REGOSARC: Regorafenib versus placebo in doxorubicin‐refractory soft‐tissue sarcoma—A quality‐adjusted time without symptoms of progression or toxicity analysis

descriptionPublicationkeyboard_double_arrow_right Article , Other literature type 10 Mar 2017 English Publisher:WileyJournal:Cancer, volume 123, pages 2,294-2,302 (issn: 0008-543X, eissn: 1097-0142,

Copyright policy )Funded by:INCa | unidentified

Authors: Berry, Vincent; Basson, Laurent; Bogart, Emilie; Mir, Olivier; Blay, Jean-Yves; Italiano, Antoine; Bertucci, François; +10 Authors

doi: 10.1002/cncr.30661

pmid: 28295221

pmc: PMC5485075

handle: 20.500.12210/17207

REGOSARC: Regorafenib versus placebo in doxorubicin‐refractory soft‐tissue sarcoma—A quality‐adjusted time without symptoms of progression or toxicity analysis

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Abstract

BACKGROUNDIn a placebo‐controlled, randomized phase 2 trial (ClinicalTrials.gov identifier NCT01900743), regorafenib improved progression‐free survival (PFS) for patients with doxorubicin‐pretreated advanced nonadipocytic sarcoma. A quality‐adjusted time without symptoms of progression or toxicity (Q‐TWiST) post hoc exploratory analysis was applied to provide an integrated measure of its clinical benefit.METHODSIn the base‐case analysis, each patient's overall survival (OS) was partitioned into 3 mutually exclusive health states: the time with a grade 3 or 4 adverse event (TOX), the time without symptoms of disease or grade 3 or 4 toxicity from treatment, and the time after tumor progression or relapse. The time spent in each state was weighted with a health‐state utility associated with that state and was summed to calculate the Q‐TWiST. The stability of the base‐case analysis was explored with several sensitivity analyses.RESULTSIn nonadipocytic sarcoma, the PFS was (4.0 months [2.6‐5.5 months] with regorafenib vs 1.0 month [0.9‐1.8 months] with a placebo; hazard ratio, 0.36 [0.25‐0.53]; P < .0001); the OS was 13.4 months (8.6‐17.3 months) with regorafenib and 9.0 months (6.8‐12.5 months) with a placebo (hazard ratio, 0.67 [0.44‐1.02]). With the classic definition of TOX (including all grade 3 and 4 clinical adverse events), the Q‐TWiSTs were 8.0 months (7.0‐9.0 months) with regorafenib and 5.7 months (4.9‐6.4 months) with a placebo (P < .001).CONCLUSIONSFor patients with doxorubicin‐pretreated soft‐tissue sarcoma, regorafenib significantly improved quality‐adjusted survival in comparison with a placebo. Cancer 2017;123:2294–2302. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Related Organizations

Université de Lille III (Charles-de-Gaulle)
France
Medica University of Vienna
Austria
Medizinische Universität Graz
Austria
MEDIZINISCHE UNIVERSITAT GRAZ
Austria
Cancéropôle Nord-Ouest
France

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Keywords

Leiomyosarcoma, Male, [SDV]Life Sciences [q-bio], Mesh:Diarrhea/chemically induced, info:eu-repo/classification/mesh/Sarcoma, info:eu-repo/classification/mesh/Asthenia/chemically induced, Mesh:Alopecia/chemically induced, info:eu-repo/classification/mesh/Female, Mesh:Phenylurea Compounds/therapeutic use*, info:eu-repo/classification/mesh/Synovial/drug therapy, info:eu-repo/classification/mesh/Phenylurea Compounds/therapeutic use*, Mesh:Aged, info:eu-repo/classification/mesh/Antineoplastic Agents/therapeutic use*, Mesh:Synovial/drug therapy, Mesh:Treatment Outcome, info:eu-repo/classification/mesh/Hospitalization, Mesh:Anorexia/chemically induced, Liposarcoma, Middle Aged, info:eu-repo/classification/mesh/Proportional Hazards Models, info:eu-repo/classification/mesh/Pyridines/therapeutic use*, Anorexia, [SDV] Life Sciences [q-bio], Hospitalization, Mesh:Quality of Life, info:eu-repo/classification/mesh/Fecal Incontinence/chemically induced, Hypertension, info:eu-repo/classification/mesh/Anorexia/chemically induced, Female, Hand-Foot Syndrome, Mesh:Proportional Hazards Models, info:eu-repo/classification/mesh/Male, Mesh:Severity of Illness Index, info:eu-repo/classification/mesh/Middle Aged, Mesh:Female, Diarrhea, Mucositis, quality-adjusted survival, info:eu-repo/classification/mesh/Treatment Outcome, Mesh:Fecal Incontinence/chemically induced, 610, Mesh:Male, info:eu-repo/classification/mesh/Double-Blind Method, Antineoplastic Agents, Mesh:Sarcoma, info:eu-repo/classification/mesh/Quality of Life, info:eu-repo/classification/mesh/Severity of Illness Index, Double-Blind Method, quality-adjusted time without symptoms of progression or toxicity (Q-TWiST), Mesh:Middle Aged, Mesh:Asthenia/chemically induced, Mesh:Liposarcoma/drug therapy, Humans, quality-adjusted time without symptoms of progression or toxicity (Q-TWiST);metastatic soft-tissue sarcoma;placebo;quality-adjusted survival;regorafenib;, Mesh:Hospitalization, Mesh:Mucositis/chemically induced, Mesh:Sarcoma/drug therapy*, Mesh:Hand-Foot Syndrome/etiology, Aged, Proportional Hazards Models, Mesh:Pyridines/therapeutic use*, info:eu-repo/classification/mesh/Mucositis/chemically induced, info:eu-repo/classification/mesh/Hand-Foot Syndrome/etiology, Phenylurea Compounds, info:eu-repo/classification/mesh/Diarrhea/chemically induced, Mesh:Antineoplastic Agents/therapeutic use*, Alopecia, Original Articles, Mesh:Leiomyosarcoma/drug therapy, info:eu-repo/classification/mesh/Liposarcoma/drug therapy, info:eu-repo/classification/mesh/Hypertension/chemically induced, info:eu-repo/classification/mesh/Aged, Mesh:Humans, info:eu-repo/classification/mesh/Sarcoma/drug therapy*, info:eu-repo/classification/mesh/Alopecia/chemically induced, info:eu-repo/classification/mesh/Leiomyosarcoma/drug therapy, Asthenia, Mesh:Hypertension/chemically induced, placebo, regorafenib, metastatic soft-tissue sarcoma, info:eu-repo/classification/mesh/Humans, Fecal Incontinence, Mesh:Double-Blind Method

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