Radiotherapy and razoxane in advanced bile duct carcinomas

Little is known about the radiation sensitivity of bile duct carcinomas. The current study was undertaken to prospectively assess the objective response rates in bile duct carcinomas treated with radiotherapy and razoxane.

Twenty-three patients with advanced cancer of the biliary tree were irradiated together with the radiosensitizer razoxane at a dose of 125 mg twice daily by mouth. There were 16 females and 7 males, median age 68 years. They received a total tumor dose of 48 Gy (range 1.7-60) at the ICRU point with single fractions of 1.7 to 2 Gy.

Among the 23 patients, 14 had measurable disease. Objective tumor responses were seen in 4/4 gallbladder carcinomas (1 CR, 3 PR), 4/5 extrahepatic cholangiocarcinomas (2 CR 2 PR), and 1/5 hepatobiliary cancers (1 PR), leading to an overall response rate of 64%. The tumors remained locally controlled in 12 out of 16 assessable patients (75%). On an intention-to-treat basis, all patients with different biliary cancer without distant metastases had a median-survival time of 10 months (range 1 to 48) from the start of the radiotherapy; the 1-year survival was 43%. No patient survived beyond 4 years. Tolerance to the treatment was fairly good. Nausea and vomiting of grade 1 and 2 (WHO) was noted in 61%, and reversible leukopenia of grade 3 and 4 in 9% of the cases. The rate of inherent complications was high.

Combined radiotherapy and razoxane led to local response rates which are superior to data from the literature when radiotherapy alone is used. Obstacles to the treatment were complications of the disease and frequent metastasis.