The Desmoid Tumor Research Foundation

December 2020

CRYODESMO-O1: A prospective, open phase II study of cryoablation in desmoid tumour patients progressing after medical treatment

Author Information

Kurtz JE(1), Buy X(2), Deschamps F(3), Sauleau E(4), Bouhamama A(5), Toulmonde M(6), Honore C(7), Bertucci F(8), Brahmi M(9), Chevreau C(10), Duffaud F(11), Gantzer J(12), Garnon J(13), Blay JY(9), Gangi A(13).

(1)Service d'Oncologie Medicale, Hopitaux Universitaires de Strasbourg, Strasbourg, France. (2)Departement de radiodiagnostic, Institut Bergonie, Bordeaux, France. (3)Departement de radiologie interventionnelle, Institut Gustave Roussy, Villejuif, France. (4)Service de Sante publique, Groupe Methode en recherche clinique, Hopitaux Universitaires de Strasbourg, Strasbourg, France. (5)Service de radiologie interventionnelle oncologique, Centre Leon Berard, Lyon, France. (6)Departement de Medecine Oncologique, Institut Bergonie, Bordeaux France. (7)Service de chirurgie viscerale oncologique et sarcomes, Institut Gustave Roussy, Villejuif, France. (8)Departement d'Oncologie medicale, Institut Paoli-Calmettes, Marseille, France. (9)Departement de medecine oncologique, Centre Leon Berard, France. (10)Departement d'oncologie medicale, IUCT Oncopole, Toulouse, France. (11)Service d'Oncologie medicale, CHU de Marseille et Aix-Marseille Universite, Marseille, France. (12)Service d'Oncologie Medicale, Hopitaux Universitaires de Strasbourg, Strasbourg, France. (13)Service de radiologie interventionnelle, Hopitaux Universitaires de Strasbourg, France.

Publication

Eur J Cancer

Summary

Cryoablation is an interventional radiology technique that is suitable for desmoid tumours (DTs) patients (pts) on the basis of repeated cycles of freezing, leading to cell death. CRYODESMO-01 (ClinicalTrials.gov Identifier: NCT02476305) is a prospective, open-label, non-randomised, non-comparative, multicenter study assessing cryoablation in non-abdominopelvic progressing DT. 50 pts were enrolled (78% female) from four French centres and all were treated. The mean age was 41 y.o. (19-73). The median number of prior treatments was 2.00 [1-4] including non-steroidal anti-inflammatory drugs (NSAIDs), hormone therapy, chemotherapy, and anti-angiogenics. Tumour location included limbs (36%), trunk (60%), and cervical area (4%). The median tumour largest diameter was 89 mm. The rate of non-progressing disease at +12 months was 86% [confidence level (CI) 95% 73-94%]. Median PFS was not reached at a median follow-up of 31 months. Cryoablation significantly improved functional status and pain scores. Cryoablation demonstrated feasibility in progressive DT pts. The study met is primary end-point with 86% of non-progressive disease at +12 months, with reduced pain, better functional status, and encouraging long-term disease control.

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