Evidence map›Paper›PMID 35635652›Full record

Trial reportInternational journal of clinical oncology2022

Efficacy and safety of regorafenib dose-escalation therapy for Japanese patients with refractory metastatic colorectal cancer (RECC study).

Shun Ishiyama, Takeshi Yamada, Masato Nakamura, Masanobu Enomoto, Kiichi Sugimoto, Hajime Yokomizo, Chihiro Kosugi, Ryo Ohta, Kei Ishimaru, Hiromichi Sonoda and 11 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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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

21 authors at 13 institutions in 1 country.

Shun Ishiyama *Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.
Takeshi Yamada *Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. y-tak@nms.ac.jp.ORCID http://orcid.org/0000-0002-1436-7482
Masato NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, Nagano, Japan.
Masanobu EnomotoDepartment of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
Kiichi SugimotoDepartment of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.
Hajime YokomizoDepartment of Surgery, Tokyo Women's Medical University, Medical Center East, Tokyo, Japan.
Chihiro KosugiDepartment of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan.
Ryo OhtaDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Kei IshimaruDepartment of Minimally Invasive Gastroenterology, Ehime University Graduate School of Medicine, Ehime, Japan.
Hiromichi SonodaDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Keiichiro IshibashiDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Hidekazu KuramochiDepartment of Chemotherapy, Tokyo Women's Medical University, Yachiyo Medical Center, Chiba, Japan.
Yoichiro YoshidaDepartment of Gastroenterological Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Daisuke IchikawaFirst Department of Surgery, Faculty of Medicine, University of Yamanashi, Yamanashi, Japan.
Keiji HirataDepartment of Surgery 1, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Hiroshi YoshidaDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Yojiro HashiguchiDepartment of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
Hideyuki IshidaDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Keiji KodaDepartment of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan.
Kenji KatsumataDepartment of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
Kazuhiro SakamotoDepartment of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.
Nippon Medical School · JPJuntendo University · JPSocial Insurance Saitama Chuo Hospital · JPTeikyo University Chiba Medical Center · JPTokyo Medical University · JPAizawa Hospital · JPEhime University · JPFukuoka University · JPTeikyo University · JPTokyo Women's Medical University · JPTokyo Women's Medical University Adachi Medical Center · JPUniversity of Occupational and Environmental Health Japan · JPUniversity of Yamanashi · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRegorafenib significantly improves overall survival in previously treated metastatic colorectal cancer patients. However, various toxicities, such as hand-foot skin reaction (HFSR), fatigue, and liver dysfunction have limited the use of regorafenib. These toxicities appear soon after treatment initiation. The ReDOS study demonstrated the effectiveness of a weekly dose-escalation therapy of regorafenib starting with a lower daily dose; however, its usefulness in Asian subjects is unknown. We conducted a phase II study to evaluate the safety and survival benefit of regorafenib dose-escalation therapy for Japanese patients.

methodsPatients with sufficient organ function, who had previously received more than two lines of chemotherapy were included. Regorafenib was started at 80 mg/day and escalated to 120 mg/day in Week 2 and 160 mg/day in Week 3, if no severe drug-related toxicities were observed. The primary endpoint was cancer progression-free survival (PFS). Tumor response and progression were assessed radiologically every 8 weeks. This study was registered in the University Hospital Medical Information Network (UMIN#UMIN000028933).

results57 patients were enrolled and all started regorafenib at 80 mg/day. 32 patients (56.1%) were subsequently escalated to 120 mg/day and 19 (33.3%) to 160 mg/day. Only 8 patients (14.0%) discontinued treatment because of adverse events. Median PFS was 1.9 months. Median overall survival was 8.9 months, the response rate was 0%, and the disease control rate was 31.6%. The most frequent adverse event greater than grade 3 was hypertension (19.3%), followed by HFSR (14.0%).

conclusionsRegorafenib dose-escalation therapy is well tolerated with PFS-like regorafenib standard therapy.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsRectal NeoplasmsHumansJapanPhenylurea CompoundsPyridinesPhenylurea CompoundsPyridinesregorafenibColorectal cancerDose-escalationJapanese patientsRegorafenib

Identifiers

PMID35635652
OpenAlexW4281641872

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.