Evidence map›Paper›PMID 36570411›Full record

ArticleTherapeutic advances in medical oncology2022

A phase II study of S-1 and cisplatin with concurrent thoracic radiotherapy followed by durvalumab for unresectable, locally advanced non-small-cell lung cancer in Japan (SAMURAI study): primary analysis.

Hisashi Tanaka, Shigeru Tanzawa, Toshihiro Misumi, Tomonori Makiguchi, Megumi Inaba, Takeshi Honda, Junya Nakamura, Koji Inoue, Takayuki Kishikawa, Masanao Nakashima and 23 more

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in medical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
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

33 authors at 20 institutions in 1 country.

Hisashi TanakaDepartment of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan.
Shigeru TanzawaDivision of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan.ORCID https://orcid.org/0000-0001-5738-0313
Toshihiro MisumiDepartment of Biostatistics, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.
Tomonori MakiguchiDepartment of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan.ORCID https://orcid.org/0000-0001-9249-7904
Megumi InabaDepartment of Respiratory Medicine, Kumamoto Chuo Hospital, Kumamoto, Kumamoto, Japan.
Takeshi HondaDivision of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan.
Junya NakamuraDepartment of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan.
Koji InoueDepartment of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan.
Takayuki KishikawaDepartment of Respiratory Medicine, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan.
Masanao NakashimaDepartment of Respiratory Medicine, Shin-Yurigaoka General Hospital, Kawasaki, Kanagawa, Japan.
Keiichi FujiwaraDepartment of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Okayama, Japan.
Tadashi KohyamaDepartment of Internal Medicine, Teikyo University Hospital, Mizonokuchi, Kawasaki, Kanagawa, Japan.
Hiroo IshidaDepartment of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Kanagawa, Japan.
Shoichi KuyamaDepartment of Respiratory Medicine, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Yamaguchi, Japan.
Naoki MiyazawaDepartment of Respiratory Medicine, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Kanagawa, Japan.
Tomomi NakamuraDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Saga, Japan.
Hiroshi MiyawakiDepartment of Respiratory Medicine, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan.
Naohiro OdaDepartment of Internal Medicine, Fukuyama City Hospital, Fukuyama, Hiroshima, Japan.
Nobuhisa IshikawaDepartment of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Hiroshima, Japan.
Ryotaro MorinagaDepartment of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Oita, Japan.
Kei KusakaThe Center for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital, Kiyose, Tokyo, Japan.
Nobukazu FujimotoDepartment of Medical Oncology, Okayama Rosai Hospital, Okayama, Okayama, Japan.ORCID https://orcid.org/0000-0002-4516-0433
Yasushi FukudaDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
Masayuki YasugiDepartment of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Hiroshima, Japan.
Takeshi TsudaDepartment of Respiratory Medicine, Toyama Prefectural Central Hospital, Toyama, Toyama, Japan.
Sunao UshijimaDepartment of Medical Oncology, Kumamoto Kenhoku Hospital, Tamana, Kumamoto, Japan.
Kazuhiko ShibataDepartment of Medical Oncology, Kouseiren Takaoka Hospital, Takaoka, Toyama, Japan.ORCID https://orcid.org/0000-0002-4864-5970
Takuo ShibayamaDepartment of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Okayama, Japan.
Akihiro BesshoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Okayama, Japan.ORCID https://orcid.org/0000-0002-0394-7377
Kyoichi KairaDepartment of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.
Kenshiro ShiraishiDepartment of Radiology, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan.ORCID https://orcid.org/0000-0002-2295-517X
Noriyuki MatsutaniDepartment of Surgery, Teikyo University Hospital, Mizonokuchi, Kawasaki, Kanagawa, Japan.
Nobuhiko SekiDivision of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan.
Teikyo University · JPEhime Prefectural Central Hospital · JPHirosaki University · JPNational Hospital Organization · JPTeikyo University Hospital · JPChugoku Central Hospital · JPFukuyama City Hospital · JPHiroshima Prefectural Hospital · JPIwakuni Medical Center · JPKagawa Prefectural Central Hospital · JPKihoku hospital · JPKouseiren Takaoka Hospital · JPKurashiki Central Hospital · JPOita Prefectural Hospital · JPOkayama Red Cross General Hospital · JPOkayama Rosai Hospital · JPSaga University · JPSaiseikai Ibaraki Hospital · JPSaiseikai Kumamoto Hospital · JPSaitama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The standard of care for unresectable, locally advanced non-small-cell lung cancer (LA-NSCLC) is chemoradiotherapy (CRT) followed by durvalumab, based on the PACIFIC study. Although multiple Japanese phase II studies have shown high efficacy and tolerability of CRT with cisplatin plus S-1 (SP), no prospective study using durvalumab after SP-based CRT has been reported. Objectives: We conducted a multicenter phase II study of this approach, the interim analysis of which showed a high transition rate to durvalumab consolidation therapy. Here, we report the primary analysis results. Design: In treatment-naïve LA-NSCLC, cisplatin (60 mg/m Methods: The primary endpoint was 1-year progression-free survival (PFS). The expected 1-year PFS and its lower limit of the 80% confidence interval (CI) were set as 63% and 47%, respectively, based on the results of TORG1018 study. Results: In all, 59 patients were enrolled, with 51 (86.4%) proceeding to durvalumab. The objective response rate throughout the study was 72.9% (95% CI: 59.7-83.6%). After median follow-up of 21.9 months, neither median PFS nor OS was reached. The 1-year PFS was 72.5% (80% CI: 64.2-79.2%, 95% CI: 59.1-82.2%), while the 1-year overall survival was 91.5% (95% CI: 80.8-96.4%). No grade 5 adverse events were observed throughout the study. The most common adverse event during the consolidation phase was pneumonitis (any grade, 78.4%; grade ⩾3, 2.0%). Eventually, 52.5% of patients completed 1-year durvalumab consolidation therapy from CRT initiation. Conclusion: This study of durvalumab after SP-based CRT met its primary endpoint and found a 1-year PFS of 73% from CRT initiation. This study provides the first prospective data on the prognosis and tolerability of durvalumab consolidation from the initiation of CRT. Trial registration: Japan Registry of Clinical Trials, jRCTs031190127, registered 1 November, 2019, https://jrct.niph.go.jp/latest-detail/jRCTs031190127.

Indexed as

chemoradiotherapycisplatindurvalumabnon-small-cell lung cancerS-1

Identifiers

PMID36570411
PMCPMC9772940
OpenAlexW4312210993

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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.