Efficacy and safety of regorafenib in patients with metastatic or locally advanced chondrosarcoma: Results of a non-comparative, randomised, double-blind, placebo controlled, multicentre phase II study
| Affiliation auteurs | !!!! Error affiliation !!!! |
| Titre | Efficacy and safety of regorafenib in patients with metastatic or locally advanced chondrosarcoma: Results of a non-comparative, randomised, double-blind, placebo controlled, multicentre phase II study |
| Type de publication | Journal Article |
| Year of Publication | 2021 |
| Auteurs | Duffaud F, Italiano A, Bompas E, Rios M, Penel N, Mir O, Piperno-Neumann S, Chevreau C, Delcambre C, Bertucci F, Boudou-Rouquette P, Cancel M, Perrin C, Saada-Bouzid E, Monard L, Schiffler C, Chaigneau L, Hervieu A, Collard O, Bouvier C, Vidal V, Chabaud S, Blay J-Y, Grp FSarcoma |
| Journal | EUROPEAN JOURNAL OF CANCER |
| Volume | 150 |
| Pagination | 108-118 |
| Date Published | JUN |
| Type of Article | Article |
| ISSN | 0959-8049 |
| Mots-clés | Metastatic chondrosarcoma, Progression after standard chemotherapy, regorafenib |
| Résumé | {Background: This multi-cohort trial explored the efficacy and safety of regorafenib for patients with advanced sarcomas of bone origin; this report details the cohort of patients with metastatic or locally advanced chondrosarcoma (CS), progressing after prior chemotherapy. Patients and methods: Patients with CS, progressing despite prior standard therapy, were randomised (2:1) to receive regorafenib or placebo. Patients on placebo could crossover to receive regorafenib after centrally confirmed progressive disease. The primary endpoint was progression-free rate (PFR) at 12 weeks. With one-sided a of 0.05, and 80% power, at least 16/24 progression-free patients at 12 weeks were needed for success (P0 = 50% |
| DOI | 10.1016/j.ejca.2021.03.039 |