1.Accuracy Goals in Predicting Preoperative Lymph Node Metastasis for T1 Colorectal Cancer Resected Endoscopically
Katsuro ICHIMASA ; Shin-ei KUDO ; Masashi MISAWA ; Khay Guan YEOH ; Tetsuo NEMOTO ; Yuta KOUYAMA ; Yuki TAKASHINA ; Hideyuki MIYACHI
Gut and Liver 2024;18(5):803-806
Submucosal invasive (T1) colorectal cancer is a significant clinical management challenge, with an estimated 10% of patients developing extraintestinal lymph node metastasis. This condition necessitates surgical resection along with lymph node dissection to achieve a curative outcome. Thus, the precise preoperative assessment of lymph node metastasis risk is crucial to guide treatment decisions after endoscopic resection. Contemporary clinical guidelines strive to identify a low-risk cohort for whom endoscopic resection will suffice, applying stringent criteria to maximize patient safety. Those failing to meet these criteria are often recommended for surgical resection, with its associated mortality risks although it may still include patients with a low risk of metastasis. In the quest to enhance the precision of preoperative lymph node metastasis risk prediction, innovative models leveraging artificial intelligence or nomograms are being developed. Nevertheless, the debate over the ideal sensitivity and specificity for such models persists, with no consensus on target metrics. This review puts forth postoperative mortality rates as a practical benchmark for the sensitivity of predictive models. We underscore the importance of this method and advocate for research to amass data on surgical mortality in T1 colorectal cancer. Establishing specific benchmarks for predictive accuracy in lymph node metastasis risk assessment will hopefully optimize the treatment of T1 colorectal cancer.
2.Accuracy Goals in Predicting Preoperative Lymph Node Metastasis for T1 Colorectal Cancer Resected Endoscopically
Katsuro ICHIMASA ; Shin-ei KUDO ; Masashi MISAWA ; Khay Guan YEOH ; Tetsuo NEMOTO ; Yuta KOUYAMA ; Yuki TAKASHINA ; Hideyuki MIYACHI
Gut and Liver 2024;18(5):803-806
Submucosal invasive (T1) colorectal cancer is a significant clinical management challenge, with an estimated 10% of patients developing extraintestinal lymph node metastasis. This condition necessitates surgical resection along with lymph node dissection to achieve a curative outcome. Thus, the precise preoperative assessment of lymph node metastasis risk is crucial to guide treatment decisions after endoscopic resection. Contemporary clinical guidelines strive to identify a low-risk cohort for whom endoscopic resection will suffice, applying stringent criteria to maximize patient safety. Those failing to meet these criteria are often recommended for surgical resection, with its associated mortality risks although it may still include patients with a low risk of metastasis. In the quest to enhance the precision of preoperative lymph node metastasis risk prediction, innovative models leveraging artificial intelligence or nomograms are being developed. Nevertheless, the debate over the ideal sensitivity and specificity for such models persists, with no consensus on target metrics. This review puts forth postoperative mortality rates as a practical benchmark for the sensitivity of predictive models. We underscore the importance of this method and advocate for research to amass data on surgical mortality in T1 colorectal cancer. Establishing specific benchmarks for predictive accuracy in lymph node metastasis risk assessment will hopefully optimize the treatment of T1 colorectal cancer.
3.Accuracy Goals in Predicting Preoperative Lymph Node Metastasis for T1 Colorectal Cancer Resected Endoscopically
Katsuro ICHIMASA ; Shin-ei KUDO ; Masashi MISAWA ; Khay Guan YEOH ; Tetsuo NEMOTO ; Yuta KOUYAMA ; Yuki TAKASHINA ; Hideyuki MIYACHI
Gut and Liver 2024;18(5):803-806
Submucosal invasive (T1) colorectal cancer is a significant clinical management challenge, with an estimated 10% of patients developing extraintestinal lymph node metastasis. This condition necessitates surgical resection along with lymph node dissection to achieve a curative outcome. Thus, the precise preoperative assessment of lymph node metastasis risk is crucial to guide treatment decisions after endoscopic resection. Contemporary clinical guidelines strive to identify a low-risk cohort for whom endoscopic resection will suffice, applying stringent criteria to maximize patient safety. Those failing to meet these criteria are often recommended for surgical resection, with its associated mortality risks although it may still include patients with a low risk of metastasis. In the quest to enhance the precision of preoperative lymph node metastasis risk prediction, innovative models leveraging artificial intelligence or nomograms are being developed. Nevertheless, the debate over the ideal sensitivity and specificity for such models persists, with no consensus on target metrics. This review puts forth postoperative mortality rates as a practical benchmark for the sensitivity of predictive models. We underscore the importance of this method and advocate for research to amass data on surgical mortality in T1 colorectal cancer. Establishing specific benchmarks for predictive accuracy in lymph node metastasis risk assessment will hopefully optimize the treatment of T1 colorectal cancer.
4.Accuracy Goals in Predicting Preoperative Lymph Node Metastasis for T1 Colorectal Cancer Resected Endoscopically
Katsuro ICHIMASA ; Shin-ei KUDO ; Masashi MISAWA ; Khay Guan YEOH ; Tetsuo NEMOTO ; Yuta KOUYAMA ; Yuki TAKASHINA ; Hideyuki MIYACHI
Gut and Liver 2024;18(5):803-806
Submucosal invasive (T1) colorectal cancer is a significant clinical management challenge, with an estimated 10% of patients developing extraintestinal lymph node metastasis. This condition necessitates surgical resection along with lymph node dissection to achieve a curative outcome. Thus, the precise preoperative assessment of lymph node metastasis risk is crucial to guide treatment decisions after endoscopic resection. Contemporary clinical guidelines strive to identify a low-risk cohort for whom endoscopic resection will suffice, applying stringent criteria to maximize patient safety. Those failing to meet these criteria are often recommended for surgical resection, with its associated mortality risks although it may still include patients with a low risk of metastasis. In the quest to enhance the precision of preoperative lymph node metastasis risk prediction, innovative models leveraging artificial intelligence or nomograms are being developed. Nevertheless, the debate over the ideal sensitivity and specificity for such models persists, with no consensus on target metrics. This review puts forth postoperative mortality rates as a practical benchmark for the sensitivity of predictive models. We underscore the importance of this method and advocate for research to amass data on surgical mortality in T1 colorectal cancer. Establishing specific benchmarks for predictive accuracy in lymph node metastasis risk assessment will hopefully optimize the treatment of T1 colorectal cancer.
5.Proof-of-concept study of the caninized anti-canine programmed death 1antibody in dogs with advanced non-oral malignant melanoma solid tumors
Masaya IGASE ; Sakuya INANAGA ; Shoma NISHIBORI ; Kazuhito ITAMOTO ; Hiroshi SUNAHARA ; Yuki NEMOTO ; Kenji TANI ; Hiro HORIKIRIZONO ; Munekazu NAKAICHI ; Kenji BABA ; Satoshi KAMBAYASHI ; Masaru OKUDA ; Yusuke SAKAI ; Masashi SAKURAI ; Masahiro KATO ; Toshihiro TSUKUI ; Takuya MIZUNO
Journal of Veterinary Science 2024;25(1):e15-
Background:
The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear.
Objective:
The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM.
Methods:
Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group.
Results:
One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%).Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively.
Conclusions
The present study demonstrated that ca-4F12-E6 was well-tolerated in nonOMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.