Feasibility Study for Biweekly Administration of Cisplatin plus Vinorelbine as Adjuvant-Chemotherapy for Completely Resected Non-Small Cell Lung Cancer Patients in a Japanese Population
Purpose: To evaluate the feasibility of
biweekly administration of cisplatin and vinorelbine as adjuvant chemotherapy
for patients with completely resected non-small cell lung cancer (NSCLC). Patients
and Methods: This was a single-arm, single-institutional study. Patients with
completely resected NSCLC (p-Stage IB-IIIA) with no previous chemotherapy or
radiotherapy were eligible. Simon’s optimal two-stage design was applied. Both
cisplatin (50 mg/m2) and vinorelbine (25 mg/m2) were
given on days 1 and 15, every 28 days. The primary endpoint of this study was
the feasibility of this combination in the four cycles of treatment. Results:Twenty patients (19 lobectomies and 1
pneumonectomy) were enrolled in this study. 10(50%) of patients had
grade 3/4 neutropenia, and 3 (15%) had grade 3/4 anemia. Severe non-hematologic
toxicities were uncommon in this series. No treatment-related death was
encountered. 18 (90%) patients completed the planned 4 cycles of chemotherapy.
The median intensity was 24.3 (range 18.1 to 25) mg/m2/week with an
average of 23.6 (21-25) mg/m2/week cisplatin and 12.5
(range10 to 12.5) mg/m2/week
with an average of 12.3 (10-12.5) mg/m2/week vinorelbine. The
median
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