title: Novel therapy in multiple myeloma.
abstract: Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a cut-off level < 65 years old) will be treated with chemotherapy and transplant procedures. However, most patients > 65 years old are not candidates for this therapeutic approach and the use of intensive chemotherapy could be associated to severe toxicity. We developed an new, not-cytotoxic regimen with dexamethasone 30 mg/m(2), iv, days 1 to 4, all trans retinoic acid 45 mg/m(2), po, days 5 to 14 and interferon alfa 2a 4.5 MU, sc, daily, days 5 to 14 (DAI regimen) administered every 28 days in number of 6 cycles, at this point patients were restaging, if they showed complete response, objective response or partial response they were conducted to received thalidomide 100-200 mg po, daily and dexamethasone 10 mg/2, po days 1 to 4 at monthly intervals, for 18 months. Forty one patients were enrolled in an Phase II study. In an intent to treat analysis all patients were evaluable. Complete response was observed in 18 cases (43%), objective response in 10 patients (24%) and partial response in 5 patients (12%), overall response rate was 80%. Eight patients were considered failures. At an median of 36 months, no relapse of progression disease has been observed, thus actuarial curves at 3-years showed that event free survival is 100% and overall survival is 91%. Toxicity was mild, all patients received the planned dose in time. This regimen appear to be useful in older patients with multiple myeloma, the response rate is higher and toxicity was mild. Controlled clinical trials comparing with conventional chemotherapy will be conducted to define the role of this therapeutic approach.
authors.affiliation: Oncology Research Unit, Department of Hematology, Oncology Hospital, National Medical Center, IMSS, México, D.F. Mexico. agaviles@avantel.net
authors.forename: Agustin
authors.initials: A
authors.lastname: Avilés
authors.forename: Natividad
authors.initials: N
authors.lastname: Neri
authors.forename: M Jesús
authors.initials: MJ
authors.lastname: Nambo
authors.forename: Sergio
authors.initials: S
authors.lastname: Cleto
authors.forename: Claudia
authors.initials: C
authors.lastname: Castañeda
authors.forename: Martha
authors.initials: M
authors.lastname: González
authors.forename: Alejandra
authors.initials: A
authors.lastname: Talavera
authors.forename: Judith
authors.initials: J
authors.lastname: Huerta-Guzmán
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000532:radiotherapy; D011994:Recombinant Proteins; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D013792:Thalidomide; D014212:Tretinoin; D003907:Dexamethasone