Nivolumab in advanced non-small-cell lung cancer patients who failed prior platinum-based chemotherapy
Mené en Corée sur 100 patients atteints d'un cancer du poumon non à petites cellules de stade avancé (stade IIIB ou IV) ou récidivant, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité du nivolumab après l'échec de chimiothérapies à base de sels de platine, selon que le cancer soit de type épidermoïde ou non
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, 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% 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 adverse events (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.
Lung Cancer 2018