title: 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.
abstract: 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.
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong Academy of Medical Sciences, Jinan, Shandong, P.R. China.|Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Qian
authors.initials: Q
authors.lastname: Zhao
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Zhongtang
authors.initials: Z
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Wei
authors.initials: W
authors.lastname: Huang
authors.affiliation: Department of Radiation Oncology, People's Hospital of Linzi District, Zibo, Shandong, P.R. China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, LiaoCheng People's Hospital, LiaoCheng, Shandong, P.R. China.
authors.forename: Shuzeng
authors.initials: S
authors.lastname: Yu
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Tao
authors.initials: T
authors.lastname: Zhou
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Dan
authors.initials: D
authors.lastname: Han
authors.affiliation: Department of Radiation Oncology, Second People's Hospital of Dezhou City, Dezhou, Shandong, P.R. China.
authors.forename: Zhenying
authors.initials: Z
authors.lastname: Wu
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Heyi
authors.initials: H
authors.lastname: Gong
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Hongfu
authors.initials: H
authors.lastname: Sun
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Jian
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Yumei
authors.initials: Y
authors.lastname: Wei
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Hongsheng
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Zicheng
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Haiqun
authors.initials: H
authors.lastname: Lin
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, P.R. China.
authors.forename: Baosheng
authors.initials: B
authors.lastname: Li
mesh_terms: D000230:Adenocarcinoma / Q000556:secondary / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D018287:Carcinoma, Large Cell / Q000556:secondary / Q000628:therapy*; D002289:Carcinoma, Non-Small-Cell Lung / Q000556:secondary / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000556:secondary / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D000068437:Pemetrexed / Q000008:administration & dosage; D011379:Prognosis; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000068437:Pemetrexed; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine
keywords: chemoradiotherapy; clinical feasibility; non-small-cell lung cancer; pemetrexed; vinorelbine