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

March 2023, Vol 4, No 1

Relapse after highly invasive surgery for biliary tract cancers (BTCs) causes medical, psychological, social, and economic distress to patients, and it is estimated that 30% of patients with curatively resected BTC will relapse within the first 12 months. Capecitabine has been determined to be the standard of care as adjuvant therapy for patients with BTC who have undergone curative resection; however, no statistically significant difference is seen in overall survival (OS) between capecitabine and observation. An oral fluoropyrimidine derivative, S-1, has demonstrated promising activity in patients with BTC, and adjuvant S-1 has been established as standard of care for patients with resected pancreatic and gastric cancer in Japan. JCOG1202 (UMIN000011688) is a randomized, phase 3 trial that demonstrated OS benefit with adjuvant S-1 in patients with resected BTC. At the 2023 ASCO Gastrointestinal Cancers Symposium, Dr Hiroaki Yanagimoto presented results from a study aimed at investigating the risk factors for early relapse of resected BTCs in the JCOG1202 cohort.

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 424 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 metas-tases (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). Importantly, 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.

Postoperative CA 19-9 level, tumor differentiation, lymph node metastases, and residual tumor significantly impact early relapse in patients with curatively resected BTCs. Similar factors are also noted as risk factors in patients receiving adjuvant S-1, suggesting that patients at high risk of early relapse may need more intensive perioperative therapy.

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.

Related Items

Characterization of Long-Term Survivors in TOPAZ-1
March 2023, Vol 4, No 1
Researchers examined the characteristics, outcomes, and genomic profiles of patients with advanced biliary tract cancer who were treated with durvalumab plus gemcitabine/cisplatin and experienced long-term survival.
MDM2-p53 Antagonist BI 907828 Demonstrated Promising Activity in Patients with Advanced BTC
March 2023, Vol 4, No 1
The novel MDM2-p53 antagonist BI 907828 is being investigated as a first-line treatment in patients with advanced biliary tract cancer.
Treatment and Survival Outcomes with Systemic Therapy for Patients with BTC with IDH1 Mutations: A Retrospective Study
March 2023, Vol 4, No 1
Long-term outcomes were evaluated in patients with IDH1-mutated biliary tract cancer who were treated with systemic therapy.
Phase 2 Study of CTX-009 plus Paclitaxel in Patients with Advanced BTC
March 2023, Vol 4, No 1
CTX-009 plus paclitaxel showed promising efficacy as second- or third-line treatment in patients with advanced biliary tract cancer.
Gunagratinib in Patients with Previously Treated Advanced CCA Harboring FGFR2 Fusions or Rearrangements
March 2023, Vol 4, No 1
Gunagratinib showed promising efficacy as a second-generation FGFR inhibitor and demonstrated potential to treat multiple FGFR pathway abnormalities.
Results from SWOG 1815: GemCis and Nab-Paclitaxel versus GemCis in Advanced BTC
March 2023, Vol 4, No 1
The SWOG 1815 trial found that treatment with gemcitabine/cisplatin and paclitaxel (GAP) did not result in a significant improvement in survival compared with gemcitabine and cisplatin in patients with advanced biliary tract cancer, though GAP may be beneficial in patients with locally advanced disease and GBC.
Impact of Gene Expression in 5-FU Metabolic Pathways on Outcomes in Patients Enrolled in JCOG1202
March 2023, Vol 4, No 1
Results from a study evaluating the impact of 5-FU metabolic pathway enzyme expression on outcomes of patients with curatively resected biliary tract cancer showed that relapse-free survival was improved in patients with certain enzymes who received adjuvant S-1.
Atezolizumab with or without Bevacizumab in Combination with GemCis in Advanced BTC: Results from IMbrave 151
March 2023, Vol 4, No 1
Researchers assessed whether VEGF blockade plus chemotherapy with gemcitabine/cisplatin can enhance responses to PD-L1 inhibition by promoting an immune-permissive tumor microenvironment in patients with advanced biliary tract cancer.
Nab-Paclitaxel plus Sintilimab as Second-Line Treatment for Advanced BTC
March 2023, Vol 4, No 1
The safety and efficacy of second-line nab-paclitaxel combined with the anti-PD-1 antibody sintilimab was studied in patients with advanced biliary tract cancer.
ICIs as Salvage Therapy for BTCs with KRAS Mutation
March 2023, Vol 4, No 1
Results are presented from a retrospective analysis of molecular profiles in patients with biliary tract cancers to assess the efficacy of immune checkpoint inhibitors according to KRAS mutation.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: