Keio University · Medicine
Professor Jun Okui's research lab specializes in clinical oncology and health outcomes research, with a primary focus on identifying and validating surrogate endpoints in cancer trials. The lab investigates the relationship between intermediate clinical outcomes—such as pathological complete response (pCR), recurrence-free survival (RFS), and progression-free survival (PFS)—and overall survival (OS) in resectable and advanced gastrointestinal cancers, including esophageal and gastric cancers. By developing and applying novel statistical methods, such as inverse probability of censoring weighting (IPCW) estimators for tied categorical data, the lab aims to improve the efficiency and design of clinical trials. The ultimate goal is to accelerate the development of perioperative and combination therapies by enabling shorter follow-up periods without compromising the validity of efficacy assessment.
Figures are computed from collected data and may differ slightly.
Early diagnosed organ/space SSI are originally severe and may therefore be detected earlier. Importantly, early diagnosed organ/space SSI is likely to be severe and refractory.
Although pCR was correlated with OS, no evidence of individual-level surrogacy with OS was demonstrated, making it inappropriate to consider pCR as a surrogate endpoint for OS in resectable oesophageal cancer.
There was a strong correlation between recurrence-free and overall survival in patients with surgically resectable OSCC who underwent neoadjuvant chemotherapy, and this was more pronounced in patients with a better response to neoadjuvant chemotherapy.
This study demonstrated strong individual- and trial-level surrogacy between RFS and OS in resectable esophageal cancer across all perioperative treatments. These findings may accelerate perioperative treatment development by shortening follow-up in esophageal cancer trials.
498 Background: Overall survival (OS) is the gold standard endpoint of treatment efficacy but requires an extended follow-up period. This study aimed to determine the validity of pathological complete response (pCR) as a surrogate endpoint for OS. Methods: The individual-level surrogacy between categorical outcome and OS was assessed using Kendall correlation coefficient, τ. Because no method has been reported to estimate τ between categorical variables and OS, we proposed the new method using a
Whether or not vascular endothelial growth factor pathway inhibitors (VPIs) increase the risk of artery dissection is still unknown. This study aimed to quantitatively evaluate the possibility of artery dissection as a class effect of VPIs using nationwide real-world data. This cohort study was conducted based on the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), which spans nearly the entire Japanese population of over 100 million individuals. We inclu
The observed PFS with ICT was comparable to the predicted PFS based on the data for each monotherapy. Our findings do not provide direct evidence of synergistic effects, but they suggest that combining ICI and chemotherapy does not compromise efficacy. These results may support the continued clinical use of ICT in patients with advanced GC/GEJC.
4068 Background: Overall survival (OS) is regarded as the gold standard efficacy endpoint but requires long follow-up. This study aimed to determine the validity of recurrence-free survival (RFS) as a surrogate endpoint for OS in resectable esophageal cancer. Methods: A systematic review of phase III randomized controlled trials (RCTs) comparing perioperative treatments for resectable advanced esophageal and gastroesophageal junction cancer was conducted. Individual patient data (IPD) were reque
Among patients who achieved pCR, postoperative outcomes varied considerably by neoadjuvant treatment modality. The markedly favourable prognosis associated with pCR after NAC suggests that these patients may represent an optimal candidate cohort for future evaluation of surgery-avoidance and watch-and-wait strategies.
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