TY - JOUR
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
N1 - Funding Information:
This study was supported by Zenyaku Kogyo (Tokyo, Japan). The authors thank the patients and their families and all the investigators, including the physicians, nurses, clinical research coordinators (CRC), and laboratory technicians in the participating institutions of this multicenter trial. The authors are grateful to Drs K. Toyama (Tokyo Medical College, Tokyo, Japan), N. Horikoshi (Juntendo University School of Medicine, Tokyo, Japan), and M. Mori (Japanese Red Cross Medical Center, Tokyo, Japan) for their critical review of the clinical data as members of the Independent Data and Safety Monitoring Committee. The authors are also grateful to Drs S. Nakamura (Nagoya University Graduate School of Medicine, Nagoya, Japan), and Y. Matsuno (Hokkaido University Hospital, Sapporo, Japan) for their histopathological review as members of the Central Pathology Review Committee, and M. Matsusako (St. Luke’s International Hospital, Tokyo, Japan) for their central radiological review as members of the CT Review Committee. The authors also acknowledge K. Endo, H. Harada, T. Ito, I. Okugaito, M. Watanabe, M. Abe, T Oba, S. Kamiyama, and T. Kayo (Zenyaku Kogyo) for their help with data collection and statistical analysis.
Funding Information:
Tadahiko Igarashi and Kiyoshi Ando received research funding from Zenyaku Kogyo. Masafumi Taniwaki and Kazuhito Yamamoto received research funding from Chugai Pharmaceutical. Hirokazu Nagai received honoraria from Chugai Pharmaceutical. Yasuo Ohashi is a board member and stockholder of Statcom and received honoraria from Chugai Pharmaceutical. Kensei Tobinai received research funding from Zenyaku Kogyo and Chugai Pharmaceutical, and honoraria from Zenyaku Kogyo. The remaining authors have no conflict of interests to disclose.
Publisher Copyright:
© 2016, The Japanese Society of Hematology.
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/m2 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/m2 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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U2 - 10.1007/s12185-016-2097-9
DO - 10.1007/s12185-016-2097-9
M3 - Article
C2 - 27714587
AN - SCOPUS:84990822029
VL - 104
SP - 700
EP - 708
JO - International Journal of Hematology
JF - International Journal of Hematology
SN - 0925-5710
IS - 6
ER -