Pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous non-small-cell lung cancer in KEYNOTE-407

被引：3

作者：

Sugawara, Shunichi ^{[1
,29
]}

Tanaka, Kentaro ^{[2
]}

Imamura, Fumio ^{[3
]}

Yamamoto, Nobuyuki ^{[4
]}

Nishio, Makoto ^{[5
]}

Okishio, Kyoichi ^{[6
]}

Hirashima, Tomonori ^{[7
]}

Tanaka, Hiroshi ^{[8
]}

Fukuhara, Tatsuro ^{[9
]}

Nakahara, Yasuharu ^{[10
]}

Kurata, Takayasu ^{[11
]}

Katakami, Nobuyuki ^{[12
]}

Okada, Morihito ^{[13
]}

Horinouchi, Hidehito ^{[14
]}

Udagawa, Hibiki ^{[15
]}

Kasahara, Kazuo ^{[16
]}

Satouchi, Miyako ^{[17
]}

Saka, Hideo ^{[18
]}

Tokito, Takaaki ^{[19
,20
]}

Hosomi, Yukio ^{[21
]}

Aoe, Keisuke ^{[22
]}

Kishi, Kazuma ^{[23
]}

Ohashi, Kadoaki ^{[24
]}

Yokoyama, Takuma ^{[25
]}

Adachi, Noriaki ^{[26
]}

Noguchi, Kazuo

Schwarzenberger, Paul ^{[27
]}

Kato, Terufumi ^{[28
]}

机构：

[1] Sendai Kousei Hosp, Dept Pulm Med, Sendai, Japan

[2] Kyushu Univ, Grad Sch Med Sci, Dept Resp Med, Fukuoka, Japan

[3] Osaka Int Canc Inst, Dept Thorac Oncol, Osaka, Japan

[4] Wakayama Med Univ, Dept Internal Med 3, Wakayama, Japan

[5] Japanese Fdn Canc Res, Dept Thorac Med Oncol, Canc Inst Hosp, Tokyo, Japan

[6] Natl Hosp Org Kinki Chuo Chest Med Ctr, Dept Thorac Oncol, Osaka, Japan

[7] Osaka Habikino Med Ctr, Dept Thorac Oncol, Osaka, Japan

[8] Niigata Canc Ctr Hosp, Dept Internal Med Pulmonol, Niigata, Japan

[9] Miyagi Canc Ctr, Dept Resp Med, Natori, Japan

[10] Natl Hosp Org Himeji Med Ctr, Dept Resp Med, Himeji, Japan

[11] Kansai Med Univ Hosp, Dept Thorac Oncol, Osaka, Japan

[12] Takarazuka City Hosp, Dept Med Oncol, Kobe, Japan

[13] Hiroshima Univ, Res Inst Radiat Biol & Med, Dept Surg Oncol, Hiroshima, Japan

[14] Natl Canc Ctr, Dept Thorac Oncol, Tokyo, Japan

[15] Natl Canc Ctr Hosp East, Dept Thorac Oncol, Kashiwa, Japan

[16] Kanazawa Univ Hosp, Resp Med, Kanazawa, Japan

[17] Hyogo Canc Ctr, Dept Thorac Oncol, Akashi, Japan

[18] Natl Hosp Org Nagoya Med Ctr, Dept Resp Med, Nagoya, Japan

[19] Kurume Univ, Div Respirol Neurol & Rheumatol, Kurume, Japan

[20] Kurume Univ, Dept Internal Med, Kurume, Japan

[21] Komagome Hosp, Dept Thorac Oncol & Resp Med, Tokyo Metropolitan Canc & Infect Dis Ctr, Tokyo, Japan

[22] Yamaguchi Ube Med Ctr, Dept Med Oncol, Yamaguchi, Japan

[23] Toranomon Gen Hosp, Resp Ctr, Dept Resp Med, Tokyo, Japan

[24] Okayama Univ Hosp, Dept Allergy & Resp Med, Okayama, Japan

[25] Kyorin Univ Hosp, Dept Resp Med, Tokyo, Japan

[26] MSD KK, Tokyo, Japan

[27] Merck & Co Inc, Rahway, NJ USA

[28] Kanagawa Canc Ctr, Dept Thorac Oncol, Yokohama, Japan

[29] Sendai Kousei Hosp, Dept Pulm Med, 4-15 Hirosemachi,Aoba Ku, Sendai, Miyagi 9800873, Japan

来源：

CANCER SCIENCE | 2023年 / 114卷 / 08期

关键词：

carcinoma; non-small-cell lung cancer; clinical trial; immune checkpoint inhibitor; immunotherapy; Japan;

D O I：

10.1111/cas.15816

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The global phase III KEYNOTE-407 (NCT02775435) trial showed that pembrolizumab plus chemotherapy prolonged overall and progression-free survival (OS/PFS) versus placebo plus chemotherapy in patients with metastatic squamous non-small-cell lung cancer (NSCLC). We present outcomes of patients from Japan enrolled in KEYNOTE-407. Patients were randomized 1:1 to receive pembrolizumab 200 mg or placebo with paclitaxel 200 mg/m(2) every 3 weeks (Q3W) or nab-paclitaxel 100 mg/m(2) (weekly) plus carboplatin area under the concentration-time curve of 6 mg/mL/min Q3W for four cycles, followed by pembrolizumab or placebo Q3W for a total of 35 cycles. Primary end-points were OS and PFS per RECIST version 1.1 by blinded independent central review. Fifty patients were randomized at Japanese sites (pembrolizumab plus chemotherapy, n = 22; placebo plus chemotherapy, n = 28). Median follow-up time at data cut-off (May 9, 2019) was 15.1 (range, 0.5-24.0) months. Median OS (95% confidence interval [CI]) was 17.3 (12.5-not reached) versus 11.0 (8.6-19.5) months in the pembrolizumab plus chemotherapy versus placebo plus chemotherapy group (hazard ratio [HR] 0.56; 95% CI, 0.27-1.15). Median PFS (95% CI) was 8.3 (6.1-13.0) versus 7.2 (3.9-8.8) months (HR 0.65; 95% CI, 0.35-1.23). Grade 3-5 adverse events (AEs) occurred in 86% and 75% of patients, respectively. There were three fatal AEs, two of which were treatment-related (one from each treatment group, pneumonitis and pulmonary hemorrhage). Efficacy and safety outcomes were consistent with the global study and support the use of pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous NSCLC.

引用

页码：3330 / 3341

页数：12

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