TY - JOUR
T1 - The association of primary tumor site with acute adverse event and efficacy of definitive chemoradiotherapy for cStage II/III esophageal cancer
T2 - an exploratory analysis of JCOG0909
AU - Hironaka, Shuichi
AU - Komori, Azusa
AU - Machida, Ryunosuke
AU - Ito, Yoshinori
AU - Takeuchi, Hiroya
AU - Ogawa, Gakuto
AU - Kato, Ken
AU - Onozawa, Masakatsu
AU - Minashi, Keiko
AU - Yano, Tomonori
AU - Nakamura, Kenichi
AU - Tsushima, Takahiro
AU - Hara, Hiroki
AU - Nozaki, Isao
AU - Ura, Takashi
AU - Chin, Keisho
AU - Fukuda, Haruhiko
AU - Kitagawa, Yuko
N1 - Funding Information:
The authors are grateful to the members of the JCOG Data Center and JCOG Operations Office for their support in data management, and oversight of the study management. JCOG0909 was supported in part by a National Cancer Center Research and Development Fund (20S-3, 23-A-16, 23-A-19, 26-A-4, 29-A-3, 2020-J-3). The authors would like to thank Enago ( www.enago.jp ) for the English language review.
Funding Information:
The authors are grateful to the members of the JCOG Data Center and JCOG Operations Office for their support in data management, and oversight of the study management. JCOG0909 was supported in part by a National Cancer Center Research and Development Fund (20S-3,?23-A-16, 23-A-19, 26-A-4, 29-A-3, 2020-J-3). The authors would like to thank Enago (www.enago.jp) for the English language review.
Funding Information:
Dr. Hironaka reports personal fees from Tsumura & Co., Bristol-Myers Squibb Japan, Yakult Honsha, Daiichi Sankyo, Eli Lilly, Ono Pharmaceutical, Taiho Pharmaceutical, Chugai Pharma, Nihonkayaku, outside the submitted work; Dr. Machida reports grants from Ministry of Health, Labour and Welfare, Japan, during the conduct of the study; Dr. Ogawa reports grants from Ministry of Health, Labour and Welfare, Japan, grants from Japan Agency for Medical Research and Development (AMED), during the conduct of the study; Dr. Kato reports other from Ono Pharmaceuticals, personal fees from BMS, Eli Lilly, other from MSD, Shionogi, Beigene, Oncolys BioPharma, Merck Biopharma, outside the submitted work; Dr. Nakamura reports personal fees from Chugai, Taiho, Bayer, outside the submitted work; Dr. Hara reports grants from Japan Agency for Medical Research and Development (AMED), during the conduct of the study; grants from Astrazeneca, Dainippon Sumitomo Pharma, Merck Biopharma, Eisai, LSK BioPharma, Incyte, Pfizer, Boehringer-ingelheim, Beigene, grants and personal fees from Daiichi Sankyo, MSD, Taiho, Chugai, Ono, BMS, personal fees from Lilly, Yakult Honsha, Sanofi, Takeda, Astellas, outside the submitted work; Dr. Nakamura reports personal fees from Chugai, personal fees from Taiho, personal fees from Bayer, outside the submitted work; Dr. Fukuda reports grants from National Cancer Center and the Ministry of Health, Labour and Welfare of Japan, during the conduct of the study; personal fees from Taiho Pharma, personal fees from Chugai Pharmaceutical, outside the submitted work; Dr. Kitagawa reports grants from Pfizer Japan Inc., Yakult Honsha Co. Ltd., Kyowa Hakko Kirin Co., Ltd., during the conduct of the study; grants from Kyowa Hakko Kirin Co., Ltd., Chugai Pharmaceutical Co., Ltd., Yakult Honsha Co., Ltd., Daiichi Sankyo Company Ltd., Merck Serono Co., Ltd., Asahi Kasei Co., Ltd., EA Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Factory Inc., Shionogi & Co., Ltd., Kaken Pharmaceutical Co., Ltd, Kowa Pharmaceutical Co., Ltd., Astellas Pharma Inc., Medicon Inc., Dainippon Sumitomo Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Pfizer Japan Inc., ONO Pharmaceutical Co., Ltd., Nihon Pharmaceutical Co., Ltd., Japan Blood Products Organization, Medtronic Japan Co., Ltd., Sanofi K.K., Eisai Co., Ltd., Tsumura & Co., KCI Licensing, Inc., Abbott Japan Co., Ltd., Fujifilm Toyama Chemical Co., Ltd., outside the submitted work; Dr. Komori, Dr. Ito, Dr. Takeuchi, Dr. Onozawa, Dr. Minashi, Dr. Yano, Dr. Tsushima, Dr. Nozaki, Dr. Ura, and Dr. Chin has nothing to disclose.
Publisher Copyright:
© 2020, The Japan Esophageal Society.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Background: JCOG0909 is a phase II trial of definitive chemoradiotherapy including salvage treatment for cStage II–III thoracic esophageal cancer; the radiation field for elective regional lymph node irradiation, which can affect patient outcome and adverse event, varied based on the primary tumor site, i.e., upper (Ut), middle (Mt), and lower thoracic (Lt) esophagus. The impact of different primary sites on the safety and efficacy of definitive chemoradiotherapy in JCOG0909 is not well characterized. Methods: Patients were categorized into three groups (Ut, Mt, and Lt) according to the primary tumor location. We compared acute adverse events during definitive chemoradiotherapy, complete response (CR) rate, 3-year progression-free survival (PFS), and overall survival (OS) among the 3 groups. Results: Out of the 96 patients enrolled in JCOG0909 between April 2010 and August 2014, 94 patients (16, 59, and 19 patients in the Ut, Mt, and Lt groups, respectively) were included in this exploratory analysis. The proportion of patients with cStage III was 25% in the Ut, 37% in the Mt, and 47% in the Lt group. Grade 3–4 leukopenia, neutropenia, and thrombocytopenia were more frequently observed in the Mt (66%, 54%, and 15%) and Lt groups (84%, 68%, and 16%) than in the Ut group (38%, 44%, and 0%). There was no significant between-group difference with respect to 3-year OS (73.3%, 77.9%, and 57.9%), 3-year PFS (60.0%, 59.3%, and 47.4%), or CR rate (62.5%, 62.7%, and 42.1%). Conclusions: In JCOG0909, the incidence of severe hematological toxicity had a trend toward higher in the Mt and Lt than the Ut esophageal cancer; however, no remarkable difference by primary sites was observed with respect to efficacy endpoints.
AB - Background: JCOG0909 is a phase II trial of definitive chemoradiotherapy including salvage treatment for cStage II–III thoracic esophageal cancer; the radiation field for elective regional lymph node irradiation, which can affect patient outcome and adverse event, varied based on the primary tumor site, i.e., upper (Ut), middle (Mt), and lower thoracic (Lt) esophagus. The impact of different primary sites on the safety and efficacy of definitive chemoradiotherapy in JCOG0909 is not well characterized. Methods: Patients were categorized into three groups (Ut, Mt, and Lt) according to the primary tumor location. We compared acute adverse events during definitive chemoradiotherapy, complete response (CR) rate, 3-year progression-free survival (PFS), and overall survival (OS) among the 3 groups. Results: Out of the 96 patients enrolled in JCOG0909 between April 2010 and August 2014, 94 patients (16, 59, and 19 patients in the Ut, Mt, and Lt groups, respectively) were included in this exploratory analysis. The proportion of patients with cStage III was 25% in the Ut, 37% in the Mt, and 47% in the Lt group. Grade 3–4 leukopenia, neutropenia, and thrombocytopenia were more frequently observed in the Mt (66%, 54%, and 15%) and Lt groups (84%, 68%, and 16%) than in the Ut group (38%, 44%, and 0%). There was no significant between-group difference with respect to 3-year OS (73.3%, 77.9%, and 57.9%), 3-year PFS (60.0%, 59.3%, and 47.4%), or CR rate (62.5%, 62.7%, and 42.1%). Conclusions: In JCOG0909, the incidence of severe hematological toxicity had a trend toward higher in the Mt and Lt than the Ut esophageal cancer; however, no remarkable difference by primary sites was observed with respect to efficacy endpoints.
KW - Chemoradiotherapy
KW - Esophageal cancer
KW - Location
KW - Primary site
UR - http://www.scopus.com/inward/record.url?scp=85084152462&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85084152462&partnerID=8YFLogxK
U2 - 10.1007/s10388-020-00741-w
DO - 10.1007/s10388-020-00741-w
M3 - Article
C2 - 32342253
AN - SCOPUS:85084152462
VL - 17
SP - 417
EP - 424
JO - Esophagus
JF - Esophagus
SN - 1612-9059
IS - 4
ER -