title: Vinorelbine is well tolerated and active in the treatment of elderly patients with advanced non-small cell lung cancer. A two-stage phase II study.
abstract: More than 30% of lung cancers arise in patients aged 70 years or more; however, because elderly patients are not considered to tolerate chemotherapy, they are generally excluded from clinical trials and are not considered eligible for aggressive cisplatin-based chemotherapy in clinical practice. The aims of the present study were to test tolerability and activity of weekly vinorelbine in advanced non-small cell lung cancer (NSCLC) patients aged 70 years or more, and to define whether minimum conditions existed for a randomised comparison with best supportive care. The study was designed as a multicentre two-stage phase II trial according to Simon's optimal design: 8 or more responses out of 43 treated patients were expected at the end of the trial. Patients aged 70 years or more were eligible if they had a cytological or histological diagnosis of NSCLC at stage IIIb-IV and a performance status less than or equal to two according to the ECOG scale. Vinorelbine was given intravenously (i.v.) at a dose of 30 mg/m2 every week for 12 doses. As planned, 43 patients entered the study; median age was 73 years (range 70-80); 11 patients were older than 75 years. Median dose-intensity (mg/m2/week) of vinorelbine was 21.2 (range 7.5-30) and was not affected by age of patients. Toxicity was generally mild, mainly haematological and never life-threatening. ECOG performance status improved in 26% of patients; cough and pain improved in more than 40% of patients symptomatic at entry, while dyspnoea improved in 28%; approximately half the patients had a stabilisation of their symptoms. 10 patients (23-95% exact confidence interval (CI): 12-39%) obtained a partial response. Median time to progression was 11 weeks (95% CI 8-30) and median survival 36 weeks (95% CI 28-53). One-year estimated progression-free and overall survival rates are 16% and 36%, respectively. In conclusion, vinorelbine was well tolerated and active in the treatment of elderly NSCLC patients. A phase III trial (ELVIS-Elderly Lung Cancer Vinorelbine Italian Study) comparing best supportive care versus best supportive care plus vinorelbine is now ongoing.
authors.affiliation: Divisione di Oncologia Medica B, Instituto Nazionale Tumori G. Pascale, Napoli, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Gridelli
authors.forename: F
authors.initials: F
authors.lastname: Perrone
authors.forename: C
authors.initials: C
authors.lastname: Gallo
authors.forename: F
authors.initials: F
authors.lastname: De Marinis
authors.forename: G
authors.initials: G
authors.lastname: Ianniello
authors.forename: S
authors.initials: S
authors.lastname: Cigolari
authors.forename: S
authors.initials: S
authors.lastname: Cariello
authors.forename: F
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: M
authors.initials: M
authors.lastname: D'Aprile
authors.forename: A
authors.initials: A
authors.lastname: Rossi
authors.forename: R
authors.initials: R
authors.lastname: Migliorino
authors.forename: R
authors.initials: R
authors.lastname: Bartolucci
authors.forename: A R
authors.initials: AR
authors.lastname: Bianco
authors.forename: M
authors.initials: M
authors.lastname: Pergola
authors.forename: S
authors.initials: S
authors.lastname: Monfardini
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D015996:Survival Rate; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine