TY - JOUR
TI - Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis
AU - Moreau, P.
AU - Dimopoulos, M.A.
AU - Richardson, P.G.
AU - Siegel, D.S.
AU - Cavo, M.
AU - Corradini, P.
AU - Weisel, K.
AU - Delforge, M.
AU - O'Gorman, P.
AU - Song, K.
AU - Chen, C.
AU - Bahlis, N.
AU - Oriol, A.
AU - Hansson, M.
AU - Kaiser, M.
AU - Anttila, P.
AU - Raymakers, R.
AU - Joao, C.
AU - Cook, G.
AU - Sternas, L.
AU - Biyukov, T.
AU - Slaughter, A.
AU - Hong, K.
AU - Herring, J.
AU - Yu, X.
AU - Zaki, M.
AU - San-Miguel, J.
JO - European Journal of Haematology
PY - 2017
VL - 99
TODO - 3
SP - 199-206
PB - Wiley-Blackwell Publishing Ltd
SN - 0902-4441, 1600-0609
TODO - 10.1111/ejh.12903
TODO - 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
TODO - 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
ER -