Nivolumab in advanced non-small-cell lung cancer patients who failed prior platinum-based chemotherapy

被引：26

作者：

Lee, Jong Seok ^{[1
]}

Lee, Ki Hyeong ^{[2
]}

Cho, Eun Kyung ^{[3
]}

Kim, Dong-Wan ^{[4
]}

Kim, Sang-We ^{[5
]}

Kim, Joo-Hang ^{[6
]}

Cho, Byoung Chul ^{[6
]}

Kang, Jin Hyoung ^{[7
]}

Han, Ji-Youn ^{[8
]}

Min, Young Joo ^{[9
]}

Park, Keunchil ^{[10
]}

机构：

[1] Seoul Natl Univ, Bundang Hosp, 82 Gumi Ro,173 Beon Gil, Seongnam Si 13620, Gyeonggi Do, South Korea

[2] Chungbuk Natl Univ Hosp, 776,1 Sunhwan Ro, Cheongju 28644, Chungcheongbuk, South Korea

[3] Gachon Univ, Gil Med Ctr, 21,Namdongdae Ro 774 Beon Gil, Incheon 21565, South Korea

[4] Seoul Natl Univ Hosp, 101 Daehak Ro, Seoul 03080, South Korea

[5] Asan Med Ctr, 88,Olymp Ro 43 Gil, Seoul 05505, South Korea

[6] Yonsei Univ, Severance Hosp, 50-1 Yonsei Ro, Seoul 03722, South Korea

[7] Catholic Univ Korea, Seoul St Marys Hosp, 222 Banpo Daero, Seoul 06591, South Korea

[8] Natl Canc Ctr, 323 Ilsan Ro, Goyang Si 10408, Gyeonggi Do, South Korea

[9] Ulsan Univ Hosp, 877 Bangeojinsunhwangdo Ro, Ulsan 44055, South Korea

[10] Sungkyunkwan Univ, Samsung Med Ctr, Sch Med, 81 Irwon Ro, Seoul 06351, South Korea

来源：

LUNG CANCER | 2018年 / 122卷

关键词：

Nivolumab; Non-small cell lung cancer; Programmed cell death-1; RANDOMIZED CONTROLLED-TRIAL; ANTI-PD-1; ANTIBODY; SOLID TUMORS; 2ND-LINE TREATMENT; PHASE-III; DOCETAXEL; SAFETY; BMS-936558; CARCINOMA;

D O I：

10.1016/j.lungcan.2018.05.023

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objectives: To investigate the efficacy and safety of nivolumab in Korean patients with stage IIIB/IV or recurrent non-small-cell lung cancer (NSCLC) who failed platinum-based chemotherapy. Materials and methods: In this multicenter, open-label, Phase II study, 100 patients with stage IIIB or IV squamous (n = 44) or non-squamous (n = 56) NSCLC received nivolumab 3 mg/kg every 2 weeks for 6 weeks per treatment cycle. Patients continued treatment until disease progression or intolerable adverse events (AEs), and then entered a follow-up phase. The primary efficacy endpoint was the centrally assessed objective response rate (ORR). Results: The ORR was 20.0% (95% confidence interval [CI]: 13.3-28.9%) in the total population, 15.9% (7/44 patients; 95% CI: 7.9-29.4%) in patients with squamous NSCLC, and 23.2% (13/56 patients; 95% CI: 14.1-35.8%) in patients with non-squamous NSCLC. Median overall survival was 13.9 (95% CI: 10.8-18.5) months in the total population, 12.3 (95% CI: 8.2-18.5) months in squamous NSCLC, and 16.3 (95% CI: 10.8,) months in non-squamous NSCLC. Median progression-free survival was 2.8 (95% CI: 1.4-5.7), 2.6 (95% CI: 1.3-5.7), and 5.3 (95% CI: 1.4-7.1) months in the total, squamous, and non-squamous NSCLC populations, respectively. The median duration of response was 11.7 (95% CI: 5.6,), 12.0 (95% CI: 4.8,-), and 12.1 (95% CI: 3.0,-) months in the total, squamous, and non-squamous NSCLC populations, respectively. The most frequent AEs were decreased appetite, dyspnea, and cough in 43 (43.0%), 32 (32.0%), and 29 (29.0%) patients, respectively. The most common Grade >= 3 AE was pneumonia, occurring in 7.0% of patients. Common treatment -related AEs included decreased appetite (14.0%) and pruritus (6.0%), neither of which was Grade >= 3. Conclusion: The efficacy and safety of nivolumab in Korean patients with advanced or recurrent squamous or non-squamous NSCLC are consistent with previous reports.

引用

页码：234 / 242

页数：9

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