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Randomized Controlled Trial
. 2024 Mar;204(3):849-860.
doi: 10.1111/bjh.19213. Epub 2023 Nov 23.

R-CHOP treatment for patients with advanced follicular lymphoma: Over 15-year follow-up of JCOG0203

Takashi Watanabe  1 , Kensei Tobinai  1 , Masaki Wakabayashi  2 , Dai Maruyama  1 , Kazuhito Yamamoto  3 , Nobuko Kubota  4 , Kazuyuki Shimada  5 , Kohsuke Asagoe  6 , Motoko Yamaguchi  7 , Kiyoshi Ando  8 , Michinori Ogura  9 , Junya Kuroda  10 , Youko Suehiro  11 , Yoshihiro Matsuno  12 , Kunihiro Tsukasaki  13 , Hirokazu Nagai  14
Affiliations
Randomized Controlled Trial

R-CHOP treatment for patients with advanced follicular lymphoma: Over 15-year follow-up of JCOG0203

Takashi Watanabe et al. Br J Haematol. 2024 Mar.

Abstract

Anti-CD20 antibody in combination with chemotherapy extends overall survival (OS) in untreated advanced-stage follicular lymphoma (FL), yet the optimal associated therapy is unclear. Data on the cumulative incidence of secondary malignancies postrelapse after conventional immunochemotherapy are scarce. A long-term analysis of rituximab combined with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) as first-line treatment was conducted in a randomised clinical trial. A six-cycle R-CHOP regimen was administered every 2 or 3 weeks without rituximab maintenance. A prespecified evaluation was conducted 15 years after the completion of enrolment, following initial analysis results that showed no significant differences in outcomes at the 3-year mark. In-depth analyses were performed on the cohort of 248 patients with FL who were allocated to the two treatment arms. With a median follow-up period of 15.9 years, the 15-year OS was 76.2%. There were no protocol treatment-related deaths, nor were there any fatal infections attributable to subsequent lymphoma treatment. At 15 years, the cumulative incidence of non-haematological and haematological malignancies was 12.8% and 3.7% respectively. Histological transformation appeared after a median of 8 years. R-CHOP maintains safety and efficacy in patients with advanced FL over extended follow-up, making it a viable first-line option for patients with advanced-stage FL.

Trial registration: ClinicalTrials.gov NCT00147121.

Keywords: R-CHOP; follicular lymphoma; histological transformation; long term; secondary malignancies.

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Conflict of interest statement

T.W. reported receiving grants from BrightPath Biotherapeutics Co., Ltd. and T Cell Nouveau Inc. and personal fees from SymBio Pharmaceuticals Ltd. and Denka Co., Ltd. outside the submitted work. M.W. reported receiving personal fees from Nihon Medi-Physics Co., Ltd. outside the submitted work. D.M. reported receiving grants and personal fees from Celgene, Kyowa Kirin, Chugai, Ono, Takeda, Janssen, Sanofi, Bristol Myers Squibb, Eisai and MSD; grants from Amgen Astellas Biopharma, Novartis, Otsuka, Astellas, AbbVie and Taiho; and personal fees from Nippon Shinyaku, Mundipharma, Zenyaku, SymBio and AstraZeneca outside the submitted work. K.Y. reports receiving grants and personal fees from AbbVie, AstraZeneca, Bristol-Myers Squibb/Celgene, Chugai, Eisai, Meiji Seika Pharma, Nippon Shinyaku, Novartis, Otsuka Pharmaceutical, Takeda and Zenyaku, grants from IQVIA/Genmab, Ono Pharmaceutical, Solasia Pharma, Yakult and Incyte and personal fees from SymBio, HUYA/IQVIA Services Japan, Janssen, Kyowa Kirin, Micron/Daiichi Sankyo, MSD, Sanofi, Nippon Kayaku and Astellas outside the submitted work. K.S. reported receiving grants and personal fees from Celgene and Kyowa Kirin, grants from Otsuka and personal fees from AstraZeneca, Eisai, Takeda, Janssen, Bristol-Meyers Squibb, Chugai, Nippon Shinyaku, Daiichi Sankyo, Meiji Seika Pharma, Ono, AbbVie, Novartis, Gilead, CSL Behling, Incyte and Genmab outside the submitted work. M.Y. reported receiving grants and personal fees from Chugai Pharma, grants from Kyowa Kirin, Astellas, Genmab, Incyte and AstraZeneca and personal fees from AbbVie, Bristol Myers Squibb, Celgene, Janssen, Kyowa Kirin, Meiji Seika Pharma, MSD, Nippon Shinyaku, Otsuka Pharmaceutical, Ono Pharmaceutical, SymBio Pharmaceuticals and Takeda Pharmaceutical outside the submitted work. M.O. reported receiving consultant fees from Mundi Pharma, Meiji Seika Pharma, SymBio, Verastem and Yakult Honsha and personal fees from Chugai Pharmaceutical Co. Ltd. outside the submitted work. J.K. reported receiving grants and personal fees from Kyowa Kirin, Chugai Pharmaceutical, Japan Blood Product Organization, Daiichi Sankyo Pharmaceutical, Ono Pharmaceutical, Sanofi, Eisai, Takeda Pharmaceutical, Nippon Shinyaku, Bristol Meyers Squibb, Sysmex and Abbvie; grants from Mochida Pharmaceutical, Taiho Pharmaceutical, Sumitomo Pharma, Asahikasei Pharma, Otsuka Pharmaceutical, MSD, CSL Behring, Teijin, Shionogi Pharmaceutical and Nihon Pharmaceutical; and personal fees from Pfizer, Astellas, Novartis, AstraZeneca, Meiji Seika Pharma and Otsuka Pharmaceutical outside the submitted work. Y.S. reported receiving grants and personal fees from Chugai, Kyowa Kirin and Genmab; grants from Otsuka, Incyte, Amgen and Teijin; and personal fees from Nippon Shinyaku, Meiji Pharma, BMS and Nippon Kayaku outside the submitted work. K. Tuskasaki reported receiving grants and personal fees from Meiji Seika Pharma, Daiichi Sankyo and HUYABIO, grants from Kyowa Kirin, Bristol-Meyers Squibb, Byer and Regeneron Pharmaceuticals, Inc. and personal fees from Ono Pharma, Solasia Pharma and Yakuruto outside the submitted work. H.N. reported receiving grants and personal fees from AstraZeneca, Celgene, Mundipharma, Takeda, Chugai, BMS, Jansen, Kyowa Kirin, SymBio, Ono Pharmaceutical, Eisai, Genmab and Nihon Shinyaku; grants from Zenyaku Kogyo, Bayer, Abbvie, MSD, Eli Lilly, Daiichi Sankyo and Regeneron; and personal fees from Sanofi, Novartis, Chordia Therapeutics, Nihon Medi-Physics, Meiji Seika Pharma, Chugai Pharmaceutical, SymBio, Bristol-Myers Squibb, Sumitomo Pharma and CSL Behring outside the submitted work. The authors have no other potential conflict of interest to declare.

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