"Thalidomide/dex is a very good treatment, but one needs to use it carefully in elderly patients."
Dr. Heinz Ludwig
To view the video full screen, click on the small button next to the volume control in the lower right hand corner. Thalidomide-Dexamethasone vs. Melphalan-Prednisone as First Line Treatment and Thalidomide-Interferon vs. Interferon Maintenance Therapy in Elderly Patients with Multiple Myeloma. Session Type: Oral Session
Heinz Ludwig, Elena Tothova, Roman Hajek, Johannes Drach, Zdenek Adam, Boris Labar, Miklós Egyed, Ivan Spicka, Heinz Gisslinger, Ingrid Kuhn, Axel Hinke Dep Med I, Wilhelminenspital, Vienna, Austria; Univ PJS Hosp, Kosice, Slovakia (Slovak Republic); Dep Hemato-Oncology, Univ Hosp, Brno, Czech Republic; Dep Int Med I, Univ Hosp, Vienna, Austria; Clin Hosp Rebro, Zagreb, Croatia; Dep Int Med, Kaposi Mr County Hosp, Kaposvr, Hungary; Dep Int Med I, Charles University, Praha, Czech Republic; Schering-Plough, Traiskirchen, Austria; Wissenschaftlicher Service, Langenfeld, Germany
Thalidomide-Dexamethasone (TD) is an active regimen both in patients (pts) with relapsing/refractory and in untreated pts with multiple myeloma (MM). Here we compare TD with standard Melphalan-Prednisone (MP) in previously untreated elderly pts with MM. 274 pts have been enrolled (median age: 72 yrs, stage I: 9 (3%), stage II: 84 (31%), stage III: 179 (65%). Pts were randomized to T 200mg/day and D 40mg, days 1-4 and 15-18 (on odd cycles) and days 1-4 (on even cycles) or M 0.25mg/kg days 1-4 and P 2mg/kg days 1-4, q 4-6 weeks. T should be dosed up to 400mg/day, if feasible. Pts achieving response or SD were randomized to maintenance therapy either with T (200mg/day)-Interferon-a2b (IFN, 3Mega U, TIW) or IFN (3Mega U/TIW). Zoledronic acid (4mg) was administered monthly to all pts during the entire treatment period. Response is defined according Blades criteria, plus nCR defined as IF positive or >90% in PP and VGPR defined as >75% reduction in PP. 231 pts are evaluable per protocol. Best response to TD: CR (14%) nCR 17%, VGPR 17%, PR 21%, yielding an ORR (CR-PR) of 68%. Best response to MP: CR 7%, nCR 8%, VGPR 14%, PR 22%; ORR 51% (ORR in TD vs. MP p=.0044). Time to response and time to best response were shorter in the TD (6, 16 weeks, respectively) compared to the MP group (16, 25 weeks, respectively; p<.001, p<.002, respectively).There was a tendency for more early treatment discontinuations in the TD arm (15 vs. 11, p=.416) and a higher mortality during the first treatment year (31 vs. 17, p=.026). Pts treated with MP showed a tendency for longer EFS (median: 43 vs. 25mos; p<.07) and had sign. longer OS compared to those on TD (median: 58 vs. 45mos;p=.029). A retrospective comparison of pts aged 72 showed no difference in OS (median: 57.9 vs. 50 mos, p<.186) but OS was longer in pts >72 yrs treated with MP (median: 46.5.9 vs. 25.4, p<.0625). Maintenance treatment in the 108 pts randomized to either T-IFN, or IFN only, did not result in a sign. difference in OS (from start of maintenance: not reached vs. 41.1 mos, p<.95). Pts on MP had a higher incidence of G 3-4 leucopenia (14% vs. 3%; p< .0001), while for thrombocytopenia only a tendency for a higher frequency was noted. Pts on TD had more G 2-3 neuropathy (28% vs. 10%, p<.001), constipation (30% vs. 10%, p<.001), psychological toxicity (18% vs. 6%, p<.0006), and a tendency for a higher rate of skin toxicity (9% vs. 5%, p=.069), and infections (23% vs. 16%, p<.12) compared to those on MP. The cumulative incidence of DVTs was 15% in pts on TD and 6% in those on MP (p=.089). In conclusion, TD treatment resulted in sign. higher rate of CR/nCR and ORR, a sign. shorter time to response and to best response. Pts on TD had similar EFS but sign. shorter OS. This was particularly true in pts aged >72 years but not in those aged 72 who showed similar OS with TD and MP. Pts on TD had more neuropathy, DVT, psychological toxicity, and a higher rate of early treatment discontinuations, while haematological toxicity was higher in pts treated with MP.
Abstract #529 appears in Blood, Volume 110, issue 11, November 16, 2007
Keywords: Venous Thromboembolism|Regimen|Remission
Disclosure: Research Funding: Schering-Plough, Janssen-Cilag. Honoraria Information: Janssen-Cilag, Roche, Amgen, Celgene.
Monday, December 10, 2007 1:30 PM
Session Info: Simultaneous Session: Myeloma: Maintenance, Consolidation, and Bone Disease in Multiple Myeloma (1:30 p.m.-3:00 p.m.)