Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial
Por:
Puig, N, Hernandez, MT, Rosinol, L, Gonzalez, E, de Arriba, F, Oriol, A, Gonzalez-Calle, V, Escalante, F, de la Rubia, J, Gironella, M, Rios, R, Garcia-Sanchez, R, Arguinano, JM, Alegre, A, Martin, J, Gutierrez, NC, Calasanz, MJ, Martin, ML, Couto, MD, Casanova, M, Arnao, M, Perez-Persona, E, Garzon, S, Gonzalez, MS, Martin-Sanchez, G, Ocio, EM, Coleman, M, Encinas, C, Vale, AM, Teruel, AI, Cortes-Rodriguez, M, Paiva, B, Cedena, MT, San-Miguel, JF, Lahuerta, JJ, Blade, J, Niesvizky, R and Mateos, MV
Publicada:
21 may 2021
Ahead of Print:
21 may 2021
Resumen:
Although case-control analyses have suggested an additive value with the association of clarithromycin to continuous lenalidomide and dexamethasone (Rd), there are not phase III trials confirming these results. In this phase III trial, 286 patients with MM ineligible for ASCT received Rd with or without clarithromycin until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). With a median follow-up of 19 months (range, 0-54), no significant differences in the median PFS were observed between the two arms (C-Rd 23 months, Rd 29 months; HR 0.783, p = 0.14), despite a higher rate of complete response (CR) or better in the C-Rd group (22.6% vs 14.4%, p = 0.048). The most common G3-4 adverse events were neutropenia [12% vs 19%] and infections [30% vs 25%], similar between the two arms; however, the percentage of toxic deaths was higher in the C-Rd group (36/50 [72%] vs 22/40 [55%], p = 0.09). The addition of clarithromycin to Rd in untreated transplant ineligible MM patients does not improve PFS despite increasing the >= CR rate due to the higher number of toxic deaths in the C-Rd arm. Side effects related to overexposure to steroids due to its delayed clearance induced by clarithromycin in this elderly population could explain these results. The trial was registered in clinicaltrials.gov with the name GEM-CLARIDEX: Ld vs BiRd and with the following identifier NCT02575144. The full trial protocol can be accessed from ClinicalTrials.gov. This study received financial support from BMS/Celgene.
Filiaciones:
Puig, N:
Univ Salamanca HUSAL, Hematol Dept, IBSAL, IBMCC,USAL,CSIC,CIBERONC, Salamanca, Spain
Hernandez, MT:
Hosp Univ Canarias, Santa Cruz De Tenerife, Spain
Rosinol, L:
Hosp Clin Barcelona, Hematol Dept, IDIBAPS, Barcelona, Spain
Gonzalez, E:
Hosp Univ Cabuenes, Gijon, Spain
de Arriba, F:
Univ Murcia, Hosp Morales Meseguer, IMIB, Murcia, Spain
:
Hosp Badalona Germans Trias & Pujol, Inst Catala Oncol, Inst Josep Carreras, Barcelona, Spain
Gonzalez-Calle, V:
Univ Salamanca HUSAL, Hematol Dept, IBSAL, IBMCC,USAL,CSIC,CIBERONC, Salamanca, Spain
Escalante, F:
Hosp Univ Leon, Leon, Spain
de la Rubia, J:
Catholic Univ Valencia, Doctor Peset, Valencia, Spain
Hosp Doctor Peset, Valencia, Spain
Gironella, M:
Hosp Univ Vall PRIME Hebron, Barcelona, Spain
Rios, R:
Hosp Univ Virgen Nieves, Inst Invest Biosanitaria IBS GRANADA, Granada, Spain
Garcia-Sanchez, R:
Hosp Univ Virgen Victoria, Malaga, Spain
Arguinano, JM:
Complejo Hosp Navarra, Pamplona, Spain
Alegre, A:
Hosp Univ Princesa, Seville, Spain
Martin, J:
Hosp Univ Virgen Rocio, Seville, Spain
Gutierrez, NC:
Univ Salamanca HUSAL, Hematol Dept, IBSAL, IBMCC,USAL,CSIC,CIBERONC, Salamanca, Spain
Calasanz, MJ:
Clin Univ Navarra, CIBERONC, IDISNA, Pamplona, Spain
Martin, ML:
Hosp Univ 12 Octubre, CIBERONC, Inst Invest, Madrid, Spain
Couto, MD:
Hosp Univ Virgen Valme, Seville, Spain
Casanova, M:
Hosp Costa Sol Marbella, Hematol Dept, Marbella, Spain
Arnao, M:
Hosp Univ & Politecn La Fe, Hematol Dept, Valencia, Spain
Perez-Persona, E:
Bioaraba Hlth Res Inst, Oncohematol Res Grp, Alava Univ Hosp, Dept Hematol, Vitoria, Spain
Garzon, S:
Hosp SAS Jerez, Jerez de la Frontera, Spain
Gonzalez, MS:
Hosp Univ Santiago, Santiago De Compostela, Spain
Martin-Sanchez, G:
Hosp Univ Marques Valdecilla, Hematol Dept, Santander, Spain
Ocio, EM:
Univ Salamanca HUSAL, Hematol Dept, IBSAL, IBMCC,USAL,CSIC,CIBERONC, Salamanca, Spain
Coleman, M:
Weill Cornell Med, Div Hematol & Oncol, New York, NY USA
Encinas, C:
Hosp Univ Gregorio Maranon, Madrid, Spain
Vale, AM:
CHUAC, La Coruna, Spain
Teruel, AI:
Hosp Clin Univ Valencia, Valencia, Spain
Cortes-Rodriguez, M:
Univ Salamanca HUSAL, Hematol Dept, IBSAL, IBMCC,USAL,CSIC,CIBERONC, Salamanca, Spain
Univ Salamanca, Stat Dept, Salamanca, Spain
Paiva, B:
Clin Univ Navarra, CIBERONC, IDISNA, Pamplona, Spain
Cedena, MT:
Hosp Univ 12 Octubre, CIBERONC, Inst Invest, Madrid, Spain
San-Miguel, JF:
Clin Univ Navarra, CIBERONC, IDISNA, Pamplona, Spain
Lahuerta, JJ:
Inst Invest Hosp Univ, 12 Octubre, Madrid, Spain
Blade, J:
Hosp Clin Barcelona, Hematol Dept, IDIBAPS, Barcelona, Spain
Niesvizky, R:
Weill Cornell Med, Div Hematol & Oncol, New York, NY USA
Mateos, MV:
Univ Salamanca HUSAL, Hematol Dept, IBSAL, IBMCC,USAL,CSIC,CIBERONC, Salamanca, Spain
Green Published, gold
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