Although randomized trials have shown that long-term maintenance therapy can prolong survival in patients with multiple myeloma (MM) who have undergone autologous hematopoietic transplantation (AHCT), concerns about potential side effects associated with continued active therapy raise the question of whether it is possible to balance living longer with living better. Results from the Connect® MM study provide some answers to that question, suggesting that health-related quality of life (QOL) is similar between patients who did or did not receive maintenance therapy.
Data from the Connect MM, a large, multicenter, prospective, observational, U.S.-based cohort study designed to characterize treatment patterns and outcomes for patients with newly diagnosed MM, was presented at the 2016 ASH Annual Meeting. Rafat Abonour, MD, from the Simon Cancer Center at Indiana University in Indianapolis, and colleagues compared health-related QOL among patients who received any maintenance therapy, maintenance therapy with lenalidomide, or no maintenance therapy post-AHCT.
Dr. Abonour and authors assessed data from 543 patients (median age = 60 years; range = 24-78 years) enrolled in the multicenter, prospective, observational, U.S.-based Connect® MM Disease Registry, comparing health-related QOL among patients who received any maintenance therapy (n=238), with lenalidomide (n=167), or no maintenance therapy (n=138) post-AHCT. Most patients had an Eastern Cooperative Oncology Group performance status of 0 or 1 (64%) and ISS stage I/II disease (56%).
Health-related QOL measurements were collected at baseline, after induction therapy but prior to AHCT, and quarterly from 100 days post-AHCT until the end of maintenance therapy or until disease progression, discontinuation, or death using the EuroQol five-dimensions questionnaire (EQ-5D™; primary analysis), which converts scores into numbers ranging from 0 (death) to 1 (perfect health).
Health-related QOL was also assessed via secondary measures of the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM); a questionnaire evaluating functional well-being from 0 to 128, with higher scores reflecting greater symptom burden, and the Brief Pain Inventory (BPI; a questionnaire assessing severity of pain on a scale of 0 to 10, with a higher score reflecting worse pain).
The median duration of maintenance therapy was similar between the any-maintenance and the lenalidomide-maintenance groups: 23 months (range = 0.8-50.4 months) versus 24.4 months (range = 0.6-50.4 months), respectively.
At baseline, the mean health-related QOL score for each measure was similar in each group on the three measures:
- EQ-5D™ score range = 0.75-0.76
- FACT-MM total score range = 114.8-119.7
- BPI score range = 3.87-4.06
There were also no significant differences in estimated mean post-AHCT scores on all three of the measures between any-maintenance or lenalidomide-maintenance and no-maintenance groups. See the TABLE for the entire health-related QOL scores.
“Few health-related QOL analyses have been published in MM, especially with regard to maintenance therapy after AHCT,” Dr. Abonour said, adding that the results from this analysis “suggest that there is no difference in health-related QOL for those who received maintenance compared with those who did not – despite the risks associated with continued active therapy.”
Abonour R, Durie BGM, Jagannath S, et al. Health-related quality of life of patients with newly diagnosed multiple myeloma receiving any or lenalidomide maintenance after autologous stem cell transplant in the Connect® MM Disease Registry. Abstract #537. Presented at the 2016 ASH Annual Meeting, December 4, 2016; San Diego, California.
|TABLE. Comparison of Health-Related Quality of Life Outcomes by Maintenance Therapy|
|Health-Related Quality of Life||Comparison||Estimated Differences on From Baseline, least squares mean||p Value|
|EQ5D overall index||Lenalidomide only versus no maintenance||0.017
(95% CI −0.0088-0.0420)
|Any versus no maintenance||0.005
(95% CI −0.0185-0.0293)
|FACT-MM total||Lenalidomide only versus no maintenance||1.384
(95% CI −2.4634-5.2305)
|Any versus no maintenance||−0.203
(95% CI −3.8118-3.4051)
|BPI||Lenalidomide only versus no maintenance||−0.278
(95% CI −0.6983-0.1431)
|Any versus no maintenance||−0.158
(95% CI −0.5507-0.2347)
|EQ5D = EuroQOL five dimensions questionnaire; FACT-MM = Functional Assessment of Cancer Therapy-Multiple Myeloma; BPI = Brief Pain Inventory|