Adjuvant Oral Chemo in Biliary Tract Cancer Extended Survival

The addition of adjuvant oral chemotherapy with capecitabine extended the overall survival of patients with biliary cancers by a median of 15 months, according to the results of the BILCAP study presented at a press conference ahead of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.

“Capecitabine compared to surveillance improves median overall survival in resected biliary tract cancer from 36 to 51 months,” said presenter John N. Primrose, MD, professor of surgery at the University of Southampton, United Kingdom, during the press conference. “We believe capecitabine should now become the standard of care for patients following curative resection of biliary tract cancer.”

The BILCAP study was designed to evaluate whether capecitabine improved overall survival compared with observation after radical surgery for patients with biliary tract cancer.

The study included 447 patients from 44 UK sites with completely resected cholangiocarcinoma or gallbladder cancer. The patients were randomly assigned to capecitabine (n = 223) 1,250 mg/m² days 1 to 14 every 21 days for 8 cycles or observation (n = 224) between 2006 to 2014.

Follow-up was at least 36 months in the majority of surviving patients. Patients were followed with regular clinical exams, CT imaging, and a variety of blood tests used to search for biomarkers of progression.

According to the intention-to-treat analysis, patients assigned capecitabine had a non-significant 19% reduced risk for mortality compared with observation. The median overall survival was 51 months with capecitabine compared with 36 months for observation (hazard ratio [HR], 0.81, 95% CI, 0.63–1.04; P = .097). When the researchers performed a sensitivity analysis correcting for prognostic factors such as nodal status, grade of disease, and gender, the HR was 0.71 (95% CI, 0.55–0.92; P < .01).

In the per-protocol analysis, which included 430 patients, patients assigned capecitabine had a 25% reduced risk for death. The median overall survival was 53 months for capecitabine compared with 36 months for observation (HR, 0.75; 95% CI, 0.58–0.97; P = .028).

The median time to cancer recurrence was 25 months for patients assigned capecitabine compared with 18 months for patients assigned to observation. According to Primrose, the toxicity associated with chemotherapy was relatively modest and similar to that observed in other studies. The most common toxicity was plantar-palmar erythema. There were no deaths related to chemotherapy.

Commenting on the study, Daniel F. Hayes, MD, ASCO president, pointed out that biliary tract cancer is much more common in Asia than in the United Kingdom.

“That will be one of the questions raised, whether these results apply to patients in Asia with the same cancer,” Hayes said.