Phase II Study of Modified Carboplatin Plus Weekly Nab-Paclitaxel in Elderly Patients with Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1301
Mené au Japon sur 32 patients atteints d'un cancer du poumon non à petites cellules de stade avancé (âge médian : 78 ans), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse globale, et la toxicité du carboplatine en combinaison avec du nab-paclitaxel
Background : The CA031 trial suggested weekly nanoparticle albumin‐bound‐paclitaxel (nab‐PTX) was superior in efficacy to paclitaxel (PTX) once every 3 weeks when combined with carboplatin (CBDCA) for advanced non‐small cell lung cancer (NSCLC) patients; a subgroup analysis of elderly patients looked promising. In a multicenter phase II trial, we prospectively evaluated the efficacy and tolerability of modified CBDCA plus weekly nab‐PTX for elderly patients with untreated advanced NSCLC. Methods : Eligible patients received CBDCA (area under the curve [AUC] 6 mg/mL/min) on day 1 and nab‐PTX (75 mg/m2) on days 1, 8, and 15 every 4 weeks. The primary endpoint was an overall response rate (ORR), and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and toxicity. Results : Of 32 patients (median age of 78 years), 84% were male, 56% had stage IV NSCLC, and 56% had squamous cell carcinoma. ORR and disease control rates were 50% (95% confidence interval (CI): 33–67) and 94% (95% CI: 85–100), respectively. Median PFS and OS were 6.4 months (95% CI: 4.8–8.0) and 17.5 months (95% CI: 11.9–23.1), respectively. Grade ≥3 toxicities were neutropenia (47%), leukopenia (38%), anemia (34%), thrombocytopenia (25%), and anorexia (9%). Febrile neutropenia and treatment‐related deaths were not observed. Conclusion : Modified CBDCA plus weekly nab‐PTX demonstrated significant efficacy and acceptable toxicities in elderly patients with advanced NSCLC.