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( Philippe Rodon ),( Brigitte Pegourie ),( Laurent Garderet ),( Philippe Casassus ),( Olivier Decaux ),( Murielle Roussel ),( Carine Chaleteix ),( Bruno Royer ),( Mourad Tiab ),( Xavier Leleu ),( Clai 대한내과학회 2014 대한내과학회 추계학술대회 Vol.2014 No.1
Background: Although infection is a major complication of multiple myeloma (MM), there are few data on its incidence, presentation and outcome. We reviewed severe infections occurring in the IFM 2009 01 protocol. Methods: The IFM 2009 01 protocol evaluated a combination of bendamustine, bortezomib and dexamethasone (BVD) in the treatment of elderly patients (65 years or more) with a relapsed or refractory (RR) MM (Rodon P. et al, Blood 2013;122:1971A). Patients did not receive any prophylactic antibiotics. All adverse events were collected and graded prospectively. We report here an analysis of the episodes of severe infection (grade 3 or more). Results: Seventy-three patients were included. The median age was 75.8 years (range 66-86). Twenty episodes of grade 3 or more infection occurred in 17 patients (23.2%): lung and respiratory tract infection 13 episodes, bloodstream infection 6 episodes and pyelonephritis 1 episode, respectively. Fourteen episodes were diagnosed in the early phase of therapy (within the 4 fi rst BVD cycles). Only 1 severe infection underwent during a chemotherapy-induced neutropenic phase (absolute neutrophil count < 1000/mm3). fifteen episodes occurred among 34 patients older than 75 years versus 5 episodes in 39 younger patients (p=0.0028). Sepsis was responsible of death in 4 of these 17 patients (23.5%), all occurring in the early phase. Conclusions: Infection was a major severe adverse event in elderly patients treated for RRMM in the IFM 2009 01 protocol, occurring in approximately one quarter of the patients. Its incidence was signifi cantly higher in patients older than 75 years. Severe episodes of infection mainly occurred in the early phase of treatment. Mortality rate was high. These fi ndings suggest that a systematic prophylactic use of antibiotics may be needed in this population of patients.
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>