Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2008
Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Penel Nicolas, Bui Binh Nguyen, Bay Jacques-Olivier, Cupissol Didier, Ray-Coquard Isabelle, Piperno-Neumann Sophie, Kerbrat Pierre, Fournier Charles, Taieb Sophie, Jimenez Marta, Isambert Nicolas, Peyrade Frédéric, Chevreau Christine, Bompas Emmanuelle, Brain Etienne G C, Blay Jean-Yves
Аннотация
PURPOSE: The objective of this phase II trial was to assess the efficacy and toxicity of weekly paclitaxel for patients with metastatic or unresectable angiosarcoma.
PATIENTS AND METHODS: Thirty patients were entered onto the study from April 2005 through October 2006. Paclitaxel was administered intravenously as a 60-minute infusion at a dose of 80 mg/m(2) on days 1, 8, and 15 of a 4-week cycle. The primary end point was the nonprogression rate after two cycles.
RESULTS: The progression-free survival rates after 2 and 4 months were 74% and 45%, respectively. With a median follow-up of 8 months, the median time to progression was 4 months and the median overall survival was 8 months. The progression-free survival rate was similar in patients pretreated with chemotherapy and in chemotherapy-naïve patients (77% v 71%). Three patients with locally advanced breast angiosarcoma presented partial response, which enabled a secondary curative-intent surgery with complete histologic response in two cases. One toxic death occurred as a result of a thrombocytopenia episode. Six patients presented with grade 3 toxicities and one patient presented with a grade 4 toxicity. Anemia and fatigue were the most frequently reported toxicities.
CONCLUSION: Weekly paclitaxel at the dose schedule used in the current study was well tolerated and demonstrated clinical benefit.
PATIENTS AND METHODS: Thirty patients were entered onto the study from April 2005 through October 2006. Paclitaxel was administered intravenously as a 60-minute infusion at a dose of 80 mg/m(2) on days 1, 8, and 15 of a 4-week cycle. The primary end point was the nonprogression rate after two cycles.
RESULTS: The progression-free survival rates after 2 and 4 months were 74% and 45%, respectively. With a median follow-up of 8 months, the median time to progression was 4 months and the median overall survival was 8 months. The progression-free survival rate was similar in patients pretreated with chemotherapy and in chemotherapy-naïve patients (77% v 71%). Three patients with locally advanced breast angiosarcoma presented partial response, which enabled a secondary curative-intent surgery with complete histologic response in two cases. One toxic death occurred as a result of a thrombocytopenia episode. Six patients presented with grade 3 toxicities and one patient presented with a grade 4 toxicity. Anemia and fatigue were the most frequently reported toxicities.
CONCLUSION: Weekly paclitaxel at the dose schedule used in the current study was well tolerated and demonstrated clinical benefit.
Предметные рубрики MeSH
AdultAgedAged, 80 and overAntineoplastic Agents, PhytogenicBreast NeoplasmsDisease-Free SurvivalDrug Administration ScheduleFemaleFranceHead and Neck NeoplasmsHemangiosarcomaHumansInfusions, IntravenousKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisPaclitaxelScalpSkin NeoplasmsSoft Tissue NeoplasmsTime FactorsTreatment Outcome