Evidence map›Paper›PMID 29713498›Full record

ArticleESMO open2018

Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set.

Axel Grothey, Takayuki Yoshino, Gyorgy Bodoky, Tudor Ciuleanu, Rocio Garcia-Carbonero, Pilar García-Alfonso, Eric Van Cutsem, Kei Muro, Daniel S Mytelka, Li Li and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in ESMO open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01183780 (A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.3field-weighted citation impact, top 16% 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.

NCT01183780 phase3completednot on this map

A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

TypeinterventionalSponsorEli Lilly and CompanyRan2010 to 2016Enrolled1,072ConditionsColorectal CancerArmsRamucirumab, Placebo, Irinotecan, Folinic Acid, 5-Fluorouracil
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Article
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  5. Article
  6. Hand-foot syndrome in cancer patients on capecitabine: examining prevalence, impacts, and associated risk factors at a cancer centre in Malaysia.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  7. Review
  8. Article
  9. Review
  10. Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2021
    Article
  11. Review
  12. 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

16 authors at 10 institutions in 6 countries.

Axel GrotheyMayo Clinic, Rochester, Minnesota, USA.
Takayuki YoshinoNational Cancer Center Hospital East, Kashiwa, Japan.
Gyorgy BodokySt László Hospital, Budapest, Hungary.
Tudor CiuleanuThe Oncology Institute Prof Dr Ion Chiricută and Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Rocio Garcia-CarboneroUniversity Hospital Virgen del Rocío, Sevilla, Spain.
Pilar García-AlfonsoHospital General Universitario Gregorio Maranon, Madrid, Spain.
Eric Van CutsemUniversity Hospitals Leuven - KU Leuven, Leuven, Belgium.
Kei MuroAichi Cancer Center Hospital, Nagoya, Japan.
Daniel S MytelkaFormerly of Eli Lilly and Company, Indianapolis, Indiana, USA.
Li LiEli Lilly and Company, Bridgewater, New Jersey, USA.
Olga LipkovichEli Lilly and Company, Bridgewater, New Jersey, USA.
Yanzhi HsuEli Lilly and Company, Bridgewater, New Jersey, USA.
Andreas SashegyiEli Lilly and Company, Bridgewater, New Jersey, USA.
David FerryEli Lilly and Company, Bridgewater, New Jersey, USA.
Federico NasroulahEli Lilly Argentina, Buenos Aires, Argentina.
Josep TaberneroVall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.
Eli Lilly (United States) · USAichi Cancer Center · JPHospital General Universitario Gregorio Marañón · ESHospital Universitario Virgen del Rocío · ESInstitute of Oncology Prof. Dr. Ion Chiricuta · ROKU Leuven · BEMayo Clinic · USNational Cancer Center Hospital East · JPUnified Szent István and Szent László Hospital · HUUniversitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the RAISE trial, ramucirumab+leucovorin/fluorouracil/irinotecan (FOLFIRI) improved the median overall survival (mOS) of patients with previously treated metastatic colorectal cancer versus patients treated with placebo+FOLFIRI but had a higher incidence of neutropaenia, leading to more chemotherapy dose modifications and discontinuations. Thus, we conducted an exploratory post-hoc analysis of RAISE and a retrospective, observational analysis of electronic medical record (EMR) data to determine and verify the association of neutropaenia, baseline absolute neutrophil count (ANC) and survival.

methodsThe RAISE analysis used the study safety population (n=1057). IMS Health Oncology Database (IMS EMR) was the source for the real-world data set (n=617).

resultsRAISE patients with treatment-emergent neutropaenia had improved mOS compared with those without (ramucirumab arm: 16.1 vs 10.7 months, HR=0.57, p<0.0001; placebo arm: 12.7 vs 10.7 months, HR=0.76, p=0.0065). RAISE patients with low ANC versus high baseline ANC also had longer mOS (ramucirumab arm: 15.2 vs 8.9 months, HR=0.49, p<0.0001; placebo arm: 13.2 vs 7.3 months, HR=0.50, p<0.0001). The results were similar for IMS EMR low versus high baseline ANC (bevacizumab+FOLFIRI patients: 14.9 vs 7.7 months, HR=0.59, p<0.0001; FOLFIRI alone: 14.6 vs 5.4 months, HR=0.37, p<0.0001). Patients in the RAISE trial with low baseline ANC were more likely to develop neutropaenia (OR: ramucirumab arm=2.62, p<0.0001; placebo arm=2.16, p=0.0003).

conclusionNeutropaenia during treatment, and subsequent dose modifications or discontinuations, do not compromise treatment efficacy. Baseline ANC is a strong prognostic factor for survival and is associated with treatment-emergent neutropaenia in the analysed population. TRIAL REGISTRATION NUMBER: NCT01183780, Results.

Indexed as

bevacizumabelectronic medical recordsneutropeniaprognosticramucirumab

Identifiers

PMID29713498
PMCPMC5922565
OpenAlexW2802663922

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.