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The Desmoid Tumor Research Foundation

June 2018

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

Author Information

M Toulmonde, I Ray-Coquard, M Pulido, T Andre, N Isambert, C Chevreau, N Penel, E Bompas, A Thyss, F Bertucci, C Lebbe, J Domont, P Soulie, S Piperno Neumann, F Cecchi, T Hembrough, F Petitprez, C Bellera, J Blay, A Italiano

Institut Bergonie, Dept of Medical Oncology, Bordeaux, France; Centre Leon-Berard, Lyon, France; Institut Bergonie, Bordeaux, France; Saint-Antoine Hospital, Paris, France; Service d'oncologie medicale CLCC Georges-Francois Leclerc, Dijon, France; IUCT-Oncopole Institut Claudius Regaud, Toulouse, France; Oscar Lambret Cancer Center, Lille, France; Centre Rene Gauducheau, Nantes, France; Centre Antoine-Lacassagne, Nice, France; Institut Paoli-Calmettes, Marseille, France; AP-HP Dermatology & CIC dept, INSERM U976, Faculte Paris 7 Diderot, Saint-Louis hospital, AP-HP, Paris, France; Gustave Roussy Cancer Campus, Villejuif, France; Institut de Cancerologie de l'Ouest, Angers, France; Medical Oncology, Institut Curie, Paris, France; NantOmics, LLC, Rockville, MD; INSERM UMR-S 1138, Cordeliers Research Center, Paris, France; Institut Bergonie, Comprehensive Cancer Centre, Bordeaux, France; Centre Leon Berard, Lyon, France.

Publication

J Clin Onc

Summary

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/m^2) + V (5mg/m^2) 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. 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). 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). The primary endpoint of the DESMOPAZ study was reached. PZ has meaningful clinical activity in pts with progressive DT.

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