title: Reduced frequency treatment with bortezomib plus dexamethasone for elderly patients with relapsed and/or refractory multiple myeloma: a phase 2 study of the Japanese Myeloma Study Group (JMSG-0902).
abstract: Bortezomib is one of the most widely used novel drugs for the treatment of multiple myeloma (MM). However, twice-weekly intravenous administration is associated with innegligible adverse events and treatment discontinuation. We therefore evaluated the long-term efficacy and feasibility of reduced frequency treatment with intravenous bortezomib in elderly patients with relapsed and/or refractory MM. A total of 47 bortezomib-naïve patients (median age 75 years) received bortezomib (1.3 mg/m(2), intravenously) and dexamethasone (20 mg) on days 1, 8, and 15 of every 4-week cycle. Twenty-six patients completed the planned 8 cycles. Best responses were stringent complete response (sCR) in 5 patients, very good partial response (VGPR) in 3, PR in 15, stable disease (SD) in 18, and disease progression (PD) in 6, respectively. Median progression-free and overall survivals were 9.6 and 35.1 months, respectively. After progression, 11 patients were retreated with bortezomib-based regimens and another 24 patients with immunomodulatory drugs. Multivariate analysis revealed that ISS 3, t(4;14), and <4 therapy cycles were significantly poor prognostic factors and that subsequent therapy with bortezomib-based regimens was a favorable factor for extended OS. The common adverse events were diarrhea, constipation, and peripheral neuropathy with no grade 4 toxicity. In conclusion, reduced frequency treatment with intravenous bortezomib + dexamethasone is an effective option for elderly patients with MM.
authors.affiliation: Department of Hematology, Tokushima Prefectural Central Hospital, 1-10-3 Kuramoto, Tokushima, 770-8539, Japan. ozaki@tph.gr.jp.
authors.forename: Shuji
authors.initials: S
authors.lastname: Ozaki
authors.affiliation: Division of Informative Clinical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Hata
authors.affiliation: Department of Medicine and Bioregulatory Sciences, University of Tokushima, Tokushima, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Abe
authors.affiliation: Department of Laboratory Sciences, Graduate School of Health Sciences, Gunma University, Maebashi, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Saitoh
authors.affiliation: Department of Hematology, Aichi Medical University, Nagakute, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Hanamura
authors.affiliation: Department of Hematology, Kainan Hospital, Aichi Prefectural Welfare Federation of Agricultural Cooperatives, Yatomi, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yano
authors.affiliation: Department of Hematology, NHO Okayama Medical Center, Okayama, Japan.
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Sunami
authors.affiliation: Department of Hematology, Ogaki Municipal Hospital, Ogaki, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kosugi
authors.affiliation: Department of Hematology, NHO Nishigunma Hospital, Shibukawa, Japan.
authors.forename: Morio
authors.initials: M
authors.lastname: Sawamura
authors.affiliation: Department of Hematology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Nakazato
authors.affiliation: Department of Hematology, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Taro
authors.initials: T
authors.lastname: Masunari
authors.affiliation: Tama-Hokubu Medical Center, Higashimurayama, Japan.
authors.forename: Mayumi
authors.initials: M
authors.lastname: Mori
authors.affiliation: Department of Hematology and Oncology, Kimitsu Chuo Hospital, Kisarazu, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Takagi
authors.affiliation: Department of Laboratory Sciences, Graduate School of Health Sciences, Gunma University, Maebashi, Japan.
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Murakami
authors.affiliation: Department of Hematology, Tokai Central Hospital, Kakamigahara, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimizu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000069286:Bortezomib / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000069286:Bortezomib; D003907:Dexamethasone
keywords: Bortezomib; Dexamethasone; Multiple myeloma; Refractory; Relapsed