Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2018 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
Risks of upper respiratory tract infection and pneumonia in patients with multiple myeloma receiving Daratumumab: A systematic review and meta-analysis of randomized controlled trials.
Hematologic Malignancies—Plasma Cell Dyscrasia
2018 ASCO Annual Meeting
J Clin Oncol 36, 2018 (suppl; abstr e20005)
Author(s): Katy Ticona, Aung Tun, Elizabeth Guevara; The Brooklyn Hospital Center, Brooklyn, NY; Brooklyn Hospital Center, Brooklyn, NY
Background: The addition of human anti CD38 IgGκ monoclonal antibody Daratumumab (DARA) to standard multiple myeloma (MM) regimen significantly improves response rates, progression-free survival and the risk of death with notable safety concerns. We performed a systematic review & meta-analysis of RCTs to determine the risk of upper respiratory tract infection (URI) and pneumonia in MM patients receiving DARA Methods: We conducted a literature search using MEDLINE, EMBASE and SCOPUS databases using the terms “multiple myeloma AND daratumumab”, “MM AND daratumumab”, “plasma cell disorder AND daratumumab” through January 2018. The primary meta-analytic approach was a fixed effects model using the Mantel-Haenszel method. It was used to calculate the estimated pooled risk ratio (RR), and risk difference (RD) with 95% confidence interval (CI). Pooled rates of URI & pneumonia were estimated by multiplying the median follow-up duration by the sample size. Results: 1744 patients were eligible. Study arm used bortezomib (V), mephalan (M), prednisone (P) plus DARA; V, dexamethasone (D) plus DARA; and lenalidomide (R), D plus DARA. The control arm used VMP, VD, and RD. The pooled risk ratio for URI was 1.59 (95% CI: 1.33 – 1.91, P = 0.00001) and the absolute RD was 0.1 (95% CI: 0.06 – 0.14, P = 0.00001) with grade 3 or 4 RR of 1.4 (95% CI: 0.63 – 3.15, P = 0.41) and the absolute RD of 0 (95% CI: -0.01 – 0.02, P = 0.41). Pooled RR for pneumonia was 1.48 (95% CI: 1.14 - 1.93, P = 0.002) & absolute RD was 0.05 (95% CI: 0.02 - 0.08, P = 0.004) while the pooled RR for grade 3 or 4 pneumonia was 1.35 (95% CI: 0.98 – 1.86, P = 0.07) and the absolute RD was 0.02 (95% CI: -0.00 – 0.05, P = 0.07). Over median follow up of 24 months, the RR for URI was 1.46 (95% CI: 1.33 – 1.61, P < 0.00001) and RD was 0.18 (95% CI: 0.14 – 0.23, P < 0.00001) while the RR for pneumonia was 1.35 (95% CI: 1.15 – 1.58, P < 0.0003) and RD was 0.07 (95% CI: 0.03 – 0.11, P < 0.0002). Conclusions: Addition of DARA to standard MM regimen contributes a significantly higher risks of URI and pneumonia, without remarkable increase in the risks of grade 3 or 4 events.
2. Pomalidomide (POM), bortezomib, and low‐dose dexamethasone (PVd) vs bortezomib and low-dose dexamethasone (Vd) in lenalidomide (LEN)-exposed patients (pts) with relapsed or refractory multiple myeloma (RRMM): Phase 3 OPTIMISMM trial.