title: A phase II study of nab-paclitaxel plus carboplatin in combination with thoracic radiation in patients with locally advanced non-small-cell lung cancer.
abstract: We investigated the efficacy and safety of albumin-bound paclitaxel (nab-PTX) and carboplatin (CBDCA) with concurrent radiotherapy for unresectable locally advanced non-small-cell lung cancer (NSCLC). Patients with Stage III NSCLC and an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Concurrent chemoradiotherapy consisted of weekly administration of nab-PTX (40 mg/m(2)) plus CBDCA (area under the plasma concentration time curve (AUC) 2) and thoracic radiotherapy (60 Gy/30 fractions) for a total of 6 weeks. After concurrent chemoradiotherapy, patients received an additional two cycles of consolidation phase chemotherapy that consisted of 4-week cycles of nab-PTX (100 mg/m(2) on Days 1, 8 and 15)/CBDCA (AUC 5 mg/ml/min on Day 1). Response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors. Progression-free survival and overall survival were estimated using the Kaplan-Meier method. Toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events. A total of 10 patients were enrolled in this trial between September 2013 and January 2014 from three institutes. The overall response rate was 40.0% and the median progression-free survival was 6.7 months. Treatment-related death occurred in two patients. Grade 2 or worse severe radiation pneumonitis was observed in all three patients that had the volume of lung receiving at least 20 Gy (V20) >30%. The results of this study indicate that no further investigation is warranted into nab-PTX and CBDCA with concurrent thoracic radiation for Stage III NSCLC with V20 > 30% due to severe toxicity.
authors.affiliation: Department of Respiratory Medicine and Medical Oncology, Gifu Municipal Hospital, 7-1 Kashima-cho, Gifu-shi, Gifu 500-8323, Japan takaaki_hase@bird.ocn.ne.jp.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Hasegawa
authors.affiliation: Department of Respiratory Medicine and Medical Oncology, Gifu Municipal Hospital, 7-1 Kashima-cho, Gifu-shi, Gifu 500-8323, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Futamura
authors.affiliation: Department of Respiratory Medicine and Medical Oncology, Gifu Municipal Hospital, 7-1 Kashima-cho, Gifu-shi, Gifu 500-8323, Japan.
authors.forename: Akane
authors.initials: A
authors.lastname: Horiba
authors.affiliation: Department of Respiratory Medicine and Medical Oncology, Gifu Municipal Hospital, 7-1 Kashima-cho, Gifu-shi, Gifu 500-8323, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Yoshida
authors.affiliation: Respirtory Medicine, National Hospital Organization Nagara Medical Center, 1300-7, Nagara, Gifu-shi, Gifu 502-8558, Japan.
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Suzuki
authors.affiliation: Respirtory Medicine, National Hospital Organization Nagara Medical Center, 1300-7, Nagara, Gifu-shi, Gifu 502-8558, Japan.
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Kato
authors.affiliation: Department of Respirology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu-shi, Gifu 501-1194, Japan.
authors.forename: Daizo
authors.initials: D
authors.lastname: Kaito
authors.affiliation: Department of Respirology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu-shi, Gifu 501-1194, Japan.
authors.forename: Yasuhi
authors.initials: Y
authors.lastname: Ohno
authors.affiliation: Department of Radiology, Gifu Municipal Hospital, 7-1 Kashima-cho, Gifu-shi, Gifu 500-8323, Japan.
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Iida
authors.affiliation: Department of Radiology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu-shi, Gifu 501-1194, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Hayashi
authors.affiliation: Department of Respiratory Medicine and Medical Oncology, Gifu Municipal Hospital, 7-1 Kashima-cho, Gifu-shi, Gifu 500-8323, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Sawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011827:Radiation; D016019:Survival Analysis; D013909:Thorax / Q000528:radiation effects; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel
keywords: carboplatin; nab-paclitaxel; non–small-cell lung cancer; radiotherapy