Nab-paclitaxel maintenance therapy following carboplatin + nab-paclitaxel combination therapy in chemotherapy naïve patients with advanced non-small cell lung cancer: multicenter, open-label, single-arm phase II trial

• Published in: Investigational new drugs 2018-10, Vol.36 (5), p.903-910
• Main Authors: Nakao, Akira, Uchino, Junji, Igata, Fumiyasu, On, Rintaro, Ikeda, Takato, Yatsugi, Hiroshi, Hirano, Ryosuke, Sasaki, Tomoya, Tanimura, Keiko, Imabayashi, Tatsuya, Tamiya, Nobuyo, Kaneko, Yoshiko, Yamada, Tadaaki, Nagata, Nobuhiko, Watanabe, Kentaro, Kishimoto, Junji, Takayama, Koichi, Fujita, Masaki
• Format: Article
• Language: English
• Subjects: Anemia; Cancer; Carboplatin; Chemotherapy; Combination therapy; Induction therapy; Lung cancer; Maintenance; Medicine; Medicine & Public Health; Neutropenia; Non-small cell lung carcinoma; Oncology; Paclitaxel; Patients; Pharmacology/Toxicology; Phase II Studies; Studies; Survival; Toxicity
• ISSN: 0167-6997; 1573-0646
• DOI: 10.1007/s10637-018-0617-6

Summary Background A global multicenter study demonstrated superiority of carboplatin + nab-paclitaxel (PTX) therapy compared to carboplatin + PTX in terms of response rate (RR) and non-inferiority in terms of progression free survival (PFS) and overall survival (OS) in untreated patients with stage IIIB/IV non-small cell lung cancer; no clinical findings have so far been reported on maintenance therapies with nab-PTX. The aim of this study was to determine the efficacy and safety of maintenance therapy with nab-PTX following carboplatin + nab-PTX combination therapy. Methods Carboplatin (AUC 6) was administered on Day 1; and nab-PTX 100 mg/m 2 on Days 1, 8, and 15, and dosing was repeated in 4 courses of 4 weeks each. In patients with clinical response was observed at the end of the 4th course, nab-PTX maintenance therapy was repeated. Results Out of 39 patients included in the efficacy analysis, 19 (48.7%) patients completed the induction therapy and 15 (38.5%) were transitioned to maintenance therapy. The median PFS in the maintenance phase was 6.5 (90%CI 1.4–11.4) months. The median OS in 15 patients was 12.6 (95%CI: 7.4-not reached). Grade ≥ 3 toxicities observed in more than 5% of patients were neutropenia (55.0%), anemia (15.0%), and febrile neutropenia (5.0%), with no increase during the maintenance phase. Conclusions Although statistically significance was not demonstrated presumably due to a limited transition rate from induction to maintenance phase, nab-PTX was suggested to be a useful treatment option following the induction therapy with nab-PTX in patients with advanced NSCLC.