Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: a pooled analysis
Moreau P (1), Dimopoulos MA (2), Richardson PG (3), Siegel DS (4), Cavo M (5), Corradini P (6), Weisel K (7), Delforge M (8), O'Gorman P (9), Song K (10), Chen C (11), Bahlis N (12), Oriol A (13), Hansson M (14), Kaiser M (15), Anttila P (16), Raymakers R (17), Joao C (18), Cook G (19), Sternas L (20), Biyukov T (21), Slaughter A (21), Hong K (20), Herring J (20), Yu X (20), Zaki M (20), San-Miguel J (22).
(1) University Hospital Hôtel-Dieu, Nantes, France.
(2) National and Kapodistrian University of Athens, Athens, Greece.
(3) Dana-Farber Cancer Institute, Boston, MA, USA.
(4) John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.
(5) Bologna University School of Medicine, Bologna, Italy.
(6) University of Milano, Fondazione IRCCS Istituto Nazionale de Tumori, Milano, Italy.
(7) University Hospital of Tuebingen, Tuebingen, Germany.
(8) University Hospital Leuven, Leuven, Belgium.
(9) Mater Misericordiae University Hospital, University College Dublin, Dublin, Ireland.
(10) Vancouver General Hospital, Vancouver, British Columbia, Canada.
(11) Princess Margaret Hospital, Toronto, Ontario, Canada.
(12) Tom Baker Cancer Center-University of Calgary, Calgary, Canada.
(13) Institut Català d'Oncologia, Institut Josep Carreras. Hospital Germans Trias i Pujol, Barcelona, Spain.
(14) Skane University Hospital, Lund University, Lund, Sweden.
(15) The Royal Marsden Hospital, Surrey, UK.
(16) Helsinki University and Helsinki University Hospital Comprehensive Cancer, Helsinki, Finland.
(17) University Medical Center Utrecht, Utrecht, The Netherlands.
(18) Hemato-Oncology Department, Champalimaud Foundation for the Unknown and Faculdade de Ciências Médicas-NOVA University, Lisbon, Portugal.
(19) St James's Institute of Oncology, St James's University Hospital, Leeds, UK.
(20) Celgene Corporation, Summit, NJ, USA.
(21) Celgene International Sàrl, Boudry, Switzerland.
(22) Clinica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain.
Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs is 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.
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.
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.
Pomalidomide plus low-dose dexamethasone showed an acceptable safety profile and AEs were well managed according to study protocols and established guidelines. This article is protected by copyright. All rights reserved.
CITA DEL ARTÍCULO Eur J Haematol. 2017 May 15. doi: 10.1111/ejh.12903