Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma:Analysis of POLLUX and CASTOR
| Autor: | Himal Amin, Nizar J. Bahlis, Shinsuke Iida, Priya Ramaswami, Jesús F. San-Miguel, Torben Plesner, Andrew Spencer, Jon Ukropec, Sagar Lonial, Xiang Qin, Saad Z. Usmani, Ming Qi, Christopher Chiu, Tineke Casneuf, Katja Weisel, M. Qi, Maria Krevvata, Rachel Kobos, Philippe Moreau, Hervé Avet-Loiseau, Steven Sun, Sonali Trivedi |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Neoplasm Residual Dexamethasone Bortezomib Internal medicine hemic and lymphatic diseases Antineoplastic Combined Chemotherapy Protocols Outcome Assessment Health Care medicine Humans Multicenter Studies as Topic Prospective Studies Lenalidomide Randomized Controlled Trials as Topic business.industry Daratumumab Antibodies Monoclonal Refractory Multiple Myeloma Minimal Residual Disease Negativity Progression-Free Survival Clinical Trials Phase III as Topic Drug Resistance Neoplasm Neoplasm Recurrence Local business Multiple Myeloma medicine.drug |
| Zdroj: | Avet-Loiseau, H, San-Miguel, J, Casneuf, T, Iida, S, Lonial, S, Usmani, S Z, Spencer, A, Moreau, P, Plesner, T, Weisel, K, Ukropec, J, Chiu, C, Trivedi, S, Amin, H, Krevvata, M, Ramaswami, P, Qin, X, Qi, M, Sun, S, Qi, M, Kobos, R & Bahlis, N J 2021, ' Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma : Analysis of POLLUX and CASTOR ', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 39, no. 10, pp. 1139-1149 . https://doi.org/10.1200/JCO.20.01814 |
| Popis: | PURPOSE In relapsed and/or refractory multiple myeloma, daratumumab reduced the risk of progression or death by > 60% in POLLUX (daratumumab/lenalidomide/dexamethasone [D-Rd]) and CASTOR (daratumumab/bortezomib/dexamethasone [D-Vd]). Minimal residual disease (MRD) is a sensitive measure of disease control. Sustained MRD negativity and outcomes were evaluated in these studies. METHODS MRD was assessed via next-generation sequencing (10−5) at suspected complete response (CR), 3 and 6 months following confirmed CR (POLLUX), 6 and 12 months following the first dose (CASTOR), and every 12 months post-CR in both studies. Sustained MRD negativity (≥ 6 or ≥ 12 months) was evaluated in the intention-to-treat (ITT) and ≥ CR populations. RESULTS The median follow-up was 54.8 months in POLLUX and 50.2 months in CASTOR. In the ITT population, MRD-negativity rates were 32.5% versus 6.7% for D-Rd versus lenalidomide and dexamethasone (Rd) and 15.1% versus 1.6% for D-Vd versus bortezomib and dexamethasone (Vd; both P < .0001). Higher MRD negativity rates were achieved in ≥ CR patients in POLLUX (D-Rd, 57.4%; Rd, 29.2%; P = .0001) and CASTOR (D-Vd, 52.8%; Vd, 17.4%; P = .0035). More patients in the ITT population achieved sustained MRD negativity ≥ 6 months with D-Rd versus Rd (20.3% v 2.1%; P < .0001) and D-Vd versus Vd (10.4% v 1.2%; P < .0001), and ≥ 12 months with D-Rd versus Rd (16.1% v 1.4%; P < .0001) and D-Vd versus Vd (6.8% v 0%). Similar results for sustained MRD negativity were observed among ≥ CR patients. More patients in the daratumumab-containing arms achieved MRD negativity and sustained MRD negativity, which were associated with prolonged progression-free survival. CONCLUSION Daratumumab-based combinations induce higher rates of sustained MRD negativity versus standard of care, which are associated with durable remissions and prolonged clinical outcomes. |
| Databáze: | OpenAIRE |
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