Τίτλος:
Deepening responses associated with improved progression-free survival with ixazomib versus placebo as posttransplant maintenance in multiple myeloma
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
In the TOURMALINE-MM3 study, post-autologous stem cell transplantation maintenance therapy with the oral proteasome inhibitor ixazomib versus placebo significantly improved progression-free survival (PFS), with a favorable safety profile. With ixazomib versus placebo maintenance, deepening responses occurred in 139/302 (46%) versus 60/187 (32%) patients with very good partial response or partial response (VGPR/PR) at study entry (relative risk 1.41, P = 0.004), and median time to best confirmed deepened response was 19.9 versus 30.8 months (24-month rate: 54.2 versus 41.4%; hazard ratio (HR): 1.384; P = 0.0342). Median PFS in patients with VGPR/PR at study entry was 26.2 versus 18.5 months (HR: 0.636, P < 0.001) with ixazomib versus placebo; in a pooled analysis across arms, in patients with versus without deepening responses, the median PFS was not reached versus 15.9 months (HR: 0.245, P < 0.001). In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028). These analyses demonstrate the significantly higher rate of deepening responses with ixazomib versus placebo maintenance and the association between deepening response and prolonged PFS. © 2020, The Author(s).
Συγγραφείς:
Goldschmidt, H.
Dimopoulos, M.A.
Rajkumar, S.V.
Weisel, K.C.
Moreau, P.
Chng, W.-J.
Mikala, G.
Cavo, M.
Ramasamy, K.
Suryanarayan, K.
Teng, Z.
Labotka, R.
Mateos, M.V.
Περιοδικό:
Leukemia Research
Εκδότης:
Springer Nature BV
Λέξεις-κλειδιά:
ixazomib; placebo; antineoplastic agent; boron derivative; glycine; ixazomib, adult; aged; Article; autologous stem cell transplantation; controlled study; double blind procedure; female; human; Kaplan Meier method; maintenance therapy; major clinical study; male; middle aged; multicenter study; multiple cycle treatment; multiple myeloma; phase 3 clinical trial; priority journal; progression free survival; survival rate; treatment response; cancer staging; clinical trial; hematopoietic stem cell transplantation; maintenance chemotherapy; mortality; multimodality cancer therapy; multiple myeloma; pathology; postoperative care; randomized controlled trial; treatment outcome; young adult, Adult; Aged; Antineoplastic Agents; Boron Compounds; Combined Modality Therapy; Female; Glycine; Hematopoietic Stem Cell Transplantation; Humans; Kaplan-Meier Estimate; Maintenance Chemotherapy; Male; Middle Aged; Multiple Myeloma; Neoplasm Staging; Postoperative Care; Treatment Outcome; Young Adult
DOI:
10.1038/s41375-020-0819-8
