Nivolumab in advanced non-small-cell lung cancer patients who failed prior platinum-based chemotherapy. (August 2018)

• Record Type: Journal Article
• 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
• Is Part Of: Lung cancer. Volume 122(2018)
• Page Start: 234
• Page End: 242
• Publication Date: 2018-08
• Subjects: AE adverse event -- ALK anaplastic lymphoma kinase -- ALT alanine aminotransferase -- AST aspartate aminotransferase -- CI confidence interval -- CR complete response -- ECOG Eastern Cooperative Oncology Group -- EGFR epidermal growth factor receptor -- HR hazard ratio -- NSCLC non-small-cell lung cancer -- OR objective response -- ORR objective response rate -- OS overall survival -- PD progressive disease -- PD-1 programmed death-1 -- PD-L1 programmed death ligand1 -- PFS progression-free survival -- PR partial response -- RECIST Response Evaluation Criteria in Solid Tumors -- SD stable disease -- TKI tyrosine kinase inhibitor; Nivolumab -- Non-small cell lung cancer -- Programmed cell death-1; Lungs -- Cancer -- Periodicals; Lung Neoplasms -- Abstracts; Lung Neoplasms -- Periodicals; Poumons -- Cancer -- Périodiques; Lungs -- Cancer; Periodicals; Electronic journals; Electronic journals; 616.99424
• DOI: 10.1016/j.lungcan.2018.05.023
• Languages: English
• ISSNs: 0169-5002

Abstract

Highlights: Historical reports state that overall survival in refractory NSCLC is <1 year. We evaluated nivolumab in 100 Koreans with NSCLC. Objective response rate (ORR) was 20% in the total population. ORR was 15.9% and 23.2% in those with squamous and non-squamous NSCLC, respectively. Median overall survival was 12.3 and 16.3 months, respectively. 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.