Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients
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- 作者：MaoFang Lin (1)
Jian Hou (2)
WenMing Chen (3)
XiaoJun Huang (4)
ZhuoGang Liu (5)
YuHong Zhou (6)
Yan Li (7)
Taiyun Zhao (8)
LinNa Wang (8)
Kwang-Wei Wu (8)
ZhiXiang Shen (9) - 关键词：Bortezomib ; Chinese ; Multiple myeloma ; Observational study ; Refractory ; Relapsed ; Response
- 刊名：Advances in Therapy
- 出版年：2014
- 出版时间：October 2014
- 年：2014
- 卷：31
- 期：10
- 页码：1082-1094
- 全文大小：623 KB
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18. San Miguel JF, Schlag R - 作者单位：MaoFang Lin (1)
Jian Hou (2)
WenMing Chen (3)
XiaoJun Huang (4)
ZhuoGang Liu (5)
YuHong Zhou (6)
Yan Li (7)
Taiyun Zhao (8)
LinNa Wang (8)
Kwang-Wei Wu (8)
ZhiXiang Shen (9)
1. Department of Hematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang, China
2. The Myeloma and Lymphoma Center, Changzheng Hospital, The Second Military Medical University, Shanghai, China
3. Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
4. Peking University People’s Hospital, Beijing, China
5. Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
6. Department of Hematology of Zhejiang Province Traditional Chinese Medical Hospital, Shenyang, Liaoning, China
7. The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
8. Xian-Janssen Pharmaceutical Company, Beijing, China
9. Ruijin Hospital, Shanghai Jiaotong University School of Medicine, 197 Ruijin 2nd Rd, Luwan District, Shanghai, China - ISSN：1865-8652
文摘
Introduction Bortezomib, a novel proteasome inhibitor, is approved for the treatment of relapsed multiple myeloma (MM). Efficacy and safety of bortezomib is well known; however, it was necessary to validate the data in patients with different ethnic backgrounds. The efficacy and safety of bortezomib was assessed in patients from China with relapsed/refractory MM in a real-world scenario. Methods This prospective, non-interventional, observational study enrolled both male and female Chinese patients, aged ?8?years and diagnosed with relapsed or refractory MM. Administration of intravenous bortezomib at 1.3?mg/m2 was recommended twice a week for 2?weeks (days 1, 4, 8 and 11), followed by a 10-day rest period (maximum of 8 cycles) and a follow-up every 12?weeks for 3?years. Efficacy assessments included best response, objective response rate (ORR), time to response, duration of response, and overall survival. Safety was also assessed. Results A total of 517 patients were enrolled with a median age of 58.7?years. Patients predominantly had immunoglobulin G type (46.2%) and stage III (47.8%) myeloma. Overall, 202 (42.3%) patients had partial response as best response, ORR was 88.9% and the proportion of patients exhibiting complete response was 24.7%. The median time to response observed was 27 (21-0) days. Median time to progression was 415?days and median overall survival was 475?days. Thrombocytopenia (14.4%) was the most common adverse event. Conclusion Bortezomib demonstrated clinical response in majority of patients and was well tolerated in this observational study in Chinese patients with relapsed/refractory MM.