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Health-Related Quality of Life after Autologous Stem Cell Transplantation for Multiple Myeloma.

ABSTRACT: Autologous stem cell transplantation (ASCT) is an integral part of the frontline therapy in eligible multiple myeloma (MM) patients. The impact of ASCT on health-related quality of life (HRQoL) in myeloma has not been well described. We performed a systematic literature search to identify studies evaluating the impact of ASCT on HRQoL. Our search retrieved 12 relevant studies: 10 manuscripts and 2 conference abstracts. There was a widespread heterogeneity across studies in instruments used to measure HRQoL, time points of measurement, and statistical analysis. Only 1 study was a randomized controlled trial with HRQoL as a prespecified secondary endpoint. The common theme that emerged from most studies is that ASCT leads to an immediate deterioration in HRQoL and increase in symptom burden. However, baseline HRQoL and symptom scores are regained as early as 1 to 2 months post-transplantation. Furthermore, an improvement in HRQoL and pain on long-term follow-up was noted in some studies. We describe opportunities for further research in this area, including routine incorporation of HRQoL as an endpoint in transplant-related clinical trials and need for trials investigating interventions that may improve short and long-term HRQoL in myeloma ASCT recipients.

SUBMITTER: Chakraborty R

PROVIDER: S-EPMC6108907 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Health-Related Quality of Life after Autologous Stem Cell Transplantation for Multiple Myeloma.

Chakraborty Rajshekhar R Hamilton Betty K BK Hashmi Shahrukh K SK Kumar Shaji K SK Majhail Navneet S NS

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation 20180404 8

Autologous stem cell transplantation (ASCT) is an integral part of the frontline therapy in eligible multiple myeloma (MM) patients. The impact of ASCT on health-related quality of life (HRQoL) in myeloma has not been well described. We performed a systematic literature search to identify studies evaluating the impact of ASCT on HRQoL. Our search retrieved 12 relevant studies: 10 manuscripts and 2 conference abstracts. There was a widespread heterogeneity across studies in instruments used to me ...[more]

PMID: 29626515

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Project description:IntroductionMultiple myeloma (MM) is considered an incurable hematological neoplasm. For transplant-eligible patients, initial treatment includes an induction phase followed by an autologous stem cell transplantation (ASCT). Despite the introduction of several drugs in the past years, relapses still occur. Nevertheless, some patients achieve sustained responses after successful induction treatment and ASCT.MethodsWe retrospectively evaluated all patients diagnosed with MM in our institution who underwent induction treatment and ASCT between 1990 and 2015. The subset of patients who achieved a sustained response (any degree) for 5 or more years after ASCT without further treatment or signs of progression were distinguished as "long-term responders" (LTRs). In the non-LTR group, a cohort referred to as "prolonged responders" (PLRs) showed sustained response of at least 5 years after ASCT but eventually relapsed. We collected and analyzed clinical and laboratory data.ResultsTwo hundred and fifty patients were diagnosed with MM and received induction treatment and ASCT at our institution in the study period. Among them, 54 (21.6%) patients met the criteria for LTR. Some diagnostic features such as a younger age, female gender, ECOG performance status of 0, lower International Staging System (ISS) stage, lower bone marrow plasma cell infiltration, and lower serum levels of calcium, C-reactive protein, and lactate dehydrogenase (LDH) were found to be more prevalent in LTR. Female gender, an ECOG performance status of 0, a localized Durie-Salmon stage, an ISS of I-II, the absence of bone disease, and an LDH within normal range were also predictive of longer progression-free survival (PFS) and overall survival (OS) in the whole cohort. The depth of the response achieved after induction and ASCT as well as the administration of an IMID-based maintenance regimen may play a role in the differences observed on PFS between cohorts. A detectable M-protein with a monoclonal gammopathy of undetermined significance (MGUS)-like behavior was detected in one-third of LTR after ASCT. Although relapses continue to occur in patients who achieve a 5-year treatment-free period after ASCT, a plateau is observed in the survival curves at approximately 21 years of follow-up.

Project description:BackgroundDecisions regarding maintenance therapy in patients with multiple myeloma should be based on both treatment efficacy and health-related quality of life (HRQL) consequences. In the CARFI trial, patients with first relapse of multiple myeloma underwent salvage autologous stem cell transplantation (salvage ASCT) before randomization to carfilzomib-dexamethasone maintenance therapy (Kd) or observation. The primary clinical endpoint was time to progression, which was extended by 8 months by Kd. The aim of this paper is to present the all HRQL endpoints of the CARFI trial including the HRQL effect of Kd maintenance therapy relative to observation. The primary HRQL endpoint was assessed by EORTC QLQ-C30 Summary score (QLQ-C30-sum) at 8 months follow-up. A key secondary HRQL endpoint was quality-adjusted progression-free-survival (QAPFS).MethodsHRQL was assessed with EORTC QLQ-C30, EORTC QLQ-MY20 and FACT/GOG-Ntx at randomization and every second month during follow-up. HRQL data were analyzed with linear mixed effect models until 8 months follow-up. QAPFS per individual was calculated by multiplying progression-free survival (PFS) by two quality-adjustment metrics, the QLQ-C30-sum and EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The QAPFS per treatment group was estimated with the Kaplan-Meier method. P < 0.05 was used for statistical significance, and a between-group minimal important difference of 10 points was interpreted as clinically relevant for the QLQ-C30-sum.Results168 patients were randomized. HRQL questionnaire compliance was 93%. For the QLQ-C30-sum, the difference of 4.62 points (95% confidence interval (CI) -8.9: -0.4, p = 0.032) was not clinically relevant. PFS was 19.3 months for the Kd maintenance group and 16.8 months for the observation group; difference = 2.5 months (95% CI 0.5; 4.5). QAPFS based on the QLQ-C30-sum for the Kd maintenance group was 18.0 months (95% CI 16.4; 19.6) and for the observation group 15.0 months (95% CI 13.5; 16.5); difference = 3.0 months (95% CI 0.8-5.3). QAPFS based on the QLU-C10D for the Kd maintenance group was 17.5 months (95% CI 15.9; 19.2) and 14.0 months (95% CI 12.4; 15.5) for the observation group; difference = 3.5 months (95% CI 1.1-5.9).ConclusionsKd maintenance therapy after salvage ASCT did not adversely affect overall HRQL, but adjustment for HRQL reduced the PFS compared to unadjusted PFS. PFS of maintenance therapy should be quality-adjusted to balance the benefits and HRQL impact.

Dataset Information

Health-Related Quality of Life after Autologous Stem Cell Transplantation for Multiple Myeloma.

Publications

Health-Related Quality of Life after Autologous Stem Cell Transplantation for Multiple Myeloma.

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