Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma

Shang Yi Huang, Tsai-Yun Chen, Ching Yuan Kuo, Yeu Chin Chen, Sheng Fung Lin, Ming Chih Chang, Xinzhu Lv, Betty Yang, Cheng Shyong Chang

Research output: Contribution to journalReview article

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 Of the withdrawn patients (n=53), there were 48 deaths (PD-related death: n=35, adverse events [AEs]-related: n=12, other reason: n=1), and 5 due to loss to follow-up.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.

Original languageEnglish
Pages (from-to)15-22
Number of pages8
JournalOncology Reviews
Volume13
Issue number1
DOIs
Publication statusPublished - 2019 Jan 14

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Multiple Myeloma
Therapeutics
Bortezomib
Safety
Proteasome Inhibitors
Survival
Hypesthesia
Thrombocytopenia
Health Personnel
Reaction Time
Disease Progression
Diarrhea
Decision Making
Delivery of Health Care

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Huang, Shang Yi ; Chen, Tsai-Yun ; Kuo, Ching Yuan ; Chen, Yeu Chin ; Lin, Sheng Fung ; Chang, Ming Chih ; Lv, Xinzhu ; Yang, Betty ; Chang, Cheng Shyong. / Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma. In: Oncology Reviews. 2019 ; Vol. 13, No. 1. pp. 15-22.
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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.",
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Huang, SY, Chen, T-Y, Kuo, CY, Chen, YC, Lin, SF, Chang, MC, Lv, X, Yang, B & Chang, CS 2019, 'Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma', Oncology Reviews, vol. 13, no. 1, pp. 15-22. https://doi.org/10.4081/oncol.2019.377

Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma. / Huang, Shang Yi; Chen, Tsai-Yun; Kuo, Ching Yuan; Chen, Yeu Chin; Lin, Sheng Fung; Chang, Ming Chih; Lv, Xinzhu; Yang, Betty; Chang, Cheng Shyong.

In: Oncology Reviews, Vol. 13, No. 1, 14.01.2019, p. 15-22.

Research output: Contribution to journalReview article

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T1 - Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma

AU - Huang, Shang Yi

AU - Chen, Tsai-Yun

AU - Kuo, Ching Yuan

AU - Chen, Yeu Chin

AU - Lin, Sheng Fung

AU - Chang, Ming Chih

AU - Lv, Xinzhu

AU - Yang, Betty

AU - Chang, Cheng Shyong

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AB - 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.

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