PMID- 32767806 OWN - NLM STAT- MEDLINE DCOM- 20201215 LR - 20210110 IS - 1349-7006 (Electronic) IS - 1347-9032 (Print) IS - 1347-9032 (Linking) VI - 111 IP - 10 DP - 2020 Oct TI - R-CHOP-14 versus R-CHOP-14/CHASER for upfront autologous transplantation in diffuse large B-cell lymphoma: JCOG0908 study. PG - 3770-3779 LID - 10.1111/cas.14604 [doi] AB - The efficiency of upfront consolidation with high-dose chemotherapy/autologous stem-cell transplantation (HDCT/ASCT) for newly diagnosed high-risk diffuse large B-cell lymphoma (DLBCL) may be influenced by induction chemotherapy. To select better induction chemotherapy regimens for HDCT/ASCT, a randomized phase II study was conducted in high-risk DLBCL patients having an age-adjusted International Prognostic Index (aaIPI) score of 2 or 3. As induction chemotherapy, 6 cycles of R-CHOP-14 (arm A) or 3 cycles of R-CHOP-14 followed by 3 cycles of CHASER (arm B) were planned, and patients who responded proceeded to HDCT with LEED and ASCT. The primary endpoint was 2-y progression-free survival (PFS), and the main secondary endpoints included overall survival, overall response rate, and adverse events (AEs). In total, 71 patients were enrolled. With a median follow-up of 40.3 mo, 2-y PFS in arms A and B were 68.6% (95% confidence interval [CI], 50.5%-81.2%) and 66.7% (95% CI: 48.8%-79.5%), respectively. Overall survival at 2 y in arms A and B was 74.3% (95% CI: 56.4%-85.7%) and 83.3% (95% CI: 66.6%-92.1%). Overall response rates were 82.9% in arm A and 69.4% in arm B. During induction chemotherapy, 45.7% and 75.0% of patients in arms A and B, respectively, had grade >/= 3 non-hematologic toxicities. One patient in arm A and 6 in arm B discontinued induction chemotherapy due to AEs. In conclusion, R-CHOP-14 showed higher 2-y PFS and less toxicity compared with R-CHOP-14/CHASER in patients with high-risk DLBCL, suggesting the former to be a more promising induction regimen for further investigations (UMIN-CTR, UMIN000003823). CI - (c) 2020 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. FAU - Kagami, Yoshitoyo AU - Kagami Y AUID- ORCID: 0000-0002-1566-3101 AD - Department of Hematology, Toyota Kosei Hospital, Toyota, Japan. AD - Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan. FAU - Yamamoto, Kazuhito AU - Yamamoto K AUID- ORCID: 0000-0002-8588-8955 AD - Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan. FAU - Shibata, Taro AU - Shibata T AD - JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan. FAU - Tobinai, Kensei AU - Tobinai K AD - Department of Hematology, National Cancer Center Hospital, Tokyo, Japan. FAU - Imaizumi, Yoshitaka AU - Imaizumi Y AUID- ORCID: 0000-0002-2954-5691 AD - Department of Hematology, Nagasaki University Hospital, Nagasaki, Japan. FAU - Uchida, Toshiki AU - Uchida T AD - Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan. FAU - Shimada, Kazuyuki AU - Shimada K AUID- ORCID: 0000-0002-1075-9219 AD - Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan. FAU - Minauchi, Koichiro AU - Minauchi K AD - Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan. FAU - Fukuhara, Noriko AU - Fukuhara N AD - Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan. FAU - Kobayashi, Hirofumi AU - Kobayashi H AD - Department of Hematology, Saitama Cancer Center, Ina-cho, Japan. FAU - Yamauchi, Nobuhiko AU - Yamauchi N AD - Department of Hematology, National Cancer Center East, Kashiwa, Japan. FAU - Tsujimura, Hideki AU - Tsujimura H AD - Division of Hematology-Oncology, Chiba Cancer Center, Chiba, Japan. FAU - Hangaishi, Akira AU - Hangaishi A AD - Division of Hematology, NTT Medical Center Tokyo, Tokyo, Japan. FAU - Tominaga, Ryo AU - Tominaga R AD - Division of Hematology, Hyogo Cancer Center, Akashi, Japan. FAU - Suehiro, Youko AU - Suehiro Y AD - Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan. FAU - Yoshida, Shinichiro AU - Yoshida S AD - Department of Hematology, National Hospital Organization Nagasaki Medical Center, Ohmura, Japan. FAU - Inoue, Yoshiko AU - Inoue Y AD - Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan. FAU - Suzuki, Sachiko AU - Suzuki S AD - Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan. FAU - Tokuhira, Michihide AU - Tokuhira M AUID- ORCID: 0000-0003-3780-5331 AD - Departments of Hematology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. FAU - Kusumoto, Shigeru AU - Kusumoto S AD - Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. FAU - Kuroda, Junya AU - Kuroda J AD - Division of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan. FAU - Yakushijin, Yoshihiro AU - Yakushijin Y AUID- ORCID: 0000-0001-6001-746X AD - First Department of Internal Medicine, Ehime University Hospital, Toon, Japan. FAU - Takamatsu, Yasushi AU - Takamatsu Y AD - Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Fukuoka, Japan. FAU - Kubota, Yasushi AU - Kubota Y AD - Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Nosaka, Kisato AU - Nosaka K AUID- ORCID: 0000-0001-6682-2451 AD - Department of Hematology, Kumamoto University Hospital, Kumamoto, Japan. FAU - Morishima, Satoko AU - Morishima S AUID- ORCID: 0000-0002-7391-4271 AD - Second Department of Internal Medicine, University of the Ryukyus Hospital, Nishihara, Japan. FAU - Nakamura, Shigeo AU - Nakamura S AD - Department of Pathology and Laboratory Medicine, Nagoya University Hospital, Nagoya, Japan. FAU - Ogura, Michinori AU - Ogura M AD - Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan. FAU - Maruyama, Dai AU - Maruyama D AUID- ORCID: 0000-0003-0654-6920 AD - Department of Hematology, National Cancer Center Hospital, Tokyo, Japan. FAU - Hotta, Tomomitsu AU - Hotta T AD - National Hospital Organization Nagoya Medical Center, Nagoya, Japan. FAU - Morishima, Yasuo AU - Morishima Y AD - Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan. FAU - Tsukasaki, Kunihiro AU - Tsukasaki K AD - Department of Hematology, International Medical Center, Saitama Medical University, Hidaka, Japan. FAU - Nagai, Hirokazu AU - Nagai H AD - Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan. LA - eng GR - 23-A-16/National Cancer Center Research and Development Fund/ GR - 23-A-17/National Cancer Center Research and Development Fund/ GR - 26-A-4/National Cancer Center Research and Development Fund/ GR - 29-A-3/National Cancer Center Research and Development Fund/ GR - 16-6/Ministry of Health, Labour and Welfare Grants-in-Aid for Cancer Research/ GR - 20S-1/Ministry of Health, Labour and Welfare Grants-in-Aid for Cancer Research/ GR - 20S-6/Ministry of Health, Labour and Welfare Grants-in-Aid for Cancer Research/ GR - 23-A-16/Ministry of Health, Labour and Welfare Grants-in-Aid for Cancer Research/ GR - 23-A-17/Ministry of Health, Labour and Welfare Grants-in-Aid for Cancer Research/ GR - 19-27/Health and Labour Sciences Research Grants for Clinical Cancer Research/ GR - 22-29/Health and Labour Sciences Research Grants for Clinical Cancer Research/ PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial DEP - 20200911 PL - England TA - Cancer Sci JT - Cancer science JID - 101168776 RN - 0 (R-CHOP protocol) RN - 4F4X42SYQ6 (Rituximab) RN - 5J49Q6B70F (Vincristine) RN - 80168379AG (Doxorubicin) RN - 8N3DW7272P (Cyclophosphamide) RN - VB0R961HZT (Prednisone) SB - IM MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Combined Modality Therapy MH - Cyclophosphamide/administration & dosage/adverse effects MH - Doxorubicin/administration & dosage/adverse effects MH - Female MH - Hematopoietic Stem Cell Transplantation/*methods MH - Humans MH - Induction Chemotherapy/*methods MH - Lymphoma, Large B-Cell, Diffuse/*therapy MH - Male MH - Middle Aged MH - Prednisone/administration & dosage/adverse effects MH - Progression-Free Survival MH - Rituximab/administration & dosage/adverse effects MH - Transplantation, Autologous/adverse effects MH - Vincristine/administration & dosage/adverse effects MH - Young Adult PMC - PMC7540987 OTO - NOTNLM OT - JCOG-LSG OT - autologous stem-cell transplantation OT - diffuse large B-cell lymphoma OT - high-dose chemotherapy OT - induction chemotherapy COIS- Yoshitoyo Kagami has nothing to disclose; Kazuhito Yamamoto reports grants from the Ministry of Health, Labor and Welfare, grants from the National Cancer Center, during the conduct of the study; grants from AbbVie, grants from AstraZeneca, grants from Bayer, grants from Celgene, grants and personal fees from Chugai, grants and personal fees from Eisai, grants from Incyte/IQVIA, grants and personal fees from Mundipharma, grants from Nippon Shinyaku, grants from Novartis, grants from Solasia Pharma, grants from SymBio, grants from Yakult, grants from Zenyaku, personal fees from HUYA/IQVIA, personal fees from Takeda; Taro Shibata has nothing to disclose; Kensei Tobinai reports personal fees from Eisai, grants and personal fees from Takeda, personal and grants from Mundipharma, personal fees from HUYA Bioscience International, personal and grants from Kyowa Kirin, personal and grants from Celgene, personal and grants from Chugai, personal and grants from Ono, personal fees from Yakult, personal fees from Daiichi Sankyo, personal fees from Bristol-Myers Squibb, personal fees from Meiji Seika Kaisha, personal fees from Solasia, personal fees from Verastem, personal fees from Zenyaku Kogyo, grants from Janssen, grants from Eisai, grants from Takeda, grants from AbbVie, outside the submitted work; Yoshitaka Imaizumi has nothing to disclose; Toshiki Uchida reports personal fees from Pfizer outside the submitted work; Kazuyuki Shimada reports grants from Celgene, grants from Otsuka, grants from MSD, grants from Kyowa Kirin outside the submitted work; Koichiro Minauchi has nothing to disclose; Noriko Fukuhara reports personal fees and grants from Chugai, personal fees from Kyowa Kirin, grants from Eisai, grants from Ono, grants from AbbVie, grants from Bayer, grants from Soleisia, grants from Gilead sciences, grants from Incyte corporation outside the submitted work; Hirofumi Kobayashi has nothing to disclose; Nobuhiko Yamauchi reports personal fees from Takeda, grants from Amgen, grants from Daiichi Sankyo, grants from Celgene outside the submitted work; Hideki Tsujimura has nothing to disclose; Akira Hangaishi has nothing to disclose; Ryo Tominaga has nothing to disclose; Youko Suehiro reports grants from Chugai, grants from Novartis, grants from Bayer, grants from Eisai, grants from Ono, grants from Otsuka, grants from Pfizer, grants from Amgen, grants from Daiichi Sankyo, grants from Biopharma, grants from Solasia, grants from Celgene, grants from Takeda, outside the submitted work; Shinichiro Yoshida has nothing to disclose; Yoshiko Inoue has nothing to disclose; Sachiko Suzuki has nothing to disclose; Michihide Tokuhira has nothing to disclose; Shigeru Kusumoto reports grants and personal fees from Chugai; Junya Kuroda reports grants from Kyowa Kirin, grants from Chugai, outside the submitted work; Yoshihiro Yakushijin has nothing to disclose; Yasushi Takamatsu reports personal fee and annual scholarship endowment from Celgene, personal fee and annual scholarship endowment from Takeda, personal fee and annual scholarship endowment from Ono, personal fees from Janssen, annual scholarship endowment from Chugai, annual scholarship endowment from TAIHO, annual scholarship endowment from Astellas, annual scholarship endowment from Kyowa Hakko Kirin, endowed chair or accepted a researcher from Takeda, Ono, Beckman Coulter, outside the submitted work; Yasushi Kubota has nothing to disclose; Kisato Nosaka reports personal fees from Celgene outside the submitted work; Satoko Morishima has nothing to disclose; Shigeo Nakamura has nothing to disclose; Michinori Ogura reports personal fees from Meiji Seika outside the submitted work; Dai Maruyama reports personal fees and grants from Takeda, personal fees and grants from Celgene, personal fees and grants from Mundipharma, personal fees from Eisai, personal fees and grants from Janssen, personal fees from Chugai, personal fees from Kyowa Kirin, grants from Ono, grants from MSD, grants from Novartis, outside the submitted work; Tomomitsu Hotta scientific advisor from SymBio, outside the submitted work; Yasuo Morishima has nothing to disclose; Kunihiro Tsukasaki reports annual scholarship endowment from Chugai, outside the submitted work; Hirokazu Nagai reports grants from Bayer, grants from AstlaZeneca, grants from Zenyaku, personal fees and grants from Takeda, grants from Mundipharma, grants from SymBio, personal fees and grants from Celgene, personal fees, grants and annual scholarship endowment from, personal fees from Eisai, outside the submitted work. EDAT- 2020/08/09 06:00 MHDA- 2020/12/16 06:00 PMCR- 2020/10/01 CRDT- 2020/08/09 06:00 PHST- 2020/05/16 00:00 [received] PHST- 2020/07/26 00:00 [revised] PHST- 2020/07/28 00:00 [accepted] PHST- 2020/08/09 06:00 [pubmed] PHST- 2020/12/16 06:00 [medline] PHST- 2020/08/09 06:00 [entrez] PHST- 2020/10/01 00:00 [pmc-release] AID - CAS14604 [pii] AID - 10.1111/cas.14604 [doi] PST - ppublish SO - Cancer Sci. 2020 Oct;111(10):3770-3779. doi: 10.1111/cas.14604. Epub 2020 Sep 11.