Your browser doesn't support javascript.
loading
Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial.
Plesner, Torben; Dimopoulos, Meletios A; Oriol, Albert; San-Miguel, Jesus; Bahlis, Nizar J; Rabin, Neil; Suzuki, Kenshi; Yoon, Sung-Soo; Ben-Yehuda, Dina; Cook, Gordon; Goldschmidt, Hartmut; Grosicki, Sebastian; Qin, Xiang; Fastenau, John; Garvin, Wendy; Carson, Robin; Renaud, Thomas; Gries, Katharine S.
Afiliação
  • Plesner T; Vejle Hospital and University of Southern Denmark, Vejle, Denmark.
  • Dimopoulos MA; National and Kapodistrian University of Athens School of Medicine, Athens, Greece.
  • Oriol A; Institut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain.
  • San-Miguel J; Clinica Universidad de Navarra, Pamplona, Spain.
  • Bahlis NJ; Tom Baker Cancer Centre, Calgary, AB, Canada.
  • Rabin N; Department of Haematology, University College London Hospitals NHS Trust, London, UK.
  • Suzuki K; Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
  • Yoon SS; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
  • Ben-Yehuda D; Hematology Department, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
  • Cook G; University of Leeds, Leeds, UK.
  • Goldschmidt H; Internal Medicine V, University Hospital Heidelberg and National Center for Tumor Diseases (NCT), Heidelberg, Germany.
  • Grosicki S; Medical University of Silesia, Katowice, Poland.
  • Qin X; Janssen Research & Development, Spring House, PA, USA.
  • Fastenau J; Janssen Global Services, Raritan, NJ, USA.
  • Garvin W; Janssen Research & Development, Spring House, PA, USA.
  • Carson R; Janssen Global Services, Raritan, NJ, USA.
  • Renaud T; Janssen Global Services, Raritan, NJ, USA.
  • Gries KS; Janssen Global Services, Raritan, NJ, USA.
Br J Haematol ; 194(1): 132-139, 2021 07.
Article em En | MEDLINE | ID: mdl-33822368
ABSTRACT
In the phase 3 POLLUX trial, daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly improved progression-free survival in patients with relapsed/refractory multiple myeloma (RRMM) compared with lenalidomide and dexamethasone (Rd) alone. Here, we present patient-reported outcomes (PROs) from POLLUX, assessed using the validated 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 (EQ-5D-5L) questionnaires. Changes from baseline are presented as least-squares mean changes with 95% confidence intervals (CIs) derived from a mixed-effects model. PRO assessment compliance rates were high and similar in both D-Rd and Rd groups through cycle 40 (week 156). In this on-treatment analysis, mean changes from baseline were significantly greater in EORTC QLQ-C30 global health status, physical functioning, and pain scores in the D-Rd group versus the Rd group at multiple time points; however, magnitude of changes was low, suggesting no meaningful impact on health-related quality of life (HRQoL). Subgroup results were similar to those in the overall population. In the POLLUX study, baseline HRQoL was maintained with prolonged D-Rd treatment. These findings complement the sustained and significant improvement in progression-free survival observed with D-Rd and supports its use in patients with RRMM. Clinical trial registration NCT02076009.
Assuntos
Palavras-chave

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Terapia de Salvação / Mieloma Múltiplo Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Terapia de Salvação / Mieloma Múltiplo Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2021 Tipo de documento: Article