Informace o publikaci

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
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.