Evidence map›Paper›PMID 28266091›Full record

Trial reportCancer science2017

Efficacy and safety of nivolumab in Japanese patients with advanced or recurrent squamous non-small cell lung cancer.

Toyoaki Hida, Makoto Nishio, Naoyuki Nogami, Yuichiro Ohe, Hiroshi Nokihara, Hiroshi Sakai, Miyako Satouchi, Kazuhiko Nakagawa, Mitsuhiro Takenoyama, Hiroshi Isobe and 12 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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

40 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  9. A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2020
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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

22 authors.

Toyoaki HidaAichi Cancer Center Hospital, Aichi, Japan.
Makoto NishioThe Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Naoyuki NogamiNational Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Yuichiro OheNational Cancer Center Hospital, Tokyo, Japan.
Hiroshi NokiharaNational Cancer Center Hospital, Tokyo, Japan.
Hiroshi SakaiSaitama Cancer Center, Saitama, Japan.
Miyako SatouchiHyogo Cancer Center, Hyogo, Japan.
Kazuhiko NakagawaKindai University Faculty of Medicine, Osaka, Japan.
Mitsuhiro TakenoyamaNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Hiroshi IsobeKKR Sapporo Medical Center, Sapporo, Japan.
Shiro FujitaInstitute of Biomedical Research and Innovation Hospital, Hyogo, Japan.
Hiroshi TanakaNiigata Cancer Center Hospital, Niigata, Japan.
Koichi MinatoGunma Prefectural Cancer Center, Gunma, Japan.
Toshiaki TakahashiShizuoka Cancer Center, Shizuoka, Japan.
Makoto MaemondoMiyagi Cancer Center, Miyagi, Japan.
Koji TakedaOsaka City General Hospital, Osaka, Japan.
Hideo SakaNational Hospital Organization Nagoya Medical Center, Aichi, Japan.
Koichi GotoNational Cancer Center Hospital East, Chiba, Japan.
Shinji AtagiNational Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
Tomonori HirashimaOsaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan.
Naoki SumiyoshiOno Pharmaceutical Co., Ltd, Osaka, Japan.
Tomohide TamuraSt. Luke's International Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Limited treatment options are available for stage IIIB/IV non-small cell lung cancer (NSCLC). Nivolumab, a programmed cell death-1 immune checkpoint inhibitor antibody, has been shown to be effective for the treatment of NSCLC. The present study investigated the effectiveness and safety of nivolumab in Japanese patients with advanced or recurrent squamous NSCLC that progressed after platinum-containing chemotherapy. In this multicenter phase II study, patients were treated with nivolumab (3 mg/kg, i.v.) every 2 weeks until progressive disease or unacceptable toxicity was seen. Primary endpoint was overall response rate (ORR) assessed by independent radiology review committee (IRC) and secondary endpoints included a study site-assessed ORR, overall survival (OS), progression-free survival (PFS), duration of response, time to response, best overall response (BOR), and safety. The study included 35 patients from 17 sites in Japan. Patients had IRC-assessed ORR of 25.7% (95% CI 14.2, 42.1) and the study site-assessed ORR was 20.0% (95% CI 10.0, 35.9). Median OS, median time to response and median PFS were 16.3 (95% CI 12.4-25.4), 2.7 (range 1.2-5.5) and 4.2 (95% CI 1.4-7.1) months, respectively. The IRC-assessed BOR was partial response, stable disease, and progressive disease for 25.7%, 28.6%, and 45.7% of patients, respectively. Treatment-related adverse events were reported in 24 patients (68.6%), most of which resolved with appropriate treatment including steroid therapy or ‎discontinuation of nivolumab. Nivolumab was effective and well tolerated in Japanese patients with advanced or recurrent squamous NSCLC that progressed after platinum-containing chemotherapy. CLINICAL TRIAL REGISTRATION NUMBER: JapicCTI-132072.

Indexed as

AgedAntibodies, MonoclonalAntineoplastic AgentsAsian PeopleCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellDisease-Free SurvivalFemaleHumansLung NeoplasmsMaleNeoplasm Recurrence, LocalNivolumabAntibodies, MonoclonalAntineoplastic AgentsNivolumabJapaneseNivolumabnon-small cell lung cancerprogrammed cell death-1squamous cell carcinoma

Identifiers

PMID28266091
PMCPMC5448646

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.