Phase II trial of weekly nab-paclitaxel for previously treated advanced non–small cell lung cancer: Kumamoto thoracic oncology study group (KTOSG) trial 1301. (September 2016)

• Record Type: Journal Article
• Authors: Sakata, Shinya; Saeki, Sho; Okamoto, Isamu; Otsubo, Kohei; Komiya, Kazutoshi; Morinaga, Ryotaro; Yoneshima, Yasuto; Koga, Yuichiro; Enokizu, Aimi; Kishi, Hiroto; Hirosako, Susumu; Yamaguchi, Emi; Aragane, Naoko; Fujii, Shinji; Harada, Taishi; Iwama, Eiji; Semba, Hiroshi; Nakanishi, Yoichi; Kohrogi, Hirotsugu
• Is Part Of: Lung cancer. Volume 99(2016)
• Page Start: 41
• Page End: 45
• Publication Date: 2016-09
• Subjects: Non–small cell lung cancer -- Nab-paclitaxel -- Objective response rate -- Overall survival -- Phase II trial; Lungs -- Cancer -- Periodicals; Lung Neoplasms -- Abstracts; Lung Neoplasms -- Periodicals; Poumons -- Cancer -- Périodiques; Lungs -- Cancer; Periodicals; Electronic journals; Electronic journals; 616.99424
• DOI: 10.1016/j.lungcan.2016.06.009
• Languages: English
• ISSNs: 0169-5002

Abstract

Highlights: This is a phase II study of nab-paclitaxel in patients with previously treated NSCLC. The ORR was 31.7%, which met the primary objective of the study. The median PFS was 4.9 months and the median OS was 13.0 months. Hematologic toxicities of grade 3 or 4 was neutropenia (19%) and leukopenia (17%). Nab-paclitaxel showed acceptable toxicity and favorable ORR. 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/m 2 ) 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/m 2 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.