title: Phase II trial of weekly nab-paclitaxel for previously treated advanced non-small cell lung cancer: Kumamoto thoracic oncology study group (KTOSG) trial 1301.
abstract: 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).
  
  
  
  Patients with advanced NSCLC who experienced failure of prior platinum-doublet chemotherapy received weekly nab-paclitaxel (100mg/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).
  
  
  
  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 89.1mg/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%.
  
  
  
  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.
authors: Department of Respiratory Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan; Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
authors: Shinya
authors: S
authors: Sakata
authors: Department of Respiratory Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
authors: Sho
authors: S
authors: Saeki
authors: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. Electronic address: okamotoi@kokyu.med.kyushu-u.ac.jp.
authors: Isamu
authors: I
authors: Okamoto
authors: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
authors: Kohei
authors: K
authors: Otsubo
authors: Division of Hematology, Respiratory Medicine and Oncology, Saga University Hospital, 5-1-1 Saga, 849-6511, Japan.
authors: Kazutoshi
authors: K
authors: Komiya
authors: Department of Respiratory Medicine and Oncology, Oita Prefectural Hospital, 476 Bunyou, Oita, 870-8511, Japan.
authors: Ryotaro
authors: R
authors: Morinaga
authors: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
authors: Yasuto
authors: Y
authors: Yoneshima
authors: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
authors: Yuichiro
authors: Y
authors: Koga
authors: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
authors: Aimi
authors: A
authors: Enokizu
authors: Department of Respiratory Medicine, Kumamoto City Hospital, 1-1-60 Koto, Higashi-ku, Kumamoto, 862-8505, Japan.
authors: Hiroto
authors: H
authors: Kishi
authors: Department of Respiratory Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
authors: Susumu
authors: S
authors: Hirosako
authors: Department of Respiratory Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
authors: Emi
authors: E
authors: Yamaguchi
authors: Division of Hematology, Respiratory Medicine and Oncology, Saga University Hospital, 5-1-1 Saga, 849-6511, Japan.
authors: Naoko
authors: N
authors: Aragane
authors: Division of Respiratory Disease, Kumamoto Regional Medical Center, 5-16-10 Honjo, Chuo-ku, Kumamoto, 860-0811, Japan.
authors: Shinji
authors: S
authors: Fujii
authors: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
authors: Taishi
authors: T
authors: Harada
authors: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan; Faculty of Medical Sciences, Department of Comprehensive Clinical Oncology, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
authors: Eiji
authors: E
authors: Iwama
authors: Division of Respiratory Disease, Kumamoto Regional Medical Center, 5-16-10 Honjo, Chuo-ku, Kumamoto, 860-0811, Japan.
authors: Hiroshi
authors: H
authors: Semba
authors: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
authors: Yoichi
authors: Y
authors: Nakanishi
authors: Department of Respiratory Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
authors: Hirotsugu
authors: H
authors: Kohrogi
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D004334:Drug Administration Schedule; D005260:Female; D018773:Genes, erbB-1; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage*; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D000970:Antineoplastic Agents; D017239:Paclitaxel
keywords: Nab-paclitaxel; Non–small cell lung cancer; Objective response rate; Overall survival; Phase II trial