Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer: a poorly tolerated regimen. Results of a multicentre phase II study.
OBJECTIVE
A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m(2) days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial.


RESULTS
Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5-59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3-6.7). Median survival was 7.9 months (95% CI: 4.8-14.4).


CONCLUSIONS
Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.
Gridelli
Cesare
C
Oncologia Medica B, Istituto Nazionale Tumori, Napoli, Italy. cgridelli@sirio-oncology.it
Rossi
Antonio
A
Barletta
Emiddio
E
Panza
Nicola
N
Brancaccio
Luigi
L
Cioffi
Riccardo
R
Pedicini
Tonino
T
Ianniello
Giovanni Pietro
GP
Piazza
Elena
E
Rossi
Nestore
N
Iaffaioli
Rosario Vincenzo
RV
Maione
Paolo
P
Di Maio
Massimo
M
Gallo
Ciro
C
Perrone
Francesco
F
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D016179:Granulocyte Colony-Stimulating Factor; D014747:Vinblastine; D016190:Carboplatin; D000077235:Vinorelbine