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)

被引：2

作者：

Tanzawa, Shigeru ^{[2
]}

Ushijima, Sunao ^{[3
]}

Shibata, Kazuhiko ^{[4
]}

Shibayama, Takuo ^{[5
]}

Bessho, Akihiro ^{[6
]}

Kaira, Kyoichi ^{[7
]}

Misumi, Toshihiro ^{[8
]}

Shiraishi, Kenshiro ^{[9
]}

Matsutani, Noriyuki ^{[10
]}

Tanaka, Hisashi ^{[11
]}

Inaba, Megumi ^{[12
]}

Haruyama, Terunobu ^{[2
]}

Nakamura, Junya ^{[13
]}

Kishikawa, Takayuki ^{[14
]}

Nakashima, Masanao ^{[15
]}

Iwasa, Keiichi ^{[4
]}

Fujiwara, Keiichi ^{[5
]}

Kohyama, Tadashi ^{[16
]}

Kuyama, Shoichi ^{[17
]}

Miyazawa, Naoki ^{[18
]}

Nakamura, Tomomi ^{[19
]}

Miyawaki, Hiroshi ^{[20
]}

Ishida, Hiroo ^{[21
]}

Oda, Naohiro ^{[22
]}

Ishikawa, Nobuhisa ^{[23
]}

Morinaga, Ryotaro ^{[24
]}

Kusaka, Kei ^{[25
]}

Fujimoto, Nobukazu ^{[26
]}

Yokoyama, Toshihide ^{[27
]}

Gemba, Kenichi ^{[28
]}

Tsuda, Takeshi ^{[29
]}

Nakagawa, Hideyuki ^{[30
]}

Ono, Hirotaka ^{[31
]}

Shimizu, Tetsuo ^{[32
]}

Nakamura, Morio ^{[33
]}

Kusumoto, Sojiro ^{[34
]}

Hayashi, Ryuji ^{[35
]}

Shirasaki, Hiroki ^{[36
]}

Ochi, Nobuaki ^{[37
]}

Aoe, Keisuke ^{[38
]}

Kanaji, Nobuhiro ^{[39
]}

Kashiwabara, Kosuke ^{[40
]}

Inoue, Hiroshi ^{[41
]}

Seki, Nobuhiko ^{[1
]}

机构：

[1] Teikyo Univ, Div Med Oncol, Dept Internal Med, Sch Med,Itabashi Ku, 2-11-1 Kaga, Tokyo 1738606, Japan

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

[3] Kumamoto City Hosp, Dept Med Oncol, Kumamoto, Kumamoto, Japan

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

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

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

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

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

[9] Teikyo Univ, Dept Radiol, Sch Med, Itabashi City, Tokyo, Japan

[10] Teikyo Univ, Dept Surg, Mizonokuchi Hosp, Kawasaki, Kanagawa, Japan

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

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

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

[14] Tochigi Canc Ctr, Div Thorac Oncol, Dept Med Oncol, Utsunomiya, Tochigi, Japan

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

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

[17] Natl Hosp Org Iwakuni Clin Ctr, Dept Resp Med, Iwakuni City, Yamaguchi, Japan

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

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

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

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

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

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

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

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

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

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

[28] Chugoku Cent Hosp, Dept Resp Med, Fukuyama, Hiroshima, Japan

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

[30] Hirosaki Hosp, Natl Hosp Org, Dept Resp Med, Hirosaki, Aomori, Japan

[31] Tsuboi Hosp, Dept Resp Med, Koriyama, Fukushima, Japan

[32] Nihon Univ, Div Resp Med, Dept Internal Med, Sch Med, Itabashi City, Tokyo, Japan

[33] Tokyo Saiseikai Cent Hosp, Dept Pulm Med, Minato City, Tokyo, Japan

[34] Showa Univ, Div Allergol & Resp Med, Sch Med, Shinagawa City, Tokyo, Japan

[35] Toyama Univ Hosp, Clin Oncol, Toyama, Toyama, Japan

[36] Fukui Ken Saiseikai Hosp, Dept Resp Med, Fukui, Fukui, Japan

[37] Kawasaki Med Sch, Gen Internal Med 4, Okayama, Okayama, Japan

[38] Natl Hosp Org Yamaguchi Ube Med Ctr, Dept Med Oncol, Ube, Yamaguchi, Japan

[39] Kagawa Univ, Div Hematol Rheumatol & Resp Med, Dept Internal Med, Fac Med, Takamatsu, Kagawa, Japan

[40] Kumamoto Reg Med Ctr, Dept Resp Med, Kumamoto, Kumamoto, Japan

[41] Karatsu Red Cross Hosp, Dept Internal Med, Karatsu, Saga, Japan

来源：

THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY | 2021年 / 13卷

关键词：

chemoradiotherapy; cisplatin; durvalumab; non-small-cell lung cancer; S-1;

D O I：

10.1177/1758835921998588

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Based on the results of the PACIFIC study, chemoradiotherapy followed by 1-year consolidation therapy with durvalumab was established as the standard of care for unresectable, locally advanced non-small-cell lung cancer (LA-NSCLC). However, some topics not foreseen in that design can be explored, including progression-free survival (PFS) and overall survival (OS) after the start of chemoradiotherapy, the proportion of patients who proceeded to consolidation therapy with durvalumab, and the optimal chemotherapeutic regimens. In Japan, the combination regimen of S-1 + cisplatin (SP), for which the results of multiple clinical studies have suggested a good balance of efficacy and tolerability, is frequently selected in clinical settings. However, the efficacy and safety of consolidation therapy with durvalumab following this SP regimen have not been evaluated. We therefore planned a multicenter, prospective, single-arm, phase II study. Methods: In treatment-naive LA-NSCLC, two cycles of combination chemotherapy with S-1 (80-120 mg/body, Days 1-14) + cisplatin (60 mg/m(2), Day 1) will be administered at an interval of 4 weeks, with concurrent thoracic radiotherapy (60 Gy). Responders will then receive durvalumab every 2 weeks for up to 1 year. The primary endpoint is 1-year PFS rate. Discussion: Compared with the conventional standard regimen in Japan, the SP regimen is expected to be associated with lower incidences of pneumonitis, esophagitis, and febrile neutropenia, which complicate the initiation of consolidation therapy with durvalumab, and have higher antitumor efficacy during chemoradiotherapy. Therefore, SP-based chemoradiotherapy is expected to be successfully followed by consolidation therapy with durvalumab in more patients, resulting in prolonged PFS and OS. Toxicity and efficacy results of the SP regimen in this study will also provide information important to the future establishment of the concurrent combination of chemoradiotherapy and durvalumab. Trial registration: Japan Registry of Clinical Trials, jRCTs031190127, registered 1 November 2019, https://jrct.niph.go.jp/latest-detail/jRCTs031190127

引用

页数：7

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