Περίληψη:
Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUS study assessed safety and efficacy of pomalidomide plus low-dose dexamethasone in the largest cohort to date of patients with RRMM. Patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy were eligible. Pomalidomide 4 mg was given on days 1-21 of 28-day cycles with low-dose dexamethasone 40 mg (20 mg for patients aged >75 years) on days 1, 8, 15, and 22 until progressive disease or unacceptable toxicity. Safety was the primary end point; secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Among 682 patients enrolled, median age was 66 years, and median time since diagnosis was 5.3 years. Median number of prior regimens was 5. Most patients were refractory to both lenalidomide and bortezomib (80.2%). Median follow-up was 16.8 months; median duration of treatment was 4.9 months. Most frequent grade 3/4 treatment-emergent adverse events were hematologic (neutropenia [49.7%], anemia [33.0%], and thrombocytopenia [24.1%]). Most common grade 3/4 nonhematologic toxicities were pneumonia (10.9%) and fatigue (5.9%). Grade 3/4 venous thromboembolism and peripheral neuropathy were rare (1.6% each). The ORR was 32.6%, and the median DOR was 7.4 months. Median PFS and OS were 4.6 months and 11.9 months, respectively. We present the largest trial to date evaluating pomalidomide plus low-dose dexamethasone in patients with RRMM, further confirming that this regimen offers clinically meaningful benefit and is generally well tolerated. www.Clinicaltrials.gov identifier NCT01712789. © 2016 by The American Society of Hematology.
Συγγραφείς:
Dimopoulos, M.A.
Palumbo, A.
Corradini, P.
Cavo, M.
Delforge, M.
Di Raimondo, F.
Weisel, K.C.
Oriol, A.
Hansson, M.
Vacca, A.
Blanchard, M.J.
Goldschmidt, H.
Doyen, C.
Kaiser, M.
Petrini, M.
Anttila, P.
Cafro, A.M.
Raymakers, R.
San-Miguel, J.
De Arriba, F.
Knop, S.
Röllig, C.
Ocio, E.M.
Morgan, G.
Miller, N.
Simcock, M.
Peluso, T.
Herring, J.
Sternas, L.
Zaki, M.H.
Moreau, P.
Λέξεις-κλειδιά:
bortezomib; dexamethasone; lenalidomide; pomalidomide; antineoplastic agent; dexamethasone; pomalidomide; thalidomide, adult; aged; anemia; Article; asthenia; backache; burning sensation; cancer chemotherapy; cancer survival; constipation; coughing; decreased appetite; deep vein thrombosis; diarrhea; disease course; drug dose reduction; drug efficacy; drug response; drug safety; drug tolerability; drug treatment failure; drug withdrawal; dysesthesia; dyspnea; fatigue; febrile neutropenia; female; follow up; gait disorder; human; hypesthesia; infection; insomnia; leukopenia; low drug dose; lung embolism; major clinical study; male; medication compliance; motor dysfunction; motor neuropathy; multiple cycle treatment; multiple myeloma; muscle atrophy; muscle spasm; nausea; neuralgia; neutropenia; open study; overall survival; patient compliance; peripheral edema; peripheral neuropathy; phase 3 clinical trial; pneumonia; polyneuropathy; priority journal; progression free survival; refractory multiple myeloma; refractory multiple myeloma; sensorimotor neuropathy; sensory dysfunction; sensory neuropathy; thrombocytopenia; thromboembolism; toxic neuropathy; treatment duration; venous thromboembolism; analogs and derivatives; clinical trial; middle aged; multicenter study; multiple myeloma; very elderly, Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Female; Follow-Up Studies; Humans; Male; Middle Aged; Multiple Myeloma; Thalidomide
