Evidence map›Paper›PMID 25937430›Full record

Trial reportInvestigational new drugs2015

A phase II study of bevacizumab with modified OPTIMOX1 as first-line therapy for metastatic colorectal cancer: the TCOG-GI 0802 study.

Norisuke Nakayama, Atsushi Sato, Soichi Tanaka, Ken Shimada, Kazuo Konishi, Eisaku Sasaki, Kenji Hibi, Hiroko Ichikawa, Yoshinori Kikuchi, Toshikazu Sakuyama and 4 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 94% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. 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

14 authors at 11 institutions in 1 country.

Norisuke NakayamaDepartment of Gastroenterology, Kanagawa Cancer Center Hospital, 2-3-2,Nakao, Asahi-ku, Yokohama City, 241-8515, Japan, norisuke@kcch.jp.
Atsushi Sato
Soichi Tanaka
Ken Shimada
Kazuo Konishi
Eisaku Sasaki
Kenji Hibi
Hiroko Ichikawa
Yoshinori Kikuchi
Toshikazu Sakuyama
Takashi Sekikawa
Kazuhiko Hayashi
Haruhiro Nishina
Tokyo Cooperative Oncology Group, Tokyo, Japan
Showa University · JPHirosaki University · JPJikei University School of Medicine · JPKanagawa Prefectural Hospital Organization · JPKoto Hospital · JPShowa University Fujigaoka Hospital · JPShowa University Northern Yokohama Hospital · JPToho University · JPTokyo Metropolitan Komagome Hospital · JPTokyo Rinkai Hospital · JPTokyo Women's Medical University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough bevacizumab plus FOLFOX is a standard treatment for metastatic colorectal cancer, oxaliplatin must be withdrawn in many patients because of cumulative neurotoxicity. We postulated that a reduced dose of oxaliplatin and modified treatment schedule would prolong the time to treatment failure and evaluated bevacizumab combined with a modified OPTIMOX1 regimen (mOPTIMOX1, oxaliplatin dose: 85 mg/m(2)).

methodsEligible patients had a histologically confirmed diagnosis of metastatic colorectal cancer and a performance status of 0-1. Patients were excluded if they had grade 1 or higher peripheral sensory neuropathy or had previously received chemotherapy for metastatic colorectal cancer. Patients received bevacizumab plus mFOLFOX6 every 2 weeks for 6 cycles, followed by 12 cycles of a simplified biweekly regimen of leucovorin and fluorouracil (sLV5FU2) plus bevacizumab. Oxaliplatin was then reintroduced, and bevacizumab plus mFOLFOX6 was continued until progressive disease.

resultsThe median duration of disease control was 11.7 months (95 % confidence interval [CI], 9.7-13.5 months). The median overall survival was 23.1 months (95 % CI, 18.8-27.9 months). The overall response rate according to both the RECIST and WHO criteria was 51.3 %. The most common grade 3 or 4 toxicities were neutropaenia (32.5 %), hypertension (17.5 %), leukocytopaenia, sensory neuropathy, and diarrhoea (10.0 %). There were no treatment-related deaths.

conclusionsBevacizumab plus mFOLFOX6 was well tolerated, and patients could continue chemotherapy for longer than with conventional FOLFOX regimens. This regimen might be an effective treatment option for patients with metastatic colorectal cancer.

Indexed as

AdultAgedAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsFemaleFluorouracilHumansKaplan-Meier EstimateLeucovorinMiddle AgedOrganoplatinum CompoundsTreatment OutcomeAngiogenesis InhibitorsBevacizumabFluorouracilLeucovorinOrganoplatinum Compounds

Identifiers

PMID25937430
OpenAlexW2037339347

What OpenQuestion holds

Textmetadata
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.