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Vol.50 No.2 contents | Japanese/English |
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- Original Article -
Dose Escalation Study of Adjuvant Chemotherapy with Cisplatin Plus Vinorelbine in Japanese Patients with Completely Resected Non-small Cell Lung Cancer
Kazuhito Funai1,2, Takahiro Mochizuki1, Shigeru Momiki11Division of Thoracic Surgery, Hamamatsu Medical Center, Japan, 2First Department of Surgery, Hamamatsu University School of Medicine, Japan
Objective. We conducted a dose escalation study to determine the recommended dose of adjuvant chemotherapy with cisplatin (CDDP) plus vinorelbine (VNR) for Japanese patients with completely resected non-small cell lung cancer (NSCLC). Methods. CDDP and VNR were given intravenously on days 1 and 8 every 4 weeks, for 4 cycles. The following dose levels for CDDP/VNR (mg/m2) were evaluated: 40/20 (level 1), 40/25 (level 2) and 45/25 (level 3), respectively. Cohorts of 3 patients each were enrolled at each dose level. Escalation to the next dose level was permitted if no dose-limiting toxicities (DLT) were observed. If 1 or 2 patients developed DLT, 3 additional patients were enrolled at that dose level. Dose escalation continued until more than one-third of the 6 patients treated at a given dose developed DLT. The maximum-tolerated dose (MTD) was defined as that dose at which all 3 patients or more than 3 of 6 patients within a cohort developed DLT. The recommended dose (RD) was defined as 1 dose level below the MTD. Results. Twelve patients were enrolled in this study. No DLT was experienced at dose levels 1 and 2 of this schedule. Therefore, 3 patients were started at level 3, but all developed DLT. Therefore, the MTD was dose level 3 and the RD was dose level 2. Conclusion. The RD for adjuvant chemotherapy with CDDP plus VNR for Japanese patients was CDDP 40 mg/m2 plus VNR 25 mg/m2 on days 1 and 8, every 4 weeks for 4 cycles.
key words: Lung cancer, Adjuvant chemotherapy, Cisplatin, Vinorelbine, Dose escalation
Received: December 16, 2009
Accepted: February 24, 2010
JJLC 50 (2): 136-140, 2010
