Three-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: Pooled analysis of ONO-4538-05 and ONO-4538-06 studies

被引：14

作者：

Horinouchi, Hidehito ^{[1
]}

Nishio, Makoto ^{[2
]}

Hida, Toyoaki ^{[3
]}

Nakagawa, Kazuhiko ^{[4
]}

Sakai, Hiroshi ^{[5
]}

Nogami, Naoyuki ^{[6
]}

Atagi, Shinji ^{[7
]}

Takahashi, Toshiaki ^{[8
]}

Saka, Hideo ^{[9
]}

Takenoyama, Mitsuhiro ^{[10
]}

Katakami, Nobuyuki ^{[11
]}

Tanaka, Hiroshi ^{[12
]}

Takeda, Koji ^{[13
]}

Satouchi, Miyako ^{[14
]}

Isobe, Hiroshi ^{[15
]}

Maemondo, Makoto ^{[16
,17
]}

Goto, Koichi ^{[18
]}

Hirashima, Tomonori ^{[19
]}

Minato, Koichi ^{[20
]}

Sumiyoshi, Naoki ^{[21
]}

Tamura, Tomohide ^{[22
]}

机构：

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

[2] Canc Inst Hosp, Dept Thorac Med Oncol, Tokyo, Japan

[3] Aichi Canc Ctr Hosp, Dept Thorac Oncol, Nagoya, Aichi, Japan

[4] Kindai Univ, Dept Med Oncol, Fac Med, Osaka, Japan

[5] Saitama Canc Ctr, Dept Thorac Oncol, Saitama, Japan

[6] Natl Hosp Org Shikoku Canc Ctr, Div Thorac Oncol & Med, Shikoku, Ehime, Japan

[7] Kinki Chuo Chest Med Ctr, Dept Internal Med, Sakai, Osaka, Japan

[8] Shizuoka Canc Ctr, Div Thorac Oncol, Shizuoka, Japan

[9] Nagoya Med Ctr, Dept Med Oncol, Nagoya, Aichi, Japan

[10] Natl Hosp Org Kyushu Canc Ctr, Dept Thorac Oncol, Fukuoka, Fukuoka, Japan

[11] Kobe City Med Ctr, Dept Med Oncol, Kobe, Hyogo, Japan

[12] Niigata Canc Ctr Hosp, Dept Internal Med, Niigata, Japan

[13] Osaka City Gen Hosp, Dept Med Oncol, Osaka, Japan

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

[15] KKR Sapporo Med Ctr, Dept Med Oncol, Sapporo, Hokkaido, Japan

[16] Iwate Med Univ, Dept Internal Med, Sch Med, Div Pulm Med Allergy & Rheumatol, Morioka, Iwate, Japan

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

[18] Natl Canc Ctr Hosp East, Div Thorac Oncol, Chiba, Japan

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

[20] Gunma Prefectural Canc Ctr, Div Resp Med, Gunma, Japan

[21] Ono Pharmaceut Co Ltd, Oncol Clin Dev Planning, Osaka, Japan

[22] St Lukes Int Hosp, Thorac Ctr, Tokyo, Japan

来源：

CANCER MEDICINE | 2019年 / 8卷 / 11期

关键词：

nivolumab; non-small cell lung cancer (NSCLC); phase II study; programmed cell death 1 ligand 1 (PD-L1); programmed cell death 1 receptor (PD-1); ADVERSE EVENTS; ASSOCIATION; DOCETAXEL; EFFICACY; SAFETY;

D O I：

10.1002/cam4.2411

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background Nivolumab is a programmed cell death 1 (PD-1) receptor inhibitor antibody that enhances immune system antitumor activity. It is associated with longer overall survival (OS) than the standard treatment of docetaxel in patients with previously treated advanced squamous (SQ) and non-squamous (non-SQ) non-small cell lung cancer (NSCLC). We previously conducted two phase II studies of nivolumab in Japanese patients with SQ (ONO-4538-05) and non-SQ (ONO-4538-06) NSCLC, showing overall response rates (ORRs) (95% CI) of 25.7% (14.2-42.1) and 22.4% (14.5-32.9), respectively, with acceptable toxicity. In this analysis, we more precisely estimated the long-term safety and efficacy in patients with SQ and non-SQ NSCLC by pooling data from these two trials. Methods SQ (N = 35) and non-SQ (N = 76) NSCLC patients received nivolumab (3 mg/kg, every 2 weeks) until progression or discontinuation. OS was estimated using the Kaplan-Meier method. A pooled analysis of SQ and non-SQ patients was also performed. Results In SQ NSCLC patients, the median OS (95% CI) was 16.3 months (12.4-25.2), and the estimated 1-year, 2-year, and 3-year survival rates were 71.4% (53.4-83.5), 37.1% (21.6-52.7), and 20.0% (8.8-34.4), respectively. In non-SQ NSCLC patients, median OS was 17.1 months (13.3-23.0), and the estimated 1-, 2-, and 3-year survival rates were 68.0% (56.2-77.3), 37.4% (26.5-48.1), and 31.9% (21.7-42.5), respectively. When SQ NSCLC and non-SQ NSCLC data were pooled, the median OS was 17.1 months (14.2-20.6), and the estimated 1-, 2-, and 3-year survival rates were 69.1% (59.6-76.8), 37.3% (28.3-46.2), and 28.1% (20.0-36.7), respectively. Twenty (76.9%) of 26 responders lived for 3 or more years. Nivolumab was well tolerated and no new safety signals were found. Conclusion Treatment with nivolumab improved long-term survival and was well tolerated in patients with SQ and non-SQ NSCLC.

引用

页码：5183 / 5193

页数：11

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