title: Long-term follow-up results of a phase I/II study of melphalan, prednisolone and bortezomib in Japanese transplant-ineligible multiple myeloma patients (JPN-102).
abstract: The phase I/II study of melphalan-prednisolone-bortezomib (MPB) therapy in Japanese patients with previously untreated multiple myeloma (MM) who are ineligible for hematopoietic stem cell transplantation (JPN-102 trial) (registered between July 2008 and March 2011) showed an overall response rate in the MPB arm equivalent to that of the VISTA trial. In this study, we followed up the clinical data of 92 of the 101 patients registered in the JPN-102 trial to clarify the long-term outcomes of MPB therapy. The median follow-up period was 50.8 (0.9-66.1) months. The median age of this cohort was 72 (48-84) years. The median progression-free survival was 25.7 (95%CI: 21.3-33.9) months and the overall survival rates at 1, 3 and 5 years were 98, 86 and 76%, respectively. There was no significant difference in either progression-free survival or overall survival when comparing a total bortezomib amount of 39 mg/m2or more being administered versus less than 39 mg/m2. The outcomes of the JPN-102 cohort appeared, at a minimum, to not be inferior to those of the MPB cohort in the VISTA trial. A prospective trial is needed to establish the MPB regimen as being suitable for Japanese patients with multiple myeloma.
authors.affiliation: Department of Hematology and Oncology, Tokai University School of Medicine.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Ogiya
authors.forename: Hirohiko
authors.initials: H
authors.lastname: Shibayama
authors.forename: Eiji
authors.initials: E
authors.lastname: Nakatani
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ando
authors.forename: Kenshi
authors.initials: K
authors.lastname: Suzuki
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Kuroda
authors.forename: Toshiki
authors.initials: T
authors.lastname: Uchida
authors.forename: Dai
authors.initials: D
authors.lastname: Maruyama
authors.forename: Morio
authors.initials: M
authors.lastname: Matsumoto
authors.forename: Kosei
authors.initials: K
authors.lastname: Matsue
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Iida
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Terui
authors.forename: Masaki
authors.initials: M
authors.lastname: Ri
authors.forename: Takaaki
authors.initials: T
authors.lastname: Chou
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Aotsuka
authors.forename: Sumie
authors.initials: S
authors.lastname: Tabata
authors.forename: Jun
authors.initials: J
authors.lastname: Konishi
authors.forename: Kazuteru
authors.initials: K
authors.lastname: Ohashi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Shinagawa
authors.forename: Isamu
authors.initials: I
authors.lastname: Sugiura
authors.forename: Junya
authors.initials: J
authors.lastname: Kuroda
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Miyamoto
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Yuzuru
authors.initials: Y
authors.lastname: Kanakura
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069286:Bortezomib; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000069286:Bortezomib; D011239:Prednisolone; D008558:Melphalan