BMC Cancer (Feb 2020)

A phase I/II study of weekly nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer

  • Yoshihiro Hattori,
  • Yuko Kono,
  • Shoichi Itoh,
  • Takako Inoue,
  • Yoshiko Urata,
  • Yoshitaka Kawa,
  • Rie Tohnai,
  • Toru Kumagai,
  • Kazumi Nishino,
  • Ryuji Uozumi,
  • Satoshi Morita,
  • Shunichi Negoro,
  • Fumio Imamura,
  • Miyako Satouchi

DOI
https://doi.org/10.1186/s12885-020-6588-y
Journal volume & issue
Vol. 20, no. 1
pp. 1 – 8

Abstract

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Abstract Background The aim of this study was to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC). Methods Chemotherapy-naïve patients with advanced NSCLC were eligible. In the phase I dose-escalation cohort (3 + 3 design), patients received nab-paclitaxel (80 or 100 mg/m2 given intravenously on days 1, 8 and 15) plus cisplatin (60 or 75 mg/m2 given intravenously on day 1) every 4 weeks. The maximum tolerated dose was not reached. Nab-paclitaxel (100 mg/m2 given intravenously on days 1, 8 and 15) plus cisplatin (75 mg/m2 given intravenously on day 1) every 4 weeks was selected for the phase II cohort. The primary endpoint was the objective response rate (ORR). Results Twenty-three patients (phase I, n = 6; phase II, n = 17) were enrolled, and 22 patients were eligible. The median age was 67.5 years (range 37–75), 90.9% were males, 45.5% had adenocarcinoma and 81.8% had stage IV disease. The ORR was 59.1% (90% confidence interval (CI); 41.8–74.4), and the disease control rate was 86.4% (95% CI; 66.7–95.3). The median progression-free survival was 5.1 months (95% CI; 4.0–6.7), and the median overall survival was 24.2 months (95% CI; 8.4 months to not estimable). The common grade ≥ 3 adverse events were neutropenia (31.8%), leukopenia (27.3%), lung infection (18.2%) and hyponatremia (18.2%). There was one instance of grade 2 interstitial pneumonia and no treatment-related death. Conclusions Nab-paclitaxel plus cisplatin was well tolerated and associated with encouraging response outcomes in chemotherapy-naïve patients with advanced NSCLC. Further investigation is warranted. Trial registration UMIN Clinical Trials Registry: UMIN000011776; Date of registration: 17 September 2013; Date of enrolment of the first participant to the trial: 23 January 2014.

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