On Location ASH Annual Meeting
TABLE 1 . Comparison of Health-Related Quality-of-Life Outcomes by Maintenance Therapy
Health-Related Quality of Life
EQ-5D™ overall index
FACT-MM total
BPI total
Comparison
Lenalidomide only versus no maintenance
Any versus no maintenance
Lenalidomide only versus no maintenance
Any versus no maintenance
Lenalidomide only versus no maintenance
Any versus no maintenance
thrombocytopenia ( 7.4 %), anemia ( 4.4 %), and peripheral neuropathy ( 1.4 %). Seventy-two second primary malignancies ( SPM ) were reported : 24 in the observation arm ( 0.04 %) and 48 ( 0.06 %) in the lenalidomide arm . “ While we found a slight excess of SPM in older patients , these were mostly noninvasive and did not impact the outcome benefit demonstrated ,” the authors wrote .
Dr . Jackson and authors also performed an exploratory analysis of 132 patients who stopped lenalidomide treatment for reasons other than disease progression ( 91 due to toxicity , 28 patient choice , and 13 clinician choice ), finding that patients on maintenance therapy for longer than 12 months appeared to have an improved median PFS , compared with those who stopped treatment earlier ( 49 vs . 31 months ; HR = 0.35 [ 95 % CI 0.18-0.68 ]; p < 0.0015 ). However , Dr . Jackson noted that these are preliminary data , and the study was not designed to answer questions about the duration of maintenance and survival outcomes .
Results from the Connect ® MM Disease Registry The second study , presented by Rafat Abonour , MD , from the Simon Cancer Center at Indiana University in Indianapolis , provided some assurance that even if patients need to be on maintenance therapy longer than a year to experience a PFS benefit , their QOL does not appear to suffer significantly .
Dr . Abonour and authors assessed data from 543 patients ( median age = 60 years ; range =
Estimated Differences from Baseline , Least Squares Mean
0.017 ( 95 % CI −0.0088-0.0420 )
0.005 ( 95 % CI −0.0185-0.0293 )
1.384 ( 95 % CI −2.4634-5.2305 )
−0.203 ( 95 % CI −3.8118-3.4051 )
−0.278 ( 95 % CI −0.6983-0.1431 )
−0.158 ( 95 % CI −0.5507-0.2347 ) p value
EQ-5D™ = EuroQOL five dimensions questionnaire ; FACT-MM = Functional Assessment of Cancer Therapy-Multiple Myeloma ; BPI = Brief Pain Inventory
0.20
0.66
0.48
0.91
0.19
0.43
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-autologous hematopoietic cell transplantation ( 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 healthrelated 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 anymaintenance or lenalidomidemaintenance and no-maintenance groups . See TABLE 1 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 .”
REFERENCES
1 . Jackson GH , Davies FE , Pawlyn C , et al . Lenalidomide is a highly effective maintenance therapy in myeloma patients of all ages ; results of the phase III Myeloma XI Study . Abstract # 1143 . Presented at the 2016 ASH Annual Meeting , December 5 , 2016 ; San Diego , CA .
2 . 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 , CA .
3 . Attal M , Palumbo A , Holstein SA , et al . Lenalidomide ( LEN ) maintenance ( MNTC ) after high-dose melphalan and autologous stem cell transplant ( ASCT ) in multiple myeloma ( MM ): A meta-analysis ( MA ) of overall survival ( OS ). Abstract # 8001 . Presented at the 2016 ASCO Annual Meeting , June 3 , 2016 ; Chicago , IL .
A New Use for an Old Method : Cryopreserving Platelets With Dimethyl Sulfoxide for Patients With Thrombocytopenia
Infusions of platelets cryopreserved with dimethyl sulfoxide ( DMSO ) could safely and effectively control bleeding in patients with severe thrombocytopenia and active bleeding , without any evidence of thrombotic complications , according to results of a phase I , dose-escalation study presented at the 2016 ASH Annual Meeting .
This preservation method also extends platelet unit shelf-life up to two years , compared with five to seven days for platelets stored at room temperature in plasma . This makes DMSO cryopreservation a promising option for military and certain civilian settings , noted the authors of the report , led by Sherrill J . Slichter , MD , from the division of Platelet Transfusion Research at Bloodworks Northwest in Seattle , Washington .
“[ The hematology community ] started to use DMSO frozen platelets in the early 1970s to support patients who were alloimmune-refractory to platelets ,” Dr . Slichter told ASH Clinical News . Attempts to harvest these patients ’ platelets , freeze them , then re-transfuse them failed , and research into the approach stalled . Five or six years ago , this area saw a resurgence when the U . S . military started looking for alternative platelet storage and delivery methods that would lengthen platelet shelf-life and could be deployed easily for soldiers in need of platelet transfusions , she explained .
Dr . Slichter and authors evaluated rates of toxicity and bleeding control with cryopreserved platelets ( CPP ) in 28 patients hospitalized with thrombocytopenia and active bleeding despite treatment with standard platelet infusions . Patients also had no history of unprovoked thrombotic events or indication of disseminated intravascular coagulation .
Patients were enrolled into one of four cohorts :
• infusion with a half CPP unit ( n = 5 )
• infusion with 1 CPP unit ( n = 7 )
• infusion with 2 CPP units ( n = 6 )
• infusion with 3 CPP units ( n = 6 )
In addition , one standard apheresis platelet unit was randomly given to one patient enrolled in each cohort ( n = 4 ). Each thawed apheresis CPP unit contained 2.5 x 10 11 ± 4.2 x 10 10 platelets in 50 ± 4 mL .
24 ASH Clinical News January 2017 Annual Meeting Edition