TY - JOUR
T1 - Nab-paclitaxel maintenance therapy following carboplatin + nab-paclitaxel combination therapy in chemotherapy naïve patients with advanced non-small cell lung cancer
T2 - multicenter, open-label, single-arm phase II trial
AU - Nakao, Akira
AU - Uchino, Junji
AU - Igata, Fumiyasu
AU - On, Rintaro
AU - Ikeda, Takato
AU - Yatsugi, Hiroshi
AU - Hirano, Ryosuke
AU - Sasaki, Tomoya
AU - Tanimura, Keiko
AU - Imabayashi, Tatsuya
AU - Tamiya, Nobuyo
AU - Kaneko, Yoshiko
AU - Yamada, Tadaaki
AU - Nagata, Nobuhiko
AU - Watanabe, Kentaro
AU - Kishimoto, Junji
AU - Takayama, Koichi
AU - Fujita, Masaki
N1 - Funding Information:
Conflicts of interests J Uchino reports grants from Eli Lilly Japan K.K., outside the submitted work. T Yamada reports grants from Nippon Boehringer Ingelheim Co., Ltd., and Ono Pharmaceutical Co., Ltd., outside the submitted work. K Takayama reports grants from Chugai-Roche Co., grants from Ono Pharmaceutical Co., personal fees from Astrazeneca Co., personal fees from Chugai-Roche Co., personal fees from MSD-Merck Co., personal fees from Eli Lilly Co., personal fees from Boehringer-Ingelheim Co., personal fees from Daiichi-Sankyo Co., outside the submitted work. A Nakao, F Igata, R On, T Ikeda, H Yatsugi, R Hirano, T Sasaki, K Tanimura, T Imabayashi, N Tamiya, Y Kaneko, N Nagata, K Watanabe, J Kishimoto, and M Fujita have no conflict of interest to declare.
Publisher Copyright:
© 2018, Springer Science+Business Media, LLC, part of Springer Nature.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2018/10/1
Y1 - 2018/10/1
N2 - 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.
AB - 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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U2 - 10.1007/s10637-018-0617-6
DO - 10.1007/s10637-018-0617-6
M3 - Article
C2 - 29846848
AN - SCOPUS:85047833600
SN - 0167-6997
VL - 36
SP - 903
EP - 910
JO - Investigational New Drugs
JF - Investigational New Drugs
IS - 5
ER -
