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01-10-2018 | PHASE II STUDIES

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

Authors: Akira Nakao, Junji Uchino, Fumiyasu Igata, Rintaro On, Takato Ikeda, Hiroshi Yatsugi, Ryosuke Hirano, Tomoya Sasaki, Keiko Tanimura, Tatsuya Imabayashi, Nobuyo Tamiya, Yoshiko Kaneko, Tadaaki Yamada, Nobuhiko Nagata, Kentaro Watanabe, Junji Kishimoto, Koichi Takayama, Masaki Fujita

Published in: Investigational New Drugs | Issue 5/2018

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/m² 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.

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Title: 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
Authors: Akira Nakao
Junji Uchino
Fumiyasu Igata
Rintaro On
Takato Ikeda
Hiroshi Yatsugi
Ryosuke Hirano
Tomoya Sasaki
Keiko Tanimura
Tatsuya Imabayashi
Nobuyo Tamiya
Yoshiko Kaneko
Tadaaki Yamada
Nobuhiko Nagata
Kentaro Watanabe
Junji Kishimoto
Koichi Takayama
Masaki Fujita
Publication date: 01-10-2018
Publisher: Springer US
Published in: Investigational New Drugs / Issue 5/2018
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI: https://doi.org/10.1007/s10637-018-0617-6

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