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Health-related quality of life maintained over time in patients with relapsed or refractory multiple myeloma treated with daratumumab in combination with bortezomib and dexamethasone: results from the phase III CASTOR trial.
Hungria, Vania; Beksac, Meral; Weisel, Katja C; Nooka, Ajay K; Masszi, Tamas; Spicka, Ivan; Munder, Markus; Mateos, María-Victoria; Mark, Tomer M; Qi, Ming; Qin, Xiang; Fastenau, John; Spencer, Andrew; Sonneveld, Pieter; Garvin, Wendy; Renaud, Thomas; Gries, Katharine S.
Afiliação
  • Hungria V; Santa Casa Medical School, São Paulo, Brazil.
  • Beksac M; Ankara University, Ankara, Turkey.
  • Weisel KC; University Medical Center of Hamburg-Eppendorf, Hamburg, Germany.
  • Nooka AK; Winship Cancer Institute, Emory University, Atlanta, GA, USA.
  • Masszi T; Semmelweis University, Budapest, Hungary.
  • Spicka I; Charles University and General Hospital, Prague, Czech Republic.
  • Munder M; Third Department of Medicine, University Medical Center of the Johannes Gutenberg-University, Mainz, Germany.
  • Mateos MV; University Hospital of Salamanca/IBSAL, Salamanca, Spain.
  • Mark TM; University of Colorado-Anschutz Medical Campus, Aurora, CO, USA.
  • Qi M; Janssen Research & Development, LLC, Spring House, PA, USA.
  • Qin X; Janssen Research & Development, LLC, Spring House, PA, USA.
  • Fastenau J; Janssen Research & Development, LLC, Raritan, NJ, USA.
  • Spencer A; Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.
  • Sonneveld P; Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
  • Garvin W; Janssen Research & Development, LLC, Spring House, PA, USA.
  • Renaud T; Janssen Research & Development, LLC, Raritan, NJ, USA.
  • Gries KS; Janssen Research & Development, LLC, Raritan, NJ, USA.
Br J Haematol ; 193(3): 561-569, 2021 05.
Article em En | MEDLINE | ID: mdl-33555030
In the phase III CASTOR trial, daratumumab, bortezomib and dexamethasone (D-Vd) significantly extended progression-free survival compared with bortezomib and dexamethasone (Vd) alone in patients with relapsed/refractory multiple myeloma (RRMM). Here, we present patient-reported outcomes (PROs) from the CASTOR trial. PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and the EuroQol 5-dimensional descriptive system questionnaire. Treatment effects through Cycle 8 were measured by a repeated measures mixed-effects model. After Cycle 8, PROs were only collected for patients in the D-Vd group who continued on daratumumab monotherapy. Compliance rates for PRO assessments were high and similar between treatment groups. Mean changes from baseline were generally similar between treatment groups for EORTC QLQ-C30 global health status (GHS), functioning and symptoms, and did not exceed 10 points for either treatment group. Subgroup analyses were consistent with the results observed in the overall population. There was no change in patients' health-related quality of life for the first eight cycles of therapy; thereafter, patients treated with daratumumab over the long-term reported improvements in GHS and pain. These results complement the significant clinical benefits observed with D-Vd in patients with RRMM and support its use in this patient population.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Qualidade de Vida / Protocolos de Quimioterapia Combinada Antineoplásica / Modelos Biológicos / Mieloma Múltiplo Tipo de estudo: Clinical_trials Aspecto: Patient_preference Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Br J Haematol Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Qualidade de Vida / Protocolos de Quimioterapia Combinada Antineoplásica / Modelos Biológicos / Mieloma Múltiplo Tipo de estudo: Clinical_trials Aspecto: Patient_preference Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Br J Haematol Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido