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)

Tohru Murayama, Takahiro Fukuda, Hirokazu Okumura, Kazutaka Sunami, Aiko Sawazaki, Yoshinobu Maeda, Hisashi Tsurumi, Naokuni Uike, Tomonori Hidaka, Yoshifusa Takatsuka, Tetsuya Eto, Hiroyuki Tsuda, Tomoaki Fujisaki, Toshihiro Miyamoto, Naoko Tsuneyoshi, Satoshi Iyama, Koji Nagafuji, Mine Harada

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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.

Original languageEnglish
Pages (from-to)676-685
Number of pages10
JournalInternational journal of hematology
Issue number6
Publication statusPublished - Jun 1 2016


All Science Journal Classification (ASJC) codes

  • Hematology

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