title: A randomised clinical trial of radiotherapy plus cisplatin versus radiotherapy alone in stage III non-small cell lung cancer.
abstract: This study was designed to compare high-dose fractionated radiotherapy alone versus the same radiotherapy plus cisplatin in stage III non-small cell lung cancer (NSCLC). We randomly assigned 176 patients with stage III non-small cell lung cancer to one of two treatments; fractionated radiotherapy alone at dose of 64 Gy for 6-7 weeks (2 Gy given 32 times, in five fractions a week) or radiotherapy in the same schedule, combined with 20mg/m2 cisplatin 1 h before radiotherapy, given on days 1-5 of the second and sixth treatment weeks. The frequency of loco-regional progression was 68% among the patients who received radiotherapy plus cisplatin and 86% among those who received radiotherapy alone (P = 0.0001). The probability of survival free of disease after 3 years was 10% among the patients assigned to radiotherapy plus cisplatin and 0% among those treated only with radiotherapy (P = 0.0006). Overall survival at 3 years was 10% among those given radiotherapy plus cisplatin and 2% among those who received radiotherapy alone (P = 0.00001). Multivariate analysis demonstrated that radiotherapy plus cisplatin significantly improved loco-regional progression-free survival and overall survival, irrespective of radiation dose. The addition of cisplatin to fractionated radiotherapy prolongs loco-regional progression-free interval and survival in stage III non-small cell lung cancer.
authors.affiliation: Department of Radiation Oncology, Ondokuz Mayis University Hospital, Samsun 55139, Turkey. sacakir@omu.edu.tr
authors.forename: Saban
authors.initials: S
authors.lastname: Cakir
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Egehan
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D002945:Cisplatin / Q000627:therapeutic use*; D003037:Cobalt Radioisotopes / Q000627:therapeutic use; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000628:therapy; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D003037:Cobalt Radioisotopes; D002945:Cisplatin