Health‐related quality of life in elderly, newly diagnosed multiple myeloma patients treated with <scp>VMP</scp> vs. <scp>MP</scp>: results from the <scp>VISTA</scp> trial

Delforge, Michel; Dhawan, Ravinder; Robinson, Don; Meunier, Juliette; Regnault, Antoine; Esseltine, Dixie‐Lee; Cakana, Andrew; Velde, Helgi van de; Richardson, Paul G.; Miguel, Jesús F. San

doi:10.1111/j.1600-0609.2012.01788.x

Cited by 68 publications

(59 citation statements)

References 53 publications

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“…The HRQoL decrease upon PD captured quantitatively here is also consistent with qualitative results on the burden of relapse on MM patients' emotional and physical well-being. 48 This adds additional support to the validity of the HRQoL measures included in the FIRST trial; further evidence of their reliability was also seen in the similarity in base-line scores between the FIRST, VISTA, 45 and HOVON 49 49 studies.…”

Section: Discussionmentioning

confidence: 89%

“…44 However, our results contrast with the HRQoL trade-off reported with bortezomib in the VISTA trial, which compared MPV versus MP in NDMM patients and in which MPV had superior PFS and OS efficacy, but where patients' HRQoL was significantly compromised, especially in the first four cycles of treatment. 45,46 In the FIRST trial, although HRQoL was improved and maintained during the progression-free state, it deteriorated when disease progression occurred, regardless of the treatment received. This finding augments the clinical importance/benefit of the prolonged PFS, and time to progression observed with Rd versus MPT, 19 as a longer PFS in this comparison is associated with better HRQoL.…”

Section: Discussionmentioning

confidence: 99%

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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

et al. 2015

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The randomized pivotal phase III FIRST trial (Frontline Investigation of lenalidomide/dexamethasone [Rev/Dex] versus Standard Thalidomide; IFM 2007-01/ MM-020; clinicaltrials.gov identifier: 00689936; EudraCT No. 2007-004823-39) compared the efficacy and safety of Rd, administered continuously until progressive disease (PD) or for a fixed 18-month duration (Rd18), with MPT given for 18 months in NDMM patients who were aged 65 years or over, or who were aged under 65 years and ineligible for stem cell transplantation. Continuous Rd showed improved progression-free survival (PFS) and overall survival (OS) benefit at interim analysis compared with MPT. 19 Although extending survival is clearly the ultimate treatment ©2015 Ferrata Storti Foundation. This is an open-access paper. doi:10.3324/haematol.2014 The online version of this article has a Supplementary Appendix. Manuscript received on November 14, 2014. Manuscript accepted on March 6, 2015 We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeatedmeasures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.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 [20][21][22][23] In this population, treatment objectives should be to improve disease management by delaying disease progression, optimizing re...

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Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

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

et al. 2015

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“…These findings differ from those of the VISTA trial, which evaluated the addition of bortezomib to MP (VMP) in transplant-ineligible patients with NDMM. 24 Since in the VISTA trial, HRQoL scores worsened during the first 4 cycles of VMP therapy compared with baseline and with MP, further studies are needed directly to compare the HRQoL impact of novel anti-myeloma treatment regimens.…”

Section: Mpr-r Hrqol Impactmentioning

confidence: 99%

Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial

Dimopoulos

Delforge²,

Hájek

et al. 2012

Haematologica

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The MM-015 trial assessed the effect of lenalidomide-based therapy on health-related quality of life. Patients (n=459) with newly diagnosed multiple myeloma aged 65 years or over were randomized 1:1:1 to nine 4-week cycles of lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance; or lenalidomide, melphalan, and prednisone, or melphalan and prednisone, with no maintenance therapy. Patients completed health-related quality of life questionnaires at baseline, after every third treatment cycle, and at treatment end. Health-related quality of life improved in all treatment groups during induction therapy. Patients receiving lenalidomide maintenance had the most pronounced improvements, Global Health Status/Quality of Life (P<0.05), Physical Functioning (P<0.01), and Side Effects of Treatment (P<0.05) out of 6 pre-selected health-related quality of life domains. More patients receiving lenalidomide maintenance achieved minimal important differences (P<0.05 for Physical Functioning). Therefore, lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in patients with newly diagnosed multiple myeloma. (Clinicaltrials.gov identifier NCT00405756). ABSTRACTLenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older:

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“…VISTA included prospective evaluation of health-related quality of life (HRQoL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). Review of these data showed a decrease in quality of life associated with initiation of PCM treatment with both VMP and MP, followed by recovery of HRQoL in both groups by completion of treatment [88].…”

Section: Melphalan Prednisone and Bortezomibmentioning

confidence: 99%

Management of Elderly Patients with Plasma Cell Myeloma

2015

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Plasma cell myeloma (PCM) is a hematologic malignancy that primarily affects the elderly. Approximately two-thirds of patients are aged 65 years or older at diagnosis. Major advances in testing, treatment, and supportive care have resulted in substantial improvement in overall survival in younger, standard-risk, PCM patients over the past 3 decades. However, this positive impact progressively diminishes with advancing age, with some studies showing no improvement in survival outcomes in the elderly. Slow improvement in survival for elderly PCM patients is likely multifactorial, influenced by factors such as age-related physiologic changes, increased comorbidities, decreased treatment tolerance, socioeconomic barriers, and possible differences in disease biology. The standard approach of basing treatment decisions on age and performance status does not account for this complexity, and can be insufficient to determine the risks and benefits of treatment. Comprehensive geriatric assessment (CGA) produces a more thorough iteration of the factors influencing an individual's treatment risk, and can potentially identify targets for intervention to lower risk. Ongoing studies are looking at developing and refining the tools available for risk screening and assessment. Treating elderly PCM patients with novel agent-based regimens with or without autologous stem cell transplantation has improved response rates and survival in some studies, but elderly PCM patients have benefitted less than their younger counterparts from recent advances in PCM treatment. Personalizing treatment decisions, based on predictions of risk, determined by geriatric assessment, and response, determined by precision medicine (our understanding of the genetic, molecular, and cellular pathways that drive an individual's cancer) will help maximize the benefit and minimize the risk of PCM treatment for each patient. Continued evaluation of new strategies and treatments for PCM in clinical trials specifically designed for elderly patients is needed to continue to improve outcomes for elderly PCM patients in the future.

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Health‐related quality of life in elderly, newly diagnosed multiple myeloma patients treated with VMP vs. MP: results from the VISTA trial

Cited by 68 publications

References 53 publications

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

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

Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial

Management of Elderly Patients with Plasma Cell Myeloma

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