Expert Point of View: Lipika Goyal, MD

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Capecitabine is an oral therapy that has been part of the standard of care for other cancers for years, so oncologists are already familiar with prescribing it.
— Lipika Goyal, MD

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Commenting on the BILCAP study, Lipika Goyal, MD, an oncologist at Massachusetts General Hospital, Boston, said: “These results are very intriguing. There is no current standard of care for adjuvant therapy of biliary tract cancer. Our high-risk patients [ie, patients with node-positive disease, those with positive surgical margins, or those with T3 or T4 disease] are treated on a case-by-case basis with gemcitabine or fluoropyrimidine-based singlet or doublet chemotherapy, with no randomized phase III evidence to support any of these choices.”

“Previous studies of adjuvant therapy for biliary tract cancer have failed to show a benefit,” she continued. “Most recently, the combination of gemcitabine/oxaliplatin failed to improve survival over surveillance alone in the randomized phase III PRODIGE 12-ACCORD 18 trial, albeit the proportion of patients with high-risk disease was lower in this trial.”

Clinical Implications

Dr. Goyal said she looks forward to seeing all the details of the study once it is presented at the 2017 ASCO Annual Meeting and published. Since the primary outcome of overall survival difference in the intent-to-treat population was not significant, and the per-protocol analysis of overall survival was significant in favor of capecitabine, she added, “It will be helpful to define the per-protocol population and understand the reasons for excluding some patients. The subgroup analysis may also be informative in understanding whether certain anatomic or high-risk groups may derive more benefit than others.”

“Pending the details of the full study, these findings are potentially practice-changing, and I think it would be adopted quickly,” predicted Dr. Goyal. “Capecitabine is an oral therapy that has been in cancer treatment for many years, so oncologists are already familiar with prescribing it.” ■

Disclosure: Dr. Goyal reported no conflicts of interest.