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• W2891842652 abstract "11501 Background: DT are a group of locally aggressive tumors of fibroblastic origin that can lead to significant morbidity. No randomized trial assessing systemic treatment activity in this rare disease has been reported previously. Methods: DESMOPAZ is a multicenter non-comparative randomized phase II trial based on a two-stage optimal Simon’s design assessing safety and efficacy of PZ in DT adult patients (pts). All pts had to have documented progressive disease (PD) according to RECIST 1.1 based on two imaging within a 6-months interval. Pts were randomly assigned to receive PZ 800 mg/day orally continuously, or M (30 mg/m²) + V (5mg/m²) intravenously once a week for 6 months and then every 15 days for 6 months. Treatment was administered until PD (cross-over then permitted), unacceptable toxicity, and for a maximum of 1 year. The primary endpoint was 6-month non-PD rate according to RECIST 1.1. Based on the following hypotheses: P0 = 60%, P1 = 80%, α = 5% and β = 20% and a 2:1 randomization, a total of 43 assessable pts were needed in PZ-arm and 22 pts in MV-Arm. PZ could be regarded as an active drug if at least 31/43 6-month non-PD. Archive FFPE samples of tumor tissue were mandatorily collected at baseline, and an on-treatment tumor biopsy at Cycle 2 was optional. Results: Accrual started in September 2012 in 12 centers of the French Sarcoma Group. As of December 2017, 72 pts (26 males, 46 females) were included: 48 in PZ-arm (46 assessable) and 24 in MV-arm (20 assessable). Median age was 40 years (18-79). The median number of previous lines of treatment was 1 (0-3). After central pathological and radiological review, 38 assessable pts (82.6%) in PZ-arm had tumor shrinkage, resulting in PR in 17 (37%) and SD in 21 (45.7%). In MV-arm, 11 assessable pts (55%) has tumor shrinkage resulting in PR in 5 (25%) and SD in 6 (30%). The 6-month non-PD rate was 86% (95%CI = 72.1-94.7) in PZ-arm (37/43) and 50% (95%CI = 27.2-72.8) in MV-arm (10/20). Conclusions: The primary endpoint of the DESMOPAZ study was reached. PZ has meaningful clinical activity in pts with progressive DT. Safety, quality of life and pharmacodynamics translational data will be presented at the meeting. Clinical trial information: NCT01876082." @default.
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• W2891842652 date "2018-05-20" @default.
• W2891842652 modified "2023-10-17" @default.
• W2891842652 title "DESMOPAZ pazopanib (PZ) versus IV methotrexate/vinblastine (MV) in adult patients with progressive desmoid tumors (DT) a randomized phase II study from the French Sarcoma Group." @default.
• W2891842652 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.11501" @default.
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