Objectives: 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/m2 on days 1, 2 and vinorelbine 20 mg/m2 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/m2 and vinorelbine 25 mg/m2, with relative dose intensities (RDIs) of 95 and 97%, respectively, and an actual received dose intensity (ARDI) of 28.62 and 16.07 mg/m2/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. Copyright © 2006 S. Karger AG.
Short schedule of cisplatin and vinorelbine: A dose-finding study in non-small-cell lung cancer
Soto Parra H.;
2007-01-01
Abstract
Objectives: 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/m2 on days 1, 2 and vinorelbine 20 mg/m2 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/m2 and vinorelbine 25 mg/m2, with relative dose intensities (RDIs) of 95 and 97%, respectively, and an actual received dose intensity (ARDI) of 28.62 and 16.07 mg/m2/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. Copyright © 2006 S. Karger AG.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
