Dr Do-Youn Oh speaks to ecancer about the TOPAZ-1 phase III trial at interim analysis. This trial showed that durvalumab, in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer (BTC). Dr Oh says that patients with advanced biliary tract cancer are in dire need of new treatments as progress in the 1st-line setting has remained largely stagnant for more than 10 years. TOPAZ-1 is the first phase III trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for patients in this setting. Dr Oh discusses the important results of this trial. She says the combination also demonstrated an improvement in progression-free survival (PFS) and overall response rate, key secondary endpoints. Durvalumab plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone. 
She concludes by saying these results are a major step forward in treating this disease and represent new hope for our patients.

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Justin Mencel, MBBS, The Royal Marsden NHS Foundation Trust, London, UK, provides an overview of the PREVAIL ctDNA pilot study (NCT04566614), which evaluated the use of ctDNA to support the diagnostic pathway for patients with suspected pancreatic and biliary tract cancers (BTC). Dr. Mencel explains how BTCs and pancreatic tumors are fairly difficult to diagnose due to their deep location within the tumor, often requiring invasive diagnostic techniques to diagnose such as endoscopies. This became more of an issue during the COVID-19 pandemic when there was a global reduction in invasive diagnostic procedures. Circulating tumor DNA (ctDNA) is DNA that has been released from the tumor into the bloodstream of patients and can be analyzed through a liquid biopsy, thereby offering a non-invasive method of diagnoses. 16 patients with suspected BTC and 16 patients with suspected pancreatic cancer were recruited onto the PREVAIL pilot study, from which ctDNA was collected and analyzed via a custom 59 gene panel at the Institute of Cancer Research. The detection rate of ctDNA was 69% and 56% for patients with suspected pancreatic cancer and BTC, respectively. A sensitivity and specificity analysis was carried out in 23 patients across the two cohorts. The sensitivity and specificity of ctDNA to detect pancreatic cancer were 80% and 100%, respectively for pancreatic cancer and for BTC 100% and 75%, respectively. A false-positive was detected in the BTC cohort, however, the patient was subsequently diagnosed with esophageal cancer, explaining the detection of ctDNA. It was therefore concluded that ctDNA may be used reliably for diagnosis in patients who are unable to undergo biopsies or for difficult to access tumors, as well as to accelerate diagnosis in those requiring repeated biopsies, which can ultimately improve diagnostic efficiencies. This interview took place at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.

Matt talks about how getting biomarker testing changed his course of treatment after he found out he had the MLH1 mutation. Learn more at biomarkersmatter.org.

Michael Lax tells his bile duct cancer story of hope. In May 2014, Michael was diagnosed with Cholangiocarcinoma. After undergoing surgery, in January 2015, Michael was declared cancer free.

Cholangiocarcinoma and gallbladder cancer are not common. But the incidence of intrahepatic cholangiocarcinoma increasing rapidly.
For the past 2 years, tremendous progress in diagnosis and treatment has been made, especially with targeted therapy and immunotherapy, improving the prognosis.

The Bili Project Foundation's Co-Founder, Sue Acquisto, shares her story of how her husband went from complaining of a stomach ache to being diagnosed with Bile Duct Cancer (Cholangiocarcinoma). Sue is now committed to bringing this cancer into the spotlight as well as funding research to find a cure and better diagnostic tools.