Evidence map›Paper›PMID 30470690›Full record

Trial reportThe oncologist2019

Initial Report of Second-Line FOLFIRI in Combination with Ramucirumab in Advanced Gastroesophageal Adenocarcinomas: A Multi-Institutional Retrospective Analysis.

Samuel J Klempner, Steven B Maron, Leah Chase, Samantha Lomnicki, Zev A Wainberg, Daniel V T Catenacci

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03081143 (Ramucirumab Plus Irinotecan / Leucovorin / 5-FU Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed One Prior Line of Palliative Chemotherapy - The Phase II/III RAMIRIS Study), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT03081143 phase2 / phase3completednot on this map

Ramucirumab Plus Irinotecan / Leucovorin / 5-FU Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed One Prior Line of Palliative Chemotherapy - The Phase II/III RAMIRIS Study

TypeinterventionalSponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestRan2017 to 2026Enrolled429ConditionsAdvanced Gastric or EGJ CancerArmsFOLFIRI, Ramucirumab, Paclitaxel
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  13. Trifluridine/tipiracil plus ramucirumab in gastric cancer.The lancet. Gastroenterology & hepatology · 2021
    Article
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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

6 authors at 3 institutions in 1 country.

Samuel J KlempnerThe Angeles Clinic and Research Institute, Los Angeles, California, USA.ORCID 0000-0002-4062-0808
Steven B MaronDepartment of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences, Chicago, Illinois, USA.
Leah ChaseDepartment of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences, Chicago, Illinois, USA.
Samantha LomnickiDepartment of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences, Chicago, Illinois, USA.
Zev A WainbergDivision of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Daniel V T CatenacciDepartment of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences, Chicago, Illinois, USA dcatenac@bsd.uchicago.edu.
University of Chicago Medical Center · USAngeles Clinic and Research Institute · USUniversity of California, Los Angeles · US

Funding

VIRAL ONCOLOGY CORE FACILITYP30CA014599 · NCI · UNIVERSITY OF CHICAGO · PI CHIEN-MIN KAO · 1985 to 2026
$122.1M
PANGEA: Personalized Antibodies for GastroEsophageal Adenocarcinoma Pilot TrialK23CA178203 · NCI · UNIVERSITY OF CHICAGO · PI CATENACCI, DANIEL · 2014 to 2016
$507k
NCI NIH HHS K23 CA178203NCI NIH HHS P30 CA014599
6 · The paper itself

Abstract

backgroundThe randomized phase III RAINBOW trial established paclitaxel (pac) plus ramucirumab (ram) as a global standard for second-line (2L) therapy in advanced gastric and gastroesophageal junction adenocarcinoma, together gastroesophageal adenocarcinoma (GEA). Patients (pts) receiving first-line (1L) FOLFOX often develop neuropathy that renders continued neurotoxic agents in the 2L setting unappealing and other regimens more desirable. As such, FOLFIRI-ram has become an option for patients with 2L GEA. FOLFIRI-ramucirumab (ram) has demonstrated safety and activity in 2L colorectal cancer, but efficacy/safety data in GEA are lacking. SUBJECTS, MATERIALS, AND

methodsPatients with GEA treated with 2L FOLFIRI-ram between August 2014 and April 2018 were identified. Clinicopathologic data including oxaliplatin neurotoxicity rates/grades (G), 2L treatment response, progression-free survival (PFS), overall survival (OS), safety, and molecular features were abstracted from three U.S. academic institutions. Kaplan-Meier survival analysis was used to generate PFS/OS; the likelihood ratio test was used to determine statistical significance.

resultsWe identified 29 pts who received 2L FOLFIRI-ram. All pts received 1L platinum + fluoropyrimidine, and 23 of 29 (79%) had post-1L neuropathy; 12 (41%) had G1, and 11 (38%) had G2. Patients were evenly split between esophagus/gastroesophageal junction (12; 41%) and gastric cancer (17; 59%). Among evaluable pts (26/29), the overall response rate was 23% (all partial response) with a disease control rate of 79%. Median PFS was 6.0 months and median OS was 13.4 months among all evaluable pts. Six- and 12-month OS were 90% (

conclusionWe provide the first data suggesting FOLFIRI-ram is a safe, non-neurotoxic regimen comparing favorably with the combination of pac + ram used in the seminal RAINBOW trial. IMPLICATIONS FOR PRACTICE: Results of this study provide initial support for the safety and efficacy of second-line (2L) FOLFIRI-ramucirumab (ram) after progression on first-line platinum/fluoropyrimidine in patients with gastroesophageal adenocarcinoma (GEA). The overall response, progression-free survival, overall survival, and toxicity profile compare favorably with paclitaxel (pac) + ram and highlight the importance of the ongoing phase II RAMIRIS trial examining FOLFIRI-ram versus pac + ram in 2L GEA (NCT03081143). FOLFIRI-ram may warrant consideration for inclusion as an alternate regimen in consensus guidelines for GEA.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilFollow-Up StudiesHumansLeucovorinMaleMiddle AgedAntibodies, Monoclonal, HumanizedCamptothecinFluorouracilLeucovorinPaclitaxelRamucirumabFOLFIRIGastric cancerGEJ adenocarcinomaRamucirumabSecond line

Identifiers

PMID30470690
PMCPMC6459251
OpenAlexW2900894539

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.