Japanese phase II study of rituximab maintenance for untreated indolent B-cell non-Hodgkin lymphoma with high tumor burden

Tadahiko Igarashi, Michinori Ogura, Kuniaki Itoh, Masafumi Taniwaki, Kiyoshi Ando, Yoshiaki Kuroda, Kazuhito Yamamoto, Naokuni Uike, Akihiro Tomita, Hirokazu Nagai, Mitsutoshi Kurosawa, Shigeo Mori, Shigeru Nawano, Takashi Terauchi, Yasuo Ohashi, Kensei Tobinai

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Abstract

Recent large-scale randomized clinical trials in Europe and the US demonstrated that maintenance therapy with rituximab significantly improved the progression-free survival (PFS) in indolent B-cell non-Hodgkin lymphoma (B-NHL) patients, especially those with follicular lymphoma (FL). However, rituximab maintenance has not been approved in Japan, because there are no clinical data supporting the benefit of rituximab maintenance in Japanese patients. Therefore, we conducted a single-arm, multicenter bridging study in previously untreated indolent B-NHL patients with high tumor burden. The primary endpoint was 4-year PFS and was expected to be 70 % based on previous studies. Sixty-two patients, including 55 FL patients, were enrolled and received induction therapy with CHOP combined with rituximab (R-CHOP). Fifty-eight patients responding to R-CHOP induction received rituximab at 375 mg/m 2 every 8 weeks for 2 years as for the rituximab maintenance arm in the PRIMA study. A 4-year PFS of 69.8 % was obtained (95 % confidence interval 55.9–80.0 %). Rituximab maintenance was well tolerated and common adverse events were infections, neutropenia, and/or leukopenia that were manageable with conventional supportive care. No patients died. These data were compatible with the PRIMA data. R-CHOP induction followed by rituximab is useful in Japanese patients with untreated indolent B-NHL having high tumor burden. Clinical trial number UMIN000001191

Original languageEnglish
Pages (from-to)700-708
Number of pages9
JournalInternational Journal of Hematology
Volume104
Issue number6
DOIs
Publication statusPublished - 01-12-2016

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B-Cell Lymphoma
Tumor Burden
Non-Hodgkin's Lymphoma
Maintenance
Disease-Free Survival
Follicular Lymphoma
Rituximab
Leukopenia
Neutropenia
Multicenter Studies
Japan
Randomized Controlled Trials
Clinical Trials
Confidence Intervals
Therapeutics
Infection

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Igarashi, Tadahiko ; Ogura, Michinori ; Itoh, Kuniaki ; Taniwaki, Masafumi ; Ando, Kiyoshi ; Kuroda, Yoshiaki ; Yamamoto, Kazuhito ; Uike, Naokuni ; Tomita, Akihiro ; Nagai, Hirokazu ; Kurosawa, Mitsutoshi ; Mori, Shigeo ; Nawano, Shigeru ; Terauchi, Takashi ; Ohashi, Yasuo ; Tobinai, Kensei. / Japanese phase II study of rituximab maintenance for untreated indolent B-cell non-Hodgkin lymphoma with high tumor burden. In: International Journal of Hematology. 2016 ; Vol. 104, No. 6. pp. 700-708.
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abstract = "Recent large-scale randomized clinical trials in Europe and the US demonstrated that maintenance therapy with rituximab significantly improved the progression-free survival (PFS) in indolent B-cell non-Hodgkin lymphoma (B-NHL) patients, especially those with follicular lymphoma (FL). However, rituximab maintenance has not been approved in Japan, because there are no clinical data supporting the benefit of rituximab maintenance in Japanese patients. Therefore, we conducted a single-arm, multicenter bridging study in previously untreated indolent B-NHL patients with high tumor burden. The primary endpoint was 4-year PFS and was expected to be 70 {\%} based on previous studies. Sixty-two patients, including 55 FL patients, were enrolled and received induction therapy with CHOP combined with rituximab (R-CHOP). Fifty-eight patients responding to R-CHOP induction received rituximab at 375 mg/m 2 every 8 weeks for 2 years as for the rituximab maintenance arm in the PRIMA study. A 4-year PFS of 69.8 {\%} was obtained (95 {\%} confidence interval 55.9–80.0 {\%}). Rituximab maintenance was well tolerated and common adverse events were infections, neutropenia, and/or leukopenia that were manageable with conventional supportive care. No patients died. These data were compatible with the PRIMA data. R-CHOP induction followed by rituximab is useful in Japanese patients with untreated indolent B-NHL having high tumor burden. Clinical trial number UMIN000001191",
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Igarashi, T, Ogura, M, Itoh, K, Taniwaki, M, Ando, K, Kuroda, Y, Yamamoto, K, Uike, N, Tomita, A, Nagai, H, Kurosawa, M, Mori, S, Nawano, S, Terauchi, T, Ohashi, Y & Tobinai, K 2016, 'Japanese phase II study of rituximab maintenance for untreated indolent B-cell non-Hodgkin lymphoma with high tumor burden', International Journal of Hematology, vol. 104, no. 6, pp. 700-708. https://doi.org/10.1007/s12185-016-2097-9

Japanese phase II study of rituximab maintenance for untreated indolent B-cell non-Hodgkin lymphoma with high tumor burden. / Igarashi, Tadahiko; Ogura, Michinori; Itoh, Kuniaki; Taniwaki, Masafumi; Ando, Kiyoshi; Kuroda, Yoshiaki; Yamamoto, Kazuhito; Uike, Naokuni; Tomita, Akihiro; Nagai, Hirokazu; Kurosawa, Mitsutoshi; Mori, Shigeo; Nawano, Shigeru; Terauchi, Takashi; Ohashi, Yasuo; Tobinai, Kensei.

In: International Journal of Hematology, Vol. 104, No. 6, 01.12.2016, p. 700-708.

Research output: Contribution to journalArticle

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T1 - Japanese phase II study of rituximab maintenance for untreated indolent B-cell non-Hodgkin lymphoma with high tumor burden

AU - Igarashi, Tadahiko

AU - Ogura, Michinori

AU - Itoh, Kuniaki

AU - Taniwaki, Masafumi

AU - Ando, Kiyoshi

AU - Kuroda, Yoshiaki

AU - Yamamoto, Kazuhito

AU - Uike, Naokuni

AU - Tomita, Akihiro

AU - Nagai, Hirokazu

AU - Kurosawa, Mitsutoshi

AU - Mori, Shigeo

AU - Nawano, Shigeru

AU - Terauchi, Takashi

AU - Ohashi, Yasuo

AU - Tobinai, Kensei

PY - 2016/12/1

Y1 - 2016/12/1

N2 - Recent large-scale randomized clinical trials in Europe and the US demonstrated that maintenance therapy with rituximab significantly improved the progression-free survival (PFS) in indolent B-cell non-Hodgkin lymphoma (B-NHL) patients, especially those with follicular lymphoma (FL). However, rituximab maintenance has not been approved in Japan, because there are no clinical data supporting the benefit of rituximab maintenance in Japanese patients. Therefore, we conducted a single-arm, multicenter bridging study in previously untreated indolent B-NHL patients with high tumor burden. The primary endpoint was 4-year PFS and was expected to be 70 % based on previous studies. Sixty-two patients, including 55 FL patients, were enrolled and received induction therapy with CHOP combined with rituximab (R-CHOP). Fifty-eight patients responding to R-CHOP induction received rituximab at 375 mg/m 2 every 8 weeks for 2 years as for the rituximab maintenance arm in the PRIMA study. A 4-year PFS of 69.8 % was obtained (95 % confidence interval 55.9–80.0 %). Rituximab maintenance was well tolerated and common adverse events were infections, neutropenia, and/or leukopenia that were manageable with conventional supportive care. No patients died. These data were compatible with the PRIMA data. R-CHOP induction followed by rituximab is useful in Japanese patients with untreated indolent B-NHL having high tumor burden. Clinical trial number UMIN000001191

AB - Recent large-scale randomized clinical trials in Europe and the US demonstrated that maintenance therapy with rituximab significantly improved the progression-free survival (PFS) in indolent B-cell non-Hodgkin lymphoma (B-NHL) patients, especially those with follicular lymphoma (FL). However, rituximab maintenance has not been approved in Japan, because there are no clinical data supporting the benefit of rituximab maintenance in Japanese patients. Therefore, we conducted a single-arm, multicenter bridging study in previously untreated indolent B-NHL patients with high tumor burden. The primary endpoint was 4-year PFS and was expected to be 70 % based on previous studies. Sixty-two patients, including 55 FL patients, were enrolled and received induction therapy with CHOP combined with rituximab (R-CHOP). Fifty-eight patients responding to R-CHOP induction received rituximab at 375 mg/m 2 every 8 weeks for 2 years as for the rituximab maintenance arm in the PRIMA study. A 4-year PFS of 69.8 % was obtained (95 % confidence interval 55.9–80.0 %). Rituximab maintenance was well tolerated and common adverse events were infections, neutropenia, and/or leukopenia that were manageable with conventional supportive care. No patients died. These data were compatible with the PRIMA data. R-CHOP induction followed by rituximab is useful in Japanese patients with untreated indolent B-NHL having high tumor burden. Clinical trial number UMIN000001191

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