Cancer Res Treat.  2020 Oct;52(4):1112-1119. 10.4143/crt.2020.245.

Real-World Experience of Nivolumab in Non-small Cell Lung Cancer in Korea

• Lim SM
• Kim SW
• Cho BC
• Kang JH
• Ahn MJ
• Kim DW
• Kim YC
• Lee JS
• Lee JS
• Lee SY
• Park KU
• An HJ
• Cho EK
• Jang TW
• Kim BS
• Kim JH
• Lee SS
• Na II
• Yoo SS
• Lee KH

• KMID: 2507937
• DOI: http://doi.org/10.4143/crt.2020.245

Abstract

Purpose
The introduction of immune checkpoint inhibitors represents a major advance in the treatment of lung cancer, allowing sustained recovery in a significant proportion of patients. Nivolumab is a monoclonal anti–programmed death cell protein 1 antibody licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. In this study, we describe the demographic and clinical outcomes of patients with advanced NSCLC treated with nivolumab in the Korean expanded access program.
Materials and Methods
Previously treated patients with advanced non-squamous and squamous NSCLC patients received nivolumab at 3 mg/kg every 2 weeks up to 36 months. Efficacy data including investigator-assessed tumor response, progression data, survival, and safety data were collected.
Results
Two hundred ninety-nine patients were treated across 36 Korean centers. The objective response rate and disease control rate were 18% and 49%, respectively; the median progression-free survival was 2.1 months (95% confidence interval [CI], 1.87 to 3.45), and the overall survival (OS) was 13.2 months (95% CI, 10.6 to 18.9). Patients with smoking history and patients who experienced immune-related adverse events showed a prolonged OS. Cox regression analysis identified smoking history, presence of immune-related adverse events as positive factors associated with OS, while liver metastasis was a negative factor associated with OS. The safety profile was generally comparable to previously reported data.
Conclusion
This real-world analysis supports the use of nivolumab for pretreated NSCLC patients, including those with an older age.

Keyword

Non-small cell lung cancer; Anti?PD-1; Real-world data

Figure

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  Fig. 1. Flow diagram of the study patients. Three hundred thirty-four patients were nominated for treatment in the nivolumab EAP. Thirty-four patients did not meet the study criteria and failed the screening. A total of 300 patients were enrolled, but one patient did not start the treatment. Overall, 299 patients were included in the analysis.

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  Fig. 2. Kaplan-Meier curves of progression-free survival and overall survival in non-small cell lung cancer patients treated with nivolumab. (A) Progression-free survival of all patients. (B) Overall survival of all patients.

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  Fig. 3. Kaplan-Meier curves. (A) Comparison of progression-free survival between former or current smokers versus never-smokers. (B) Comparison of overall survival between former or current smokers versus never-smokers. (C) Comparison of progression-free survival between squamous cell carcinoma and adenocarcinoma. (D) Comparison of overall survival between squamous cell carcinoma and adenocarcinoma. HR, hazard ratio; CI, confidence interval.

Reference

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