Evidence map›Paper›PMID 28894015›Full record

Observational studyThe oncologist2018

Propensity Score Analysis of Regorafenib Versus Trifluridine/Tipiracil in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapy (REGOTAS): A Japanese Society for Cancer of the Colon and Rectum Multicenter Observational Study.

Toshikazu Moriwaki, Shota Fukuoka, Hiroya Taniguchi, Atsuo Takashima, Yusuke Kumekawa, Takeshi Kajiwara, Kentaro Yamazaki, Taito Esaki, Chinatsu Makiyama, Tadamichi Denda and 16 more

Open access · hybridAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in The oncologist, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 7 pooled it
4.9field-weighted citation impact, top 3% 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

59 citing papers in PubMed, 7 syntheses or guidelines pooled it, 104 citations in OpenAlex.

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  7. Beyond second-line therapy in patients with metastatic colorectal cancer: a systematic review.Annals of oncology : official journal of the European Society for Medical Oncology · 2018
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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

26 authors at 20 institutions in 1 country.

Toshikazu MoriwakiDivision of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan tmoriwak@gmail.com.
Shota FukuokaDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Hiroya TaniguchiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya, Aichi, Japan.
Atsuo TakashimaGastrointestinal Medical Oncology Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Yusuke KumekawaDepartment of Gastroenterology, Saitama Cancer Center, Ina-machi, Kitaadachi-gun, Saitama, Japan.
Takeshi KajiwaraDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Minamiumemoto-machi, Matsuyama, Ehime, Japan.
Kentaro YamazakiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Minami-ku, Fukuoka, Fukuoka, Japan.
Chinatsu MakiyamaDepartment of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan.
Tadamichi DendaDivision of Gastroenterology, Chiba Cancer Center, Chuo-ku, Chiba, Chiba, Japan.
Hironaga SatakeDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Chuo-ku, Kobe, Hyogo, Japan.
Takeshi SutoDepartment of Gastroenterological Surgery, Yamagata Prefectural Central Hospital, Yamagata, Yamagata, Japan.
Naotoshi SugimotoDepartment of Medical Oncology, Osaka International Cancer Institute, Chuo-ku, Osaka, Osaka, Japan.
Masanobu EnomotoDepartment of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.
Toshiaki IshikawaDepartment of Specialized Surgeries, Tokyo Medical and Dental University, Graduate School of Medicine and Dentistry, Bunkyo-ku, Tokyo, Japan.
Tomomi KashiwadaDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Saga, Japan.
Masahiko SugiyamaDepartment Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Higashi-ku, Fukuoka, Fukuoka, Japan.
Yoshito KomatsuDepartment of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Kita-ku, Sapporo, Hokkaido, Japan.
Hiroyuki OkuyamaDepartment of Clinical Oncology, Faculty of Medicine, Kagawa University, Miki-cho, Kita-gun, Kagawa, Japan.
Eishi BabaDepartment of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University, Higashi-ku, Fukuoka, Fukuoka, Japan.
Daisuke SakaiDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Tomoki WatanabeDepartment of Surgery, National Defense Medical College Hospital, Tokorozawa, Saitama, Japan.
Takao TamuraDepartment of Medical Oncology, Kindai University, Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
Kimihiro YamashitaDivision of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Chuo-ku, Kobe, Hyogo, Japan.
Masahiko GoshoDepartment of Clinical Trial and Clinical Epidemiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Yasuhiro ShimadaClinical Oncology Division, Kochi Health Sciences Center, Kochi, Kochi, Japan.
Kyushu University · JPNational Cancer Center Hospital East · JPUniversity of Tsukuba · JPAichi Cancer Center · JPChiba Cancer Center · JPHokkaido University Hospital · JPKagawa University · JPKindai University · JPKobe City Medical Center General Hospital · JPKobe University · JPKyushu Hospital · JPNational Defense Medical College Hospital · JPNational Hospital Organization Kyushu Cancer Center · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPOsaka University · JPSaga University · JPSaitama Cancer Center · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPTokyo Medical and Dental University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study compared the efficacy of regorafenib and trifluridine/tipiracil (TFTD) in patients with metastatic colorectal cancer (mCRC) who are refractory to standard chemotherapy, because despite their clinical approval, it still remains unclear which of these two drugs should be used as initial treatment. MATERIALS AND

methodsThe clinical data of patients with mCRC who were treated with regorafenib or TFTD and those of drug-naive patients, between June 2014 and September 2015, were retrospectively collected from 24 institutions in Japan. Overall survival (OS) was evaluated using the Cox's proportional hazard models based on propensity score adjustment for baseline characteristics.

resultsA total of 550 patients (223 patients in the regorafenib group and 327 patients in the TFTD group) met all criteria. The median OS was 7.9 months (95% confidence interval [CI], 6.8-9.2) in the regorafenib group and 7.4 months (95% CI, 6.6-8.3) in the TFTD group. The propensity score adjusted analysis showed that OS was similar between the two groups (adjusted hazard ratio [HR], 0.96; 95% CI, 0.78-1.18). In the subgroup analysis, a significant interaction with age was observed. Regorafenib showed favorable survival in patients aged <65 years (HR, 1.29; 95% CI, 0.98-1.69), whereas TFTD was favored in patients aged ≥65 years (HR, 0.78; 95% CI, 0.59-1.03).

conclusionNo significant difference in OS between regorafenib and TFTD was observed in patients with mCRC. Although the choice of the drug by age might affect survival, a clearly predictive biomarker to distinguish the two drugs should be identified in further studies. IMPLICATIONS FOR PRACTICE: Previous studies of patients with metastatic colorectal cancer refractory to standard chemotherapy had demonstrated that both regorafenib and trifluridine/tipiracil could result in increased overall survival compared with placebo, but there are no head-to-head trials. This large, multicenter, observational study retrospectively compared the efficacy of regorafenib and trifluridine/tipiracil in 550 patients with metastatic colorectal cancer refractory to standard chemotherapy who had access to both drugs. Although no difference in overall survival was found between the two drugs in adjusted analysis using propensity score, regorafenib showed favorable survival in patients aged <65 years, whereas trifluridine/tipiracil was favored in patients aged ≥65 years in the subgroup analysis.

Indexed as

Salvage TherapyAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsColorectal NeoplasmsDrug CombinationsDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansJapanLiver NeoplasmsMaleDrug CombinationsPhenylurea CompoundsPyridinesPyrrolidinesregorafenibThymineTrifluridinetrifluridine tipiracil drug combinationUracilColorectal cancerPropensity scoreRegorafenibTAS‐102Trifluridine/tipiracil

Identifiers

PMID28894015
PMCPMC5759812
OpenAlexW2754547251

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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.