PMID- 12203106 OWN - NLM STAT- MEDLINE DCOM- 20021017 LR - 20151119 IS - 0344-5704 (Print) IS - 0344-5704 (Linking) VI - 50 IP - 3 DP - 2002 Sep TI - Recombinant human soluble tumor necrosis factor (TNF) receptor (p75) fusion protein Enbrel in patients with refractory hematologic malignancies. PG - 237-42 AB - PURPOSE: Tumor necrosis factor-alpha (TNF-alpha) is an important effector and regulatory cytokine involved in the pathophysiology of hematologic malignancies, including hairy cell leukemia (HCL), chronic lymphocytic leukemia (CLL), agnogenic myeloid metaplasia (AMM) and Philadelphia-negative myeloproliferative disorders (MPD). We conducted a pilot study to assess the safety of the soluble TNF receptor, etanercept (p75 TNFR:Fc; Enbrel) in patients with refractory hematologic malignancies. METHODS: Patients were eligible if they had refractory HCL, CLL, AMM, or Philadelphia-negative MPD. Enbrel was administered twice weekly at a dose of 25 mg subcutaneously for a minimum of eight doses, and was continued in patients without overt progression. RESULTS: Among the 26 patients enrolled on study, 25 patients were evaluable. Nine patients had AMM, eight CLL, three HCL, and five Philadelphia-negative MPD. Their median age was 60 years (range 30-83 years). A total of 70 courses consisting of 486 doses of Enbrel were administered. Enbrel was well tolerated, without any overt increase in infectious episodes. Stable disease/no objective response was seen in 22 patients (88%) and progression in 3 patients (12%). Three patients with AMM improved (two showed hematologic improvement, and one showed a reduction in liver and spleen size), and two patients (one with CLL and one with Philadelphia-negative MPD) showed improvement in disease-related symptoms. CONCLUSIONS: Enbrel was well tolerated, but no responses were noted in these immunosuppressed patients with refractory hematologic malignancies. FAU - Tsimberidou, Apostolia-Maria AU - Tsimberidou AM AD - Department of Leukemia, University of Texas M.D. Anderson Cancer Center, Houston, Texas, 77030, USA. FAU - Thomas, Deborah AU - Thomas D FAU - O'Brien, Susan AU - O'Brien S FAU - Andreeff, Michael AU - Andreeff M FAU - Kurzrock, Razelle AU - Kurzrock R FAU - Keating, Michael AU - Keating M FAU - Albitar, Maher AU - Albitar M FAU - Kantarjian, Hagop AU - Kantarjian H FAU - Giles, Francis AU - Giles F LA - eng PT - Clinical Trial PT - Journal Article DEP - 20020726 PL - Germany TA - Cancer Chemother Pharmacol JT - Cancer chemotherapy and pharmacology JID - 7806519 RN - 0 (Immunoglobulin G) RN - 0 (Immunologic Factors) RN - 0 (Receptors, Tumor Necrosis Factor) RN - OP401G7OJC (Etanercept) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Etanercept MH - Female MH - Hematologic Neoplasms/*drug therapy MH - Humans MH - Immunocompromised Host MH - Immunoglobulin G/administration & dosage/*pharmacology MH - Immunologic Factors/administration & dosage/pharmacokinetics/*pharmacology MH - Injections, Subcutaneous MH - Male MH - Middle Aged MH - Receptors, Tumor Necrosis Factor/administration & dosage MH - Treatment Outcome EDAT- 2002/08/31 10:00 MHDA- 2002/10/18 04:00 CRDT- 2002/08/31 10:00 PHST- 2002/02/12 00:00 [received] PHST- 2002/05/02 00:00 [accepted] PHST- 2002/08/31 10:00 [pubmed] PHST- 2002/10/18 04:00 [medline] PHST- 2002/08/31 10:00 [entrez] AID - 10.1007/s00280-002-0479-6 [doi] PST - ppublish SO - Cancer Chemother Pharmacol. 2002 Sep;50(3):237-42. doi: 10.1007/s00280-002-0479-6. Epub 2002 Jul 26.