title: Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: a phase II study of three different doses. Gem Vin Investigators.
abstract: Our aim was to study the activity and toxicity of the gemcitabine plus vinorelbine (Gem Vin) combination and to identify the optimal dose. Previously untreated patients aged < 70 years, with stage IV or IIIb (not candidates for radiotherapy) non-small cell lung cancer were eligible. Studied dose-levels of Gem Vin, administered on days 1 and 8 every 3 weeks, were (mg m(-2)): level I = 1000/25; level II = 1200/25; level III = 1000/30; level IV = 1200/30. A feasibility study was performed at each dose-level, followed by a single-stage phase II study. Dose-level IV was unfeasible because of grade 4 neutropenia. Overall, out of 126 patients enrolled in phase II studies, there were one complete and 32 partial responses (response rate 26%: 95% CI 18-34%). Response rates were 27.9%, 21.4% and 29.3% at levels I, II and III, respectively. The treatment was well tolerated. Toxicity was less frequent and severe at level I. Overall median survival was 33 weeks (95% CI 28-40). Descriptive quality of life analysis showed that patients with a worse baseline global health status score tended to drop out of the study earlier than those with a better score. Gem Vin is feasible at different doses. It is sufficiently active and well tolerated. A phase III study to compare the effect on quality of life of Gem Vin (level I) vs cisplatin-based chemotherapy is ongoing.
authors.affiliation: Oncologia Medica B, IstitutoNazionale Tumori, Napoli, Italia.
authors.forename: C
authors.initials: C
authors.lastname: Gridelli
authors.forename: L
authors.initials: L
authors.lastname: Frontini
authors.forename: F
authors.initials: F
authors.lastname: Perrone
authors.forename: C
authors.initials: C
authors.lastname: Gallo
authors.forename: M
authors.initials: M
authors.lastname: Gulisano
authors.forename: S
authors.initials: S
authors.lastname: Cigolari
authors.forename: F
authors.initials: F
authors.lastname: Castiglione
authors.forename: S F
authors.initials: SF
authors.lastname: Robbiati
authors.forename: G
authors.initials: G
authors.lastname: Gasparini
authors.forename: G P
authors.initials: GP
authors.lastname: Ianniello
authors.forename: A
authors.initials: A
authors.lastname: Farris
authors.forename: M C
authors.initials: MC
authors.lastname: Locatelli
authors.forename: R
authors.initials: R
authors.lastname: Felletti
authors.forename: E
authors.initials: E
authors.lastname: Piazza
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine