Efficacy and safety of weekly nab-paclitaxel plus carboplatin in patients with advanced non-small cell lung cancer

Miyako Satouchi, Isamu Okamoto, Hiroshi Sakai, Nobuyuki Yamamoto, Yukito Ichinose, Hironobu Ohmatsu, Naoyuki Nogami, Koji Takeda, Tetsuya Mitsudomi, Kazuo Kasahara, Shunichi Negoro

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26 Citations (Scopus)

Abstract

Purpose: In a large multicenter international phase III study (CA031) of nab-paclitaxel (nab-P, 130. nm albumin-bound paclitaxel particles). +. carboplatin (C) vs solvent-based paclitaxel (sb-P). +. C, conducted in 6 countries including Japan, nab-PC produced significantly higher overall response rate (ORR), primary end point compared with sb-PC, and acceptable safety profile. The aim of this analysis was to evaluate the efficacy and tolerability of nab-PC vs sb-PC in Japanese patients with advanced non-small-cell lung cancer (NSCLC) who were enrolled in the CA031 study. Patients and methods: In the CA031 study, a total of 1052 patients were randomized to receive either nab-P 100mg/m2 weekly or sb-P 200mg/m2 every 3 weeks both in combination with C at area under the concentration-time curve (AUC)=6 on day 1 of each 3-week cycle. This analysis included 149 Japanese patients with previously untreated stage IIIB or IV NSCLC. Results: The baseline and histologic characteristics of patients were well balanced between the two arms. ORR was higher with nab-PC vs sb-PC (35% vs 27%; response rate ratio = 1.318). Progression-free survival (median 6.9 vs 5.6 months; hazard ratio [HR] = 0.845) and overall survival (median 16.7 vs 15.9 months; HR = 0.930) were better with nab-PC vs sb-PC. Of the grade ≥3 treatment-related adverse events, anemia and thrombocytopenia were more common in nab-PC arm, but sensory neuropathy was less common. Conclusion: The nab-PC treatment yielded promising results regarding the efficacy endpoint, and it was generally well tolerated as first-line therapy for Japanese patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)97-101
Number of pages5
JournalLung Cancer
Volume81
Issue number1
DOIs
Publication statusPublished - Jul 1 2013

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Carboplatin
Non-Small Cell Lung Carcinoma
Safety
Paclitaxel
Thrombocytopenia
Disease-Free Survival
130-nm albumin-bound paclitaxel
Anemia
Japan
Therapeutics
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Efficacy and safety of weekly nab-paclitaxel plus carboplatin in patients with advanced non-small cell lung cancer. / Satouchi, Miyako; Okamoto, Isamu; Sakai, Hiroshi; Yamamoto, Nobuyuki; Ichinose, Yukito; Ohmatsu, Hironobu; Nogami, Naoyuki; Takeda, Koji; Mitsudomi, Tetsuya; Kasahara, Kazuo; Negoro, Shunichi.

In: Lung Cancer, Vol. 81, No. 1, 01.07.2013, p. 97-101.

Research output: Contribution to journalArticle

Satouchi, M, Okamoto, I, Sakai, H, Yamamoto, N, Ichinose, Y, Ohmatsu, H, Nogami, N, Takeda, K, Mitsudomi, T, Kasahara, K & Negoro, S 2013, 'Efficacy and safety of weekly nab-paclitaxel plus carboplatin in patients with advanced non-small cell lung cancer', Lung Cancer, vol. 81, no. 1, pp. 97-101. https://doi.org/10.1016/j.lungcan.2013.02.020
Satouchi, Miyako ; Okamoto, Isamu ; Sakai, Hiroshi ; Yamamoto, Nobuyuki ; Ichinose, Yukito ; Ohmatsu, Hironobu ; Nogami, Naoyuki ; Takeda, Koji ; Mitsudomi, Tetsuya ; Kasahara, Kazuo ; Negoro, Shunichi. / Efficacy and safety of weekly nab-paclitaxel plus carboplatin in patients with advanced non-small cell lung cancer. In: Lung Cancer. 2013 ; Vol. 81, No. 1. pp. 97-101.
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AU - Yamamoto, Nobuyuki

AU - Ichinose, Yukito

AU - Ohmatsu, Hironobu

AU - Nogami, Naoyuki

AU - Takeda, Koji

AU - Mitsudomi, Tetsuya

AU - Kasahara, Kazuo

AU - Negoro, Shunichi

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N2 - Purpose: In a large multicenter international phase III study (CA031) of nab-paclitaxel (nab-P, 130. nm albumin-bound paclitaxel particles). +. carboplatin (C) vs solvent-based paclitaxel (sb-P). +. C, conducted in 6 countries including Japan, nab-PC produced significantly higher overall response rate (ORR), primary end point compared with sb-PC, and acceptable safety profile. The aim of this analysis was to evaluate the efficacy and tolerability of nab-PC vs sb-PC in Japanese patients with advanced non-small-cell lung cancer (NSCLC) who were enrolled in the CA031 study. Patients and methods: In the CA031 study, a total of 1052 patients were randomized to receive either nab-P 100mg/m2 weekly or sb-P 200mg/m2 every 3 weeks both in combination with C at area under the concentration-time curve (AUC)=6 on day 1 of each 3-week cycle. This analysis included 149 Japanese patients with previously untreated stage IIIB or IV NSCLC. Results: The baseline and histologic characteristics of patients were well balanced between the two arms. ORR was higher with nab-PC vs sb-PC (35% vs 27%; response rate ratio = 1.318). Progression-free survival (median 6.9 vs 5.6 months; hazard ratio [HR] = 0.845) and overall survival (median 16.7 vs 15.9 months; HR = 0.930) were better with nab-PC vs sb-PC. Of the grade ≥3 treatment-related adverse events, anemia and thrombocytopenia were more common in nab-PC arm, but sensory neuropathy was less common. Conclusion: The nab-PC treatment yielded promising results regarding the efficacy endpoint, and it was generally well tolerated as first-line therapy for Japanese patients with advanced NSCLC.

AB - Purpose: In a large multicenter international phase III study (CA031) of nab-paclitaxel (nab-P, 130. nm albumin-bound paclitaxel particles). +. carboplatin (C) vs solvent-based paclitaxel (sb-P). +. C, conducted in 6 countries including Japan, nab-PC produced significantly higher overall response rate (ORR), primary end point compared with sb-PC, and acceptable safety profile. The aim of this analysis was to evaluate the efficacy and tolerability of nab-PC vs sb-PC in Japanese patients with advanced non-small-cell lung cancer (NSCLC) who were enrolled in the CA031 study. Patients and methods: In the CA031 study, a total of 1052 patients were randomized to receive either nab-P 100mg/m2 weekly or sb-P 200mg/m2 every 3 weeks both in combination with C at area under the concentration-time curve (AUC)=6 on day 1 of each 3-week cycle. This analysis included 149 Japanese patients with previously untreated stage IIIB or IV NSCLC. Results: The baseline and histologic characteristics of patients were well balanced between the two arms. ORR was higher with nab-PC vs sb-PC (35% vs 27%; response rate ratio = 1.318). Progression-free survival (median 6.9 vs 5.6 months; hazard ratio [HR] = 0.845) and overall survival (median 16.7 vs 15.9 months; HR = 0.930) were better with nab-PC vs sb-PC. Of the grade ≥3 treatment-related adverse events, anemia and thrombocytopenia were more common in nab-PC arm, but sensory neuropathy was less common. Conclusion: The nab-PC treatment yielded promising results regarding the efficacy endpoint, and it was generally well tolerated as first-line therapy for Japanese patients with advanced NSCLC.

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