Vinorelbine and low-dose cyclophosphamide in the treatment of pediatric sarcomas: pilot study for the upcoming European Rhabdomyosarcoma Protocol.

摘要: BACKGROUND Following their previous report on the activity of vinorelbine in treatment rhabdomyosarcoma, authors results a pilot study aimed at defining optimal dose when this agent is used conjunction with continuous, orally administered low-dose cyclophosphamide to treat patients refractory or recurrent sarcoma. It hoped that combination and can be as maintenance regimen an upcoming European trial involving high-risk rhabdomyosarcoma. METHODS In current study, was fixed 25 mg/m2 per day for 28 days. Vinorelbine intravenously Days 1, 8, 15, doses escalated from initial level 15 steps 5 mg/m2; intrapatient escalation not allowed. RESULTS Between April 2002 November 2003, 18 ages 2–23 years were treated after having received 1–4 (median, 2) other regimens previously. Ninety cycles total patient; range, 1–10 patient). Two cases dose-limiting toxicity (Grade 4 neutropenia both cases) observed among who 30 mg/m2. Of 41 which mg/m2, Grade ≥ 3 (37%); no major documented association these cycles. One complete remission 6 partial remissions noted 17 had measurable disease. Three eight assessable rhabdomyosarcoma (which embryonal two alveolar one) responses treatment. CONCLUSIONS Combination therapy found feasible possess against sarcomas. The recommended use are days 15. Cancer 2004. © 2004 American Society.