In this exclusive roundtable video from MedPage Todaythree expert leaders in gastrointestinal cancer Discuss the latest data presented at of American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium.
moderator Ghassan K. Abou-Alfa, MDat Memorial Sloan-Kettering Cancer Center in New York City, are participating in Anthony B. El-Khoueiry, MDof the University of Southern California Norris Comprehensive Cancer Center, Los Angelesand Stephen Mallon, MD, MScagain of Memorial Sloan Kettering Cancer Center, In the final part of these four episodes, they Phase 3 NRG/RTOG 1112 study.
Below is a transcript of their remarks.
Abu Alpha: Hello everyone. Nice to meet you again. Oops, we’re still kind of wrapping up from GI ASCO, still continuing with a lot of the information we thought. Why not have a round table and discuss the new things that were evolving. We learned from each other, learned a lot and reflected a lot.
As you know, my name is Gassan Abou Alfa of Memorial Sloan Kettering Cancer Center in New York. And today, I would like to welcome Dr. Anthony El-Khoueiry from the University of Southern California Norris Cancer Center and Dr. Steve Maron from Memorial Sloan Kettering Cancer Center in New York.
Now let’s switch gears. Amazing you and I have been living it since the beginning and see where we are now. Interestingly, now we are talking about radiotherapy for liver cancer. Please give us an overview of NRG research.
El Coueilly: yeah so this NRG/RTOG 1112 [study] Presented by Laura Dawson. This was the first phase III trial to investigate the benefits of stereotactic body radiation therapy, or SBRT, in patients with advanced HCC. As such, there were many early data from phase I and II trials suggesting the benefit of SBRT, especially in patients with vascular invasion, portal vein tumor thrombosis. This is what her RTOG 1112 was built for. And Gassin, you allowed that study to be conducted through the National Clinical Trial Network, Collaborative Group, and you played a big part in making sure we got it done.
Therefore, the study randomized patients to sorafenib, the standard at the time. [Nexavar] vs SBRT followed by sorafenib. Also, the total tumor burden in the liver was limited. Therefore, the sum of lesion diameters should not exceed 20 cm. And the patient was reliably allowed vascular invasion. If there was extrahepatic disease, it had to be less than 3 cm.
Looking at the patients recruited to the trial, the majority had vascular invasion.and most of them were BCLC [Barcelona Clinic Liver Cancer] Stage C patient. Of course, they’re all Child-Pugh A, and I think those are important traits to remember.
Now the study has slowed down and the statistics have changed.Therefore, as the study’s overall incidence decreased, the power dropped to about 65 instead of the 80–90% power. rice field [progression-free survival] SBRT was added to sorafenib in that patient population.
Median OS [overall survival] With this SBRT sorafenib combination, it was about 15.3 months. Therefore, cross-trial comparisons with the use of single-agent PD-1 in these patients are not far off.
So I was concerned that the confidence interval was just above 1 and the P-value was 0.055 and not below 0.05. But the body of the data – because there was an improvement in OS, the corresponding PFS was acceptable and feasible, this is a difficult population, mostly vascular invasion – it establishes a role for SBRT. I think in some patients. And, as Dr. Dawson said, I think the next step of evaluating this in the context of modern regimens will be very important.
Abu Alpha: i totally agree with everything you said. This is the reality we live in. We saw it with Dr. Maron and Dr. El Coueiri. field. It’s not like we do research and stay silent until the results of the research come out. Things are moving fast. For example, as you heard earlier, the comparator in the RTOG study was sorafenib, which itself is not really used today due to the advent of new therapies. Really, big kudos to Laura Dawson for bringing it up. She remembers her clearly. She said it’s time to seriously consider comparisons with newer approaches, including checkpoint inhibitors. from those studies. That’s right. Thank you for acknowledging my efforts.
Of course, when I was chairing the task force, both the 1812 and NRG research was kind of encouraging and supportive. However, I have to say that we have a great team in Gastro or Hepatobiliary and are always ready to help in any way we can to help the patient himself.
I’ve heard a lot from both Dr. Maron and Dr. El-Khoueiry. especially, Claudin 18.2 and zolbetuximab from Dr. Maron Also from Dr. El-Khoueiry. We may not have had very positive data, but we are nevertheless a step in the right direction for a combination of checkpoint inhibitor augmentation and a perfect baseline that provides better care and treatment for HCC patients. I’m in.
Now, thank you again for listening. Have a great day. Hope to connect again soon.
Watch Episode 1: Two Biliary Tract Cancer Trials Featured at ASCO GI
Watch Episode 2: Role of checkpoint inhibitors in gastric cancer
Watch Episode 3: Tislelizumab + chemotherapy for advanced gastric cancer/GEJ cancer