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)

• Published in: International journal of hematology 2016-06, Vol.103 (6), p.676-685
• Main Authors: Murayama, Tohru, Fukuda, Takahiro, Okumura, Hirokazu, Sunami, Kazutaka, Sawazaki, Aiko, Maeda, Yoshinobu, Tsurumi, Hisashi, Uike, Naokuni, Hidaka, Tomonori, Takatsuka, Yoshifusa, Eto, Tetsuya, Tsuda, Hiroyuki, Fujisaki, Tomoaki, Miyamoto, Toshihiro, Tsuneyoshi, Naoko, Iyama, Satoshi, Nagafuji, Koji, Harada, Mine
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cyclophosphamide - therapeutic use; Doxorubicin - therapeutic use; Etoposide - therapeutic use; Hematology; Humans; Lymphoma, Large B-Cell, Diffuse - drug therapy; Lymphoma, Large B-Cell, Diffuse - mortality; Lymphoma, Large B-Cell, Diffuse - therapy; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Article; Peripheral Blood Stem Cell Transplantation; Prednisone - therapeutic use; Rituximab - administration & dosage; Transplantation, Autologous; Treatment Outcome; Vincristine - therapeutic use
• ISSN: 0925-5710; 1865-3774
• DOI: 10.1007/s12185-016-1976-4

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.