Phase I/II study of tandem high-dose chemotherapy with autologous peripheral blood stem cell transplantation for advanced multiple myeloma.
The efficacy and safety of high-dose chemotherapy with tandem autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in a multicenter clinical study of patients with advanced multiple myeloma. Eligible patients (n = 40) were consecutively enrolled in the phase I/II study and received 2-4 cycles of vincristine-adriamycin-dexamethasone regimen. The responding patients underwent PBSC harvesting following high-dose cyclophosphamide and filgrastim administration. The first auto-PBSCT (n = 32) following high-dose melphalan (200 mg/m(2)) was performed within 2 months of PBSC harvesting; the second auto-PBSCT (n = 28) was scheduled 3-6 months later. Treatment-related mortality was 2.5% (n = 1) throughout the protocol. Grade 4 nonhematologic toxicity occurred in 12.5 and 14.3% of the first and second auto-PBSCT patients, respectively. All but one patient (who died) achieved hematopoietic recovery. For the 28 patients completing the second auto-PBSCT, the results were favorable with a response rate of 65% (complete response rate = 27.5%, n = 11); the five-year progression-free survival and overall survival were 20.3 and 66.5%, respectively. In conclusion, high-dose chemotherapy with tandem auto-PBSCT is feasible and safe with a favorable response rate in treating advanced multiple myeloma in Japan.
Sunami
Kazutaka
K
Division of Hematology, Department of Internal Medicine, National Hospital Organization Okayama Medical Center, 1711-1 Tamasu, Kitaku, Okayama, 701-1192, Japan. kazusuna@pop12.odn.ne.jp.
Shinagawa
Katsuji
K
Division of Hematology/Oncology, Okayama University Medical School, Okayama, Japan.
Sawamura
Morio
M
Department of Internal Medicine, Nishigunma National Hospital, Shibukawa, Gunma, Japan.
Sakai
Akira
A
Department of Hematology/Oncology, Institute for Rad. Biology and Medicine, Hiroshima University, Hiroshima, Japan.
Saburi
Yoshio
Y
Department of Hematology, Oita Prefectural Hospital, Oita, Japan.
Imamura
Yutaka
Y
Division of Hematology, St. Mary's Hospital, Kurume, Fukuoka, Japan.
Mizuno
Ishikazu
I
Hematology Division, Department of Medicine, Hyogo Cancer Center, Akashi, Hyogo, Japan.
Tamaki
Shigehisa
S
Department of Internal Medicine, Yamada Red Cross Hospital, Ise, Mie, Japan.
Kamimura
Tomohiko
T
Department of Hematology, Harasanshin Hospital, Fukuoka, Japan.
Tsuda
Hiroyuki
H
Division of Hematology/Oncology, Kumamoto City Hospital, Kumamoto, Japan.
Gondo
Hisashi
H
Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.
Hino
Norihiko
N
Department of Internal Medicine, Kure Kyosai Hospital, Kure, Hiroshima, Japan.
Shimazaki
Chihiro
C
Division of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Miyata
Akira
A
Department of Internal Medicine, Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuyama, Hiroshima, Japan.
Tajima
Fumihito
F
Division of Blood Transfusion, Tottori University Hospital, Yonago, Tottori, Japan.
Takemoto
Yoshinobu
Y
Medical Corporation Kouryokai CPC Clinic, Kagoshima, Japan.
Miwa
Akiyoshi
A
Department of Hematology, International Medical Center of Japan, Tokyo, Japan.
Chou
Takaaki
T
Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
Harada
Mine
M
Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, Fukuoka, Japan.
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods / Q000401:mortality; D003907:Dexamethasone / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D006801:Humans; D009101:Multiple Myeloma / Q000401:mortality / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods*; D015996:Survival Rate; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin