title: Continuous prednisolone versus conventional prednisolone with VMCP-interferon-alpha2b as first-line chemotherapy in elderly patients with multiple myeloma.
abstract: We report on a randomised trial that aimed to compare the efficacy of continued daily prednisolone treatment during the entire induction phase, with prednisolone given for 2 weeks of each cycle in combination with VMCP (vincristine, melphalan, cyclophosphamide, prednisolone)-interferon-alpha 2b (IFN-alpha 2b) treatment in 299 previously untreated elderly patients (median age: 67 years) with multiple myeloma. After completion of induction treatment patients were randomised to IFN-alpha 2b with or without prednisolone, thrice weekly. Response rate was 62% in the continuous and 60% in the control arm (intent to treat analysis, P=0.81). Progression-free survival [median: 20 months vs. 19 months; hazard ratio (HR): 0.99, 95% confidence interval (CI): 0.74-1.33, P=0.97] and overall survival (median: 34 months vs. 37 months; HR: 1.16, 95% CI: 0.85-1.59, P=0.35) were similar in both groups. Reduced performance status (Eastern Cooperative Oncology Group, grades 2-4) was the predominant risk factor for poor survival followed by age >65 years, high beta2-microglobulin, and impaired renal function. There was more grades 3-4 dyspnoea and cardiac impairment and grades 1-2 hyperglycaemia, but less nausea, emesis and anaemia in patients on continuous prednisolone therapy. In conclusion, continuing prednisolone treatment during the entire duration of the induction phase with VMCP-IFN-alpha 2b did not improve outcome.
authors.affiliation: Department of Medicine and Medical Oncology, Wilhelminenspital, Vienna, Austria. heinz.ludwig@weinkav.at
authors.forename: Heinz
authors.initials: H
authors.lastname: Ludwig
authors.forename: Ivan
authors.initials: I
authors.lastname: Spicka
authors.forename: Pavel
authors.initials: P
authors.lastname: Klener
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
authors.forename: Zdenek
authors.initials: Z
authors.lastname: Adam
authors.forename: Heinz
authors.initials: H
authors.lastname: Gisslinger
authors.forename: Gábor
authors.initials: G
authors.lastname: Tarkovács
authors.forename: Werner
authors.initials: W
authors.lastname: Linkesch
authors.forename: Alice
authors.initials: A
authors.lastname: Maniatis
authors.forename: Rudolf
authors.initials: R
authors.lastname: Morant
authors.forename: Johannes
authors.initials: J
authors.lastname: Drach
authors.forename: Ingrid
authors.initials: I
authors.lastname: Kuhn
authors.forename: Judith
authors.initials: J
authors.lastname: Schuster
authors.forename: Axel
authors.initials: A
authors.lastname: Hinke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011239:Prednisolone / Q000008:administration & dosage*; D011241:Prednisone / Q000008:administration & dosage; D011994:Recombinant Proteins; D016019:Survival Analysis; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D005938:Glucocorticoids; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D014750:Vincristine; D003520:Cyclophosphamide; D011239:Prednisolone; D008558:Melphalan; D011241:Prednisone