Evidence map›Paper›PMID 33508242›Full record

Trial reportThe lancet. Gastroenterology & hepatology2021

Safety and activity of trifluridine/tipiracil and ramucirumab in previously treated advanced gastric cancer: an open-label, single-arm, phase 2 trial.

Akihito Kawazoe, Takayuki Ando, Hisashi Hosaka, Junya Fujita, Keisuke Koeda, Kazuhiro Nishikawa, Kenji Amagai, Kazumasa Fujitani, Kazuhiro Ogata, Keita Watanabe and 2 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in The lancet. Gastroenterology & hepatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 4% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

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  17. Efficacy and safety of trifluridine/tipiracil plus ramucirumab in comparison with trifluridine/tipiracil monotherapy for patients with advanced gastric cancer-single institutional experience.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 1 country.

Akihito KawazoeDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Takayuki AndoThird Department of Internal Medicine, Toyama University Hospital, Toyama, Japan.
Hisashi HosakaDepartment of Gastroenterology, Gunma Prefectural Cancer Center, Ota, Japan.
Junya FujitaDepartment of Surgery, Sakai City Medical Center, Osaka, Japan.
Keisuke KoedaDepartment of Medical Safety Science, Iwate Medical University Hospital, Shiwa, Japan.
Kazuhiro NishikawaDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Kenji AmagaiGastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan.
Kazumasa FujitaniDepartment of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan.
Kazuhiro OgataDepartment of Medical Affairs, Taiho Pharmaceutical Co, Tokyo, Japan.
Keita WatanabeDepartment of Clinical Development, Taiho Pharmaceutical Co, Tokyo, Japan.
Yuji YamamotoDepartment of Clinical Development, Taiho Pharmaceutical Co, Tokyo, Japan.
Kohei ShitaraDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: kshitara@east.ncc.go.jp.
Taiho Pharmaceutical (Japan) · JPNational Cancer Center Hospital East · JPHyogo Prefectural Cancer Center · JPIbaraki Prefectural Central Hospital · JPIwate Medical University · JPOsaka National Hospital · JPOsaka Prefectural Medical Center · JPSakai Municipal Hospital · JPToyama University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFindings of preclinical and clinical trials in colorectal cancer have shown promising antitumour effects of the co-formulation trifluridine/tipiracil and VEGF inhibition. We aimed to investigate the safety and activity of trifluridine/tipiracil and ramucirumab for previously treated advanced gastric cancer.

methodsWe did an open-label, single-arm, two-cohort, phase 2 study at eight centres in Japan. We enrolled patients with unresectable advanced gastric cancer or gastro-oesophageal junction adenocarcinoma. Cohort A included patients previously treated with one line of chemotherapy without ramucirumab and cohort B included patients previously treated with two to four lines of chemotherapy, including ramucirumab. Patients received trifluridine/tipiracil (35 mg/m

findingsBetween April 8 and Oct 11, 2019, 64 patients were enrolled and included in the safety and activity analyses, 33 in cohort A and 31 in cohort B. In cohort A, the disease control rate was 85% (95% CI 68-95; 28 of 33 patients) and in cohort B it was 77% (59-90; 24 of 31 patients). Common treatment-related adverse events of grade 3 or worse were neutrophil count decreased (27 [82%] in cohort A and 23 [74%] in cohort B), white blood cell count decreased (eight [24%] and seven [23%]), and platelet count decreased (eight [24%] and four [13%]). Serious treatment-related adverse events were recorded in three patients in cohort A (fatigue and neutrophil count decreased; large intestine perforation; and febrile neutropenia, platelet count decreased, and anaemia). No patients in cohort B had a serious treatment-related adverse event, and no treatment-related deaths were reported in either cohort.

interpretationTrifluridine/tipiracil and ramucirumab showed an acceptable safety profile and clinical activity in patients with previously treated advanced gastric cancer regardless of previous ramucirumab exposure.

fundingTaiho Pharmaceutical and Eli Lilly.

Indexed as

AdenocarcinomaAdministration, IntravenousAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCase-Control StudiesDrug CombinationsEsophageal NeoplasmsFemaleHumansJapanMaleMiddle AgedNeoplasm StagingProgression-Free SurvivalPyrrolidinesAntibodies, Monoclonal, HumanizedDrug CombinationsPyrrolidinesRamucirumabThymineTrifluridinetrifluridine tipiracil drug combination

Identifiers

PMID33508242
OpenAlexW3125158795

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.