PMID- 28402945 OWN - NLM STAT- MEDLINE DCOM- 20180319 LR - 20221207 IS - 1949-2553 (Electronic) IS - 1949-2553 (Linking) VI - 8 IP - 23 DP - 2017 Jun 6 TI - 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. PG - 37605-37618 LID - 10.18632/oncotarget.16790 [doi] AB - 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), beta2-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. FAU - Kim, Min Kyoung AU - Kim MK AD - Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea. FAU - Kim, Kihyun AU - Kim K AD - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. FAU - Min, Chang-Ki AU - Min CK AD - Division of Hematology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea. FAU - Kwak, Jae-Yong AU - Kwak JY AD - Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea. FAU - Bae, Sang-Byung AU - Bae SB AD - Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan, Korea. FAU - Yoon, Sung-Soo AU - Yoon SS AD - Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. FAU - Lee, Je-Jung AU - Lee JJ AD - Department of Hematology/Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea. FAU - Kim, Ki Hwan AU - Kim KH AD - Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea. FAU - Nam, Seung-Hyun AU - Nam SH AD - Department of Internal Medicine, VHS Medical Center, Seoul, Korea. FAU - Mun, Yeung-Chul AU - Mun YC AD - Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea. FAU - Kim, Hyo Jung AU - Kim HJ AD - Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea. FAU - Bae, Sung Hwa AU - Bae SH AD - Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea. FAU - Shin, Ho-Jin AU - Shin HJ AD - Department of Internal Medicine, Division of Hematology/Oncology, School of Medicine, Medical Research Institute, Pusan National University Hospital, Busan, Korea. FAU - Lee, Jung-Hee AU - Lee JH AD - Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. FAU - Park, Joon Seong AU - Park JS AD - Department of Hematology/Oncology, Ajou University School of Medicine, Suwon, Korea. FAU - Jeong, Seong Hyun AU - Jeong SH AD - Department of Hematology/Oncology, Ajou University School of Medicine, Suwon, Korea. FAU - Lee, Mark Hong AU - Lee MH AD - Department of Internal Medicine, Konkuk University Medical Center, Seoul, Korea. FAU - Kim, Yang-Soo AU - Kim YS AD - Department of Hematology/Oncology, Kosin University College of Medicine, Busan, Korea. FAU - Lee, Ho Sup AU - Lee HS AD - Department of Hematology/Oncology, Kosin University College of Medicine, Busan, Korea. FAU - Park, Keon Woo AU - Park KW AD - Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea. FAU - Lee, Won-Sik AU - Lee WS AD - Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea. FAU - Lee, Sang Min AU - Lee SM AD - Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea. FAU - Lee, Jeong-Ok AU - Lee JO AD - Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Korea. FAU - Hyun, Myung Soo AU - Hyun MS AD - Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea. FAU - Jo, Deog Yeon AU - Jo DY AD - Department of Hematology/Oncology, Chungnam National University Hospital, Daejeon, Korea. FAU - Lim, Sung-Nam AU - Lim SN AD - Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea. FAU - Lee, Jae Hoon AU - Lee JH AD - Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea. FAU - Cho, Do-Yeun AU - Cho DY AD - Department of Internal Medicine, Konyang University Hospital, Daejeon, Korea. FAU - Do, Young Rok AU - Do YR AD - Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea. FAU - Kim, Jeong-A AU - Kim JA AD - Department of Hematology, College of Medicine, The Catholic University of Korea, Seoul, Korea. FAU - Park, Seong Kyu AU - Park SK AD - Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea. FAU - Kim, Jin Seok AU - Kim JS AD - Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Kim, Soo-Jeong AU - Kim SJ AD - Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Kim, Hawk AU - Kim H AD - Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea. FAU - Yi, Hyeon Gyu AU - Yi HG AD - Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea. FAU - Moon, Joon Ho AU - Moon JH AD - Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea. FAU - Choi, Chul Won AU - Choi CW AD - Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea. FAU - Kim, Sung-Hyun AU - Kim SH AD - Department of Internal Medicine, Dong-A Medical Center, Dong-A University College of Medicine, Busan, Korea. FAU - Joo, Young-Don AU - Joo YD AD - Department of Hemato-Oncology, Inje University Haeundae Paik Hospital, Busan, Korea. FAU - Kim, Hoon-Gu AU - Kim HG AD - Department of Internal Medicine, Gyeongsang Institute of Health Sciences, Gyeongsang National University School of Medicine and Gyeongsang National University Changwon Hospital, Changwon, Korea. FAU - Kim, Byung Soo AU - Kim BS AD - Department of Hematology, Korea University Medical Center, Korea University College of Medicine, Seoul, Korea. FAU - Park, Moo-Rim AU - Park MR AD - Department of Internal Medicine, School of Medicine, Wonkwang University, Iksan, Korea. FAU - Song, Moo-Kon AU - Song MK AD - Department of Hemato-Oncology, Hanyang University Hanmaeum Changwon Hospital, Changwon, Korea. FAU - Kim, Su-Youn AU - Kim SY AD - Medical Affairs, Janssen Korea, Seoul, Korea. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PL - United States TA - Oncotarget JT - Oncotarget JID - 101532965 RN - 69G8BD63PP (Bortezomib) RN - Q41OR9510P (Melphalan) RN - VB0R961HZT (Prednisone) SB - IM MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Asian People MH - Bortezomib/administration & dosage/adverse effects MH - Diarrhea/chemically induced MH - Drug Administration Schedule MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Melphalan/administration & dosage/adverse effects MH - Middle Aged MH - Multiple Myeloma/*drug therapy/ethnology/pathology MH - Neoplasm Staging MH - Neutropenia/chemically induced MH - Prednisone/administration & dosage/adverse effects MH - Prospective Studies MH - Republic of Korea MH - Treatment Outcome PMC - PMC5514934 OTO - NOTNLM OT - aged OT - bortezomib OT - combination OT - drug therapy OT - multiple myeloma COIS- CONFLICTS OF INTEREST The authors have no potential conflicts of interest. EDAT- 2017/04/14 06:00 MHDA- 2018/03/20 06:00 PMCR- 2017/06/06 CRDT- 2017/04/14 06:00 PHST- 2016/09/20 00:00 [received] PHST- 2017/01/10 00:00 [accepted] PHST- 2017/04/14 06:00 [pubmed] PHST- 2018/03/20 06:00 [medline] PHST- 2017/04/14 06:00 [entrez] PHST- 2017/06/06 00:00 [pmc-release] AID - 16790 [pii] AID - 10.18632/oncotarget.16790 [doi] PST - ppublish SO - Oncotarget. 2017 Jun 6;8(23):37605-37618. doi: 10.18632/oncotarget.16790.