Phase 3 Randomized Low-Dose Paclitaxel Chemoradiotherapy Study for Locally Advanced Non-Small Cell Lung Cancer

• Published in: Frontiers in oncology 2016-12, Vol.6, p.260-260
• Main Authors: Lin, Hongmei, Chen, Yuhchyau, Shi, Anhui, Pandya, Kishan J, Yu, Rong, Yuan, Yannan, Li, Jiancheng, Li, Hang, Wang, Yingjie, Xia, Tingyi, Feng, Linchun, Ma, Huimin, Geng, Jianhao, Zhu, Guangying
• Format: Article
• Language: English
• Subjects: Chemoradiotherapy; Non-small cell lung cancer; Oncology; Paclitaxel; Phase 3 trial; radiosensitization
• ISSN: 2234-943X; 2234-943X
• DOI: 10.3389/fonc.2016.00260

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. 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/m , three times per week (Monday, Wednesday, and Friday) for 6 weeks,  = 74] or Arm 2 (weekly paclitaxel at 45 mg/m for 6 weeks,  = 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. 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%) ( =0.001). RFS was superior in Arm 1: median 14.6 vs. 9.4 months,  = 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,  = 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 (