Original Study: Risk Factors for Early Recurrence in Patients With Biliary Tract Cancers Who Underwent Curative Resection: An Exploratory Subgroup Analysis of JCOG1202.

BACKGROUND AND

OBJECTIVES

Postoperative early recurrence (ER) of biliary tract cancers (BTCs) leads to significant medical, psychological, social, and economic disadvantages for patients. Approximately 30% of patients with curatively resected BTCs experience recurrence within the first 12 months after the surgery. JCOG1202 randomized phase III trial demonstrated the survival benefit of adjuvant S-1 in patients with resected BTCs. The objective of this exploratory study was to investigate the risk factors for ER in patients with resected BTCs in the JCOG1202 cohort.

METHODS

Of the 440 patients enrolled in JCOG1202, 217 who underwent observation and 207 who received adjuvant S-1 were eligible in this analysis. ER was defined as recurrence or death within 12 months after enrollment.

RESULTS

ER was observed in 59 and 38 patients in observation and adjuvant S-1, respectively. Multivariable logistic regression analysis identified CA19-9 levels > 37 U/ml (odds ratio (OR): 2.79, 95% confidence interval (CI): 1.26-6.17), poorly differentiation (vs. well-differentiated/papillary) (OR: 4.75, 95% CI: 1.93-11.69), moderate differentiation (vs. well-differentiated/papillary) (OR: 1.96, 95% CI: 1.07-3.57), lymph node metastases ≥ 4 (vs. 0) (OR: 3.99, 95% CI: 1.67-9.51), lymph node metastases 1-3 (vs. 0) (OR: 2.66, 95% CI: 1.47-4.81), and R1 resection (OR: 2.17, 95% CI: 1.07-4.41) as independent risk factors for ER. Adjuvant S-1 chemotherapy significantly reduced ER (OR: 0.49, 95% CI: 0.29-0.83).

CONCLUSIONS

Postoperative CA19-9 levels, tumor differentiation, lymph node metastases, residual tumors, and adjuvant S-1 significantly affected ER in patients with curatively resected BTCs. Patients at high ER risk may require more intensive adjuvant therapy.

TRIAL REGISTRATION: UMIN000011688.