Evidence map›Paper›PMID 37703596›Full record

Trial reportESMO open2023

Ramucirumab plus FOLFIRI as second-line treatment for patients with RAS wild-type metastatic colorectal cancer previously treated with anti-EGFR antibody: JACCRO CC-16.

H Yasui, Y Okita, M Nakamura, T Sagawa, T Watanabe, K Kataoka, D Manaka, K Shiraishi, N Akazawa, T Okuno and 10 more

Open access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
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  5. Review
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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

20 authors at 17 institutions in 1 country.

H YasuiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe.
Y OkitaDepartment of Clinical Oncology, Faculty of Medicine, Kagawa University, Kita-gun.
M NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto.
T SagawaDepartment of Gastroenterology, National Hospital Organization Hokkaido Cancer Center, Sapporo.
T WatanabeDepartment of Surgery, Japanese Red Cross Society Himeji Hospital, Himeji.
K KataokaDivision of Lower GI, Department of Gastroenterological Surgery, Hyogo Medical University, Nishinomiya.
D ManakaDepartment of Surgery, Gastro-Intestinal Center, Kyoto Katsura Hospital, Kyoto.
K ShiraishiDepartment of Medical Oncology, National Hospital Organization Nagoya Medical Center, Nagoya.
N AkazawaDepartment of Gastroenterological Surgery, Sendai City Medical Center Sendai Open Hospital, Sendai.
T OkunoDepartment of Medical Oncology, Osaka Rosai Hospital, Sakai.
T ShimuraDepartment of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya.
M ShiozawaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama.
Y SunakawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki.
H OtaDepartment of Gastroenterological Surgery, Ikeda City Hospital, Ikeda.
M KotakaGastrointestinal Cancer Center, Sano Hospital, Kobe.
H OkuyamaDepartment of Clinical Oncology, Faculty of Medicine, Kagawa University, Kita-gun.
M TakeuchiGraduate School of Mathematical Sciences, The University of Tokyo, Meguro-ku.
W IchikawaDivision of Medical Oncology, Showa University Fujigaoka Hospital, Yokohama.
M FujiiDepartment of Digestive Surgery, Nihon University School of Medicine, Itabashi-ku, Japan.
A TsujiDepartment of Clinical Oncology, Faculty of Medicine, Kagawa University, Kita-gun. Electronic address: tsuji.akihito@kagawa-u.ac.jp.
Kagawa University · JPAizawa Hospital · JPHimeji Red Cross Hospital · JPHyogo University · JPIkeda Municipal Hospital · JPKanagawa Prefectural Hospital Organization · JPKobe City Medical Center General Hospital · JPKyoto Katsura Hospital · JPNagoya City University · JPNagoya Medical Center · JPNational Hospital Organization Hokkaido Medical Center · JPNihon University · JPOsaka Rosai Hospital · JPSendai Medical Center · JPShowa University Fujigaoka Hospital · JPSt. Marianna University School of Medicine · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemotherapy in combination with anti-epidermal growth factor receptor (EGFR) antibody is considered a first-line treatment regimen for RAS wild-type and left-sided metastatic colorectal cancer (mCRC), whereas second-line treatment regimens have not yet been established. Few studies have prospectively evaluated second-line treatment with anti-vascular endothelial growth factor antibody after first-line anti-EGFR antibody therapy for RAS wild-type mCRC. PATIENTS AND

methodsThis non-randomized phase II trial investigated the clinical outcomes of second-line ramucirumab (RAM) plus fluorouracil, levofolinate, and irinotecan (FOLFIRI) after first-line anti-EGFR antibody in combination with doublet or triplet regimen in patients with RAS wild-type mCRC. The primary endpoint was the 6-month progression-free survival (PFS) rate. The secondary endpoints were PFS, overall survival (OS), objective response rate (ORR), rate of early tumor shrinkage (ETS), and safety. We hypothesized a threshold 6-month PFS rate of 30% and an expected 6-month PFS rate of 45%. Treatment was considered effective if the lower limit of the 90% confidence interval (CI) of the 6-month PFS rate was >0.30.

resultsNinety-two patients were enrolled in the study. The primary tumor was located on the left side in 86 (95.6%) patients. Twenty (22.0%) patients had received triplet plus cetuximab as previous therapy. Six-month PFS rate was 58.2% (90% CI 49.3% to 66.2%) with a median PFS of 7.0 months (95% CI 5.7-7.6 months). Median OS was 23.6 months (95% CI 16.5-26.3 months). The ORR and ETS rate were 10.7% and 16.9%, respectively, in 83 patients with measurable lesions. The 6-month PFS rate was comparable between patients previously treated with doublet and triplet regimens; however, median PFS was longer for the doublet regimen (7.4 versus 6.4 months, P = 0.036).

conclusionsOur study demonstrated prospectively that RAM plus FOLFIRI is an effective second-line treatment after anti-EGFR antibody-containing first-line therapy in RAS wild-type and left-sided mCRC. Furthermore, the results were similar for patients who were previously treated with triplet regimen.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCetuximabErbB ReceptorsHumansRamucirumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCetuximabEGFR protein, humanErbB ReceptorsRamucirumabchemotherapycolorectal cancerramucirumabRAS wild-type

Identifiers

PMID37703596
PMCPMC10594013
OpenAlexW4386642693

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.