Page 171 - 2021_10-Haematologica-web

Carfilzomib or bortezomib in first relapse MM
KCd arm was 11.7 months versus 10.2 months in the VCd arm (HR=0.95, 80% CI: 0.77, 1.18) (Figure 4A). Factors prognostic for longer PFS were no previous ASCT and lower b2-microglobulin level (Online Supplementary Table S4). PFS was not significantly different between treatment arms; however, subgroup analysis suggests that patients relapsing earlier and/or who had not received ASCT may benefit from KCd therapy (Figure 4B). For analysis of TTNT, 66 participants in the KCd arm were censored at maintenance randomization. The median TTNT in the KCd arm was 19.1 months, compared with 17.7 months in the VCd arm.
All participants in the analysis population were included in the OS analysis (n=59 events in participants not weight- ed 0). The median (inverse probability of censoring weighted) OS with KCd was 30.9 months versus 28.1 months with VCd (HR=1.10, 90% CI: 0.68, 1.80) (Online Supplementary Figure S1).
A
Safety and tolerability of induction treatment
The number of participants who received the planned 24 weeks of treatment was 164 of 201 (81.6%) in the KCd arm, compared to 53 of 99 (53.5%) in the VCd arm. Among the patients receiving KCd, 14 (7.0%) stopped treatment because of toxicity, compared to 19 (19.2%) of those receiving VCd (Online Supplementary Table S5). In the KCd arm, 11 (5.4%) subjects stopped treatment because of the patients’ withdrawal or clinicians’ decision, com- pared to 20 (20%) in the VCd arm (Online Supplementary Table S5). Dose modifications were reported for 78.6% of KCd participants, compared to 85.4% for VCd (Online Supplementary Table S6). Neuropathy (grade ≥3, or ≥2 with pain) was more common with VCd (19.8%) than with KCd (1.5%) for a proportional difference of -18.3 (90% CI: -25.1, -11.4; P<0.0001) (Online Supplementary Table S7A, B).
There were 142 serious adverse events in 88 (44.9%) participants in the KCd arm, compared with 74 events in
B
Figure 4. Progression-free survival accord- ing to induction randomization. (A) The inverse probability of censoring weighted methodology was used to provide esti- mates of the progression-free survival (PFS), which is shown with 80% confi- dence intervals. (B) Results are shown of an analysis of PFS in pre-specified sub- groups of the intention-to-treat popula- tion. Forest plot hazard ratios were provid- ed from Cox proportional hazards model- ing, using the inverse probability of censor- ing weighted methodology. KCd: carfil- zomib, cyclophosphamide, dexametha- sone; VCd: bortezomib, cyclophos- phamide, dexamethasone; ASCT: autolo- gous stem cell transplantation; 12m: 12 months; len: lenalidomide; CI: confidence interval.
haematologica | 2021; 106(10)
2699