Impact of prior therapy on the efficacy and safety of oral ixazomib-lenalidomide-dexamethasone vs. placebo-lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in TOURMALINE-MM1

• Autoři: MATEOS M.V.; MASSZI T.; GRZASKO N.; HANSSON M.; SANDHU I.; POUR Luděk; VITERBO L.; JACKSON S.R.; STOPPA A.M.; GIMSING P.; HAMADANI M.; BORSARU G.; BERG D.; LIN J.C.; DI BACCO A.; VAN DE VELDE H.; RICHARDSON P.G.; MOREAU P.
• Rok publikování: 2017
• Druh: Článek v odborném periodiku
• Časopis / Zdroj: haematologica
• Fakulta / Pracoviště MU: Lékařská fakulta
• Citace: MATEOS, M.V., T. MASSZI, N. GRZASKO, M. HANSSON, I. SANDHU, Luděk POUR, L. VITERBO, S.R. JACKSON, A.M. STOPPA, P. GIMSING, M. HAMADANI, G. BORSARU, D. BERG, J.C. LIN, A. DI BACCO, H. VAN DE VELDE, P.G. RICHARDSON a P. MOREAU. Impact of prior therapy on the efficacy and safety of oral ixazomib-lenalidomide-dexamethasone vs. placebo-lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in TOURMALINE-MM1. haematologica. PAVIA: FERRATA STORTI FOUNDATION, 2017, roč. 102, č. 10, s. 1767-1775. ISSN 0390-6078. Dostupné z: https://dx.doi.org/10.3324/haematol.2017.170118.
• www: http://dx.doi.org/10.3324/haematol.2017.170118
• Doi: http://dx.doi.org/10.3324/haematol.2017.170118
• Obor: Onkologie a hematologie
• Klíčová slova: ixazomib-lenalidomide-dexamethasone; placebo-lenalidomide-dexamethasone
• Popis: Prior treatment exposure in patients with relapsed/refractory multiple myeloma may affect outcomes with subsequent therapies. We analyzed efficacy and safety according to prior treatment in the phase 3 TOURMALINE-MM1 study of ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) versus placebo-Rd. Patients with relapsed/refractory multiple myeloma received ixazomib-Rd or placebo-Rd. Efficacy and safety were evaluated in subgroups defined according to type (proteasome inhibitor [ PI] and immunomodulatory drug) and number (1 vs. 2 or 3) of prior therapies received. Of 722 patients, 503 (70%) had received a prior PI, and 397 (55%) prior lenalidomide/thalidomide; 425 patients had received 1 prior therapy, and 297 received 2 or 3 prior therapies. At a median follow up of similar to 15 months, PFS was prolonged with ixazomib-Rd vs. placebo-Rd regardless of type of prior therapy received; HR 0.739 and 0.749 in PI-exposed and -naive patients, HR 0.744 and 0.700 in immunomodulatory-drug-exposed and -naive patients, respectively. PFS benefit with ixazomib-Rd vs. placebo-Rd appeared greater in patients with 2 or 3 prior therapies (HR 0.58) and in those with 1 prior therapy without prior transplant (HR 0.60) versus those with 1 prior therapy and transplant (HR 1.23). Across all subgroups, toxicity was consistent with that seen in the intent-to-treat population. In patients with relapsed/refractory multiple myeloma, ixazomib-Rd was associated with a consistent clinical benefit vs. placebo-Rd regardless of prior treatment with bortezomib or immunomodulatory drugs. Patients with 2 or 3 prior therapies, or 1 prior therapy without transplant seemed to have greater benefit than patients with 1 prior therapy and transplant.