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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

2017; Impact Journals LLC; Volume: 8; Issue: 23 Linguagem: Inglês

10.18632/oncotarget.16790

1949-2553

Min Kyoung Kim, Kihyun Kım, Chang‐Ki Min, Jae-Yong Kwak, Sang Byung Bae, Sung‐Soo Yoon, Je‐Jung Lee, Ki Hwan Kim, Seung-Hyun Nam, Yeung‐Chul Mun, Hyo Jung Kim, Sung Hwa Bae, Ho‐Jin Shin, Jung‐Hee Lee, Joon Seong Park, Seong Hyun Jeong, Mark Hong Lee, Yang‐Soo Kim, Ho Sup Lee, Keon Woo Park, Won Sik Lee, Sang Min Lee, Jeong‐Ok Lee, Myung Soo Hyun, Deog Yeon Jo, Sung-Nam Lim, Jae Hoon Lee, Do-Yeun Cho, Young Rok, Jeong‐A Kim, Seong Kyu Park, Jin Seok Kim, Soo‐Jeong Kim, Hawk Kim, Hyeon Gyu Yi, Joon Ho Moon, Chul Won Choi, Sung‐Hyun Kim, Young‐Don Joo, Hoon-Gu Kim, Byung Soo Kim, Moo-Rim Park, Gyung Hyuck Ko, Su-Youn Kim,

PI3K/AKT/mTOR signaling in cancer

// Min Kyoung Kim 1 , Kihyun Kim 2 , Chang-Ki Min 3 , Jae-Yong Kwak 4 , Sang-Byung Bae 5 , Sung-Soo Yoon 6 , Je-Jung Lee 7 , Ki Hwan Kim 8 , Seung-Hyun Nam 9 , Yeung-Chul Mun 10 , Hyo Jung Kim 11 , Sung Hwa Bae 12 , Ho-Jin Shin 13 , Jung-Hee Lee 14 , Joon Seong Park 15 , Seong Hyun Jeong 15 , Mark Hong Lee 16 , Yang-Soo Kim 17 , Ho Sup Lee 17 , Keon Woo Park 18 , Won-Sik Lee 19 , Sang Min Lee 19 , Jeong-Ok Lee 20 , Myung Soo Hyun 1 , Deog Yeon Jo 21 , Sung-Nam Lim 22 , Jae Hoon Lee 23 , Do-Yeun Cho 24 , Young Rok Do 25 , Jeong-A Kim 26 , Seong Kyu Park 27 , Jin Seok Kim 28 , Soo-Jeong Kim 28 , Hawk Kim 29 , Hyeon Gyu Yi 30 , Joon Ho Moon 31 , Chul Won Choi 32 , Sung-Hyun Kim 33 , Young-Don Joo 34 , Hoon-Gu Kim 35 , Byung Soo Kim 36 , Moo-Rim Park 37 , Moo-Kon Song 38 and Su-Youn Kim 39 1 Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea 2 Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea 3 Division of Hematology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea 4 Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea 5 Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan, Korea 6 Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea 7 Department of Hematology/Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea 8 Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea 9 Department of Internal Medicine, VHS Medical Center, Seoul, Korea 10 Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea 11 Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea 12 Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea 13 Department of Internal Medicine, Division of Hematology/Oncology, School of Medicine, Medical Research Institute, Pusan National University Hospital, Busan, Korea 14 Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea 15 Department of Hematology/Oncology, Ajou University School of Medicine, Suwon, Korea 16 Department of Internal Medicine, Konkuk University Medical Center, Seoul, Korea 17 Department of Hematology/Oncology, Kosin University College of Medicine, Busan, Korea 18 Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea 19 Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea 20 Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Korea 21 Department of Hematology/Oncology, Chungnam National University Hospital, Daejeon, Korea 22 Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea 23 Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea 24 Department of Internal Medicine, Konyang University Hospital, Daejeon, Korea 25 Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea 26 Department of Hematology, College of Medicine, The Catholic University of Korea, Seoul, Korea 27 Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea 28 Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea 29 Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea 30 Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea 31 Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea 32 Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea 33 Department of Internal Medicine, Dong-A Medical Center, Dong-A University College of Medicine, Busan, Korea 34 Department of Hemato-Oncology, Inje University Haeundae Paik Hospital, Busan, Korea 35 Department of Internal Medicine, Gyeongsang Institute of Health Sciences, Gyeongsang National University School of Medicine and Gyeongsang National University Changwon Hospital, Changwon, Korea 36 Department of Hematology, Korea University Medical Center, Korea University College of Medicine, Seoul, Korea 37 Department of Internal Medicine, School of Medicine, Wonkwang University, Iksan, Korea 38 Department of Hemato-Oncology, Hanyang University Hanmaeum Changwon Hospital, Changwon, Korea 39 Medical Affairs, Janssen Korea, Seoul, Korea Correspondence to: Kihyun Kim, email: kihyunkimk@gmail.com 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), β 2 -microglobulin level (< 5.5 vs. ≥ 5.5 mg/L; p = 0.0481), and cumulative dose of bortezomib (< 35.1 vs. ≥ 35.1 mg/m 2 ; 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.