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
Department of Hematology, Hyogo Cancer Center, 13-70, Kita-oji, Akashi, Hyogo, 673-8558, Japan.
Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
Int J Hematol. 2016 Jun;103(6):676-85. doi: 10.1007/s12185-016-1976-4. Epub 2016 Mar 21.
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.
为评估新诊断的高中间（HI）-和高（H）风险弥漫性大B细胞淋巴瘤（DLBCL）患者先行大剂量化疗（HDCT）联合利妥昔单抗（R）继以自体外周血干细胞移植（auto-PBSCT）的疗效和可行性，我们开展了一项多中心前瞻性II期试验。在15至60岁的H或HI风险DLBCL患者中，在进行三个疗程的（R-）CHOP14方案治疗后，于外周血干细胞采集前给予大剂量依托泊苷。在再进行三个疗程的（R-）CHOP14方案治疗后，HDCT后进行auto-PBSCT。本研究的主要终点是符合条件的患者登记后2年的无进展生存期（PFS）。预计PFS和阈值PFS分别估计为70%和50%。在登记的40例符合条件的患者中，30例患者完成了治疗。存活的符合条件患者的中位观察期为63个月，登记后2年和4年的PFS分别为79.9%和72.0%。2年和4年的总生存期（OS）分别为92.5%和84.6%。在30例完成治疗的患者中，auto-PBSCT后4年的PFS和OS分别为79.2%和85.9%。总之，我们的研究结果表明，先行HDCT和auto-PBSCT联合利妥昔单抗作为HI-和H风险DLBCL的初始治疗是非常有效的。
