Τίτλος:
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Objectives: Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs are important to ensure patients continue therapy long enough to receive the best clinical benefit. Data from the MM-002, MM-003, and MM-010 trials were pooled to further characterize the safety profile of pomalidomide plus low-dose dexamethasone and AE management. Methods: This analysis included 1088 patients who received ≥ 2 prior therapies, including lenalidomide and bortezomib, and progressed ≤ 60 days of last therapy. Patients received 28-day cycles of pomalidomide 4 mg/day on days 1-21 and low-dose dexamethasone 40 mg (20 mg if aged > 75 years) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. Results: The most common grade 3/4 AEs were neutropenia (56.2%), anemia (32.3%), and thrombocytopenia (25.8%), which occurred within the first few cycles of treatment. Grade 3/4 infections occurred in 33.7% patients, of whom 13.9% had pneumonia, and 40.3% had neutropenia. Pomalidomide dose reductions or interruptions were reported in 24.2% and 66.0% of patients, respectively. AEs were managed by dose modifications and/or supportive care. Conclusions: Pomalidomide plus low-dose dexamethasone showed an acceptable safety profile, and AEs were well managed according to study protocols and established guidelines. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Συγγραφείς:
Moreau, P.
Dimopoulos, M.A.
Richardson, P.G.
Siegel, D.S.
Cavo, M.
Corradini, P.
Weisel, K.
Delforge, M.
O'Gorman, P.
Song, K.
Chen, C.
Bahlis, N.
Oriol, A.
Hansson, M.
Kaiser, M.
Anttila, P.
Raymakers, R.
Joao, C.
Cook, G.
Sternas, L.
Biyukov, T.
Slaughter, A.
Hong, K.
Herring, J.
Yu, X.
Zaki, M.
San-Miguel, J.
Περιοδικό:
European Journal of Haematology
Εκδότης:
Wiley-Blackwell Publishing Ltd
Λέξεις-κλειδιά:
bortezomib; dexamethasone; granulocyte colony stimulating factor; lenalidomide; pomalidomide; antineoplastic agent; dexamethasone; pomalidomide; thalidomide, adult; adverse outcome; age; aged; anemia; Article; cancer combination chemotherapy; cancer recurrence; drug dose reduction; drug safety; drug withdrawal; fatigue; febrile neutropenia; female; human; incidence; infection; low drug dose; major clinical study; male; multicenter study; multiple cycle treatment; multiple myeloma; neutropenia; patient history of stem cell transplantation; peripheral neuropathy; pneumonia; priority journal; respiratory tract infection; sepsis; thrombocyte transfusion; thrombocytopenia; adverse drug reaction; analogs and derivatives; clinical trial (topic); disease management; drug resistance; middle aged; multicenter study (topic); multimodality cancer therapy; multiple myeloma; pathology; time factor; tumor recurrence; very elderly, Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Combined Modality Therapy; Dexamethasone; Disease Management; Drug Resistance, Neoplasm; Drug-Related Side Effects and Adverse Reactions; Humans; Middle Aged; Multicenter Studies as Topic; Multiple Myeloma; Neoplasm Recurrence, Local; Thalidomide; Time Factors
