TY - JOUR
T1 - 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)
AU - Ogiya, Daisuke
AU - Shibayama, Hirohiko
AU - Nakatani, Eiji
AU - Ando, Kiyoshi
AU - Suzuki, Kenshi
AU - Kuroda, Yoshiaki
AU - Uchida, Toshiki
AU - Maruyama, Dai
AU - Matsumoto, Morio
AU - Matsue, Kosei
AU - Iida, Shinsuke
AU - Terui, Yasuhito
AU - Ri, Masaki
AU - Chou, Takaaki
AU - Aotsuka, Nobuyuki
AU - Tabata, Sumie
AU - Konishi, Jun
AU - Ohashi, Kazuteru
AU - Shinagawa, Atsushi
AU - Sugiura, Isamu
AU - Kuroda, Junya
AU - Miyamoto, Toshihiro
AU - Ogura, Michinori
AU - Tobinai, Kensei
AU - Kanakura, Yuzuru
AU - Hotta, Tomomitsu
PY - 2016/1/1
Y1 - 2016/1/1
N2 - 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/m2 or 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.
AB - 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/m2 or 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.
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M3 - Article
C2 - 27941278
AN - SCOPUS:85016108490
VL - 57
SP - 2311
EP - 2318
JO - [Rinsho ketsueki] The Japanese journal of clinical hematology
JF - [Rinsho ketsueki] The Japanese journal of clinical hematology
SN - 0485-1439
IS - 11
ER -