Evidence map›Paper›PMID 33249761›Full record

Trial reportCancer medicine2021

Trifluridine/tipiracil plus bevacizumab as a first-line treatment for elderly patients with metastatic colorectal cancer (KSCC1602): A multicenter phase II trial.

Eiji Oki, Akitaka Makiyama, Yuji Miyamoto, Masahiko Kotaka, Hirofumi Kawanaka, Keisuke Miwa, Akira Kabashima, Tomohiro Noguchi, Kotaro Yuge, Tomomi Kashiwada and 7 more

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 1 country.

Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID 0000-0002-9763-9366
Akitaka MakiyamaDepartment of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.
Yuji MiyamotoDepartment of Gastroenterological Surgery, Kumamoto University Graduate School of Medicine, Kumamoto, Japan.
Masahiko KotakaGastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.
Hirofumi KawanakaDepartment of Surgery, National Hospital Organization Beppu Medical Center, Beppu, Japan.
Keisuke MiwaDepartment of Surgery, Kurume University Hospital, Kurume, Japan.
Akira KabashimaDepartment of Surgery, National Hospital Organization Oita Medical Center, Oita, Japan.
Tomohiro NoguchiDepartment of Surgery, Imakiire General Hospital, Kagoshima, Japan.
Kotaro YugeDepartment of Surgery, Social Insurance Tagawa Hospital, Tagawa, Japan.
Tomomi KashiwadaDepartment of Internal Medicine, Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga University, Saga, Japan.
Koji AndoDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University, Yamaguchi, Japan.
Hiroshi SaekiDepartment of Gastroenterological Surgery, Gunma University Graduate School of Medicine, Maebashi, Japan.
Yoshito AkagiDepartment of Surgery, Kurume University Hospital, Kurume, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Kumamoto University Graduate School of Medicine, Kumamoto, Japan.ORCID 0000-0002-3183-3115
Yoshihiko MaeharaKyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
Masaki MoriDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kyushu University · JPKumamoto University · JPKurume University Hospital · JPBeppu Medical Center · JPGifu University Hospital · JPGunma University · JPImakiire General Hospital · JPKyushu Central Hospital of the Mutual Aid Association of Public School Teachers · JPOita Medical Center · JPSaga University · JPSanno Medical Center · JPTamagawa University · JPYamaguchi University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA previous Phase I/II study demonstrated that TAS-102 (trifluridine/tipiracil [FTD/TPI]) plus bevacizumab (Bev) has encouraging efficacy and controllable safety for patients with previously treated metastatic colorectal cancer. Therefore, we designed for assessing the efficacy and safety of FTD/TPI plus Bev in elderly patients with previously untreated metastatic colorectal cancer.

methodsThis is a multicenter, single-arm Phase II study included patients ≥70 years old with previously untreated, unresectable metastatic colorectal cancer. Treatment consisted of FTD/TPI plus Bev given every 4 weeks. The primary endpoint was progression-free survival (PFS), assuming a null hypothesis of a PFS of 5 months. The secondary endpoints were the overall survival (OS), overall response rate (ORR), and adverse events (AEs).

resultsBetween 5 January 2017 and 13 March 2018, 39 patients were enrolled from 18 institutions. The median patient age was 76.0 years (range, 70-88); the ECOG-PS was 0 in 24 patients and 1 in 15 patients. The median PFS was 9.4 months as a primary endpoint, and the median OS was 22.4 months. The ORR was 40.5% and the disease control rate was 86.5%. Grade 3-4 AEs included neutropenia (71.8%), leukopenia (51.3%), anorexia (15.4%), febrile neutropenia (10.3%), and fatigue (10.3%).

conclusionsFTD/TPI plus Bev is an effective and well-tolerated regimen for elderly patients with previously untreated metastatic colorectal cancer. Capecitabine/bevacizumab can be selected as a subsequent maintenance therapy without irinotecan and oxaliplatin because FTD/TPI has no cross-resistance with 5-fluorouracil. CLINICAL

trial registrationUMIN clinical trials registry (UMIN000025241).

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsFemaleFollow-Up StudiesHumansMalePrognosisPyrrolidinesSurvival RateThymineTrifluridineBevacizumabPyrrolidinesThyminetipiracilTrifluridinebevacizumabcolorectal cancerelderlythymidine phosphorylase inhibitorTrifluridine

Identifiers

PMID33249761
PMCPMC7877360
OpenAlexW3107837247

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.