Second-line chemotherapy in patients with biliary tract cancer.

Background: Biliary tract cancers are rare malignancies with a very poor prognosis. Several studies comparing chemotherapy and supportive care showed significant survival prolongation and improvement in life quality with chemotherapy. The association of gemcitabine and a platinum compound is considered the standard first-line treatment but there are no adequate data supporting any second-line therapy. Our retrospective study aims at evaluating retrospectively the impact of second-line chemotherapy in this setting. Methods: We reviewed medical records of patients (pts) affected by histologically confirmed biliary tract cancer, treated in our institution from 2005 to 2010 with a second line chemotherapy after first-line treatment progression. Results: We identified 121 pts progressing after first-line chemotherapy. 56 (46%) of these were considered fit for a second-line treatment and 49 (40%) were effectively treated. Of these 49, 34 had relapsed after radical surgery and 15 were unresectable at diagnosis. The primary site was intrahepatic in 25 pts, extrahepatic in 18 and gallbladder in 6. The first-line schedules were mainly gemcitabine plus a platinum compound (n=35) or gemcitabine plus capecitabine (n=8). As second line, gemcitabine plus a platinum compound and gemcitabine plus capecitabine were delivered respectively in 15 and 14 pts. The remaining 20 were treated with other regimens (6 gemcitabine plus irinotecan, 14 monochemotherapy). Median time to progression was 3.5 months (IC95% 2.0-5.0) and median overall survival, calculated since second-line treatment start, was 8.1 months (IC95% 4.3-11.9). Median overall survival calculated since first-line start was 18.7 months (IC95% 13.9-23.5). Conclusions: Many patients affected by biliary tract cancer have still a good performance status after first-line chemotherapy and could be treated in second-line with potential survival benefit. The optimal regimen has not yet been identified.