CLINICAL NEWS
• admitting women to two designated wards to provide more coordinated care
• implementing simple protocols for preventing and treating acute chest syndrome ( ACS )
• purchasing balloons as a less expensive substitute for incentive spirometry devices to be used routinely during the management of acute pain episodes and after surgery
• integrating multiple pulse oximetry machines into routine clinical practice to monitor oxygen desaturation
• monitoring maternal and fetal progress more closely
The researchers assessed mortality outcomes of 158 patients during a 16-month , pre-intervention period ( January 2014 to April 2015 ), then compared those with outcomes from 90 patients in a 12-month , post-intervention period ( May 2015 to May 2016 ) until six weeks post-partum .
The median patient age was 29 years for both the preintervention ( range = 18-43 years ) and post-intervention ( range = 18-41 years ) periods , and the median gestational age at delivery was 38 weeks ( range = 26-41 weeks ).
Prior to the intervention , pregnant women with SCD received standard of care ( mostly from their obstetrician ) and were admitted to multiple wards throughout the hospital . During the intervention period , women received integrated , multidisciplinary care under the protocols outlined above . Members of the multidisciplinary team evaluated patients at enrollment , during outpatient visits , and during acute illnesses ( including both inpatient and outpatient ). After just 13 months , both maternal and perinatal mortality rates decreased significantly , compared with the pre-intervention period :
• maternal mortality : 9.5 % ( 15 deaths and 139 live births ) versus 1.1 % ( 1 maternal death and 85 live births ), representing an 89.1 % decrease ( p value not reported )
• perinatal mortality : 60.8 % ( 9 perinatal deaths and 148 births ) versus 23 % ( 2 perinatal deaths and 87 births ), representing a 62.2 % decrease ( p value not reported )
The most common cause of death before the multidisciplinary intervention was cardiopulmonary disease ( 60 %), followed by preeclampsia ( 6.67 %), acute kidney injury ( 6.67 %), severe anemia ( 20 %), and hypovolemic shock ( 6.67 %). The one death that occurred in the postintervention period was caused by a massive pulmonary embolism .
Although the comparison between the pre- and postintervention periods is limited by incomplete data prior to the multidisciplinary care team intervention , Dr . Asare and researchers concluded that this approach is promising for SCD patients in sub-Saharan Africa and even in areas of the United States where such clinics are not the norm .
“ Sickle cell disease has acute and chronic complications , and to manage it well , especially in the context of pregnancy and childbirth , you need to have a number of specialists on board , including a hematologist ,” Dr . Asare said . Though this strategy led to substantial reductions in SCD-related maternal and perinatal mortality , she added that “ further strategies are needed to decrease the SCDrelated maternal and perinatal mortality rates to levels expected in the non-SCD population and to implement multidisciplinary SCD obstetric teams in other regions .”
The researchers hope to expand their approach to decrease maternal and perinatal mortality in other hospitals in Accra , Ghana .
REFERENCE
Asare EVNK , Adomakoh Y , Olayemi E , et al . Prospective implementation of multi-disciplinary obstetric team decreases the mortality rate of pregnant women with sickle cell disease in Ghana . Abstract # 1017 . Presented at the ASH Annual Meeting and Exhibition , December 5 , 2016 ; San Diego , CA .
Living Longer , Living Better : Should Lenalidomide Be Standard of Care for Patients With Myeloma ?
Results from two studies presented at the 2016 ASH Annual Meeting support incorporating lenalidomide maintenance therapy for patients with multiple myeloma ( MM ). First , the large phase III Myeloma XI study demonstrated that the use of lenalidomide maintenance therapy significantly improved progression-free survival ( PFS ) compared with no lenalidomide maintenance 1 ; second , an analysis of the Connect ® MM Disease Registry suggested that health-related quality of life ( QOL ) is similar between transplant recipients who did receive maintenance therapy and those who did not . 2
Results from Myeloma XI Outcomes data with lenalidomide maintenance therapy have been mixed , with evidence that lenalidomide maintenance therapy prolongs PFS in certain patient groups , but has no significant effect ( and may expose patients to unnecessary toxicity ) in others . With the randomized , controlled Myeloma IX study , researchers , led by Graham H . Jackson , MD , PhD , from the Northern Institute for Cancer Research at Newcastle University in Newcastle upon Tyne , United Kingdom , compared rates of PFS in patients treated with or without lenalidomide maintenance therapy in a large population that included both transplant-eligible and transplant-ineligible patients of all ages .
“ This has been an area of some controversy for a while ,” Dr . Jackson told ASH Clinical News . “[ Myeloma XI ] is the largest study ever carried out in newly diagnosed MM , and with these results , hopefully , we can finally define the role of lenalidomide in the maintenance setting across all patients with myeloma .”
More than 4,000 patients with newly diagnosed , symptomatic MM were enrolled from more than 100 centers across the United Kingdom . The analysis included 1,550 patients : 828 transplanteligible patients ( median age = 61 years ; range = 18-92 ) and 722 transplant-ineligible patients ( median age = 74 years ; range
= 18-88 years ). Induction treatment consisted of thalidomide or lenalidomide plus cyclophosphamide and dexamethasone , with appropriate dose reductions for transplantineligible patients , Dr . Jackson noted during his presentation of the results . Transplant-eligible patients then proceeded to transplant with melphalan 200 mg / m 2 .
Patients were randomized to either maintenance with lenalidomide 10 mg daily on days 1-21 ( n = 857 ), or to observation ( n = 693 ) starting at 100 days posttransplant or after achieving maximum response ( transplant-ineligible patients ). The arms were well balanced for clinical features and response to induction therapy ( e . g . International Staging System [ ISS ] stage III : 27 % vs . 23 %; very good partial response / complete response : 73 % vs . 73 %).
“ Hopefully , [ with the results from Myeloma XI ] we can finally define the role of lenalidomide in the maintenance setting across all patients with myeloma .”
— GRAHAM H . JACKSON , MD , PhD
Graham H . Jackson , MD , PhD
After a median follow-up of 26 months ( range = 12-41 months ), the maintenance arm met the study ’ s primary endpoints for PFS , demonstrating a 55 percent lower risk for progression or death , compared with patients in the observation arm ( median PFS = 37 vs . 19 months ; hazard ratio [ HR ] = 0.45 ; 05 % CI 0.39-0.52 ; p < 0.0001 ).
“ In the transplant-eligible patients , that [ PFS ] improvement was 22 months ,” Dr . Jackson reported , with an HR for progression or death of 0.46 ( 95 % CI 0.36-0.58 ; p < 0.0001 ) for patients receiving maintenance therapy . “ And , even among older , frail patients , the improvement in PFS was 13 months ( HR = 0.44 ; 95 % CI 0.36-0.53 ; p < 0.0001 ).”
“ Our findings interdigitate nicely with a meta-analysis that was presented earlier this year , which showed that , in the transplant-eligible population , lenalidomide maintenance clearly had a significant effect on PFS ,” Dr . Jackson noted . 3
The researchers observed 35 grade 3 / 4 adverse events in the study population , including neutropenia ( 35 %),
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