Τίτλος:
Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
This analysis assessed the efficacy and safety of lenalidomide + dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + dexamethasone despite prior thalidomide exposure. Among lenalidomide + dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + dexamethasone-treated patients (36.1 vs 33.3 months, P > .05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + dexamethasone, independent of prior thalidomide exposure. Lenalidomide + dexamethasone was superior to placebo + dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + dexamethasone; similar benefits compared with placebo + dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials. gov under NCT00056160 and NCT00424047. © 2008 by The American Society of Hematology.
Συγγραφείς:
Wang, M.
Dimopoulos, M.A.
Chen, C.
Cibeira, M.T.
Attal, M.
Spencer, A.
Rajkumar, S.V.
Yu, Z.
Olesnyckyj, M.
Zeldis, J.B.
Knight, R.D.
Weber, D.M.
Περιοδικό:
Blood advances
Εκδότης:
American Society of Hematology
Λέξεις-κλειδιά:
bortezomib; dexamethasone; lenalidomide; placebo; thalidomide; vincristine; antineoplastic agent; dexamethasone; drug derivative; lenalidomide; thalidomide, adult; anemia; article; bone marrow suppression; cancer relapse; cancer survival; clinical assessment; clinical trial; controlled clinical trial; controlled study; deep vein thrombosis; disease duration; drug dose reduction; drug efficacy; fatigue; febrile neutropenia; gastrointestinal symptom; human; infection; lung embolism; major clinical study; multiple myeloma; neutropenia; peripheral neuropathy; priority journal; progression free survival; prospective study; therapy effect; thrombocytopenia; treatment response; adjuvant chemotherapy; dose response; drug effect; drug resistance; evaluation; middle aged; mortality; multicenter study; multiple myeloma; phase 3 clinical trial; randomized controlled trial; recurrent disease; retrospective study; survival; treatment outcome, Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Adjuvant; Clinical Trials, Phase III as Topic; Dexamethasone; Dose-Response Relationship, Drug; Drug Resistance, Neoplasm; Humans; Middle Aged; Multiple Myeloma; Placebos; Randomized Controlled Trials as Topic; Recurrence; Retrospective Studies; Survival Analysis; Thalidomide; Treatment Outcome
DOI:
10.1182/blood-2008-02-141614
