Evidence map›Paper›PMID 29484450›Full record

Trial reportInternational journal of colorectal disease2018

Safety of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: phase II clinical study (The FACOS study).

Chihiro Kosugi, Keiji Koda, Keiichiro Ishibashi, Kazuhiko Yoshimatsu, Soichi Tanaka, Ryouji Kato, Hiroyuki Kato, Masatoshi Oya, Kazuo Narushima, Mikito Mori and 2 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.0field-weighted citation impact, top 20% 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

10 citing papers in PubMed, 15 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

12 authors at 7 institutions in 1 country.

Chihiro KosugiDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. ckosugi0126@yahoo.co.jp.ORCID http://orcid.org/0000-0003-3719-6425
Keiji KodaDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.
Keiichiro IshibashiDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Kazuhiko YoshimatsuDepartment of Surgery, Medical Center East, Tokyo Women's Medical University, Tokyo, Japan.
Soichi TanakaDepartment of Surgery, Matsuda Hospital, Sendai, Japan.
Ryouji KatoDepartment of Surgery, Sakura Medical Center, School of Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.
Hiroyuki KatoFirst Department of Surgery, Dokkyo Medical University, Mibu, Japan.
Masatoshi OyaDepartment of Surgery, Koshigaya Hospital, Dokkyo Medical University, Mibu, Japan.
Kazuo NarushimaDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.
Mikito MoriDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.
Kiyohiko ShutoDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.
Hideyuki IshidaDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Teikyo University Chiba Medical Center · JPSocial Insurance Saitama Chuo Hospital · JPDokkyo Medical University · JPDokkyo Medical University Saitama Medical Center · JPSendai Shakai Hoken Hospital · JPToho University · JPTokyo Women's Medical University Adachi Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAdjuvant chemotherapy with oxaliplatin combined with a fluoropyrimidine derivative is widely accepted as standard therapy for patients with stage III colon cancer, since few clinical data are available for Japanese patients. The FACOS trial investigated the tolerability of modified FOLFOX6 (mFOLFOX6) and XELOX regimens in Japanese colon cancer patients.

methodsTwelve cycles of mFOLFOX6 or 8 cycles of XELOX were given to patients with eligibility: stage III curatively resected colon cancer, performance status of 0-1, age from 20 to 75 years, and adequate organ function. The primary endpoint was 3-year disease-free survival. Secondary endpoints were the incidence of adverse events (AEs) and the completion rate of study therapy.

resultsFrom April 2010 to April 2014, a total of 132 patients were enrolled. Safety was analyzed in 130 patients, with finalized data from 73 patients receiving mFOLFOX6 and 57 patients receiving XELOX. A total of 130 patients (100%) experienced AEs (any grade), and 52 patients (40.0%) experienced AEs of grade ≥ 3. No significant difference in the frequency of grade ≥ 3 AEs was observed between mFOLFOX6 and XELOX groups. Continuation of the planned cycle rate of protocol treatment was 69.9% in the mFOLFOX6 group and 68.4% in the XELOX group. Treatment was discontinued because of AEs in 14 patients (19.2%) in the mFOLFOX6 group and 8 (14.0%) in the XELOX group. Mean relative dose intensity for oxaliplatin was 78.0% in the mFOLFOX6 group and 82.8% in the XELOX group.

conclusionAs adjuvant chemotherapy for stage III colon cancer, mFOLFOX6/XELOX regimens are acceptable.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineChemotherapy, AdjuvantColonic NeoplasmsDeoxycytidineDose-Response Relationship, DrugFemaleFluorouracilFollow-Up StudiesHumansLeucovorinMaleMiddle AgedNeoplasm StagingCapecitabineDeoxycytidineFluorouracilLeucovorinOrganoplatinum CompoundsOxaloacetatesAdjuvant chemotherapyColon cancermFOLFOX6Stage IIIXELOX

Identifiers

PMID29484450
OpenAlexW2793692814

What OpenQuestion holds

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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.