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

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

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)903-910
Number of pages8
JournalInvestigational New Drugs
Volume36
Issue number5
DOIs
Publication statusPublished - Oct 1 2018

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Carboplatin
Non-Small Cell Lung Carcinoma
Drug Therapy
Therapeutics
Maintenance
Disease-Free Survival
130-nm albumin-bound paclitaxel
Febrile Neutropenia
Survival
Paclitaxel
Neutropenia
Multicenter Studies
Area Under Curve
Anemia
Safety

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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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. / 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.

In: Investigational New Drugs, Vol. 36, No. 5, 01.10.2018, p. 903-910.

Research output: Contribution to journalArticle

Nakao, A, Uchino, J, Igata, F, On, R, Ikeda, T, Yatsugi, H, Hirano, R, Sasaki, T, Tanimura, K, Imabayashi, T, Tamiya, N, Kaneko, Y, Yamada, T, Nagata, N, Watanabe, K, Kishimoto, J, Takayama, K & Fujita, M 2018, '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', Investigational New Drugs, vol. 36, no. 5, pp. 903-910. https://doi.org/10.1007/s10637-018-0617-6
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. / 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. In: Investigational New Drugs. 2018 ; Vol. 36, No. 5. pp. 903-910.
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abstract = "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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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

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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