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
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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. / Scheid, Christof; Sonneveld, Pieter; Schmidt-Wolf, Ingo G H; van der Holt, Bronno; el Jarari, Laila; Bertsch, Uta; Salwender, Hans; Zweegman, Sonja; Blau, Igor Wolfgang; Vellenga, Edo; Weisel, Katja; Pfreundschuh, Michael; Jie, Kon-Siong; Neben, Kai; van de Velde, Helgi; Duehrsen, Ulrich; Schaafsma, M Ron; Lindemann, Walter; Kersten, Marie José; Peter, Norma; Hänel, Mathias; Croockewit, Sandra; Martin, Hans; Wittebol, Shulamiet; Bos, Gerard Mj; van Marwijk-Kooy, Marinus; Wijermans, Pierre; Goldschmidt, Hartmut; Lokhorst, Henk M.
In: HAEMATOLOGICA, Vol. 99, No. 1, 01.2014, p. 148-54.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - 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
AU - Scheid, Christof
AU - Sonneveld, Pieter
AU - Schmidt-Wolf, Ingo G H
AU - van der Holt, Bronno
AU - el Jarari, Laila
AU - Bertsch, Uta
AU - Salwender, Hans
AU - Zweegman, Sonja
AU - Blau, Igor Wolfgang
AU - Vellenga, Edo
AU - Weisel, Katja
AU - Pfreundschuh, Michael
AU - Jie, Kon-Siong
AU - Neben, Kai
AU - van de Velde, Helgi
AU - Duehrsen, Ulrich
AU - Schaafsma, M Ron
AU - Lindemann, Walter
AU - Kersten, Marie José
AU - Peter, Norma
AU - Hänel, Mathias
AU - Croockewit, Sandra
AU - Martin, Hans
AU - Wittebol, Shulamiet
AU - Bos, Gerard Mj
AU - van Marwijk-Kooy, Marinus
AU - Wijermans, Pierre
AU - Goldschmidt, Hartmut
AU - Lokhorst, Henk M
PY - 2014/1
Y1 - 2014/1
N2 - 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/m(2) 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<0.001) with a progression-free survival rate at 3 years of 16% in the VAD-arm versus 48% in the PAD-arm (P=0.004). Overall and progression-free survival rates in the PAD-arm were similar in patients with a baseline creatinine ≥ 2 mg/dL or <2 mg/dL. We conclude that a bortezomib-containing treatment before and after autologous stem cell transplantation overcomes the negative prognostic impact of renal impairment in patients with newly diagnosed multiple myeloma. The trial was registered at www.trialregister.nl as NTR213 and at www.controlled-trials.com as ISRCTN 64455289.
AB - 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/m(2) 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<0.001) with a progression-free survival rate at 3 years of 16% in the VAD-arm versus 48% in the PAD-arm (P=0.004). Overall and progression-free survival rates in the PAD-arm were similar in patients with a baseline creatinine ≥ 2 mg/dL or <2 mg/dL. We conclude that a bortezomib-containing treatment before and after autologous stem cell transplantation overcomes the negative prognostic impact of renal impairment in patients with newly diagnosed multiple myeloma. The trial was registered at www.trialregister.nl as NTR213 and at www.controlled-trials.com as ISRCTN 64455289.
KW - Adult
KW - Aged
KW - Antineoplastic Agents
KW - Boronic Acids
KW - Bortezomib
KW - Creatinine
KW - Hematopoietic Stem Cell Transplantation
KW - Humans
KW - Middle Aged
KW - Multiple Myeloma
KW - Pyrazines
KW - Remission Induction
KW - Renal Insufficiency
KW - Transplantation, Autologous
KW - Treatment Outcome
KW - Clinical Trial, Phase III
KW - Journal Article
KW - Randomized Controlled Trial
KW - Research Support, Non-U.S. Gov't
U2 - 10.3324/haematol.2013.087585
DO - 10.3324/haematol.2013.087585
M3 - SCORING: Journal article
C2 - 23996482
VL - 99
SP - 148
EP - 154
JO - HAEMATOLOGICA
JF - HAEMATOLOGICA
SN - 0390-6078
IS - 1
ER -