Recurrence-free survival as a surrogate endpoint for overall survival after neoadjuvant chemotherapy and surgery for...

Area of Science:

• Oncology
• Clinical Trials
• Surgical Oncology

Background:

• Overall survival is a key treatment efficacy endpoint but requires extensive follow-up.
• Recurrence-free survival is a potential surrogate endpoint for overall survival.
• This study investigates recurrence-free survival's validity in advanced esophageal squamous cell carcinoma (OSCC).

Purpose of the Study:

• To determine the validity of recurrence-free survival as a surrogate endpoint for overall survival.
• To assess the correlation between recurrence-free and overall survival in surgically resectable OSCC patients.
• To evaluate the impact of neoadjuvant chemotherapy response on this correlation.

Main Methods:

• Retrospective review of 3154 patients with OSCC treated at 58 Japanese centers.
• Patients received neoadjuvant cisplatin and 5-fluorouracil, or docetaxel, cisplatin and 5-fluorouracil.
• Correlation assessed using Kendall's τ and meta-regression analysis.

Main Results:

• A strong individual-level correlation was found between recurrence-free survival and overall survival (Kendall's τ = 0.797).
• The 5-year overall and recurrence-free survival rates were 56.6% and 47.7%, respectively.
• A more favorable pathological response to neoadjuvant chemotherapy correlated with a higher τ value.

Conclusions:

• Recurrence-free survival is a valid surrogate endpoint for overall survival in surgically resectable OSCC patients.
• The correlation is stronger in patients with a better response to neoadjuvant chemotherapy.
• This finding supports using recurrence-free survival to expedite treatment efficacy evaluation in OSCC.