Evidence map›Paper›PMID 27712015›Full record

Trial reportCancer science2016

Randomized study of FOLFIRI plus either panitumumab or bevacizumab for wild-type KRAS colorectal cancer-WJOG 6210G.

Kohei Shitara, Kimio Yonesaka, Tadamichi Denda, Kentaro Yamazaki, Toshikazu Moriwaki, Masahiro Tsuda, Toshimi Takano, Hiroyuki Okuda, Tomohiro Nishina, Kazuko Sakai and 6 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 8 pooled it
4.1field-weighted citation impact, top 5% 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

43 citing papers in PubMed, 8 syntheses or guidelines pooled it, 68 citations in OpenAlex.

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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

16 authors at 12 institutions in 1 country.

Kohei ShitaraDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Kimio YonesakaDepartment of Medical Oncology, Kinki University Faculty of Medicine, Osaka, Japan.
Tadamichi DendaDivision of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
Kentaro YamazakiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Toshikazu MoriwakiDivision of Gastroenterology, University of Tsukuba, Tsukuba, Japan.
Masahiro TsudaDepartment of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.
Toshimi TakanoDepartment of Medical Oncology, Toranomon Hospital, Tokyo, Japan.
Hiroyuki OkudaDepartment of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Kazuko SakaiDepartment of Genome Biology, Kindai University Faculty of Medicine, Osaka, Japan.
Kazuto NishioDepartment of Genome Biology, Kindai University Faculty of Medicine, Osaka, Japan.
Shoji TokunagaMedical Information Center, Kyushu University Hospital, Fukuoka, Japan.
Takeharu YamanakaDepartment of Biostatistics, Yokohama City University, Yokohama, Japan.
Narikazu BokuDivision of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Ichinosuke HyodoDivision of Gastroenterology, University of Tsukuba, Tsukuba, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Kindai University · JPNational Cancer Center Hospital East · JPUniversity of Tsukuba · JPAichi Cancer Center · JPChiba Cancer Center · JPHyogo Prefectural Cancer Center · JPKeiyukai Sapporo Hospital · JPKyushu University Hospital · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPToranomon Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This randomized phase II trial compared panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) with bevacizumab plus FOLFIRI as second-line chemotherapy for wild-type (WT) KRAS exon 2 metastatic colorectal cancer (mCRC) and to explore the values of oncogenes in circulating tumor DNA (ctDNA) and serum proteins as predictive biomarkers. Patients with WT KRAS exon 2 mCRC refractory to first-line chemotherapy containing oxaliplatin and bevacizumab were randomly assigned to panitumumab plus FOLFIRI or bevacizumab plus FOLFIRI. Of 121 randomly assigned patients, 117 were eligible. Median overall survival (OS) for panitumumab plus FOLFIRI and bevacizumab plus FOLFIRI were 16.2 and 13.4 months [hazard ratio (HR), 1.16; 95% CI, 0.76-1.77], respectively. Progression-free survival (PFS) was also similar (HR, 1.14; 95% CI, 0.78-1.66). KRAS, NRAS, and BRAF status using ctDNA was successfully examined in 109 patients, and mutations were identified in 19 patients (17.4%). Panitumumab plus FOLFIRI showed favorable survival compared with bevacizumab plus FOLFIRI in WT patients and unfavorable survival in those with mutations (P for interaction = 0.026 in OS and 0.054 in PFS). OS with bevacizumab plus FOLFIRI was better than panitumumab plus FOLFIRI in patients with high serum vascular endothelial growth factor-A (VEGF-A) levels and worse in those with low levels (P for interaction = 0.016). Second-line FOLFIRI plus panitumumab and FOLFIRI plus bevacizumab showed a similar efficacy in patients with WT KRAS exon 2 mCRC. RAS and BRAF mutation in ctDNA could be a negative predictive marker for panitumumab.

Indexed as

AdultAgedAged, 80 and overAllelesAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorCamptothecinColorectal NeoplasmsFemaleFluorouracilHumansKaplan-Meier EstimateLeucovorinMaleAntibodies, MonoclonalBevacizumabBiomarkers, TumorCamptothecinFluorouracilLeucovorinPanitumumabProto-Oncogene Proteins B-rafras ProteinsBevacizumabcolorectal cancerliquid biopsypanitumumabRAS mutation

Identifiers

PMID27712015
PMCPMC5198953
OpenAlexW2529551829

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.