A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients: The SPIRAL-0 Study

被引：11

作者：

Chihara, Yusuke ^{[1
]}

Takeda, Takayuki ^{[2
]}

Goto, Yasuhiro ^{[3
]}

Nakamura, Yoichi ^{[4
]}

Tsuchiya-Kawano, Yuko ^{[5
]}

Nakao, Akira ^{[6
]}

Onoi, Keisuke ^{[7
]}

Hibino, Makoto ^{[8
]}

Fukuda, Minoru ^{[9
]}

Honda, Ryoichi ^{[10
]}

Yamada, Takahiro ^{[11
]}

Taniguchi, Ryusuke ^{[12
]}

Sakamoto, Sinjiro ^{[13
]}

Date, Koji ^{[14
]}

Nagashima, Seiji ^{[15
]}

Tanzawa, Shigeru ^{[16
]}

Minato, Koichi ^{[17
]}

Nakatani, Koichi ^{[18
]}

Izumi, Miiru ^{[19
]}

Shimose, Takayuki ^{[20
]}

Kishimoto, Junji ^{[21
]}

Uchino, Junji ^{[22
]}

Takayama, Koichi ^{[22
]}

机构：

[1] Uji Tokushukai Med Ctr, Dept Resp Med, Uji, Japan

[2] Japanese Red Cross Kyoto Daini Hosp, Dept Resp Med, Kyoto, Japan

[3] Fujita Hlth Univ, Dept Resp Med, Sch Med, Toyoake, Aichi, Japan

[4] Tochigi Canc Ctr, Div Thorac Oncol, Utsunomiya, Tochigi, Japan

[5] Kitakyushu Municipal Med Ctr, Dept Resp Med, Kitakyushu, Fukuoka, Japan

[6] Fukuoka Univ Hosp, Dept Resp Med, Fukuoka, Japan

[7] Kyoto Prefectural Univ Med, Dept Pulm Med, Kyoto, Japan

[8] Shonan Fujisawa Tokushukai Hosp, Dept Resp Med, Fujisawa, Kanagawa, Japan

[9] Nagasaki Univ Hosp, Dept Resp Med, Nagasaki, Japan

[10] Asahi Gen Hosp, Dept Resp Med, Asahi, Japan

[11] Matsushita Mem Hosp, Dept Pulm Med, Moriguchi, Osaka, Japan

[12] Otsu City Hosp, Dept Resp Med, Otsu, Shiga, Japan

[13] Hiroshima Univ Hosp, Dept Resp Med, Hiroshima, Japan

[14] Kyoto Chubu Med Ctr, Dept Pulm Med, Kyoto, Japan

[15] Natl Hosp Org Nagasaki Med Ctr, Dept Resp Med, Omura, Japan

[16] Teikyo Univ, Dept Internal Med, Div Med Oncol, Sch Med, Tokyo, Japan

[17] Gunma Prefectural Canc Ctr, Div Resp Med, Ota, Japan

[18] Natl Hosp Org Kyoto Med Ctr, Div Resp Med, Kyoto, Japan

[19] Natl Hosp Org Omuta Natl Hosp, Dept Resp Med, Omuta, Japan

[20] Clin Res Support Ctr Kyushu, Dept Stat & Data Ctr, Fukuoka, Japan

[21] Kyushu Univ Hosp, Ctr Clin & Translat Res, Fukuoka, Japan

[22] Kyoto Prefectural Univ Med, Dept Pulm Med, Kyoto, Japan

来源：

ONCOLOGIST | 2022年 / 27卷 / 11期

关键词：

non-small cell lung cancer; EGFR-TKI; osimertinib; elderly patients; CELL LUNG-CANCER; TKI; RESISTANCE; DISEASE;

D O I：

10.1093/oncolo/oyac193

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The number of elderly patients with lung cancer is increasing, and optimal first-line treatment in this patient group is unclear. This phase II study investigated the efficacy and safety of osimertinib for elderly patients with EGFRmutation-positive advanced non-small cell lung cancer. Background Osimertinib is one of the standard first-line treatments for advanced non-small cell lung cancer in patients with epidermal growth factor receptor (EGFR) mutations, because it achieves significantly longer progression-free survival (PFS) than conventional first-line treatments (hazard ratio: 0.46). However, the efficacy and safety of osimertinib as a first-line treatment for patients aged >= 75 years remain unclear. Methods This phase II study was performed to prospectively investigate the efficacy and safety of osimertinib for elderly patients with EGFR mutation-positive advanced non-small cell lung cancer. The primary endpoint was 1-year PFS rate; secondary endpoints were overall response rate (ORR), PFS, overall survival (OS), and safety. Results Thirty-eight patients were included in the analysis. The 1-year PFS rate was 59.4% (95% confidence interval [CI], 46.1%-72.7%), which did not meet the primary endpoint (the threshold 1-year PFS rate of 50% predicted using data from the NEJ003 study). The most common grade 3/4 adverse events were rash/dermatitis acneiform/ALT increased/hypokalemia (2 patients, 5%). Seven patients developed pneumonitis (17.5%). There were no other cases of treatment discontinuation due to adverse events other than pneumonitis. Conclusion Although this study did not meet the primary endpoint, osimertinib was tolerable for elderly patients with EGFR mutation-positive advanced non-small cell lung cancer. (Japan Registry of Clinical Trials [JRCT] ID number: jRCTs071180007).

引用

页码：903 / E834

页数：8

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