https://scholars.lib.ntu.edu.tw/handle/123456789/540529
Title: | Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma | Authors: | SHANG-YI HUANG Chen T.-Y. Kuo C.-Y. Chen Y.-C. Lin S.-F. Chang M.-C. Lv X. Yang B. Chang C.-S. |
Keywords: | Bortezomib; Effectiveness; Multiple myeloma; Observational; Real-world | Issue Date: | 2019 | Publisher: | Page Press Publications | Journal Volume: | 13 | Journal Issue: | 1 | Start page/Pages: | 15-22 | Source: | Oncology reviews | Abstract: | Bortezomib is a proteasome inhibitor, approved for treating newly diagnosed and relapsed multiple myeloma (MM). This real-world, multicenter, observational, non-interventional study of bortezomib was designed to collect and analyze prospective data in Taiwanese patients with relapsed or refractory MM. The primary endpoints included clinical effectiveness outcomes (disease response, disease progression [PD], time-to-response, time-to-progression, response duration, and overall survival [OS]). Secondary endpoints were safety and healthcare resource utilization. Total 100 patients (median [range] age 64.9 [37.0-85.5] years) were enrolled; 47 patients completed the study. Of the withdrawn patients (n=53), there were 48 deaths (PD-related death: n=35, adverse events [AEs]-related: n=12, other reason: n=1), and 5 due to loss to follow-up. Four patients in Cycle 1, 6 patients each in Cycle 2 and 5, 7 in Cycle 3, 10 patients in Cycle 4, 5 patients in Cycle 6, and 3 patients each in Cycle 7 and 8 achieved overall response during the study. Time-to-response was 4.68 months (95%CI: 3.2, NE) and response duration was 10.08 months (95%CI: 2.3, 28.6). Median OS was 9.8 months (95%CI: 3.8, 13.7), and median time-to-progression was 11.3 months (95%CI: 6.2, 20.2). Most common non-hematological AEs were diarrhea (n=32) and hypoesthesia (n=25); most common hematological AE was thrombocytopenia (n=18). Efficacy and safety profile of bortezomib in Taiwanese patients with MM was similar to global and other Asian population. Study provides a critical insight on use of bortezomib in real-world clinical practice, which can be helpful for Taiwanese healthcare providers’ decision-making processes. ?Copyright S-Y. Huang et al., 2019. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85060199238&doi=10.4081%2foncol.2019.377&partnerID=40&md5=57bac565e151b0c3b8cafa63c05adda3 https://scholars.lib.ntu.edu.tw/handle/123456789/540529 |
ISSN: | 1970-5557 | DOI: | 10.4081/oncol.2019.377 | SDG/Keyword: | bortezomib; lactate dehydrogenase; M protein; abdominal distension; abdominal pain; acute heart infarction; acute respiratory failure; adult; adult respiratory distress syndrome; aged; backache; basophil; bone lesion; clinical practice; constipation; coughing; decreased appetite; diarrhea; dizziness; drug dose reduction; drug efficacy; drug safety; drug withdrawal; eosinophil; erythrocyte count; fatigue; female; fever; follow up; health care utilization; hematocrit; hemoglobin blood level; herpes zoster; human; hypesthesia; hypokalemia; insomnia; lacunar stroke; lymphocyte; major clinical study; malaise; male; median survival time; medication compliance; monocyte; multicenter study; multiple cycle treatment; multiple myeloma; neutrophil; observational study; patient compliance; peripheral edema; peripheral neuropathy; plasmacytoma; platelet count; pneumonia; post treatment survival; priority journal; rash; respiratory failure; Review; rhinorrhea; sepsis; septic shock; spinal cord compression; Taiwanese; thrombocytopenia; treatment duration; treatment response time; upper respiratory tract infection; vomiting |
Appears in Collections: | 醫學系 |
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