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

. 2021 May ; 193 (3) : 561-569. [epub] 20210208

Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid33555030

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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Ramsenthaler C, Kane P, Gao W, Siegert RJ, Edmonds PM, Schey SA, et al. Prevalence of symptoms in patients with multiple myeloma: a systematic review and meta-analysis. Eur J Haematol. 2016;97(5):416-29.

Baz R, Lin HM, Hui AM, Harvey RD, Colson K, Gallop K, et al. Development of a conceptual model to illustrate the impact of multiple myeloma and its treatment on health-related quality of life. Support Care Cancer. 2015;23(9):2789-97.

Osborne TR, Ramsenthaler C, Siegert RJ, Edmonds PM, Schey SA, Higginson IJ. What issues matter most to people with multiple myeloma and how well are we measuring them? A systematic review of quality of life tools. Eur J Haematol. 2012;89(6):437-57.

Nielsen LK, Stege C, Lissenberg-Witte B, van der Holt B, Mellqvist UH, Salomo M, et al. Health-related quality of life in transplant ineligible newly diagnosed multiple myeloma patients treated with either thalidomide or lenalidomide-based regimen until progression: a prospective, open-label, multicenter, randomized, phase 3 study. Haematologica. 2020;105(6):1650-9.

Robinson D Jr, Esseltine DL, Regnault A, Meunier J, Liu K, van de Velde H. The influence of baseline characteristics and disease stage on health-related quality of life in multiple myeloma: findings from six randomized controlled trials. Br J Haematol. 2016;174(3):368-81.

Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, et al. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015;100(6):826-33.

Richardson PG, Schlossman RL, Roy AN, Panneerselvam A, Acharyya S, Sopala M, et al. Patient-reported outcomes of multiple myeloma patients treated with panobinostat after ≥2 lines of therapy based on the international phase 3, randomized, double-blind, placebo-controlled PANORAMA-1 trial. Br J Haematol. 2018;181(5):628-36.

Weisel K, Dimopoulos M, Moreau P, Yagci M, Larocca A, Kanate AS, et al. Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma. Leuk Lymphoma. 2020;61(8):1850-9.

Delforge M, Dhawan R, Robinson D Jr, Meunier J, Regnault A, Esseltine DL, et al. Health-related quality of life in elderly, newly diagnosed multiple myeloma patients treated with VMP vs. MP: results from the VISTA trial. Eur J Haematol. 2012;89(1):16-27.

Szabo AG, Iversen KF, Möller S, Plesner T. The clinical course of multiple myeloma in the era of novel agents: a retrospective, single-center, real-world study. Clin Hematol Int. 2019;1(14):220-8.

Jordan K, Proskorovsky I, Lewis P, Ishak J, Payne K, Lordan N, et al. Effect of general symptom level, specific adverse events, treatment patterns, and patient characteristics on health-related quality of life in patients with multiple myeloma: results of a European, multicenter cohort study. Support Care Cancer. 2014;22(2):417-26.

Ludwig H, Moreau P, Dimopoulos MA, Mateos MV, Kaiser M, Hajek R, et al. Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma. Blood Cancer J. 2019;9(3):23.

LeBlanc MR, Hirschey R, Leak Bryant A, LeBlanc TW, Smith SK. How are patient-reported outcomes and symptoms being measured in adults with relapsed/refractory multiple myeloma? A systematic review. Qual Life Res. 2020;29(6):1419-31.

Palumbo A, Rajkumar SV, San Miguel JF, Larocca A, Niesvizky R, Morgan G, et al. International Myeloma Working Group consensus statement for the management, treatment, and supportive care of patients with myeloma not eligible for standard autologous stem-cell transplantation. J Clin Oncol. 2014;32(6):587-600.

de Weers M, Tai YT, van der Veer MS, Bakker JM, Vink T, Jacobs DC, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol. 2011;186(3):1840-8.

Lammerts van Bueren J, Jakobs D, Kaldenhoven N, Roza M, Hiddingh S, Meesters J, et al. Direct in vitro comparison of daratumumab with surrogate analogs of CD38 antibodies MOR03087, SAR650984 and Ab79. Blood. 2014;124(21):3474.

Overdijk MB, Jansen JH, Nederend M, Lammerts van Bueren JJ, Groen RW, Parren PW, et al. The therapeutic CD38 monoclonal antibody daratumumab induces programmed cell death via Fcγ receptor-mediated cross-linking. J Immunol. 2016;197(3):807-13.

Overdijk MB, Verploegen S, Bogels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7(2):311-21.

Krejcik J, Casneuf T, Nijhof IS, Verbist B, Bald J, Plesner T, et al. Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016;128(3):384-94.

Chiu C, Casneuf T, Axel A, Lysaght A, Bald J, Khokhar NZ, et al. Daratumumab in combination with lenalidomide plus dexamethasone induces clonality increase and T-cell expansion: results from a phase 3 randomized study (POLLUX). Blood. 2016;128(22):4531.

Adams HC 3rd, Stevenaert F, Krejcik J, Van der Borght K, Smets T, Bald J, et al. High-parameter mass cytometry evaluation of relapsed/refractory multiple myeloma patients treated with daratumumab demonstrates immune modulation as a novel mechanism of action. Cytometry A. 2019;95(3):279-89.

Janssen Biotech, Inc. DARZALEX® (daratumumab) injection, for intravenous use [prescribing information]. Horsham, PA, 2019.

Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(8):754-66.

Spencer A, Lentzsch S, Weisel K, Avet-Loiseau H, Mark TM, Spicka I, et al. Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR. Haematologica. 2018;103(12):2079-87.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365-76.

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727-36.

Kvam AK, Fayers PM, Wisloff F. Responsiveness and minimal important score differences in quality-of-life questionnaires: a comparison of the EORTC QLQ-C30 cancer-specific questionnaire to the generic utility questionnaires EQ-5D and 15D in patients with multiple myeloma. Eur J Haematol. 2011;87(4):330-7.

Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes. 2007;5:70.

Seitzler S, Finley-Oliver E, Simonelli C, Baz R. Quality of life in multiple myeloma: considerations and recommendations. Expert Rev Hematol. 2019;12(6):419-24.

Dimopoulos MA, Palumbo A, Hajek R, Kropff M, Petrucci MT, Lewis P, et al. Factors that influence health-related quality of life in newly diagnosed patients with multiple myeloma aged ≥65 years treated with melphalan, prednisone and lenalidomide followed by lenalidomide maintenance: results of a randomized trial. Leuk Lymphoma. 2014;55(7):1489-97.

Nolte S, Liegl G, Petersen MA, Aaronson NK, Costantini A, Fayers PM, et al. General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States. Eur J Cancer. 2019;107:153-63.

Scott NW, Fayers PM, Aaronson NK, Bottomley A, de Graeff A, Groenvold M, et al. EORTC QLQ-C30 reference values. EORTC Quality of Life Group; 2008 [cited July 2008]. Available from: https://www.eortc.org/app/uploads/sites/2/2018/02/reference_values_manual2008.pdf.

Roydhouse JK, Fiero MH, Kluetz PG. Investigating potential bias in patient-reported outcomes in open-label cancer trials. JAMA Oncol. 2019;5(4):457-8.

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