Short schedule of cisplatin and vinorelbine: a dose-finding study in non-small-cell lung cancer.
OBJECTIVE
A dose-finding study of a new cisplatin/vinorelbine schedule was done to increase activity of the combination, and improve compliance of non-small-cell lung cancer PATIENTS.


METHODS
Beginning with cisplatin 40 mg/m(2) on days 1, 2 and vinorelbine 20 mg/m(2) on days 1, 3, increasing dose levels up to the maximum tolerated dose (MTD) were tested in a series of 6-patient cohorts. If 3 of 6 patients experienced dose-limiting toxicity in the first 3 cycles, the previous dose was considered the recommended dose (RD). Once the MTD was reached, granulocyte-colony-stimulating factor was prophylactically added to the treatment of a new patient cohort to improve the therapeutic ratio.


RESULTS
We enrolled 35 stage IIIA/B or IV patients between August 2001 and February 2002. The RD was cisplatin 45 mg/m(2) and vinorelbine 25 mg/m(2), with relative dose intensities (RDIs) of 95 and 97%, respectively, and an actual received dose intensity (ARDI) of 28.62 and 16.07 mg/m(2)/week, respectively. Overall grade 3-4 toxicities were: neutropenia (71%), febrile neutropenia (25%), anemia (8%), and constipation (17%). The overall response rate was 64.3% (CI: 44.1-81.4%).


CONCLUSIONS
ARDI and RDI of our modified cisplatin/vinorelbine regimen were not inferior to those of conventional weekly schedules; its acceptable toxicity profile and manageability may justify its use in clinical practice.
Zucali
Paolo Andrea
PA
Department of Medical Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan, Italy. Paolo.Zucali@humanitas.it
Soto Parra
Hector Jose
HJ
Cavina
Raffaele
R
Campagnoli
Elisabetta
E
Latteri
Fiorenza
F
De Vincenzo
Fabio
F
Ceresoli
Giovanni Luca
GL
Fazio
Maria
M
Alloisio
Marco
M
Santoro
Armando
A
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010865:Pilot Projects; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine