Risk Factors for Early Relapse in Patients Undergoing Curative Resection in JCOG1202 Subgroup Analysis

In the JCOG1202 subgroup analysis, researchers analyzed risk factors for early relapse in patients with biliary tract cancer undergoing surgical resection.

Relapse following invasive surgery for biliary tract cancers (BTCs) causes medical, psychological, social, and economic anguish to patients. It is predicted that 30% of patients with curatively resected BTC would experience relapse within the first 12 months. For BTC patients who have received curative resection, capecitabine has been found to be the standard of care as adjuvant therapy; nonetheless, there is no significant difference in overall survival (OS) between capecitabine and observation. S-1, an oral fluoropyrimidine derivative, has demonstrated promising efficacy in patients with BTC, and adjuvant S-1 has been established as the standard of care for patients with resected pancreatic and gastric cancer in Japan. In patients with resected BTC, the randomized, phase 3 study, JCOG1202 (UMIN000011688), showed OS improvement with adjuvant S-1. Dr Hiroaki Yanagimoto presented findings from JCOG1202, which looked at the risk factors for early relapse in patients with resected BTC, at the 2023 ASCO Gastrointestinal Cancers Symposium.

Dr Hiroaki Yanagimoto presented findings from JCOG1202, which looked at the risk factors for early relapse in patients with resected BTC.

Of 440 patients enrolled in JCOG1202, 217 eligible patients underwent surgery alone (arm A) and 207 eligible patients received adjuvant S-1 (arm B). Early relapse was defined as relapse or death within 12 months after enrollment. Predictive factors for early relapse were assessed using logistic regression analyses in the 424 eligible patients. Of these patients, 97 (22.9%) experienced postoperative early relapse, 59 (27.2%) in arm A and 38 (18.4%) in arm B. Multivariable logistic regression analysis determined that independent risk factors for early relapse included CA 19-9 level >37 U/mL (odds ratio [OR], 2.790; 95% confidence interval [CI], 1.262-6.170; P=.011), poor differentiation (OR, 4.746; 95% CI, 1.927-11.688; P=.0007), moderate differentiation (OR, 1.955; 95% CI, 1.071-3.567; P=.029), >4 lymph node metastases (OR, 3.991; 95% CI, 1.674-9.514; P=.0018), 1 to 3 lymph node metastases (OR, 2.661; 95% CI, 1.471-4.814; P=.0012), and presence of residual tumor (OR, 2.171; 95% CI, 1.070-4.408; P=.032). It is important to note that adjuvant S-1 chemotherapy significantly reduced early relapse (OR, 0.491; 95% CI, 0.290-0.833; P=.0084). Tumor differentiation, lymph node metastases, perineural invasion, and residual tumor were also considered possible risk factors for early relapse despite S-1 adjuvant therapy.

In patients with curatively resected BTCs, postoperative CA 19-9 level, tumor differentiation, lymph node metastases, and residual tumor had a substantial influence on early relapse. Similar characteristics were also identified as risk factors in patients who received adjuvant S-1, indicating that individuals who are at a high risk of early relapse may require more rigorous perioperative care.

Source:

Yanagimoto H, Nakachi K, Ikeda M, et al. Risk factors for early relapse in patients with biliary tract cancers who underwent curative resection: an exploratory subgroup analysis of JCOG1202. Poster presented at: ASCO Gastrointestinal Cancers Symposium, January 19-21, 2023; San Francisco, CA. Abstract 541.