Page 159 - 2018_12-Haematologica-web

Subgroup analyses of CASTOR
months
(months)
Figure 2. PFS based on prior treatment history and cytogenetic risk (ITT population). Subgroup analysis of PFS based on prior lines of therapy, prior treatment expo- sure, refractoriness to lenalidomide at the last prior line of therapy, treatment-free interval, and cytogenetic risk. Patients with high-risk cytogenetics had any of t(4;14), t(14;16), or del17p cytogenetic abnormalities as determined by central next-generation sequencing. Standard-risk patients had an absence of high-risk abnormalities. PFS: progression-free survival; ITT: intent-to-treat; D-Vd: daratumumab plus bortezomib and dexamethasone; Vd: bortezomib and dexamethasone; CI: confidence interval; NR: not reached.
ly prolonged PFS versus Vd (median: not reached versus 16.2 months; HR, 0.19; 95% CI, 0.05-0.73; P=0.0080 [Figure 3B]). The rate of MRD-negativity (10–5) continued to increase over time for patients in the overall study pop- ulation who received D-Vd versus Vd (Figure 4).
hypertension, and peripheral sensory neuropathy. Discontinuations due to TEAEs remained low and bal- anced between groups (D-Vd: 9.5%; Vd: 9.3%). Transfusions were received by 26.3% versus 20.3% of patients (D-Vd versus Vd).
With longer follow up, second primary malignancies (SPMs) occurred in 10 (4.1%) patients who received D-Vd (4 new cases following the primary analysis13 included basal and squamous cell carcinoma, Bowen disease, and prostate cancer) versus 1 (0.4%) patient who received Vd (no new cases with longer follow up).
The EORTC QLQ-C30 and EQ-5D-5L tools showed that HRQoL was maintained during treatment for patients in both groups who remained on the study. Significant dif- ferences in the least squares mean changes from baseline were not observed between D-Vd and Vd at any time for the EORTC QLQ-C30 Global Health Status Scores or the EQ-5D-5L Utility Score. A significant difference was
Within the safety population (D-Vd, n=243; Vd, n=237), longer follow up revealed a tolerability profile consistent with the primary analysis and no new emergent toxicities. Among the most common (≥15%) hematologic treat- ment-emergent adverse events (TEAEs) were thrombocy- topenia and anemia. Among the most common (≥15%) non-hematologic TEAEs were peripheral sensory neu- ropathy, diarrhea, upper respiratory tract infection, and cough (Table 3).
The most common (≥5%) grade 3 or 4 hematologic TEAEs included thrombocytopenia, anemia, neutropenia, and lymphopenia (Table 3). The most common (≥5%) grade 3 or 4 non-hematologic TEAEs included pneumonia,
haematologica | 2018; 103(12)
2083