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RISS 인기검색어
- 검색키워드
- 저자 : Cavo, M (검색결과 3 건)
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Facon, Thierry,Dimopoulos, Meletios A.,Dispenzieri, Angela,Catalano, John V.,Belch, Andrew,Cavo, Michele,Pinto, Antonello,Weisel, Katja,Ludwig, Heinz,Bahlis, Nizar J.,Banos, Anne,Tiab, Mourad,Delforge American Society of Hematology 2018 Blood Vol.131 No.3
<P>This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified >= 60 months' follow-up). Patientswere randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.59-0.79; P < .00001) andwas similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.67-0.92; P = .0023), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had an approximate to 30-month longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vsMPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM.</P>
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Kumar, S K,Dimopoulos, M A,Kastritis, E,Terpos, E,Nahi, H,Goldschmidt, H,Hillengass, J,Leleu, X,Beksac, M,Alsina, M,Oriol, A,Cavo, M,Ocio, E M,Mateos, M V,O'Donnell, E K,Vij, R,Lokhorst, H M,van de Do Macmillan Publishers Limited, part of Springer Nat 2017 Leukemia Vol.31 No.11
<P>Introduction of new myeloma therapies offers new options for patients refractory to immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). In this multicenter study, patients with relapsed multiple myeloma, who have received at least three prior lines of therapy, are refractory to both an IMiD (lenalidomide or pomalidomide) and a PI (bortezomib or carfilzomib), and have been exposed to an alkylating agent were identified. The time patients met the above criteria was defined as time zero (T-0). Five hundred and forty-three patients diagnosed between 2006 and 2014 were enrolled in this study. Median age at T-0 was 62 years (range 31-87); 61% were males. The median duration between diagnosis and T-0 was 3.1 years. The median number of lines of therapy before T-0 was 4 (range 3-13). The median overall survival (OS) from T-0 for the entire cohort was 13 (95% confidence interval (CI) 11, 15) months. At least one regimen recorded after T-0 in 462 (85%) patients, with a median (95% CI) progression-free survival and OS from T-0 of 5 (4, 6), and 15.2 (13, 17) months, respectively. The study provides the expected outcome of relapsed multiple myeloma that is refractory to a PI and an IMiD, a benchmark for comparison of new therapies being evaluated.</P>
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Spencer, Andrew,Lentzsch, Suzanne,Weisel, Katja,Avet-Loiseau, Hervé,Mark, Tomer M.,Spicka, Ivan,Masszi, Tamas,Lauri, Birgitta,Levin, Mark-David,Bosi, Alberto,Hungria, Vania,Cavo, Michele,Lee, Je Ferrata Storti Foundation 2018 Haematologica/The Hematology Journal Vol.103 No.12
<P>Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone <I>versus</I> bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A <I>post hoc</I> analysis based on treatment history and longer follow up is presented. After 19.4 (range: 0–27.7) months of median follow up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 <I>versus</I> 7.1 months; hazard ratio, 0.31; 95% confidence interval, 0.24-0.39; <I>P</I><0.0001) and improved the overall response rate (83.8% <I>versus</I> 63.2%; <I>P</I><0.0001) compared with bortezomib and dexamethasone alone. The progression-free survival benefit of daratumumab plus bortezomib and dexamethasone was most apparent in patients with 1 prior line of therapy (median: not reached <I>versus</I> 7.9 months; hazard ratio, 0.19; 95% confidence interval, 0.12-0.29; <I>P</I><0.0001). Daratumumab plus bortezomib and dexamethasone was also superior to bortezomib and dexamethasone alone in subgroups based on prior treatment exposure (bortezomib, thalidomide, or lenalidomide), lenalidomide-refractory status, time since last therapy (≤12, >12, ≤6, or >6 months), or cytogenetic risk. Minimal residual disease–negative rates were >2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse. Trial registration: <I>clinicaltrials.gov identifier: 02136134</I>.</P>
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