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Adjuvant Triple Therapy Boosts Survival in Biliary Cancers

TOPLINE: Camrelizumab plus concurrent capecitabine and radiotherapy (combination treatment) improved overall survival (OS) and recurrence-free survival in patients with resectable extrahepatic cholangiocarcinoma (EHC) and gallbladder cancer. METHODOLOGY: Patients with EHC and gallbladder cancer have a high recurrence rate and poor survival after surgery. Existing adjuvant therapies provide limited benefit, underscoring the need for novel treatment combinations. This multicenter, randomized clinical trial investigated the safety and efficacy of chemoradiation with anti-PD-1 immunotherapy in these patients. A total of 93 patients with histologically confirmed EHC or gallbladder cancer (median age, 62 years; 52% women) who underwent curative resection with stage pT2-4 or N1M0 disease were randomly assigned to either the combination treatment group (n = 46) or the observation group (no anticancer treatment unless relapse was detected; n = 47). Those in the combination treatment group received 200 mg camrelizumab intravenously every 3 weeks, followed by concurrent 1330 mg/m 2 oral capecitabine twice daily with radiotherapy (45 Gy in 25 fractions for lymph nodes and 52.5-55.0 Gy for tumor beds). oral capecitabine twice daily with radiotherapy (45 Gy in 25 fractions for lymph nodes and 52.5-55.0 Gy for tumor beds). The primary endpoint was OS, and secondary endpoints were recurrence-free survival and adverse events (AEs). The median follow-up duration was 36 months. TAKEAWAY: The combination treatment significantly improved OS (hazard ratio [HR], 0.43; P = .004), with 3-year OS rate of 58.2% vs 30.5% in the observation group. The median recurrence-free survival was longer in the combination treatment group than in the observation group (26 months vs 13 months; HR, 0.46; P < .001), with the 3-year recurrence-free survival rate of 40.3% vs 17.2%. No treatment-related deaths were observed. The most common severe AEs of grade 3 or 4 were anemia (15%), radiation-associated dermatitis (11%), nausea (11%), and hand-foot syndrome (4%) in the combination group and anemia (4%), fatigue (4%), and neutropenia (4%) in the observation group. Subgroup analyses suggested patients with EHC vs gallbladder cancer and those with an Eastern Cooperative Oncology Group score of 0 and tumors ≤ 5 cm were more likely to benefit from the combination treatment. IN PRACTICE: 'We congratulate the authors for conducting and reporting an important clinical trial that moves the field forward. Considering the current level of evidence used to guide patient management after resection, we suspect this regimen may be adopted into practice even prior to the conduct of a phase 3 trial,' Edgar Ben-Josef, MD, University of Pennsylvania, Philadelphia, wrote, in an invited commentary on the new research published in JAMA Oncology. 'However, we would caution that this study should be viewed not as an ending but as a building block toward studies that demonstrate an even greater level of confidence [in] more effective adjuvant regimens for patients with biliary cancers. SOURCE: The study, led by Han Xiao, MD, The First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China, was published online in JAMA Oncology. LIMITATIONS: This study was only conducted on Chinese patients, limiting generalizability to Western populations. Although the study met the predefined 2-year follow-up for all patients, both groups showed better-than-expected OS rates, resulting in fewer endpoint events than anticipated. Additionally, the open-label design and the combination of multiple treatments might have confounded efficacy assessment for each treatment component. DISCLOSURES: This study received project grants from the National Natural Science Foundation of China and the Science and Technology Program of Guangzhou. The authors reported having no relevant conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.