Nivolumab in advanced non-small-cell lung cancer patients who failed prior platinum-based chemotherapy
- Authors
- Lee, Jong Seok; Lee, Ki Hyeong; Cho, Eun Kyung; Kim, Dong-Wan; Kim, Sang-We; Kim, Joo-Hang; Cho, Byoung Chul; Kang, Jin Hyoung; Han, Ji-Youn; Min, Young Joo; Park, Keunchil
- Issue Date
- Aug-2018
- Publisher
- ELSEVIER IRELAND LTD
- Keywords
- Nivolumab; Non-small cell lung cancer; Programmed cell death-1
- Citation
- LUNG CANCER, v.122, pp.234 - 242
- Journal Title
- LUNG CANCER
- Volume
- 122
- Start Page
- 234
- End Page
- 242
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/3532
- DOI
- 10.1016/j.lungcan.2018.05.023
- ISSN
- 0169-5002
- Abstract
- 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.
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