Evidence map›Paper›PMID 29713499›Full record

ArticleESMO open2018

Safety data from the phase III Japanese ACHIEVE trial: part of an international, prospective, planned pooled analysis of six phase III trials comparing 3 versus 6 months of oxaliplatin-based adjuvant chemotherapy for stage III colon cancer.

Masahito Kotaka, Takeharu Yamanaka, Takayuki Yoshino, Dai Manaka, Tetsuya Eto, Junichi Hasegawa, Akinori Takagane, Masato Nakamura, Takeshi Kato, Yoshinori Munemoto and 10 more

Open 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. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 15% 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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 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

20 authors at 17 institutions in 1 country.

Masahito KotakaGastrointestinal Cancer Center, Sano Hospital, Hyogo, Japan.
Takeharu YamanakaDepartment of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan.
Takayuki YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Dai ManakaDepartment of Surgery, Gastrointestinal Center, Kyoto Katsura Hospital, Kyoto, Japan.
Tetsuya EtoDepartment of Gastroenterology, Tsuchiura Kyodo General Hospital, Ibaraki, Japan.
Junichi HasegawaDepartment of Surgery, Osaka Rosai Hospital, Osaka, Japan.
Akinori TakaganeDepartment of Surgery, Hakodate Goryoukaku Hospital, Hokkaido, Japan.
Masato NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, Nagano, Japan.
Takeshi KatoDepartment of Surgery, Kansai Rosai Hospital, Hyogo, Japan.
Yoshinori MunemotoDepartment of Surgery, Fukui-ken Saiseikai Hospital, Fukui, Japan.
Fumitaka NakamuraDepartment of Surgery, Teine Keijinkai Hospital, Hokkaido, Japan.
Hiroyuki BandoGastroenterological Surgery, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.
Hiroki TaniguchiDepartment of Surgery, Kyoto Second Red Cross Hospital, Kyoto, Japan.
Makio GamohDepartment of Medical Oncology, Osaki Citizen Hospital, Miyagi, Japan.
Manabu ShiozawaGastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan.
Shigetoyo SajiJapanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
Yoshihiko MaeharaKyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Tsunekazu MizushimaDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Atsushi OhtsuDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Masaki MoriDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
National Cancer Center Hospital East · JPOsaka University · JPAizawa Hospital · JPFukui-ken Saiseikai Hospital · JPHakodate National Hospital · JPIshikawa Prefectural Central Hospital · JPJapanese Foundation for Multidisciplinary Treatment of Cancer · JPKanagawa Prefectural Hospital Organization · JPKansai Rosai Hospital · JPKyoto first Red Cross hospital · JPKyoto Katsura Hospital · JPKyushu University · JPOsaka Rosai Hospital · JPOsaki Citizen Hospital · JPTeine Keijinkai Hospital · JPTsuchiura Kyodo General Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe International Duration Evaluation of Adjuvant chemotherapy project investigated whether a shorter duration of oxaliplatin-based adjuvant chemotherapy was as effective as 6 months of identical chemotherapy for resected stage III colon cancer. As part of this project, we report safety data from the Japanese ACHIEVE study (JFMC47-1202-C3). PATIENTS AND

methodsACHIEVE was an open-label, multicentre trial randomising patients with stage III colon cancer to receive 3 m or 6 m of mFOLFOX6/CAPOX after surgery. Choice of regimen was declared before randomisation by a site investigator.

resultsBetween August 2012 and June 2014, 1313 patients were enrolled and, of those, 1277 were analysed for the safety analysis, with 635 in arm 6 (mFOLFOX6, n=158; CAPOX, n=477) and 642 in arm 3 (mFOLFOX6, n=161; CAPOX, n=481). Grade 3 or worse peripheral sensory neuropathy (PSN) developed in 5%/0.6% of patients receiving mFOLFOX6 in arm 6/3 (p=0.019) and 6%/1% of those receiving CAPOX in arm 6/3 (p<0.001). Similarly, grade 2 or worse PSN developed in 36%/11% of patients receiving mFOLFOX6 in arm 6/3 (p<0.001) and 37%/14% of those receiving CAPOX in arm 6/3 (p<0.001). An association between baseline creatinine clearance (CCr) and adverse events (AEs) was found that patients with CAPOX were significantly more likely to develop AEs ≥grade 3 when they had a CCr ≤50 (OR 1.67; p=0.048).

conclusionsWe confirmed in the Japanese population that the shorter duration of adjuvant chemotherapy resulted in a significant reduction of PSN. In patients with CAPOX, renal function was significantly related to severe AEs. TRIAL REGISTRATION NUMBER: UMIN000008543, Results.

Indexed as

adjuvant oxaliplatincolon cancercreatinine clearanceneuropathytreatment duration

Identifiers

PMID29713499
PMCPMC5922566
OpenAlexW2801386470

What OpenQuestion holds

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LicenceCC BY-NC
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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.