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- Title
Risk factors for, and reversibility of, peripheral neuropathy associated with bortezomib-melphalan-prednisone in newly diagnosed patients with multiple myeloma: subanalysis of the phase 3 VISTA study.
- Authors
Dimopoulos, Meletios A.; Mateos, Maria-Victoria; Richardson, Paul G.; Schlag, Rudolf; Khuageva, Nuriet K.; Shpilberg, Ofer; Kropff, Martin; Spicka, Ivan; Palumbo, Antonio; Wu, Ka Lung; Esseltine, Dixie-Lee; Liu, Kevin; Deraedt, William; Cakana, Andrew; Van De Velde, Helgi; San Miguel, Jesús F.
- Abstract
This subanalysis of the phase 3 VISTA trial aimed to assess the frequency, characteristics and reversibility of, and prognostic factors for, bortezomib-associated peripheral neuropathy (PN) in newly diagnosed patients with multiple myeloma ineligible for high-dose therapy who received bortezomib plus melphalan-prednisone. Patients received nine 6-wk cycles of VMP (bortezomib 1.3 mg/m, days 1, 4, 8, 11, 22, 25, 29, 32, cycles 1-4, and days 1, 8, 22, 29, cycles 5-9; melphalan 9 mg/m, days 1-4, cycles 1-9; and prednisone 60 mg/m, days 1-4, cycles 1-9). Overall, 47% of patients receiving VMP developed PN, including 19% grade 2 and 13% grade ≥3 (<1% grade 4). The PN incidence was dose-related and reached a plateau at a cumulative bortezomib dose of approximately 45 mg/m. Median time to PN onset was 2.3 months. Bortezomib-associated PN was reversible; 79% of events improved by at least one NCI CTCAE grade within a median of 1.9 months and 60% completely resolved within a median of 5.7 months, with reversibility similar in responding and non-responding patients. By multivariate analysis, baseline neuropathy was the only consistent risk factor for any PN [hazard ratio (HR) 1.785, P = 0.0065], grade ≥2 PN (HR 2.205, P = 0.0032), and grade ≥3 PN (HR 2.438, P = 0.023); age, pre-existing diabetes, International Staging System stage, obesity, and creatinine clearance did not affect the overall rate of PN. Rates of bortezomib-induced PN in the frontline setting were similar to those in relapsed patients and resolved in most cases. (Clinicaltrials.gov identifier: NCT00111319).
- Subjects
NEUROPATHY; PREDNISONE; MULTIPLE myeloma; POEMS syndrome; PLASMACYTOMA; CREATININE; MULTIVARIATE analysis; PATIENTS; DISEASE risk factors
- Publication
European Journal of Haematology, 2011, Vol 86, Issue 1, p23
- ISSN
0902-4441
- Publication type
Article
- DOI
10.1111/j.1600-0609.2010.01533.x