Phase II trial of weekly nab-paclitaxel for previously treated advanced non–small cell lung cancer: Kumamoto thoracic oncology study group (KTOSG) trial 1301

Shinya Sakata, Sho Saeki, Isamu Okamoto, Kohei Otsubo, Kazutoshi Komiya, Ryotaro Morinaga, Yasuto Yoneshima, Yuichiro Koga, Aimi Enokizu, Hiroto Kishi, Susumu Hirosako, Emi Yamaguchi, Naoko Aragane, Shinji Fujii, Taishi Harada, Eiji Iwama, Hiroshi Semba, Yoichi Nakanishi, Hirotsugu Kohrogi

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17 Citations (Scopus)

Abstract

Objectives We performed an open-label, multicenter, single-arm phase II study (UMIN ID 000010532) to prospectively evaluate the efficacy and safety of nab-paclitaxel for previously treated patients with advanced non–small cell lung cancer (NSCLC). Methods Patients with advanced NSCLC who experienced failure of prior platinum-doublet chemotherapy received weekly nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of a 21-day cycle until disease progression or the development of unacceptable toxicity. The primary end point of the study was objective response rate (ORR). Results Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7% (90% confidence interval, 19.3%–44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4–7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0–18.0 months) months. The median number of treatment cycles was four (range, 1–17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%. Conclusion Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.

Original languageEnglish
Pages (from-to)41-45
Number of pages5
JournalLung Cancer
Volume99
DOIs
Publication statusPublished - Sep 1 2016

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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    Sakata, S., Saeki, S., Okamoto, I., Otsubo, K., Komiya, K., Morinaga, R., Yoneshima, Y., Koga, Y., Enokizu, A., Kishi, H., Hirosako, S., Yamaguchi, E., Aragane, N., Fujii, S., Harada, T., Iwama, E., Semba, H., Nakanishi, Y., & Kohrogi, H. (2016). Phase II trial of weekly nab-paclitaxel for previously treated advanced non–small cell lung cancer: Kumamoto thoracic oncology study group (KTOSG) trial 1301. Lung Cancer, 99, 41-45. https://doi.org/10.1016/j.lungcan.2016.06.009