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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)

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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.

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Acknowledgments

This work was supported by a Grant from the Regional Medicine Research Foundation (Tochigi, Japan).

Author information

Authors and Affiliations

  1. Department of Hematology, Hyogo Cancer Center, 13-70, Kita-oji, Akashi, Hyogo, 673-8558, Japan

    Tohru Murayama

  2. Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan

    Takahiro Fukuda

  3. Hematology Department, Toyama Prefectural Central Hospital, Toyama, Japan

    Hirokazu Okumura

  4. Division of Hematology, Department of Internal Medicine National Hospital Organization, Okayama Medical Center, Okayama, Japan

    Kazutaka Sunami

  5. Department of Hematology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan

    Aiko Sawazaki

  6. Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan

    Yoshinobu Maeda

  7. First Department of Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan

    Hisashi Tsurumi

  8. Department of Hematology, National Kyushu Cancer Center, Fukuoka, Japan

    Naokuni Uike

  9. Division of Gastroenterology and Hematology, University of Miyazaki Hospital, Miyazaki, Japan

    Tomonori Hidaka

  10. Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan

    Yoshifusa Takatsuka

  11. Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan

    Tetsuya Eto

  12. Division of Hematology and Oncology, Kumamoto City Hospital, Kumamoto, Japan

    Hiroyuki Tsuda

  13. Department of Internal Medicine, Matsuyama Red Cross Hospital, Matsuyama, Japan

    Tomoaki Fujisaki

  14. Department of Hematology and Oncology, Kyusyu University Hospital, Fukuoka, Japan

    Toshihiro Miyamoto

  15. Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan

    Naoko Tsuneyoshi

  16. Fourth Department of Internal Medicine, Sapporo Medical University Hospital, Sapporo, Japan

    Satoshi Iyama

  17. Division of Hematology and Oncology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan

    Koji Nagafuji

  18. Department of Internal Medicine, Karatsu Matsuura Ishikai Hospital, Karatsu, Japan

    Mine Harada

  19. Japan Study Group for Cell Therapy and Transplantation (JSCT), Tochigi, Japan

    Mine Harada

Authors
  1. Tohru Murayama
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  2. Takahiro Fukuda
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  3. Hirokazu Okumura
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  4. Kazutaka Sunami
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  8. Naokuni Uike
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  18. Mine Harada
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Correspondence to Tohru Murayama.

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Murayama, T., Fukuda, T., Okumura, H. et al. 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). Int J Hematol 103, 676–685 (2016). https://doi.org/10.1007/s12185-016-1976-4

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  • DOI: https://doi.org/10.1007/s12185-016-1976-4

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