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

  • Shang-Yi Huang National Taiwan University Hospital, Taiwan, Province of China.
  • Tsai-Yun Chen National Cheng Kung University Hospital, Taiwan, Province of China.
  • Ching-Yuan Kuo Kaohsiung Chang Gung Memorial Hospital, Taiwan, Province of China.
  • Yeu-Chin Chen Tri-Service General Hospital, National Defense Medical Center, Taiwan, Province of China.
  • Sheng-Fung Lin Kaohsiung Medical University Memorial Hospital, Taiwan, Province of China.
  • Ming-Chih Chang Mackay Memorial Hospital, Taiwan, Province of China.
  • Xinzhu Lv Johnson and Johnson Investment Ltd, Shanghai, China.
  • Betty Yang Janssen Medical Affairs, Taiwan, Province of China.
  • Cheng-Shyong Chang | cs4816@gmail.com Chang-Hua Christian Hospital, Taiwan, Province of China.

Abstract

Bortezomib is a proteasome inhibitor, approved for treating newly diagnosed and relapsed multiple myeloma (MM). This realworld, 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-toprogression, 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 Of the withdrawn patients (n=53), there were 48 deaths (PD-related death: n=35, adverse events [AEs]-related: n=12, other reason: n=1), and 5 due to loss to follow-up.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 realworld clinical practice, which can be helpful for Taiwanese healthcare providers’ decision-making processes.

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Published
2019-01-18
Section
Reviews
Keywords:
Bortezomib, effectiveness, multiple myeloma, observational, real-world.
Statistics
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How to Cite
Huang, S.-Y., Chen, T.-Y., Kuo, C.-Y., Chen, Y.-C., Lin, S.-F., Chang, M.-C., Lv, X., Yang, B., & Chang, C.-S. (2019). Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma. Oncology Reviews, 13(1). https://doi.org/10.4081/oncol.2019.377