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Adjuvant capecitabine therapy extends survival in biliary tract cancer
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The use of capecitabine as adjuvant therapy significantly extended survival of patients with biliary tract cancer, according to results of the BILCAP clinical trial scheduled for presentation at the ASCO Annual Meeting.
“Capecitabine should become the standard of care for patients following curative resection of biliary tract cancer,” John N. Primrose, MD, FRCS, professor of surgery at University of Southampton in the United Kingdom, said during a press conference.
Approximately 20% of biliary tract cancers can be surgically removed. However, despite successful removal, fewer than 10% of these patients survive 5 years.
Primrose and colleagues enrolled 447 patients (median age, 63 years; interquartile range, 55-69) — from 44 clinical sites across the UK — with resected cholangiocarcinoma or gallbladder cancer. The researchers randomly assigned patients to 1,250 mg/m2 capecitabine (n = 223) every 21 days for 6 months or observation (n = 224) based on tumor site, resection status, surgical center and ECOG performance status.
The researchers chose capecitabine over other chemotherapies because it is in tablet form and has already shown positive effects and outcomes for patients with pancreatic cancer, according to the release.
OS in the intention-to-treat population served as the primary outcome.
Researchers followed more than 80% of patients for a minimum of 3 years.
On intention-to-treat analysis, patients who received capecitabine experienced a longer median OS than patients who underwent observation (51 months vs. 36 months). Sensitivity analysis showed an HR of 0.71 (95% CI, 0.55-0.92) after adjusting for nodal status, grade of disease and sex.
The per-protocol analysis also showed longer median OS for patients who received capecitabine (53 months vs. 36 months; HR = 0.75; 95% CI, 0.58-0.97).
Among the intention-to-treat population, median RFS was 25 months (95% CI, 19-37) for patients who received capecitabine and 18 months (95% CI, 13-28) for patients who underwent observation.
The amount of toxicities experienced appeared modest, Primrose said. The most common toxicity was plantar palmar erythema (20.7%). Fewer than expected grade 3 and grade 4 adverse events occurred, and no deaths occurred.
The study results give patients with biliary tract cancers a change to live longer with this adjuvant therapy, according to Daniel F. Hayes, MD, FACP, FASCO, professor of internal medicine, the Stuart B. Padnos professor in breast cancer and clinical director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center, and president of ASCO.
“This study helps resolve long-standing questions about adjuvant treatment for biliary tract cancer, for which there has been no standard of care,” Hayes said in the release. “This oral chemotherapy is widely available and can offer patients the chance to live more than a year longer.” – by Melinda Stevens
Reference:
Primrose, J et al. Abstract 4006. Scheduled for presentation at: ASCO Annual Meeting; June 2-6, 2017; Chicago.
Disclosures: Cancer Research UK funded the study. Primrose reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures. Hayes reports stock and other ownership interests with InBiomotion and OncoImmune; honoraria from Eli Lilly; institutional research funding from AstraZeneca, Janssen Research and Development, Merrimack Pharmaceuticals/Parexel International Corporation and Puma Biotechnology; patents, royalties and other intellectual property with royalties from licensed technology to Janssen Diagnostics regarding circulating tumor cells; and travel, accommodations and expenses from Janssen Diagnostics.
Perspective
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Allyson Ocean, MD
I had a patient with this exact question — what should we do after someone has surgery for their biliary cancer because, up until now, there existed no standard of care? Because we know this is such a bad cancer in terms of high recurrence rates for any stage, as oncologists, we tend to lean more toward treating, and sometimes we do that without evidence.
It is important that researchers conducted a large trial in this disease state, showing patients who take capecitabine for 6 months after their surgery had a better outcome. In a way, the results validate our usual practice of thinking these patients need to have adjuvant therapy due to the high recurrence rates. I applaud the researchers, because it is very hard to conduct such a large study in such a rare disease. Even specialty centers do not see many patients with this disease, so being able to conduct a large study like this was important.
With these 447 patients from whom researchers collected samples, there is now an extensive database of genomics where we can hopefully find information and figure out why these cancers are so difficult to treat, determine why they come back and define their resistance to treatment. We now have a library of data we can sift through in a more meaningful way.
We know biliary cancers tend to have a lot of mutations within the genome of the cancer. As we study these genomes further, patients will be eligible for studies looking at targeted therapies against the cancer, potentially leading to more patient enrollment in clinical trials. In biliary cancer, there are not a lot of clinical trials, and that is a huge issue for patients with this disease. However, now that we have this large database of genomic information, we will be able to study it and design clinical trials from it.
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