Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma
Francesca Gay, S Vincent Rajkumar, Morton Coleman, Shaji Kumar, Tomer Mark, Angela Dispenzieri, Roger Pearse, Morie A Gertz, John Leonard, Martha Q Lacy, Selina Chen-Kiang, Vivek Roy, David S Jayabalan, John A Lust, Thomas E Witzig, Rafael Fonseca, Robert A Kyle, Philip R Greipp, A Keith Stewart, Ruben Niesvizky, Francesca Gay, S Vincent Rajkumar, Morton Coleman, Shaji Kumar, Tomer Mark, Angela Dispenzieri, Roger Pearse, Morie A Gertz, John Leonard, Martha Q Lacy, Selina Chen-Kiang, Vivek Roy, David S Jayabalan, John A Lust, Thomas E Witzig, Rafael Fonseca, Robert A Kyle, Philip R Greipp, A Keith Stewart, Ruben Niesvizky
Abstract
The objective of this case-matched study was to compare the efficacy and toxicity of the addition of clarithromycin (Biaxin) to lenalidomide/low-dose dexamethasone (BiRd) vs. lenalidomide/low-dose dexamethasone (Rd) for newly diagnosed myeloma. Data from 72 patients treated at the New York Presbyterian Hospital-Cornell Medical Center were retrospectively compared with an equal number of matched pair mates selected among patients seen at the Mayo Clinic who received Rd. Case matching was blinded and was performed according to age, gender, and transplant status. On intention-to-treat analysis, complete response (45.8% vs. 13.9%, P < 0.001) and very-good-partial-response or better (73.6% vs. 33.3%, P < 0.001) were significantly higher with BiRd. Time-to-progression (median 48.3 vs. 27.5 months, P = 0.071), and progression-free survival (median 48.3 vs. 27.5 months, P = 0.044) were higher with BiRd. There was a trend toward better OS with BiRd (3-year OS: 89.7% vs. 73.0%, P = 0.170). Main grade 3-4 toxicities of BiRd were hematological, in particular thrombocytopenia (23.6% vs. 8.3%, P = 0.012). Infections (16.7% vs. 9.7%, P = 0.218) and dermatological toxicity (12.5% vs. 4.2%, P = 0.129) were higher with Rd. Results of this case-matched analysis suggest that there is significant additive value when clarithromycin is added to Rd. Randomized phase III trials are needed to confirm these results.
Conflict of interest statement
Conflict of Interest Disclosures: F.G. has received honoraria from Celgene. M.A.G has received honoraria from Celgene, Millenium, Genzyme and Amgen. S.K. has a consultant/advisory relationship and has received research support from Celgene. M.Q.L., A.D., T.E.W, have received research funding/grants from Celgene. T.M. has received research funding from Celgene and honoraria from Celgene and Millenium. J. L consultancy for celgene. R.F. consultancy for Celgene, Medtronic, Genzyme, Amgen, Bristol-Myers Squibb, Otsuka American Pharmaceutical. R.A.K. has received honoraria from Celgene. P.R.G., has received honoraria from Celgene and Amgen. A.K.S. has a consultant/advisory relationship with Celgene and Millenium and has received research funding from Millenium. R.N. has received honoraria from Celgene, Millenium and Onyx, has a consultant/advisory relation with Celgene, Millenium and Onyx and has received research funding from Celgene. The remaining authors declare no conflict of interest.
© 2010 Wiley-Liss, Inc.
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Source: PubMed