Jannis Duhn, Lennart von Fritsch, Kim C Honselmann, Rüdiger Braun, Lars Peters, Julia Strässer, Kees Kleihues-van Tol, Constanze Schneider, Fabian Reinwald, Andrea Sackmann, Bianca Franke, Anna Krauß, Saskia Thies, Steffen Deichmann, Monika Klinkhammer-Schalke, Sylke R Zeissig, Tobias Keck, Ulrich F Wellner, Louisa Bolm
This study shows that adjuvant chemotherapy is associated with improved survival in certain subgroups of distal bile duct carcinoma patients only. Careful selection of patients for adjuvant chemotherapy after resection is crucial, and prospective trials focusing on distal bile duct carcinoma are needed, yet challenging because of the rarity of the tumor.
BACKGROUND: Distal bile duct carcinomas are rare neoplasms of the extrahepatic bile duct. Surgical resection remains the only curative treatment option. Previous studies showed conflicting results regarding the impact of adjuvant chemotherapy. We aimed to investigate the association of adjuvant chemotherapy with survival of distal bile duct carcinoma patients in a nationwide cohort study.
METHODS: Patients with distal bile duct carcinoma were identified from the pooled data set of clinical cancer registries in Germany, collated by the Association of German Tumor Centers. Patients receiving neoadjuvant therapy, radiotherapy, and patients with 90-day postoperative mortality were excluded. Multiple imputation was performed to account for missing data. We analyzed prognostic factors and outcomes following adjuvant chemotherapy using univariable and multivariable analyses.
RESULTS: We identified 736 patients, of whom 20.4% received adjuvant chemotherapy. Adjuvant chemotherapy patients were younger (67 vs 72 years, P < .001) and showed advanced locoregional invasion as compared with surgery alone. Age ≥70 years, advanced pT status, lymph node metastases, and advanced grading were independent negative prognostic factors for overall survival. Overall, adjuvant chemotherapy was not associated with improved overall survival (median overall survival, 26.9 vs 24.9 months; P = .072) but was proven as an independent positive prognostic factor in a multivariable Cox regression (hazard ratio, 0.76; P = .03). In patients with pT1-2 tumors, the presence of lymph node metastases or lymphovascular invasion, adjuvant chemotherapy was associated with improved overall survival.
CONCLUSION: This study shows that adjuvant chemotherapy is associated with improved survival in certain subgroups of distal bile duct carcinoma patients only. Careful selection of patients for adjuvant chemotherapy after resection is crucial, and prospective trials focusing on distal bile duct carcinoma are needed, yet challenging because of the rarity of the tumor.