Ixazomib, Daratumumab, and Low-Dose Dexamethasone in Frail Patients With Newly Diagnosed Multiple Myeloma: The Hovon 143 Study
| العنوان: | Ixazomib, Daratumumab, and Low-Dose Dexamethasone in Frail Patients With Newly Diagnosed Multiple Myeloma: The Hovon 143 Study |
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| المؤلفون: | Inge Ludwig, Ellen van der Spek, Paul A F Geerts, Pieter Sonneveld, Margriet Oosterveld, Yavuz M. Bilgin, Savita Soechit, Niels W.C.J. van de Donk, Noortje Thielen, Nicole C H P de Graauw, Mark-David Levin, Gert Jan Timmers, Inger S. Nijhof, Kazem Nasserinejad, Alain Kentos, Marjolein van der Klift, Claudia A.M. Stege, Saskia K. Klein, Esther G.M. De Waal, Matthijs H Silbermann, Maaike Sohne, Marie-Christiane Vekemans, Sonja Zweegman, Roel J.W. van Kampen, Nazik Durdu-Rayman |
| المساهمون: | UCL - (SLuc) Centre du cancer, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'hématologie, Internal medicine, Hematology, CCA - Cancer Treatment and quality of life |
| المصدر: | Journal of clinical oncology, Vol. 39, no. 25, p. 2758-2767 (2021) Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 39(25), 2758-2767. American Society of Clinical Oncology Stege, C A M, Nasserinejad, K, van der Spek, E, Bilgin, Y M, Kentos, A, Sohne, M, van Kampen, R J W, Ludwig, I, Thielen, N, Durdu-Rayman, N, de Graauw, N C H P, van de Donk, N W C J, de Waal, E G M, Vekemans, M C, Timmers, G J, van der Klift, M, Soechit, S, Geerts, P A F, Silbermann, M H, Oosterveld, M, Nijhof, I S, Sonneveld, P, Klein, S K, Levin, M D & Zweegman, S 2021, ' Ixazomib, Daratumumab, and Low-Dose Dexamethasone in Frail Patients With Newly Diagnosed Multiple Myeloma : The Hovon 143 Study ', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 39, no. 25, pp. 2758-2767 . https://doi.org/10.1200/JCO.20.03143 |
| بيانات النشر: | American Society of Clinical Oncology, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Oncology, Boron Compounds, Male, Cancer Research, medicine.medical_specialty, Frail Elderly, Glycine, Dexamethasone, Ixazomib, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Prospective Studies, Prospective cohort study, Survival rate, Multiple myeloma, Aged, Aged, 80 and over, business.industry, Daratumumab, Antibodies, Monoclonal, medicine.disease, Prognosis, Discontinuation, Clinical trial, Survival Rate, chemistry, 030220 oncology & carcinogenesis, Quality of Life, Female, business, Multiple Myeloma, 030215 immunology, medicine.drug, Follow-Up Studies |
| الوصف: | PURPOSE Frail patients with newly diagnosed multiple myeloma have an inferior outcome, mainly because of a high discontinuation rate due to toxicity. We designed a phase II trial specifically for frail patients, evaluating the efficacy and tolerability of ixazomib-daratumumab-low-dose-dexamethasone (Ixa-Dara-dex). METHODS Sixty-five patients, who were frail according to the International Myeloma Working Group frailty index, were treated with nine induction cycles Ixa-Dara-dex followed by maintenance with Ixa-Dara for a maximum of 2 years. RESULTS The overall response rate on induction therapy was 78%. After a median follow-up of 22.9 months, median progression-free survival (PFS) was 13.8 months and 12-month overall survival (OS) was 78%. Median PFS and 12-month OS were 21.6 months and 92% in patients who were frail based on age > 80 years alone, versus 13.8 months and 78%, and 10.1 months and 70% in patients who were frail based on additional frailty parameters either ≤ 80 or > 80 years of age, respectively. In 51% of patients, induction therapy had to be discontinued prematurely, of which 6% because of noncompliance to study treatment, 9% because of toxicity, and 9% because of death (8% within 2 months, of which 80% because of toxicity). Quality of life improved during induction treatment, being clinically meaningful already after three induction cycles. CONCLUSION Ixa-Dara-dex lead to a high response rate and improved quality of life. However, treatment discontinuation because of toxicity and early mortality, negatively influencing PFS and OS, remains a concern in frail patients. The outcome was heterogeneous across frail subpopulations. This should be taken into account in the design and interpretation of future studies in frail patients, to pave the way for more precise treatment guidance. |
| اللغة: | English |
| تدمد: | 0732-183X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1bd16999f1d8f8fc2bbefd1520cedee3 https://hdl.handle.net/2078.1/261917 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....1bd16999f1d8f8fc2bbefd1520cedee3 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 0732183X |
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