Phase II study of concurrent chemoradiotherapy with carboplatin and vinorelbine for locally advanced non-small-cell lung cancer.
Patients with non-small cell lung cancer (NSCLC) have locally advanced disease with poor prognosis. Although concurrent chemoradiotherapy is the standard treatment, more effective regimens are required. The aim of this study was to assess the safety and efficacy of concurrent chemoradiotherapy with a divided schedule of carboplatin and vinorelbine in patients with locally advanced NSCLC. Patients with unresectable, stage IIIA or IIIB NSCLC were eligible for enrollment if they exhibited a performance status of 0-2 and were ≤75 years of age. Patients were treated with carboplatin at an area under the plasma concentration vs. time curve of 2.5 mg/ml/min and vinorelbine at 20 mg/m2on days 1 and 8 every 3 weeks. Thoracic radiotherapy at a total dose of 60 Gy was concurrently administered (2 Gy per fraction). Twenty-eight patients (23 men and 5 women; median age, 67 years; range 47-75 years) were enrolled in the present study. The overall response rate was 85.7% [95% confidence interval (CI), 67.3-96.0%] and the disease control rate was 96.4% (95% CI, 81.7-99.9%). The median survival time (MST) was 23 months and the median progression-free survival (PFS) time was 8 months. Grade 3-4 toxicities included neutropenia, thrombocytopenia, anemia and infection in 100, 14, 46 and 36% of patients, respectively. One patient (4%) developed grade 3 radiation esophagitis that resolved completely without residual dilation. Grade 3 radiation pneumonitis occurred in 2 patients (7%); however, the symptoms and radiographic abnormalities subsided with corticosteroid therapy. In conclusion, concurrent chemoradiotherapy with a divided schedule of carboplatin and vinorelbine is well-tolerated and effective in patients with locally advanced NSCLC.
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, Shinagawa, Tokyo 142-8666;
Koko
K
Ishida
Department of Respirology, National Hospital Organization, Tokyo Hospital, Tokyo 204-8585;
Takashi
T
Hirose
Department of Radiology, Showa University School of Medicine, Shinagawa, Tokyo 142-8666, Japan.
Junichi
J
Yokouchi
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, Shinagawa, Tokyo 142-8666;
Yasunari
Y
Oki
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, Shinagawa, Tokyo 142-8666;
Sojiro
S
Kusumoto
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, Shinagawa, Tokyo 142-8666;
Tomohide
T
Sugiyama
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, Shinagawa, Tokyo 142-8666;
Hiroo
H
Ishida
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, Shinagawa, Tokyo 142-8666;
Takao
T
Shirai
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, Shinagawa, Tokyo 142-8666;
Masanao
M
Nakashima
Institute of Molecular Oncology, Showa University School of Medicine, Shinagawa, Tokyo 142-8666, Japan.
Toshimitsu
T
Yamaoka
Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, Shinagawa, Tokyo 142-8666;
Tsukasa
T
Ohnishi
Institute of Molecular Oncology, Showa University School of Medicine, Shinagawa, Tokyo 142-8666, Japan.
Tohru
T
Ohmori
Department of Radiology, Showa University School of Medicine, Shinagawa, Tokyo 142-8666, Japan.
Yoshikazu
Y
Kagami
carboplatin; chemoradiotherapy; non-small-cell lung cancer; vinorelbine