Chemoradiation treatment with gemcitabine plus stereotactic body radiotherapy for unresectable, non-metastatic, locally advanced hilar cholangiocarcinoma. Results of a five year experience.

Background: Hilar cholangiocarcinoma (Klatskin tumor-KT) accounts for about 0.5-1.5% of all gastrointestinal cancers and for 40-60% of all biliary malignancies. Tumor resection is attainable in about 30-50% of patients. When resection is not possible other treatment options have little or no impact on survival. We present the results of hypofractionated Stereotactic Body Radiotherapy (SBRT) on a small series of non resectable locally advanced KT patients.

Materials And Methods: Ten patients with histologically proven KT underwent SBRT plus gemcitabine. Radiotherapy (30Gy) was delivered in three fractions. Treatment toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE v. 3.0). Alive patients with less than 1 year of follow up were excluded from the present study. Local control was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Results: Two grade 1 and Two grade 2 acute toxicities were observed, moreover one grade 2 late toxicity was recorded. The overall local response ratio was 80% (4 PR+2 SD). SBRT showed a good efficacy in achieving local control. Median time to progression was 30 months. Two-year survival was 80% and four-year survival 30%. Six patients developed metastatic disease. Response to treatment and nodal metastases were the only independent indicators of prolonged survival.

Conclusions: The chemoradiation given by SBRT plus gemcitabine is a promising treatment for non-metastatic unresectable KT. High local control rates, even compared to historical data from conventional radiotherapy, can be achieved with minimal toxicity.