changes in renal function. Proteinuria was reversible after withdrawal of the drug and was reproducible at reexposure. The extent of proteinuria was dose dependent. Renal biopsy revealed a (possibly pre-existing) minimal change glomerulonephritis. Uncovering of an underlying autoimmune defect by IFN seems an unlikely pathoetiologic mechanism, causing the observed renal functional impairment, since autoantibodies (ANA, autoantibodies against double-stranded DNA, RF, and ASL titer as well as CRP) were negative. Hyperuricemia as a causative agent was excluded, since serum uric acid levels were normal throughout the treatment period.We conclude that IFN exhibits in rare instances a severe renal toxicity that may range from isolated proteinuria (as in our patient) to acute anuric renal failure [2]. Close monitoring of renal function during IFN therapy is warranted.REFERENCES I. . 3. 4. .~ ~ ~~. Quesada JR, Talpaz M, RiosA, Kurzrock R, Gutterman JU: Clinical toxicity of interfcrons in cancer patients: A review. J Clin Oncol4:234-243, 1986. Ault BH, Stapleton FB, Gaber L, Martin A, Roy S 111, Murphy SB: Acute renal failure during therapy with recombinant human gamma interferon. N Engl J Med 3 19: 1397-14O0, 1988. Avcrbuch SD, Austin HA 111, Shenvin SA, Antonovych T, Bunn PA Jr, Longo DL: Acute interstitial nephritis with the nephrotic syndrome following recombinant leukocyte A interferon therapy for mycosis fungoides. N Engl J Med 310:32-35, 1984. Nair S, Emstoff MS, Bahnson RR, Arthur S, Johnston J, Downs MA, Neuhart I, Kirkwood KM: Interferon-induced reversible acute renal failure with nephrotic syndrome. Urology 29 16P-172, 1992. Selby P, Kohn J, Raymond J, Judson I, McElwain T: Ncphrotic syndrome during treatment with interferon. BMJ 290:1180, 1985.
Introduction Although a large variety of conditioning regimens are used in autologous hematopoietic stem cell transplantation (autoSCT), including the widely used BEAM (carmustine, etoposide, cytarabine, melphalan), there is no consensus regarding a standard approach. In the context of a carmustine shortage, we replaced it with thiotepa. However, clinical data on the TEAM (thiotepa, etoposide, cytarabine, melphalan) conditioning regimen are sparse and only retrospective. Thus, we designed a multicenter prospective study (NCT02504190) to assess the efficacy and toxicity of a TEAM conditioning regimen. Patients and methods The TEAM regimen consisted of a total dose of thiotepa of 8 mg/kg on day -6; etoposide 100 mg/m2/12h and cytarabine 200 mg/m2/12h (day -5 to -2); melphalan 200 mg/m2 on day-1. Inclusion criteria were the following: age between 18 and 65 years, biopsy-proven Hodgkin or non-Hodgkin lymphoma, HIV seronegative, and first autoSCT. Results Seventy-four male and eighteen female patients with a median age of 53 years (range, 19-65) were included. Karnofsky score was <90% in 17 patients (18%). Lymphoma diagnoses comprised diffuse large B cell (n=48), mantle cell (n=8), follicular (n=12), Hodgkin (n=14), peripheral T-cell (n=9) and miscellaneous (n=4). Advanced stage disease (Ann Arbor stage III-IV) was noted in 83 patients (90%). Disease status at time of autoSCT was complete response (CR) in 69 patients (75%), partial response in 22 (24%), including 12 patients who never reached CR, and progressive disease in 1 (1%). Median number CD34+ cells infused in the graft were 4.6x10e6/kg (range, 1.39-12.7). Median time to neutrophil recovery was 12 days (range, 9-48) and to platelet recovery >20 G/L was 13 days (range, 7-197). The most significant regimen-related toxicities were mucositis in 100% of patients (median grade=3, range, 1-4) and diarrhea in 98% of patients (median grade=1, range, 0-3). Other non-hematologic grade 3 adverse events occurred in 17 patients (18%). Blood cultures were positive for Staphyloccocus sp. in 27% patents, other Gram- positive bacteria in 5% and Gram negative in 6%. Central line-associated bloodstream infection occurred in 22 patients (24%). Invasive fungal infection occurred in 3 patients. Four patients required transfer to the intensive care unit. The median length of stay in hospital was 27 days (range, 16-62). At day+100, 89 patients were evaluable for response and all were in CR. Deaths directly attributed to disease progression or relapse occurred in 5 patients. After a median follow-up of 31 months (range, 15-48), the non-relapse mortality (NRM) was 3.3%. Two patients died of infection during aplasia and one patient died 67 days after autoSCT of necrotizing fasciitis. At last follow-up, 17 patients (19%) relapsed, 9 died and 83 were alive. The estimated 3-year overall survival (OS) and progression-free survival (PFS) were 90.2% and 77.2%, respectively. In patients with double expressor diffuse large B-cell lymphoma (n=15), the estimated 3-year OS and PFS were 93% and 73%, respectively. None of the 31 patients with intermediate or high-risk CNS international prognostic index experienced CNS relapse. Conclusion The TEAM conditioning regimen is a safe and valid platform in autoSCT for patients with high-risk or relapsed/refractory lymphoma. Although mucositis and diarrhea were frequent, the NRM was similar to that reported for BEAM conditioning. Most notably, no CNS relapse occurred in patients at intermediate or high-risk of CNS relapse. Disclosures Duléry: Keocyt: Honoraria. Choquet:Keocyt: Honoraria. Di Blasi:Novartis: Honoraria. Malard:Therakos/Mallinckrodt: Honoraria; Janssen: Honoraria; Keocyte: Honoraria; Sanofi: Honoraria; JAZZ pharmaceutical: Honoraria; Astellas: Honoraria. Coppo:Ablynx/Sanofi: Consultancy; Shire: Consultancy; Alexion: Consultancy. Mohty:Jazz Pharmaceuticals: Honoraria, Research Funding.
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