“This study helps resolve long-standing questions about adjuvant treatment for biliary tract cancer, for which there has been no standard of care,” said ASCO President Daniel F. Hayes, MD, FACP, FASCO. “This oral chemotherapy is widely available and can offer patients the chance to live more than a year longer.”
ALEXANDRIA, Va. – A phase III randomized clinical trial of 447 patients with biliary tract cancers (BTCs, cancers of the bile duct and gallbladder) showed that giving capecitabine after surgery extends survival by a median of 15 months compared to surgery alone. The finding could provide the basis for a new standard of care in the disease.
This trial, called BILCAP, is one of the first randomized studies of adequate size to look at the use of adjuvant therapy in this rare and hard-to-treat cancer. The study will be presented at the upcoming 2017 ASCO Annual Meeting in Chicago.
“Biliary tract cancer is a disease of decidedly unmet need as until recently there has been little research on treating the disease,” said lead study author John N. Primrose, MD, Professor of Surgery at the University of Southampton, United Kingdom. “Our trial is the first to enroll a sufficient number of patients to show that chemotherapy after surgery can have a significant improvement in survival, with modest side effects.”
About Biliary Tract Cancer and the BILCAP Study
Bile ducts inside and outside of the liver and gallbladder comprise the biliary tract. The tract conducts and stores bile, a product of the liver that helps digest fat. Patients with biliary tract cancers face considerable odds in that only about 20% of such cancers can be surgically removed, and for those that have a successful surgery, fewer than 10% survive five years.
At the time the trial was designed in the U.K. there was no standard of care for adjuvant therapy in BTC. Capecitabine was chosen out of several commonly used systemic therapies because it could be given as a tablet and had shown efficacy in pancreatic cancer, a disease with similarly poor outcomes. Subsequent to the start of the trial, two chemotherapy agents in combination, gemcitabine and cisplatin, have evolved to be the current standards of care in the setting of advanced BTC on the basis of results from other studies done in the U.K.
In the trial, 447 patients were randomly assigned to either treatment with capecitabine for 6 months or observation for recurrence of cancer. More than 80% of the patients were followed for at least three years with regular clinical exams, CT imaging, and a variety of blood tests that could be useful later in determining biomarkers for tumors.
While patients in the observation group lived a median of 36 months after surgery, those who received capecitabine lived a median of 51 months. Capecitabine was associated with a 20% lower chance of death than observation, but the difference was not statistically significant for the overall population of 447 patients in this study, which includes patients that stopped capecitabine early. However, in the subgroup of 430 patients that received treatment per study protocol, capecitabine was associated with a 25% lower chance of death than observation, and this difference was statistically significant.
The median time to cancer recurrence was 25 months for patients who received capecitabine and 18 months for patients in the control group. The most notable side effect related to treatment was a rash on the hands and feet, which is common with capecitabine. There were no deaths due to the use of capecitabine.
“One of the major benefits of our trial is the fact that we now have a tumor tissue collection associated with very robust clinical data which will be used for genomic exploration,” said Dr. Primrose. “Since we started planning this trial at the start of this century, a number of new agents have become available, including several that treat cancer based on its genetic profile. This is where our tumor tissue repository will play an important role.”
Dr. Primrose emphasized, however, that new approaches are urgently needed to develop and recruit patients for clinical trials in biliary cancer, as this trial’s ten-year timeline is much too long to conduct a trial in a rapidly evolving era of treatments and approaches. International cooperation is desperately needed, he noted.
The authors are currently working on a subgroup analysis as there are four distinct types of BTC – three of which involve the liver and its ducts and one of which involves the gallbladder. This analysis may help define more precisely which patients could benefit the most from adjuvant chemotherapy.
This study received funding from Cancer Research UK.
View the full abstract.
For your readers:
View the disclosures for the 2017 ASCO Annual Meeting News Planning Team.
Disclosures for Daniel F. Hayes, MD, FACP, FASCO: Stock and Other Ownership Interests with OncoImmune and InBiomotion; Honoria from Lilly; Research Funding with Janssen Research & Development (Inst.), AstraZeneca (Inst.), Puma Biotechnology (Inst.), Pfizer (Inst.), Lilly (Inst.), and Merrimack Pharmaceuticals/Parexel International Corporation (Inst.); Patents, Royalties and Other Intellectual Property with royalties from licensed technology to Janssen Diagnostics regarding circulating tumor cells; Travel, Accommodations, Expenses from Janssen Diagnostics.
Disclosures for Bruce E. Johnson, MD, FASCO: Stock and Other Ownership Interests with KEW Group; Honoraria from Chugai Pharma and Merck; Consulting or Advisory Role with Amgen, AstraZeneca, Boehringer Ingelheim, Chugai Pharma, Clovis Oncology, Genentech, GlaxoSmithKline, KEW Group, Lilly, Merck, Novartis, and Transgene; Research Funding from Novartis (Inst.); Expert Testimony for Genentech.
ATTRIBUTION TO THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING IS REQUESTED IN ALL COVERAGE.
Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube.