title: Efficacy of upfront high-dose chemotherapy plus rituximab followed by autologous peripheral blood stem cell transplantation for untreated high-intermediate-, and high-risk diffuse large B-cell lymphoma: a multicenter prospective phase II study (JSCT-NHL04).
abstract: To evaluate the efficacy and feasibility of upfront high-dose chemotherapy (HDCT) and rituximab (R) followed by autologous peripheral blood stem cell transplantation (auto-PBSCT) in patients with newly diagnosed high-intermediate(HI)-, and high(H)-risk diffuse large B-cell lymphoma (DLBCL), we conducted a multicenter prospective phase II trial. In 15-60-year-old patients with H- or HI-risk DLBCL, after three courses of (R-)CHOP14, high-dose etoposide was given prior to peripheral blood stem cell harvesting. After an additional three courses of (R-)CHOP14, auto-PBSCT was performed following HDCT. The primary endpoint of the study is progression-free survival (PFS) at 2 years after registration in eligible patients. The expected PFS and the threshold PFS were estimated to be 70 and 50 %, respectively. Among 40 eligible patients registered, 30 patients completed treatment. With a median observation period in surviving eligible patients of 63 months, the 2- and 4-year PFS after registration were 79.9 and 72.0 %, respectively. The 2- and 4-year overall survival (OS) were 92.5 and 84.6 %, respectively. In 30 patients who completed treatment, the 4-year PFS and OS after auto-PBSCT were 79.2 and 85.9 %, respectively. In conclusion, the results of our study suggest that upfront HDCT and auto-PBSCT combined with rituximab is highly effective as an initial treatment for HI-, and H-risk DLBCL.
authors.affiliation: Department of Hematology, Hyogo Cancer Center, 13-70, Kita-oji, Akashi, Hyogo, 673-8558, Japan. tmurayam@hp.pref.hyogo.jp.
authors.forename: Tohru
authors.initials: T
authors.lastname: Murayama
authors.affiliation: Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Fukuda
authors.affiliation: Hematology Department, Toyama Prefectural Central Hospital, Toyama, Japan.
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Okumura
authors.affiliation: Division of Hematology, Department of Internal Medicine National Hospital Organization, Okayama Medical Center, Okayama, Japan.
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Sunami
authors.affiliation: Department of Hematology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
authors.forename: Aiko
authors.initials: A
authors.lastname: Sawazaki
authors.affiliation: Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Maeda
authors.affiliation: First Department of Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Tsurumi
authors.affiliation: Department of Hematology, National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Naokuni
authors.initials: N
authors.lastname: Uike
authors.affiliation: Division of Gastroenterology and Hematology, University of Miyazaki Hospital, Miyazaki, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hidaka
authors.affiliation: Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
authors.forename: Yoshifusa
authors.initials: Y
authors.lastname: Takatsuka
authors.affiliation: Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Eto
authors.affiliation: Division of Hematology and Oncology, Kumamoto City Hospital, Kumamoto, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tsuda
authors.affiliation: Department of Internal Medicine, Matsuyama Red Cross Hospital, Matsuyama, Japan.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Fujisaki
authors.affiliation: Department of Hematology and Oncology, Kyusyu University Hospital, Fukuoka, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Miyamoto
authors.affiliation: Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Tsuneyoshi
authors.affiliation: Fourth Department of Internal Medicine, Sapporo Medical University Hospital, Sapporo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Iyama
authors.affiliation: Division of Hematology and Oncology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Nagafuji
authors.affiliation: Department of Internal Medicine, Karatsu Matsuura Ishikai Hospital, Karatsu, Japan.|Japan Study Group for Cell Therapy and Transplantation (JSCT), Tochigi, Japan.
authors.forename: Mine
authors.initials: M
authors.lastname: Harada
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D005047:Etoposide / Q000627:therapeutic use; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy / Q000401:mortality* / Q000628:therapy*; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation; D011241:Prednisone / Q000627:therapeutic use; D000069283:Rituximab / Q000008:administration & dosage*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014750:Vincristine / Q000627:therapeutic use
chemical_list: D000069283:Rituximab; D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone
keywords: Autologous peripheral blood stem cell transplantation; CHOP14; Diffuse large B-cell lymphoma; High-dose chemotherapy; Rituximab