TY - JOUR
T1 - Assessment of Outcomes from 1-Year Surveillance after Detection of Early Gastric Cancer among Patients at High Risk in Japan
AU - Yamamoto, Yoshinobu
AU - Yoshida, Naohiro
AU - Yano, Tomonori
AU - Horimatsu, Takahiro
AU - Uedo, Noriya
AU - Kawata, Noboru
AU - Kanzaki, Hiromitsu
AU - Hori, Shinichiro
AU - Yao, Kenshi
AU - Abe, Seiichiro
AU - Katada, Chikatoshi
AU - Yokoi, Chizu
AU - Ohata, Ken
AU - Doyama, Hisashi
AU - Yoshimura, Kenichi
AU - Ishikawa, Hideki
AU - Muto, Manabu
N1 - Funding Information:
Funding/Support: This study was funded by joint research funding from Kyoto University and Olympus Medical Systems.
Funding Information:
Acquisition, analysis, or interpretation of data: Yamamoto, Yoshida, Yano, Horimatsu, Uedo, Kawata, Kanzaki, Hori, Yao, Abe, Katada, Yokoi, Ohata, Yoshimura, Ishikawa, Muto. Drafting of the manuscript: Yamamoto, Yoshida, Yoshimura, Muto. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: Yoshimura, Muto. Obtained funding: Muto. Administrative, technical, or material support: Yamamoto, Yano, Horimatsu, Kanzaki, Doyama, Ishikawa, Muto. Supervision: Yoshida, Yao, Yokoi, Doyama, Muto. Conflict of Interest Disclosures: Dr Yamamoto reported receiving personal fees from Meiji Seika Pharma and Taiho Pharmaceutical outside the submitted work. Dr Yoshida reported receiving personal fees from Olympus Medical Systems outside the submitted work. Dr Yano reported receiving grants from Fujifilm, Kotobuki Medical, Olympus Medical Systems, Pentax Medical, Rakuten Medical, Shimadzu, and Tokyo Giken and personal fees from AstraZeneca, Meiji Seika Pharma, Olympus Medical Systems, Otsuka Pharmaceutical, Piolax Medical Devices, Rakuten Medical, Takeda Pharmaceutical, and Terumo outside the submitted work. Dr Horimatsu reported receiving personal fees from Daiichi Sankyo, Eli Lilly and Company, GuardantHealth, and Taiho Pharmaceutical outside the submitted work. Dr Uedo reported receiving personal fees from Olympus Medical Systems during the conduct of the study and personal fees from AstraZeneca, Boston Scientific Japan, Daiichi Sankyo, EA Pharma, Fujifilm, Miyarisan Pharmaceutical, Otsuka Pharmaceutical, and Takeda Pharmaceutical outside the submitted work. Dr Kanzaki reported receiving personal fees from Bristol Myers Squibb, Fujifilm, Kaneka, Olympus Medical Systems, Ono Pharmaceutical, and Taiho Pharmaceutical outside the submitted work. Dr Hori reported receiving personal fees from Fujifilm and Kaneka outside the submitted work. Dr Yao reported receiving grants from Astellas Pharma, Daiichi Sankyo, Eli Lilly and Company, Janssen Pharmaceuticals, Mochida Pharmaceutical, Nippon Chemiphar, Olympus Medical Systems, Otsuka Pharmaceutical, and Takeda Pharmaceutical and personal fees from AI Medical Service, AstraZeneca, Boston Scientific, EA Pharma, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Miyarisan Pharmaceutical, Mochida Pharmaceutical, Mylan Pharmaceuticals, Olympus Medical Systems, and Otsuka Pharmaceutical outside the submitted work. Dr Abe reported receiving grants from Fujifilm and Olympus Medical Systems and personal fees from AstraZeneca, Boston Scientific, Fujifilm, Olympus Medical Systems, and Takeda Pharmaceutical during the conduct of the study. Dr Ohata reported receiving personal fees from Amco Pharmaceuticals, AstraZeneca, Boston Scientific, Century Medical, Japan Medicalnext, Kaneka, MC Medical, Medico’s Hirata, Micro-tec, Olympus Medical Systems, Otsuka Pharmaceutical, Pentax Medical, Takeda Pharmaceutical, and Zeon during the conduct of the study. Dr Doyama reported receiving personal fees from EA Pharma, Eisai, Olympus Medical Systems, and Otsuka Pharmaceutical outside the submitted work. Dr Muto reported receiving grants from AstraZeneca, Bayer, Bristol Myers Squibb, Canon Medical Systems, Chugai Pharma, Daiichi Sankyo, GuardantHealth, Merck Biopharma, Molecular Health, Nippon Kayaku, Novartis, Olympus Medical Systems, Pfizer, Roche, and Shionogi outside the submitted work. No other disclosures were reported.
Publisher Copyright:
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PY - 2022/8/19
Y1 - 2022/8/19
N2 - Importance: Single endoscopic examination often misses early gastric cancer (GC), even when both high-definition white light imaging and narrow-band imaging are used. It is unknown whether new GC can be detected approximately 1 year after intensive index endoscopic examination. Objective: To examine whether new GC can be detected approximately 1 year after intensive index endoscopic examination using both white light and narrow-band imaging. Design, Setting, and Participants: This case-control study was a preplanned secondary analysis of a randomized clinical trial involving 4523 patients with a high risk of GC who were enrolled between October 1, 2014, and September 22, 2017. Data were analyzed from December 26, 2019, to April 21, 2021. Participants in the clinical trial received index endoscopy to detect early GC via 2 examinations of the entire stomach using white light and narrow-band imaging. The duration of follow-up was 15 months. The secondary analysis included 107 patients with newly detected GC (case group) and 107 matched patients without newly detected GC (control group) within 15 months after index endoscopy. Interventions: Surveillance endoscopy was scheduled between 9 and 15 months after index endoscopy. If new lesions suspected of being early GC were detected during surveillance endoscopy, biopsies were obtained to confirm the presence of cancer. Main Outcomes and Measures: The primary end point was the rate of new GC detected within 15 months after index endoscopy. The main secondary end point was identification of risk factors associated with new GC detected within 15 months after index endoscopy. Results: Among 4523 patients (mean [SD] age, 70.6 [7.5] years; 3527 men [78.0%]; all of Japanese ethnicity) enrolled in the clinical trial, 4472 received index endoscopy; the rate of early GC detected on index endoscopy was 3.0% (133 patients). Surveillance endoscopy was performed in 4146 of 4472 patients (92.7%) who received an index endoscopy; the rate of new GC detected within 15 months after index endoscopy was 2.6% (107 patients). Among 133 patients for whom early GC was detected during index endoscopy, 110 patients (82.7%) received surveillance endoscopy within 15 months after index endoscopy; the rate of newly detected GC was 10.9% (12 patients). For the secondary analysis of risk factors associated with newly detected GC, characteristics were well balanced between the 107 patients included in the case group vs the 107 patients included in the matched control group (mean [SD] age, 71.7 [7.2] years vs 71.8 [7.0] years; 94 men [87.9%] in each group; 82 patients [76.6%] vs 87 patients [81.3%] with a history of gastric neoplasm). Multivariate analysis revealed that the presence of open-type atrophic gastritis (odds ratio, 6.00; 95% CI, 2.25-16.01; P <.001) and early GC detection by index endoscopy (odds ratio, 4.67; 95% CI, 1.08-20.21; P =.04) were independent risk factors associated with new GC detection. Conclusions and Relevance: In this study, the rate of new GC detected by surveillance endoscopy approximately 1 year after index endoscopy was similar to that of early GC detected by index endoscopy. These findings suggest that 1-year surveillance is warranted for patients at high risk of GC.
AB - Importance: Single endoscopic examination often misses early gastric cancer (GC), even when both high-definition white light imaging and narrow-band imaging are used. It is unknown whether new GC can be detected approximately 1 year after intensive index endoscopic examination. Objective: To examine whether new GC can be detected approximately 1 year after intensive index endoscopic examination using both white light and narrow-band imaging. Design, Setting, and Participants: This case-control study was a preplanned secondary analysis of a randomized clinical trial involving 4523 patients with a high risk of GC who were enrolled between October 1, 2014, and September 22, 2017. Data were analyzed from December 26, 2019, to April 21, 2021. Participants in the clinical trial received index endoscopy to detect early GC via 2 examinations of the entire stomach using white light and narrow-band imaging. The duration of follow-up was 15 months. The secondary analysis included 107 patients with newly detected GC (case group) and 107 matched patients without newly detected GC (control group) within 15 months after index endoscopy. Interventions: Surveillance endoscopy was scheduled between 9 and 15 months after index endoscopy. If new lesions suspected of being early GC were detected during surveillance endoscopy, biopsies were obtained to confirm the presence of cancer. Main Outcomes and Measures: The primary end point was the rate of new GC detected within 15 months after index endoscopy. The main secondary end point was identification of risk factors associated with new GC detected within 15 months after index endoscopy. Results: Among 4523 patients (mean [SD] age, 70.6 [7.5] years; 3527 men [78.0%]; all of Japanese ethnicity) enrolled in the clinical trial, 4472 received index endoscopy; the rate of early GC detected on index endoscopy was 3.0% (133 patients). Surveillance endoscopy was performed in 4146 of 4472 patients (92.7%) who received an index endoscopy; the rate of new GC detected within 15 months after index endoscopy was 2.6% (107 patients). Among 133 patients for whom early GC was detected during index endoscopy, 110 patients (82.7%) received surveillance endoscopy within 15 months after index endoscopy; the rate of newly detected GC was 10.9% (12 patients). For the secondary analysis of risk factors associated with newly detected GC, characteristics were well balanced between the 107 patients included in the case group vs the 107 patients included in the matched control group (mean [SD] age, 71.7 [7.2] years vs 71.8 [7.0] years; 94 men [87.9%] in each group; 82 patients [76.6%] vs 87 patients [81.3%] with a history of gastric neoplasm). Multivariate analysis revealed that the presence of open-type atrophic gastritis (odds ratio, 6.00; 95% CI, 2.25-16.01; P <.001) and early GC detection by index endoscopy (odds ratio, 4.67; 95% CI, 1.08-20.21; P =.04) were independent risk factors associated with new GC detection. Conclusions and Relevance: In this study, the rate of new GC detected by surveillance endoscopy approximately 1 year after index endoscopy was similar to that of early GC detected by index endoscopy. These findings suggest that 1-year surveillance is warranted for patients at high risk of GC.
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U2 - 10.1001/jamanetworkopen.2022.27667
DO - 10.1001/jamanetworkopen.2022.27667
M3 - Article
C2 - 35984658
AN - SCOPUS:85137008751
SN - 2574-3805
VL - 5
SP - E2227667
JO - JAMA network open
JF - JAMA network open
IS - 8
ER -