title: 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.
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.
authors.affiliation: Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea.
authors.forename: Min Kyoung
authors.initials: MK
authors.lastname: Kim
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Kihyun
authors.initials: K
authors.lastname: Kim
authors.affiliation: Division of Hematology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
authors.forename: Chang-Ki
authors.initials: CK
authors.lastname: Min
authors.affiliation: Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
authors.forename: Jae-Yong
authors.initials: JY
authors.lastname: Kwak
authors.affiliation: Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan, Korea.
authors.forename: Sang-Byung
authors.initials: SB
authors.lastname: Bae
authors.affiliation: Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
authors.forename: Sung-Soo
authors.initials: SS
authors.lastname: Yoon
authors.affiliation: Department of Hematology/Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea.
authors.forename: Je-Jung
authors.initials: JJ
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea.
authors.forename: Ki Hwan
authors.initials: KH
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, VHS Medical Center, Seoul, Korea.
authors.forename: Seung-Hyun
authors.initials: SH
authors.lastname: Nam
authors.affiliation: Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
authors.forename: Yeung-Chul
authors.initials: YC
authors.lastname: Mun
authors.affiliation: Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
authors.forename: Sung Hwa
authors.initials: SH
authors.lastname: Bae
authors.affiliation: Department of Internal Medicine, Division of Hematology/Oncology, School of Medicine, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Ho-Jin
authors.initials: HJ
authors.lastname: Shin
authors.affiliation: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Jung-Hee
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Hematology/Oncology, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Joon Seong
authors.initials: JS
authors.lastname: Park
authors.affiliation: Department of Hematology/Oncology, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Seong Hyun
authors.initials: SH
authors.lastname: Jeong
authors.affiliation: Department of Internal Medicine, Konkuk University Medical Center, Seoul, Korea.
authors.forename: Mark Hong
authors.initials: MH
authors.lastname: Lee
authors.affiliation: Department of Hematology/Oncology, Kosin University College of Medicine, Busan, Korea.
authors.forename: Yang-Soo
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Department of Hematology/Oncology, Kosin University College of Medicine, Busan, Korea.
authors.forename: Ho Sup
authors.initials: HS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea.
authors.forename: Keon Woo
authors.initials: KW
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
authors.forename: Won-Sik
authors.initials: WS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
authors.forename: Sang Min
authors.initials: SM
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.
authors.forename: Jeong-Ok
authors.initials: JO
authors.lastname: Lee
authors.affiliation: Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea.
authors.forename: Myung Soo
authors.initials: MS
authors.lastname: Hyun
authors.affiliation: Department of Hematology/Oncology, Chungnam National University Hospital, Daejeon, Korea.
authors.forename: Deog Yeon
authors.initials: DY
authors.lastname: Jo
authors.affiliation: Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.
authors.forename: Sung-Nam
authors.initials: SN
authors.lastname: Lim
authors.affiliation: Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Konyang University Hospital, Daejeon, Korea.
authors.forename: Do-Yeun
authors.initials: DY
authors.lastname: Cho
authors.affiliation: Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
authors.forename: Young Rok
authors.initials: YR
authors.lastname: Do
authors.affiliation: Department of Hematology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jeong-A
authors.initials: JA
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
authors.forename: Seong Kyu
authors.initials: SK
authors.lastname: Park
authors.affiliation: Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Soo-Jeong
authors.initials: SJ
authors.lastname: Kim
authors.affiliation: Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Hawk
authors.initials: H
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
authors.forename: Hyeon Gyu
authors.initials: HG
authors.lastname: Yi
authors.affiliation: Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, Korea.
authors.forename: Joon Ho
authors.initials: JH
authors.lastname: Moon
authors.affiliation: Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Chul Won
authors.initials: CW
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Dong-A Medical Center, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Sung-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Department of Hemato-Oncology, Inje University Haeundae Paik Hospital, Busan, Korea.
authors.forename: Young-Don
authors.initials: YD
authors.lastname: Joo
authors.affiliation: Department of Internal Medicine, Gyeongsang Institute of Health Sciences, Gyeongsang National University School of Medicine and Gyeongsang National University Changwon Hospital, Changwon, Korea.
authors.forename: Hoon-Gu
authors.initials: HG
authors.lastname: Kim
authors.affiliation: Department of Hematology, Korea University Medical Center, Korea University College of Medicine, Seoul, Korea.
authors.forename: Byung Soo
authors.initials: BS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, School of Medicine, Wonkwang University, Iksan, Korea.
authors.forename: Moo-Rim
authors.initials: MR
authors.lastname: Park
authors.affiliation: Department of Hemato-Oncology, Hanyang University Hanmaeum Changwon Hospital, Changwon, Korea.
authors.forename: Moo-Kon
authors.initials: MK
authors.lastname: Song
authors.affiliation: Medical Affairs, Janssen Korea, Seoul, Korea.
authors.forename: Su-Youn
authors.initials: SY
authors.lastname: Kim
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D000069286:Bortezomib / Q000008:administration & dosage / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008558:Melphalan / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D056910:Republic of Korea; D016896:Treatment Outcome
chemical_list: D000069286:Bortezomib; D008558:Melphalan; D011241:Prednisone
keywords: aged; bortezomib; combination; drug therapy; multiple myeloma