达雷妥尤单抗治疗复发/难治多发性骨髓瘤的疗效与安全性

OBJECTIVE: To investigate the efficacy and safety of daratumumab in relapsed and refractory multiple myeloma (RRMM). METHODS: The clinical characteristics, adverse reactions, efficacy, and prognosis of 46 patients with RRMM treated with daratumumab in Shanghai Changzheng Hospital from September 2017 to March 2020 were retrospectively analyzed. RESULTS: All patients were treated with daratumumab-based regimen: 8 in the Dd group, 35 in the DRd group, and 3 in the DVd group. With a median follow-up of 9.6 months, the overall response rate (ORR) was 75% [complete remission (CR) rate 18.2% ] among the 44 patients available for evaluation. The ORRs of patients resistant to bortezomib, lenalidomide, and both were 70.6%, 69.2%, and 63.6%, respectively. The CR rates of patients resistant to bortezomib, lenalidomide, and both were 17.6%, 11.5%, and 13.6%, respectively. No significant difference was observed in ORR and CR rates among the three groups. The ORRs of the DRd, DVd, and Dd groups were 85.3%, 66.7%, and 28.6%, respectively (P=0.007). The median PFS of 46 patients was 8.9 months, the median OS was not reached, and the 1-year OS rate was 74%. The median PFS and OS in the DRd group were longer than those in the Dd group (PFS: 14.4 months vs 2.0 months; OS: not reached vs 5.2 months). After treatment with daratumumab, neutropenia is the most common hematological adverse reaction above grade 3. Non-hematological adverse reactions are mainly infusion-related adverse reactions and infections. Prognostic analysis showed that patients with extramedullary invasion had shorter PFS and OS compard with patients without extramedullary invasion (PFS: 5.7 vs 14.4 months, P=0.033; OS: 6.3 months vs not reached, P=0.029). The OS of patients with an ECOG score of 3–4 was significantly shorter than patients with an ECOG score of 1–2 (5.9 months vs not reached, P=0.004). CONCLUSION: Daratumumab-based regimens have good efficacy and safety in the treatment of RRMM.