, LM-: 180) or placebo and paclitaxel (PL+PAC) (LM+: 138, LM-: 197). The overall survival (OS) and progression-free survival (PFS) were evaluated using stratified Kaplan-Meier and Cox regression models. The correlation of dichotomized biomarkers (VEGF-C, D; VEGFR-1,2) with efficacy in the LM+ versus LM- subgroups was analyzed using the Cox regression model with reported interaction P-values.

resultsThe presence of LM was associated with earlier progression than those without LM, particularly in patients receiving PL+PAC (hazard ratio [HR], 1.68). RAM+PAC treatment improved OS and PFS irrespective of LM status but showed greater improvement in LM+ than that in LM- (OS HR, 0.71 [LM+] vs. 0.88 [LM-]; PFS HR, 0.47 [LM+] vs. 0.76 [LM-]). Treatment-emergent adverse events were similar between patients with and without LM. No predictive relationship was observed between biomarker levels (VEGF-C, D; VEGFR-1,2) and efficacy outcome (OS, PFS) (all interaction P-values >0.05).

conclusionsRAM provided a significant benefit, irrespective of LM status; however, its effect was numerically stronger in patients with LM. Therefore, RAM+PAC is a clinically meaningful therapeutic option for patients with mGEA and LM.

trial registrationClinicalTrials.gov Identifier: NCT01170663.

Indexed as

RamucirumabStomach neoplasmsVascular endothelial growth factors

Identifiers

PMID37129153
PMCPMC10154140
OpenAlexW4327661434

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.