title: Phase 3 Randomized Low-Dose Paclitaxel Chemoradiotherapy Study for Locally Advanced Non-Small Cell Lung Cancer.
abstract: BACKGROUND
  Concurrent chemoradiotherapy (CCRT) is the standard treatment for locally advanced non-small cell lung cancer (LA-NSCLC) but is associated with poor chest tumor control. Here, we report results of a randomized phase 3 study comparing two CCRT regimens in improving chest tumor control by low-dose paclitaxel chemoradiation for LA-NSCLC.
  
  
  METHODS
  Due to the logistics of local referral pattern, the study was designed to enroll patients with stage III LA-NSCLC who had completed 2-4 cycles of full-dose chemotherapy. One hundred thirty four were randomized to either Arm 1 [paclitaxel at 15 mg/m2, three times per week (Monday, Wednesday, and Friday) for 6 weeks,n= 74] or Arm 2 (weekly paclitaxel at 45 mg/m2for 6 weeks,n= 60). Chest radiotherapy was 60-70 Gy in standard fractionation. Response rate was the primary endpoint, with recurrence-free survival (RFS) as the secondary endpoint.
  
  
  RESULTS
  From March 2006 to February 2013, 71 patients completed Arm 1 treatment and 59 completed Arm 2 treatment. The response rate for Arm 1 was significantly higher (83.1%) than Arm 2 (54.2%) (p=0.001). RFS was superior in Arm 1: median 14.6 vs. 9.4 months,p= 0.005, Hazard ratio (HR) 1.87 [95% confidence interval (CI) 1.20, 2.90]. Overall survival was not significantly different: median 32.6 months in Arm 1 vs. 31.3 months in Arm 2,p= 0.91, HR 0.97 (95% CI 0.55, 1.70). Toxicity was significantly lower in Arm 1 for Grade 3 and 4 leukopenia/neutropenia (p< 0.001).
  
  
  CONCLUSIONS
  Pulsed low-dose paclitaxel CCRT resulted in significantly better RFS and tumor response rate, and less hematologic toxicities than weekly CCRT for LA-NSCLC.
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China; Department of Radiation Oncology, China-Japan Friendship Hospital, Beijing, China.
authors.forename: Hongmei
authors.initials: H
authors.lastname: Lin
authors.affiliation: Department of Radiation Oncology, James P. Wilmot Cancer Institute, University of Rochester Medical Center , Rochester, NY , USA.
authors.forename: Yuhchyau
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital & Institute , Beijing , China.
authors.forename: Anhui
authors.initials: A
authors.lastname: Shi
authors.affiliation: Division of Hematology and Oncology, Department of Medicine, James P. Wilmot Cancer Institute, University of Rochester Medical Center , Rochester, NY , USA.
authors.forename: Kishan J
authors.initials: KJ
authors.lastname: Pandya
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital & Institute , Beijing , China.
authors.forename: Rong
authors.initials: R
authors.lastname: Yu
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital & Institute , Beijing , China.
authors.forename: Yannan
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: Department of Radiation Oncology, Fujian Province Cancer Hospital , Fuzhou , China.
authors.forename: Jiancheng
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Radiation Oncology, Guizhou Province People's Hospital , Guiyang , China.
authors.forename: Hang
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Radiation Oncology, Air Force General Hospital, PLA , Beijing , China.
authors.forename: Yingjie
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, Air Force General Hospital, PLA , Beijing , China.
authors.forename: Tingyi
authors.initials: T
authors.lastname: Xia
authors.affiliation: Department of Radiation Oncology, Chinese PLA General Hospital , Beijing , China.
authors.forename: Linchun
authors.initials: L
authors.lastname: Feng
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital & Institute , Beijing , China.
authors.forename: Huimin
authors.initials: H
authors.lastname: Ma
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital & Institute , Beijing , China.
authors.forename: Jianhao
authors.initials: J
authors.lastname: Geng
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China; Department of Radiation Oncology, China-Japan Friendship Hospital, Beijing, China.
authors.forename: Guangying
authors.initials: G
authors.lastname: Zhu
keywords: chemoradiotherapy; non-small cell lung cancer; paclitaxel; phase 3 trial; radiosensitization