학술논문
Bortezomib before and after autologous stem cell transplantation overcomes the negative prognostic impact of renal impairment in newly diagnosed multiple myeloma: a subgroup analysis from the HOVON-65/GMMG-HD4 trial
Document Type
article
Author
Christof Scheid; Pieter Sonneveld; Ingo G.H. Schmidt-Wolf; Bronno van der Holt; Laila el Jarari; Uta Bertsch; Hans Salwender; Sonja Zweegman; Igor Wolfgang Blau; Edo Vellenga; Katja Weisel; Michael Pfreundschuh; Kon-Siong Jie; Kai Neben; Helgi van de Velde; Ulrich Duehrsen; M. Ron Schaafsma; Walter Lindemann; Marie José Kersten; Norma Peter; Mathias Hänel; Sandra Croockewit; Hans Martin; Shulamiet Wittebol; Gerard MJ Bos; Marinus van Marwijk-Kooy; Pierre Wijermans; Hartmut Goldschmidt; Henk M. Lokhorst
Source
Haematologica, Vol 99, Iss 1 (2014)
Subject
Language
English
ISSN
0390-6078
1592-8721
1592-8721
Abstract
Renal impairment is frequent in patients with multiple myeloma and is correlated with an inferior prognosis. This analysis evaluates the prognostic role of renal impairment in patients with myeloma treated with bortezomib before and after autologous stem cell transplantation within a prospective randomized phase III trial. Eight hundred and twenty-seven newly diagnosed myeloma patients in the HOVON-65/GMMG-HD4 trial were randomized to receive three cycles of vincristine, adriamycin, dexamethasone (VAD) or bortezomib, adriamycin, dexamethasone (PAD) followed by autologous stem cell transplantation and maintenance with thalidomide 50 mg daily (VAD-arm) or bortezomib 1.3 mg/m2 every 2 weeks (PAD-arm). Baseline serum creatinine was less than 2 mg/dL (Durie-Salmon-stage A) in 746 patients and 2 mg/dL or higher (stage B) in 81. In myeloma patients with a baseline creatinine ≥2 mg/dL the renal response rate was 63% in the VAD-arm and 81% in the PAD-arm (P=0.31). The overall myeloma response rate was 64% in the VAD-arm versus 89% in the PAD-arm with 13% complete responses in the VAD-arm versus 36% in the PAD-arm (P=0.01). Overall survival at 3 years for patients with a baseline creatinine ≥2 mg/dL was 34% in the VAD-arm versus 74% in the PAD-arm (P