Treatment rationale and design of the PROLONG study: safety and efficacy of pembrolizumab as first-line therapy for elderly patients with non-small cell lung cancer

被引：5

作者：

Masuda, Takeshi ^{[1
]}

Fujitaka, Kazunori ^{[1
]}

Ishikawa, Nobuhisa ^{[2
]}

Nakano, Kikuo ^{[3
]}

Yamasaki, Masahiro ^{[4
,5
]}

Kitaguchi, Souichi ^{[6
]}

Masuda, Ken ^{[7
]}

Yamaguchi, Kakuhiro ^{[1
]}

Sakamoto, Shinjiro ^{[1
]}

Horimasu, Yasushi ^{[1
]}

Kawase, Shigeo ^{[8
]}

Miyamoto, Shintaro ^{[1
]}

Nakashima, Taku ^{[1
]}

Iwamoto, Hiroshi ^{[1
]}

Shiota, Naoki ^{[9
]}

Senoo, Tadashi ^{[10
]}

Awaya, Yoshikazu ^{[11
]}

Kondo, Tomohiro ^{[12
]}

Yoshida, Takashi ^{[13
]}

Hamada, Hironobu ^{[1
]}

Murakami, Isao ^{[14
]}

Hattori, Noboru ^{[1
]}

机构：

[1] Hiroshima Univ Hosp, Dept Resp Internal Med, Minami Ku, 1-2-3 Kasumi, Hiroshima 7348551, Japan

[2] Hiroshima Prefectural Hosp, Dept Resp Med, Minami Ku, 1-5-54 Ujinakanda, Hiroshima 7348530, Japan

[3] Kure Med Ctr, Dept Resp Internal Med, 3-1 Aoyama, Kure 7370023, Japan

[4] Hiroshima Red Cross Hosp, Dept Resp Internal Med, Naka Ku, 1-9-6 Sendamachi, Hiroshima 7308619, Japan

[5] Atom Bomb Survivors Hosp, Naka Ku, 1-9-6 Sendamachi, Hiroshima 7308619, Japan

[6] Hiroshima City Asa Citizens Hosp, Dept Med Oncol, Asakita Ku, 2-1-1 Kabeminami, Hiroshima 7310293, Japan

[7] Hiroshima City Hiroshima Citizens Hosp, Dept Resp Internal Med, Naka Ku, 7-33 Motomachi, Hiroshima 7308518, Japan

[8] Kure Kyosai Hosp, Dept Resp Internal Med, 2-3-28 Nishichuo, Kure 7378505, Japan

[9] Chugoku Rosai Hosp, Dept Resp Internal Med, 1-5-1 Hirotakaya, Kure 7370193, Japan

[10] Hiroshima Univ Hosp, Dept Clin Oncol, Minami Ku, 1-2-3 Kasumi, Hiroshima 7348551, Japan

[11] Miyoshi Cent Hosp, Dept Resp Internal Med, 10531 Higashisakaya, Miyoshi 7288502, Japan

[12] JA Hiroshima Gen Hosp, Dept Resp Internal Med, 1-3-3 Jigozen, Hatsukaichi 7388503, Japan

[13] JA Onomichi Gen Hosp, Dept Resp Internal Med, 1-10-23 Hirahara, Onomichi 7228508, Japan

[14] Higashihiroshima Med Ctr, Dept Resp Internal Med, 513 Jike, Higashihiroshima 7390041, Japan

来源：

JOURNAL OF THORACIC DISEASE | 2020年 / 12卷 / 03期

关键词：

Pembrolizumab; elderly patient; non-small cell lung cancer (NSCLC); PHASE-III; CHEMOTHERAPY;

D O I：

10.21037/jtd.2019.12.46

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

Background: Pembrolizumab is recommended as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and a Programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) of >= 50% without driver mutations. However, the safety and efficacy were not investigated among patients who were >= 75 years old. Methods: This open-label single-arm phase II study is designed to evaluate pembrolizumab as first-line therapy for patients who are >= 75 years old with advanced NSCLC and a PD-L1 TPS of >= 50% without driver mutations. The primary endpoint is progression-free survival, and the secondary endpoints are overall survival, objective response rate, safety, and quality of life. Recruitment started in October 2017 and is expected to continue for approximately 3 years. Conclusions: Given the currently poor prognosis of elderly patients with advanced NSCLC, we hope that the findings of this study will facilitate more effective treatment in this setting.

引用

页码：1079 / 1084

页数：6

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