Oncology · 2009
Cisplatin and vinorelbine chemotherapy in recurrent vulvar carcinoma.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Cormio Gennaro, Loizzi Vera, Gissi Francesca, Serrati Giuseppe, Panzarino Mariantonietta, Carriero Carmine, Selvaggi Luigi
Аннотация
PURPOSE: To evaluate the activity and toxicity of the combination of cisplatin and vinorelbine in patients with recurrent carcinoma of the vulva that has not been previously treated with chemotherapy.
PATIENTS AND METHODS: Sixteen women with a median age of 65 years (range 43-79) with recurrent vulvar carcinoma were enrolled in the study. Nine patients had local recurrent disease (perineum, vagina and/or vulva), whereas 7 had disease in the groin; 9 patients had received prior radiotherapy. Cisplatin was administered intravenously on day 1 and vinorelbine was given on day 1 immediately after cisplatin and on day 8.
RESULTS: A total of 68 cycles of chemotherapy were administered. Fifteen women were assessed for response. Objective responses were recorded in 6 patients (40%) - with 4 patients (27%) achieving a complete response and 2 (13%) achieving a partial response -, whereas 4 patients (27%) had stable disease and 5 had progressive disease. The median progression-free survival was 10 months (range 3-17), whereas the overall survival from the beginning of the chemotherapy was 19 months (range 1-30). Due to the small number of patients, no significant correlation with site of recurrence could be found.
CONCLUSION: The combination of cisplatin and vinorelbine is a well-tolerated and active regimen in the treatment of patients with recurrent vulvar carcinoma.
PATIENTS AND METHODS: Sixteen women with a median age of 65 years (range 43-79) with recurrent vulvar carcinoma were enrolled in the study. Nine patients had local recurrent disease (perineum, vagina and/or vulva), whereas 7 had disease in the groin; 9 patients had received prior radiotherapy. Cisplatin was administered intravenously on day 1 and vinorelbine was given on day 1 immediately after cisplatin and on day 8.
RESULTS: A total of 68 cycles of chemotherapy were administered. Fifteen women were assessed for response. Objective responses were recorded in 6 patients (40%) - with 4 patients (27%) achieving a complete response and 2 (13%) achieving a partial response -, whereas 4 patients (27%) had stable disease and 5 had progressive disease. The median progression-free survival was 10 months (range 3-17), whereas the overall survival from the beginning of the chemotherapy was 19 months (range 1-30). Due to the small number of patients, no significant correlation with site of recurrence could be found.
CONCLUSION: The combination of cisplatin and vinorelbine is a well-tolerated and active regimen in the treatment of patients with recurrent vulvar carcinoma.