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Bortezomib, doxorubicin, and dexamethasone combination therapy followed by thalidomide and dexamethasone consolidation as a salvage treatment for relapsed or refractory multiple myeloma: analysis of efficacy and safety
Authors:Sung Sook Lee  Cheolwon Suh  Bong-Seog Kim  Jooseop Chung  Young-Don Joo  Hun-Mo Ryoo  Young Rok Do  Jong-Youl Jin  Hye Jin Kang  Gyeong-Won Lee  Moon Hee Lee  Hyeok Shim  Kihyun Kim  Sung-Soo Yoon  Soo Mee Bang  Ho Young Kim  Je-Jung Lee  Jinny Park  Dong Soon Lee  Jae-Hoon Lee
Affiliation:1. Yonsei Cancer Center, Severance Hospital, Seoul, South Korea
2. Asan Medical Center, Seoul, South Korea
3. Seoul Veterans Hospital, Seoul, South Korea
4. Busan National University Hospital, Busan, South Korea
5. Busan Paik Hospital, Busan, South Korea
6. Daegu Catholic University Hospital, Daegu, South Korea
7. Keimyung University, Dongsan Medical Center, Daegu, South Korea
8. Bucheon St. Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea
9. Korea Institute of Radiological and Medical Sciences, Seoul, South Korea
10. Gyeongsang National University Hospital, Jinju, South Korea
11. Inha University Hospital, Incheon, South Korea
12. Wonkwang University Hospital, Iksan, South Korea
13. Sungkyunkwan University Samsung Medical Center, Seoul, South Korea
14. Seoul National University College of Medicine, Seoul, South Korea
15. Seoul National University Bundang Hospital, Seoul, South Korea
16. Hallym University Medical Center, Seoul, South Korea
17. Chonnam National University Hwasun Hospital, Gwangju, South Korea
18. Gachon University Gil Hospital, Incheon, South Korea
19. Division of Hematology/Oncology, Gachon University Gil Hospital, 1198 Guwol-dong Namdong-gu, Incheon, South Korea, 405-220
Abstract:We conducted a phase 2 study with bortezomib, doxorubicin, and dexamethasone (PAD) followed by thalidomide and dexamethasone (TD) in patients with relapsed multiple myeloma (MM). Forty patients were enrolled between November 2005 and October 2007, with follow-up continuing until January 2009. Efficacy could be assessed in 37 patients. The overall response rate to PAD followed by TD was 83.6%: complete response 51.4%, near-complete response 13.4%, very good partial remission 5.4%, and partial response 13.4%. The median follow-up was 27 months (range 13–39). The median progression-free survival (PFS) from the start of treatment was 18 months (95% CI, 9.7–26.2 months), with a 1-year PFS rate of 56.9% and 3-year PFS rate of 25.7%. Median overall survival was 35.1 months (95% CI, 18.5–51.7), with a 1-year survival rate of 75% and 3-year survival rate of 27.3%. One hundred seventy-eight PAD cycles (median 6, range 1–6) in 38 patients were assessable for safety. The most common hematologic toxicity was thrombocytopenia, with grade 3–4 in 35.8%. Sensory neuropathy occurred at grade 2 in 26.3% and grade 3 in 10.3%. Two hundred TD treatment cycles (median 4, range 0–12 cycles) were administered. Most adverse events were of mild degree and manageable. PAD followed by TD in patients with relapsed MM is very effective and tolerable.
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