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A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7
Author(s) -
Shustik Chaim,
Belch Andrew,
Robinson Sue,
Rubin Sheldon H.,
Dolan Sean P.,
Kovacs Michael J.,
Grewal Kuljit S.,
Walde David,
Barr Robert,
Wilson Jonathan,
Gill Kulwant,
Vickars Linda,
Rudinskas Leona,
Sicheri Dolores A.,
Wilson Kenneth,
Djurfeldt Marina,
Shepherd Lois E.,
Ding Keyue,
Meyer Ralph M.
Publication year - 2007
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.1365-2141.2006.06405.x
Subject(s) - dexamethasone , medicine , prednisone , melphalan , induction therapy , multiple myeloma , oncology , maintenance therapy , chemotherapy
Summary The effectiveness of melphalan plus dexamethasone (M‐Dex) with melphalan plus prednisone (MP) as induction therapy and dexamethasone with observation as maintenance therapy was compared in 585 older patients with multiple myeloma. Randomization to the M‐Dex arm was stopped as a result of an analysis performed which met a predetermined event‐related criterion. Of 466 patients randomised to MP or M‐Dex, no differences were detected in the respective median progression‐free survivals (PFS) [1·8 vs. 1·9 years; Hazard Ratio (HR) = 0·88, 95% CI 0·72–1·07; P = 0·2] or overall survivals (OS) (2·5 vs. 2·7 years; HR = 0·91, 95% CI 0·74–1·11; P = 0·3). Of the initial 585 patients, 292 remained evaluable for maintenance therapy. Patients randomised to maintenance dexamethasone had a superior median PFS (2·8 years vs. 2·1 years; HR = 0·61, 95% CI 0·47–0·79; P = 0·0002). No difference in median OS was detected (4·1 years vs. 3·8 years; HR = 0·88, 95% CI 0·65–1·18; P = 0·4). The maintenance therapy results were robust when analysed by using two additional methodologies. Dexamethasone did not improve clinical outcome when combined with melphalan during induction; maintenance dexamethasone improved PFS, but this did not translate into a detectable survival advantage.