Biliary stenting implantation with 125I seed strand followed by chemotherapy plus PD-1 inhibitor in cholangiocarcinoma with malignant obstructive jaundice: a retrospective comparative study.

[BACKGROUND] Owing to the nonspecific symptoms in early stage and the propensity for secondary obstructive jaundice, cholangiocarcinoma (CCA) is frequently diagnosed at an advanced stage, thereby missing the optimal window for surgical intervention. The aim of this study was to evaluate the efficacy and safety of biliary stenting implantation with 125I seed strand (SI) plus chemotherapy with PD-1inhibitor for patients with CCA and malignant obstructive jaundice (MOJ).

[METHODS] Between January 2015 and December 2023, 88 patients diagnosed with CCA and MOJ were enrolled for this retrospective study. Then, 36 patients (observation group) received SI plus chemotherapy with PD-1inhibitor, whereas 52 patients (control group) received biliary stenting implantation plus chemotherapy. The response to therapy and adverse effect were compared between both groups. The data of stent patency time, progression-free survival (PFS) and overall survival (OS) obtained through clinical follow-up, were performed using the Kaplan-Meier method and analysed with the log-rank test. Prognostic risk factors were evaluated using Cox regression analysis.

[RESULTS] After the 6-month follow-up, the DCR (86.11% vs 67.31%) was statistically different (P = 0.045), while ORR (33.33% vs 23.08%) not (P = 0.288) between both groups. There were no serious interventional treatment-related adverse events and the differences of severe toxicities of chemotherapy between both groups were not statistically significant (P > 0.05). The median stent patency time, PFS and OS were 300 days (95%CI 260-330) vs 215 days (95%CI 194-240), 360 days (95%CI 260-372) vs 230 days (95%CI 200-248) and 420 days (95%CI 330-452) vs 309 days (95%CI 252-340) between both groups, respectively and the differences between both groups were statistically significant (P < 0.05). Staging of CCA and subsequent therapy method were independent risk factors that affected the prognosis for survival.

[CONCLUSIONS] SI plus chemotherapy with PD-1inhibitor is an effective and safe therapy and shows promising results compared to biliary stenting implantation plus chemotherapy for CCA patients with MOJ.