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Safety and efficacy of bortezomib‐based regimens for multiple myeloma patients with renal impairment: a retrospective study of Italian Myeloma Network GIMEMA
Author(s) -
Morabito Fortunato,
Gentile Massimo,
Ciolli Stefania,
Petrucci Maria T.,
Galimberti Sara,
Mele Giuseppe,
Casulli Antonio F.,
Mannina Donato,
Piro Eugenio,
Pinotti Graziella,
Palmieri Salvatore,
Catalano Lucio,
Callea Vincenzo,
Offidani Massimo,
Musto Pellegrino,
Bringhen Sara,
Baldini Luca,
Tosi Patrizia,
Di Raimondo Francesco,
Boccadoro Mario,
Palumbo Antonio,
Cavo Michele
Publication year - 2010
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/j.1600-0609.2009.01385.x
Subject(s) - bortezomib , discontinuation , medicine , multiple myeloma , retrospective cohort study , dialysis , toxicity , surgery , complication , gastroenterology
Renal impairment (RI) is a severe complication throughout the course of multiple myeloma (MM). Bortezomib has been shown to be highly active in MM patients with RI. We designed this retrospective analysis to investigate the safety and efficacy of bortezomib‐based therapy in 117 MM patients with RI, 14 cases required dialysis. A total of 603 cycles of bortezomib were administered (median number, five cycles/patient). Ten patients required early discontinuation of bortezomib because of WHO grade IV toxicity. The rate of bortezomib discontinuation in cases with severe, moderate and mild RI was 11%, 5% and 0%, respectively ( P = NS). Overall, 91 episodes of WHO grade III/IV toxicity were observed. At least a partial response was documented in 83/113 evaluable patients (73%), including complete response (19%) and near complete response (8%). The overall response rate was similar across RI subgroups. Reversal of RI was documented in 41% of patients after a median of 2.3 months (range 0.4–7.9). In three of 14 patients on dialysis, renal replacement therapy was discontinued after 1, 1 and 4 months. The 2‐yr estimate of response duration and overall survival was 70% and 51%, respectively. In conclusion, bortezomib‐based regimens are safe and effective and should be considered as appropriate treatment options for MM patients with any degree of RI.