Clinical Research Papers:
Phase III study of cisplatin with pemtrexed or vinorelbine plus concurrent late course accelerated hyperfractionated radiotherapy in patients with unresectable stage III non-small cell lung cancer
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Qian Zhao1,2,*, Zhongtang Wang2,*, Wei Huang2, Qiang Wang3, Shuzeng Yu4, Tao Zhou2, Dan Han2, Zhenying Wu5, Heyi Gong2, Hongfu Sun2, Jian Zhang2, Yumei Wei2, Hongsheng Li2, Zicheng Zhang2, Haiqun Lin2 and Baosheng Li2
1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong Academy of Medical Sciences, Jinan, Shandong, P.R. China
2 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China
3 Department of Radiation Oncology, People’s Hospital of Linzi District, Zibo, Shandong, P.R. China
4 Department of Radiation Oncology, LiaoCheng People’s Hospital, LiaoCheng, Shandong, P.R. China
5 Department of Radiation Oncology, Second People’s Hospital of Dezhou City, Dezhou, Shandong, P.R. China
* These authors contributed equally to this manuscript and should be considered co-first authors
BaoSheng Li, email:
Keywords: chemoradiotherapy, clinical feasibility, vinorelbine, pemetrexed, non-small-cell lung cancer
Received: August 03, 2015 Accepted: January 01, 2016 Published: January 09, 2016
Our aim was to evaluate the efficacy and safety of cisplatin with pemtrexed or vinorelbine and concurrent late course accelerated hyperfractionated radiotherapy (LCAHRT). Patients with unresectable stage III non-small-cell lung cancer (NSCLC) were randomly assigned to two regimens. The experimental (PP) arm included cisplatin, pemtrexed and concurrent LCAHRT based on bilateral lung V20 = 33%. The control (NP) arm used cisplatin, vinorelbine with the same radiotherapy protocol. The primary endpoint was overall survival. Median survival times were 26.0 months (95% CI 23.2 to 28.7 months) and 28.5 months (95% CI 17.1 to 39.9 months) for the NP and PP arms, respectively (P = 0.26). Median progression-free survival was 12.5 months and 17.5 months in the NP and PP arms (P = 0.07). In both arms of the study, there were no differences in overall survival between patients with squamous and nonsquamous NSCLC. The incidences of grade 3 or 4 toxicity were higher in NP than PP arm. With concurrent LCAHRT, pemetrexed/cisplatin was equally as efficacious as vinorelbine/cisplatin, but showed a more favorable toxicity profile.
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