title: Randomized trial comparing postoperative chemotherapy with vindesine and cisplatin plus thoracic irradiation with irradiation alone in stage III (N2) non-small cell lung cancer.
abstract: This prospective randomized trial was performed to determine whether postoperative chemotherapy with vindesine and cisplatin could lengthen time to progression and overall survival in stage III (T1-3N2M0) non-small cell lung cancer (NSCLC) patients. Seventy-two patients were entered; 36 were randomized to receive chemotherapy. Patients were stratified by extent of resection (complete vs. incomplete) and histology (squamous vs. nonsquamous). All had surgery and mediastinal irradiation 6-7 weeks post-thoracotomy. Incompletely resected patients had intraoperative 125I and/or 192Ir implantation. Vindesine (3 mg/m2) weekly x 5, then every 2 weeks x 8, and cisplatin (120 mg/m2) days 1, 29, 71, 113 were planned for those randomized to chemotherapy. No difference in time to progression (median 9.2 months for radiation + chemotherapy vs. 9.0 months for radiation, P = 0.35) or overall survival (16.3 months for radiation + chemotherapy vs. 19.1 months for radiation, P = 0.42) was found. Postoperative vindesine and cisplatin did not prolong time to progression or survival in this population of stage III NSCLC.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York 10021.
authors.forename: K M
authors.initials: KM
authors.lastname: Pisters
authors.forename: M G
authors.initials: MG
authors.lastname: Kris
authors.forename: R J
authors.initials: RJ
authors.lastname: Gralla
authors.forename: B
authors.initials: B
authors.lastname: Hilaris
authors.forename: P M
authors.initials: PM
authors.lastname: McCormack
authors.forename: M S
authors.initials: MS
authors.lastname: Bains
authors.forename: N
authors.initials: N
authors.lastname: Martini
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods; D016019:Survival Analysis; D016896:Treatment Outcome; D014751:Vindesine / Q000008:administration & dosage
chemical_list: D002945:Cisplatin; D014751:Vindesine