TT: Prof. Tawesak Tanwandee
SS: Asst. Prof. Sansnee Senawong
Introduction
TT: My name is Tawesak Tanwandee, Professor of Medicine, Head of Division of Gastroenterology, Faculty of Medicine, Siriraj Hospital.
SS: Hello, I am the Assistant Professor of Medicine, Sansanee Senawong, Chief of the Immunology Department, Faculty of Medicine, Siriraj Hospital, Mahidol University.
TT: Siriraj Hospital is the largest and the oldest hospital in Thailand. As it is a large and highly advanced hospital, a large number of patients come to Siriraj Hospital annually.
SS: The laboratory of the Department of Immunology was certified by the international standard ISO 15189 since May 2006. It has passed the continuous evaluation and inspection for the ISO 15189:2012 standards to date.
TT: As we are a large hospital, we receive patients from other hospitals. The patients who are referred to our hospital are mostly terminally ill. They are already in the terminal stage of cancer.
What is the unmet need in HCC surveillance and diagnosis in Siriraj Hospital?
SS: In Thailand, liver cancer is one of the most common and leading causes of death in cancer patients in the country. We find that over 70% of patients who die of liver cancer are not admitted to the surveillance program, resulting in delayed diagnosis at the terminal stage and they pass away soon after.
TT: For patients at risk of liver cancer, we don’t always have the chance to screen them sufficiently at an early stage. Moreover, an early stage of liver cancer has no visible symptoms. Therefore, the patient does not realize they need to be tested.
SS: In terms of liver cancer, there are still challenges regarding the effectiveness of liver cancer surveillance.
TT: The standard practice for liver cancer surveillance today is composed of ultrasound scans and blood (biomarker) tests to check alpha fetoprotein (AFP) levels every 6 months.
SS: However, we find that the sensitivity rate is as low as 63%.
TT: Due to ultrasound capacity limitations, patients may have to wait for months or even a year for a scan. Ultrasound also relies heavily on the doctor conducting the scan and how meticulous they are. Patients who are obese or have been diagnosed with liver cirrhosis, may be difficult to detect liver cancer by ultrasound.
SS: As a laboratory, when choosing a test or a platform for our services, we must take into account the challenge of reporting laboratory results quickly and efficiently to keep up with the increasing laboratory workloads. Also, it has to minimize human errors as much as possible. We need to find an appropriate system that can support various biomarker testing and is reliable.
What is your clinical experience with PIVKA-II? How has it brought value to HCC diagnosis?
TT: The data from studies show that PIVKA-II was quicker to detect early stages of liver cancer in patients. Checking the levels of AFP and PIVKA-II at the same time is much more convenient to doctors. Therefore, a single blood test from the patient allows both tests to be run. When testing both, we see for some patients, that the level of AFP is normal but the PIVKA-II level is abnormal. This helps to alert the doctor to abnormalities in the patient.
SS: Providing PIVKA-II to use in our laboratory will help improve the efficiency of early liver cancer surveillance in the future.
What is your experience using digital algorithms? How does the digital algoritm bring value to enable early HCC diagnosis?
TT: There are about 50-60 patients who have used the digital algorithm. And it has been very beneficial to some patients.
SS: But due to the limitations of ultrasound access combined with the sensitivity performance of AFP, considering to add ew biomarkers such as PIVKA-II and the digital algorithm will play a very important role.
TT: When applying the digital algorithm, in practice, we have to add two other factors, age and gender. Sometimes, abnormalities in the AFP level or PIVKA-II level is detected. But the digital algorithm shows it as normal. The algorithm makes surveillance more accurate.
SS: According to many studies and the reports from the doctors who directly treat the patients, it was found that using PIVKA-II and the digital algorithm, compared to the results of AFP and ultrasound, which is considered standard/conventional practice, helps detect liver cancer at an early stage more efficiently.
TT: We had liver cancer patients who have been treated and followed up with MRI scans every 3-4 months. The MRI scan was normal and no new tumors were found. But fortunately, at that time, we started using the digital algorithm. We found that the AFP level was normal but the PIVKA-II level was abnormal. After using the digital algorithm, the score was also abnormal. So we changed appointments with the patient to be sooner, every two months. We checked with the digital algorithm again. The test showed even more abnormalities than before (the score was higher than previous test). The PIVKA-II level was also higher. We had to do the MRI scan again. A tumor was found, only a little over a centimeter long, and is treatable. Presently, the patient is undergoing cancer treatment. I think this is a good case study of using multiple markers together with the digital algorithm to help detect cancer at an early stage, when the patient can be successfully treated.
What does your workflow using the digital algorithm look like?
TT: The digital algorithm has simplified the workflow. Every time a patient has a health check, it’s standard practice to run a blood test to check the liver health. With the blood sample, we can run the digital algorithm at the same time. This means the patient only needs to give one blood sample. Everything is done in one visit.
SS: After collecting the samples, the laboratory performs AFP, PIVKA-II, and digital algorithm tests. After the AFP and PIVKA-II test results are reported, the laboratory results will be combined with gender and age to automatically calculate the score. The result will be sent to the LIS or HIS system of the hospital, allowing the doctors to see the test results quickly. This makes the laboratory workflow more convenient and reporting of results faster.
TT: It’s very easy to interpret the result because there is only ‘positive’ or ‘negative’ (score). The doctors don’t need to interpret complicated numbers. When an abnormality in the digital algorithm is found, the doctor should conduct further (confirmatory) testing, especially using medical imaging techniques such as X-ray, CT or MRI scans.
What’s your expectation for the digital algorithm in the future?
TT: If we use the digital algorithm or PIVKA-II in addition to AFP, the liver cancer surveillance will likely be more accurate because this test already shares the same platform as their regular blood tests. And this will help us to decide is the patient is at risk of cancer, or need further surveillance tests. We might be able to detect the liver cancer at an earlier stage in more patients and provide successful treatment.
What is Siriraj Hospital’s vision for the liver disease and HCC management?
TT: In patients who have been screened and found to have liver cancer, over 90% of them live longer than 5 years. In this case, it changes the patient’s life. If we can use other surveillance methods such as PIVKA-II or the digital algorithm, it might help to improve surveillance effectiveness.
SS: The department is very pleased to have been a part of an important step in using digital diagnostic tools which are helping liver cancer patients have a better quality of life and increase the survival rate.
TT: At Siriraj Hospital, we provide knowledge and raise awareness for everyone, which includes both patients and healthcare workers. So, the patients who are at risk of liver cancer, can receive surveillance regularly. We hope that in the future, every patient who is at risk of liver cancer, everyone in Siriraj Hospital, will receive the surveillance process regularly.
The views and opinions expressed by Prof. Tawesak Tanwandee and Asst. Prof. Sansnee Senawong are their own views and opinions. Roche disclaims all liability in relation to these views and opinions.