Research Papers:
A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalan-prednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma
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Abstract
Min Kyoung Kim1, Kihyun Kim2, Chang-Ki Min3, Jae-Yong Kwak4, Sang-Byung Bae5, Sung-Soo Yoon6, Je-Jung Lee7, Ki Hwan Kim8, Seung-Hyun Nam9, Yeung-Chul Mun10, Hyo Jung Kim11, Sung Hwa Bae12, Ho-Jin Shin13, Jung-Hee Lee14, Joon Seong Park15, Seong Hyun Jeong15, Mark Hong Lee16, Yang-Soo Kim17, Ho Sup Lee17, Keon Woo Park18, Won-Sik Lee19, Sang Min Lee19, Jeong-Ok Lee20, Myung Soo Hyun1, Deog Yeon Jo21, Sung-Nam Lim22, Jae Hoon Lee23, Do-Yeun Cho24, Young Rok Do25, Jeong-A Kim26, Seong Kyu Park27, Jin Seok Kim28, Soo-Jeong Kim28, Hawk Kim29, Hyeon Gyu Yi30, Joon Ho Moon31, Chul Won Choi32, Sung-Hyun Kim33, Young-Don Joo34, Hoon-Gu Kim35, Byung Soo Kim36, Moo-Rim Park37, Moo-Kon Song38 and Su-Youn Kim39
1Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea
2Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
3Division of Hematology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea
4Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea
5Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan, Korea
6Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
7Department of Hematology/Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea
8Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea
9Department of Internal Medicine, VHS Medical Center, Seoul, Korea
10Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
11Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea
12Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea
13Department of Internal Medicine, Division of Hematology/Oncology, School of Medicine, Medical Research Institute, Pusan National University Hospital, Busan, Korea
14Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
15Department of Hematology/Oncology, Ajou University School of Medicine, Suwon, Korea
16Department of Internal Medicine, Konkuk University Medical Center, Seoul, Korea
17Department of Hematology/Oncology, Kosin University College of Medicine, Busan, Korea
18Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
19Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea
20Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Korea
21Department of Hematology/Oncology, Chungnam National University Hospital, Daejeon, Korea
22Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea
23Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
24Department of Internal Medicine, Konyang University Hospital, Daejeon, Korea
25Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea
26Department of Hematology, College of Medicine, The Catholic University of Korea, Seoul, Korea
27Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
28Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
29Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea
30Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea
31Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea
32Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
33Department of Internal Medicine, Dong-A Medical Center, Dong-A University College of Medicine, Busan, Korea
34Department of Hemato-Oncology, Inje University Haeundae Paik Hospital, Busan, Korea
35Department of Internal Medicine, Gyeongsang Institute of Health Sciences, Gyeongsang National University School of Medicine and Gyeongsang National University Changwon Hospital, Changwon, Korea
36Department of Hematology, Korea University Medical Center, Korea University College of Medicine, Seoul, Korea
37Department of Internal Medicine, School of Medicine, Wonkwang University, Iksan, Korea
38Department of Hemato-Oncology, Hanyang University Hanmaeum Changwon Hospital, Changwon, Korea
39Medical Affairs, Janssen Korea, Seoul, Korea
Correspondence to:
Kihyun Kim, email: [email protected]
Keywords: multiple myeloma, aged, bortezomib, drug therapy, combination
Received: September 20, 2016 Accepted: January 10, 2017 Published: April 03, 2017
ABSTRACT
Bortezomib-melphalan-prednisone (VMP) showed superior efficacy versus MP as first-line treatment for transplantation-ineligible multiple myeloma (MM). This study investigated the efficacy of VMP for Korean patients with MM.
Overall, 177 MM patients received 9 cycles of VMP in this prospective, multicenter, observational study. The primary endpoint was 2-year progression-free survival (PFS).
Thirty-nine (22%) patients were aged ≥ 75 years and 83 (47.4%) patients had International Staging System stage III. A median of 5 cycles were delivered. Overall response rate (ORR) was 72.9%, and complete response (CR) rate was 20.3%. With a median follow-up of 11.9 months, median PFS was 17 months. The 2-year PFS and overall survival (OS) rates were 29.2% and 80.0%, respectively. Median OS was not reached. PFS was significantly different depending on performance status (Eastern Cooperative Oncology Group < 2 vs. ≥ 2; p = 0.0002), β2-microglobulin level (< 5.5 vs. ≥ 5.5 mg/L; p = 0.0481), and cumulative dose of bortezomib (< 35.1 vs. ≥ 35.1 mg/m2; p < 0001). The common adverse events (AEs) were in line with the well-known toxicity profiles associated with VMP.
In conclusion, VMP is a feasible and effective front-line treatment for transplant-ineligible older patients with MM in Korea. Continuing therapy with prompt adjustment of treatment according to AEs may be important to improve outcomes of elderly patients.
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