Περίληψη:
Carfilzomib, a proteasome inhibitor, is approved as monotherapy and in combination with dexamethasone or lenalidomide- dexamethasone (Rd) for relapsed or refractory multiple myeloma. The approval of carfilzomib-lenalidomide-dexamethasone (KRd) was based on results from the randomized, phase 3 study ASPIRE (NCT01080391), which showed KRd significantly improved progression-free survival (PFS) vs Rd (median 26.3 vs 17.6 months; hazard ratio (HR) = 0.690; P = 0.0001). This subgroup analysis of ASPIRE evaluated KRd vs Rd by number of previous lines of therapy and previous exposure to bortezomib, thalidomide or lenalidomide. Treatment with KRd led to a 12-month improvement in median PFS vs Rd after first relapse (HR 0.713) and a 9-month improvement after 2 previous lines of therapy (HR 0.720). Treatment with KRd led to an approximate 8-month improvement vs Rd in median PFS in bortezomib-exposed patients (HR 0.699), a 15-month improvement in thalidomide-exposed patients (HR 0.587) and a 5-month improvement in lenalidomideexposed patients (HR 0.796). Objective response and complete response or better rates were higher with KRd vs Rd, irrespective of previous treatment. KRd had a favorable benefit-risk profile and should be considered an appropriate treatment option for patients with 1 or 2 previous lines of therapy and those previously exposed to bortezomib, thalidomide or lenalidomide. © The Author(s) 2017.
Συγγραφείς:
Dimopoulos, M.A.
Stewart, A.K.
Masszi, T.
Spicka, I.
Oriol, A.
Hájek, R.
Rosiñol, L.
Siegel, D.
Mihaylov, G.G.
Goranova-Marinova, V.
Rajnics, P.
Suvorov, A.
Niesvizky, R.
Jakubowiak, A.
San-Miguel, J.
Ludwig, H.
Ro, S.
Aggarwal, S.
Moreau, P.
Palumbo, A.
Λέξεις-κλειδιά:
carfilzomib; dexamethasone; lenalidomide; antineoplastic agent; carfilzomib; dexamethasone; lenalidomide; oligopeptide; thalidomide, acute kidney failure; adult; adverse drug reaction; aged; anemia; arthralgia; Article; asthenia; backache; bronchitis; cataract; comparative study; constipation; controlled study; coughing; decreased appetite; diarrhea; disease course; disease severity; dizziness; drug efficacy; dyspnea; edema; faintness; fatigue; fever; heart failure; human; hyperglycemia; hypertension; hypocalcemia; hypokalemia; hypophosphatemia; insomnia; ischemic heart disease; leukopenia; lung embolism; lymphocytopenia; multiple myeloma; muscle spasm; nausea; neutropenia; open study; overall survival; pain; phase 3 clinical trial; pneumonia; progression free survival; quality of life; randomized controlled trial; rash; refractory multiple myeloma; relapse; relapsed multiple myeloma; respiratory tract infection; rhinopharyngitis; thrombocytopenia; treatment duration; treatment response; upper respiratory tract infection; very elderly; vomiting; analogs and derivatives; clinical trial; disease free survival; female; male; middle aged; multiple myeloma; pathology; treatment outcome; tumor recurrence, Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disease-Free Survival; Female; Humans; Male; Middle Aged; Multiple Myeloma; Neoplasm Recurrence, Local; Oligopeptides; Thalidomide; Treatment Outcome
