title: [Results of a randomized study comparing combination of navelbine-cisplatin to combination of vindesine-cisplatin and to navelbine alone in 612 patients with inoperable non-small cell lung cancer].
abstract: The combination of vindesine and cisplatin is considered a reference regimen in advanced NSCLC which has yielded a significant improvement in the duration of survival. A phase II study of a new semi-synthetic vinca alkaloid, Navelbine, reported an unusually high 29% response rate in stage III-IV NSCLC and a phase I-II study established the feasibility of the combination of Navelbine and cisplatin. We, therefore, designed a prospective randomized trial to compare Navelbine and cisplatin (NVB-P) to vindesine and cisplatin (VDS-P) and to evaluate whether the best of these regimens affords a survival benefit compared to Navelbine alone (NVB), an outpatient regimen. Forty-five centers included 612 patients in this study: 206 in NVB-P, 200 in VDS-P and 206 in NVB. Navelbine was given at a dose of 30 mg/m2 weekly, cisplatin at 120 mg/m2 on day 1, day 29 and then every 6 weeks and vindesine at 3 mg/m2 weekly for 6 weeks and then every other week. Treatment was continued until progression or toxicity. Patients' characteristics were similar in the three groups with 59% of patients presenting with metastatic disease. An objective response rate was observed in 30% of patients in NVB-P versus 19% in VDS-P (P = .02) and 14% in NVB (P < .001). The median duration of survival was 40 weeks in NVB-P compared to 32 weeks in VDS-P and 31 weeks in NVB. The comparison of survival between the three groups demonstrated an advantage for NVB-P compared to VDS-P (P = .04) and NVB (P = .02). Neutropenia was significantly higher in the NVB-P group (P < .001) and neurotoxicity more frequent with VDS-P (P < .004). Since our results have demonstrated that NVB-P yields a longer survival duration and a higher response rate than VDS-P or NVB alone, with acceptable toxicity, this combination should be considered a reference regimen in advanced NSCLC.
authors.affiliation: Institut Gustave-Roussy, Villejuif, France.
authors.forename: T
authors.initials: T
authors.lastname: Le Chevalier
authors.forename: D
authors.initials: D
authors.lastname: Brisgand
authors.forename: J L
authors.initials: JL
authors.lastname: Pujol
authors.forename: J Y
authors.initials: JY
authors.lastname: Douillard
authors.forename: A
authors.initials: A
authors.lastname: Monnier
authors.forename: A
authors.initials: A
authors.lastname: Rivière
authors.forename: P
authors.initials: P
authors.lastname: Chomy
authors.forename: A
authors.initials: A
authors.lastname: Le Groumellec
authors.forename: P
authors.initials: P
authors.lastname: Ruffie
authors.forename: M
authors.initials: M
authors.lastname: Gottfried
authors.forename: M H
authors.initials: MH
authors.lastname: Gaspard
authors.forename: C
authors.initials: C
authors.lastname: Chevreau
authors.forename: V
authors.initials: V
authors.lastname: Alberola
authors.forename: S
authors.initials: S
authors.lastname: Cigolari
authors.forename: F
authors.initials: F
authors.lastname: Besson
authors.forename: A
authors.initials: A
authors.lastname: Martinez
authors.forename: M
authors.initials: M
authors.lastname: Besenval
authors.forename: P
authors.initials: P
authors.lastname: Berthaud
authors.forename: T
authors.initials: T
authors.lastname: Tursz
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010166:Palliative Care; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects; D014751:Vindesine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D014751:Vindesine
vernacular_title: Résultats d'une étude randomisée comparant l'association Navelbine-cisplatinum à l'association vindésine-cisplatinum et à la Navelbine seule chez 612 malades porteurs d'un carcinome bronchique non à petites cellules inopérable.