Clinical breast cancer · 2010
Low-dose metronomic oral administration of vinorelbine in the first-line treatment of elderly patients with metastatic breast cancer.
Клиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Addeo Raffaele, Sgambato Alessandro, Cennamo Gregorio, Montella Liliana, Faiola Vincenzo, Abbruzzese Alberto, Capasso Elena, Leo Luigi, Botti Gerardo, Caraglia Michele, Del Prete Salvatore
Аннотация
BACKGROUND: The concept of metronomic chronic administration of low-dose chemotherapy has become relevant for the treatment of cancer in the last several years. This study sought to determine the safety and activity of oral vinorelbine (VNB), using a metronomic schedule of administration, in elderly patients with metastatic breast cancer (MBC).
PATIENTS AND METHODS: From October 2004 to March 2007, 34 patients with MBC (median age, 74 years; range, 70-84 years) were treated with oral VNB at 70 mg/m2, fractionated on days 1, 3, and 5, for 3 weeks on and 1 week off, every 4 weeks, for a maximum of 12 cycles. The objective response rate was the primary endpoint.
RESULTS: All 34 patients received at least 3 cycles of therapy and were evaluable. Two achieved complete responses (6%), and 11 achieved partial responses (32%). Median progression-free survival and median overall survival entailed 7.7 months (95% confidence interval, 6.9-9.05 months) and 15.9 months (95% CI, 13.1-15.91 months), respectively, for all patients.
CONCLUSION: The fractionated administration of oral VNB is well tolerated and presents promising activity in elderly patients with metastatic cancer, warranting further investigation in combination with other chemotherapy agents.
PATIENTS AND METHODS: From October 2004 to March 2007, 34 patients with MBC (median age, 74 years; range, 70-84 years) were treated with oral VNB at 70 mg/m2, fractionated on days 1, 3, and 5, for 3 weeks on and 1 week off, every 4 weeks, for a maximum of 12 cycles. The objective response rate was the primary endpoint.
RESULTS: All 34 patients received at least 3 cycles of therapy and were evaluable. Two achieved complete responses (6%), and 11 achieved partial responses (32%). Median progression-free survival and median overall survival entailed 7.7 months (95% confidence interval, 6.9-9.05 months) and 15.9 months (95% CI, 13.1-15.91 months), respectively, for all patients.
CONCLUSION: The fractionated administration of oral VNB is well tolerated and presents promising activity in elderly patients with metastatic cancer, warranting further investigation in combination with other chemotherapy agents.