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K.L. Yong et al.
45 (46.9%) participants in the VCd arm (Online Supplementary Table S8A). Serious adverse events reported more frequently with KCd included cardiac, respiratory/thoracic, vascular and renal events while neu- rological and blood/lymphatic events were more frequent with VCd. The grade ≥3 adverse reactions that occurred are summarized in Online Supplementary Table S8B, C. More participants in the VCd arm experienced thrombo- cytopenia and neutropenia, but more in the KCd arm experienced anemia, hyponatremia and hypophos- phatemia. Cardiac adverse reactions were similar in both arms, although grade 3 events were only reported in the KCd arm (n=6, 3.6%). Hypertension grade ≥3 was only reported among patients receiving KCd (3.6%). Infections accounted for around half of the serious adverse events, with rates being similar in the two arms. There were six deaths during the induction phase, of which five were in the KCd arm. Safety and treatment tolerability were not influenced by age (≥70 years) or renal impairment
A
(glomerular filtratrion rate ≤60 mL/min) (Online Supplementary Table S9).
Maintenance comparison
A total of 141 participants were randomized between maintenance (n=69) and no maintenance (n=72) between August 2013 and March 2017. The data lock took place on January 3, 2018 (median follow-up from maintenance ran- domization 10.5 months: maintenance 12.7, observation 7.3). All participants were eligible for the safety analysis: two participants randomized to maintenance did not actu- ally receive the maintenance therapy and were included in the no maintenance arm for the safety analysis (Figure 2). Sixty-six patients given maintenance and 72 not given maintenance were eligible for the efficacy analysis. The patients in the two arms were balanced for baseline char- acteristics at study entry, and disease response at the time of maintenance randomization (Table 3). The median number of cycles received in the maintenance arm was
B
Figure 5. Progression-free survival accord- ing to maintenance randomization. (A) Kaplan-Meier estimate of progression-free survival (PFS), shown with 80% confidence intervals, and numbers at risk indicated. (B) Forest plot of PFS in pre-specified sub- groups, with hazard ratios and 80% confi- dence intervals. K Maint: maintenance with carfilzomib; No maint: no maintenance ther- apy; CI: confidence interval; KCd: carfil- zomib, cyclophosphamide, dexamethasone; VCd: bortezomib, cyclophosphamide, dex- amethasone; ASCT, autologous stem cell transplantation; 12m: 12 months; len: lenalidomide;.KCD: carfilzomib, cyclophos- phamide, dexamethasone; PR: partial response; VGPR: very good partial response; ASCT: autologous stem cell transplantation; 12m: 12 months; len: lenalidomide; MRD: minimal residual disease.
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