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

被引：3

作者：

Tanaka, Hisashi ^{[1
]}

Tanzawa, Shigeru ^{[2
]}

Misumi, Toshihiro ^{[3
]}

Makiguchi, Tomonori ^{[1
]}

Inaba, Megumi ^{[1
,4
]}

Honda, Takeshi ^{[2
]}

Nakamura, Junya ^{[5
,6
]}

Inoue, Koji ^{[5
,6
]}

Kishikawa, Takayuki ^{[7
]}

Nakashima, Masanao ^{[8
]}

Fujiwara, Keiichi ^{[9
]}

Kohyama, Tadashi ^{[10
]}

Ishida, Hiroo ^{[11
]}

Kuyama, Shoichi ^{[12
]}

Miyazawa, Naoki ^{[13
]}

Nakamura, Tomomi ^{[14
]}

Miyawaki, Hiroshi ^{[15
]}

Oda, Naohiro ^{[16
]}

Ishikawa, Nobuhisa ^{[17
]}

Morinaga, Ryotaro ^{[18
]}

Kusaka, Kei ^{[19
]}

Fujimoto, Nobukazu

Fukuda, Yasushi ^{[20
]}

Yasugi, Masayuki ^{[21
,22
]}

Tsuda, Takeshi ^{[23
]}

Ushijima, Sunao ^{[24
]}

Shibata, Kazuhiko ^{[25
]}

Shibayama, Takuo ^{[9
]}

Bessho, Akihiro ^{[26
]}

Kaira, Kyoichi ^{[27
]}

Shiraishi, Kenshiro ^{[28
]}

Matsutani, Noriyuki ^{[30
]}

Seki, Nobuhiko ^{[29
]}

机构：

[1] Hirosaki Univ, Grad Sch Med, Dept Resp Med, Hirosaki, Aomori, Japan

[2] Teikyo Univ, Sch Med, Dept Internal Med, Div Med Oncol, Itabashi Ku, Tokyo, Japan

[3] Yokohama City Univ, Sch Med, Dept Biostat, Yokohama, Kanagawa, Japan

[4] Kumamoto City Hosp, Dept Resp Med, Kumamoto, Japan

[5] Teikyo Univ, Sch Med, Dept Internal Med, Div Med Oncol, Itabashi Ku, Tokyo, Japan

[6] Ehime Prefectural Cent Hosp, Dept Resp Med, Matsuyama, Ehime, Japan

[7] Tochigi Canc Ctr, Dept Resp Med, Utsunomiya, Tochigi, Japan

[8] Shin Yurigaoka Gen Hosp, Dept Resp Med, Kawasaki, Kanagawa, Japan

[9] Natl Hosp Org Okayama Med Ctr, Dept Resp Med, Okayama, Japan

[10] Teikyo Univ Hosp, Dept Internal Med, Kawasaki, Kanagawa, Japan

[11] Showa Univ, Northern Yokohama Hosp, Dept Internal Med, Yokohama, Kanagawa, Japan

[12] Natl Hosp Org, Iwakuni Clin Ctr, Dept Resp Med, Iwakuni, Japan

[13] Saiseikai Yokohamashi Nanbu Hosp, Dept Resp Med, Yokohama, Kanagawa, Japan

[14] Saga Univ, Fac Med, Dept Internal Med, Div Hematol Resp Med & Oncol, Saga, Saga, Japan

[15] Kagawa Prefectural Cent Hosp, Dept Resp Med, Takamatsu, Kagawa, Japan

[16] Fukuyama City Hosp, Dept Internal Med, Hiroshima, Japan

[17] Hiroshima Prefectural Hosp, Dept Resp Med, Hiroshima, Hiroshima, Japan

[18] Oita Prefectural Hosp, Dept Thorac Med Oncol, Oita, Oita, Japan

[19] Natl Hosp Org Tokyo Natl Hosp, Ctr Pulm Dis, Kiyose, Tokyo, Japan

[20] Okayama Rosai Hosp, Dept Med Oncol, Okayama, Okayama, Japan

[21] Kurashiki Cent Hosp, Dept Resp Med, Kurashiki, Okayama, Japan

[22] Chugoku Cent Hosp, Dept Resp Med, Hiroshima, Japan

[23] Toyama Prefectural Cent Hosp, Dept Resp Med, Toyama, Toyama, Japan

[24] Kumamoto Kenhoku Hosp, Dept Med Oncol, Tamana, Kumamoto, Japan

[25] Kouseiren Takaoka Hosp, Dept Med Oncol, Takaoka, Toyama, Japan

[26] Japanese Red Cross Okayama Hosp, Dept Resp Med, Okayama, Okayama, Japan

[27] Saitama Med Univ, Int Med Ctr, Dept Resp Med, Hidaka, Saitama, Japan

[28] Teikyo Univ, Sch Med, Dept Radiol, Itabashi Ku, Tokyo, Japan

[29] Teikyo Univ, Sch Med, Dept Internal Med, Div Med Oncol, 2-11-1 Kaga,Itabashi Ku, Tokyo 1738605, Japan

[30] Teikyo Univ Hosp, Dept Surg, Kawasaki, Kanagawa, Japan

来源：

THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY | 2022年 / 14卷

关键词：

cisplatin; chemoradiotherapy; durvalumab; non-small-cell lung cancer; S-1; TGF-BETA-1; GENE; STAGE; TRIAL; CHEMOTHERAPY; PNEUMONITIS; DOCETAXEL;

D O I：

10.1177/17588359221142786

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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-naive LA-NSCLC, cisplatin (60 mg/m(2), day 1) and S-1 (80-120 mg/body, days 1-14) were administered with two 4-week cycles with concurrent thoracic radiotherapy (60 Gy) followed by durvalumab (10 mg/kg) every 2 weeks for up to 1 year.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.

引用

页数：14

共 27 条

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