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Continuous prednisolone versus conventional prednisolone with VMCP–interferon‐ α 2b as first‐line chemotherapy in elderly patients with multiple myeloma
Author(s) -
Ludwig Heinz,
Spicka Ivan,
Klener Pavel,
Greil Richard,
Adam Zdenek,
Gisslinger Heinz,
Tarkovács Gábor,
Linkesch Werner,
Maniatis Alice,
Morant Rudolf,
Drach Johannes,
Kuhn Ingrid,
Schuster Judith,
Hinke Axel
Publication year - 2005
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2005.05779.x
Subject(s) - prednisolone , medicine , hazard ratio , vincristine , cyclophosphamide , melphalan , gastroenterology , surgery , chemotherapy , confidence interval
Summary 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‐ α 2b (IFN‐ α 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‐ α 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 β 2‐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‐ α 2b did not improve outcome.