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New data on the management of HCC from ESMO 2017
Interview with Arndt Vogel
‘Filmed by PracticeUpdate with permission for inclusion on Advances in Gastrointestinal Cancer. More information and additional ESMO coverage can be found at www.practiceupdate.com‘
Dr. Caudle: Your team is presenting an abstract at ESMO this year pertaining to health-related quality of life and disease symptoms in patients with hepatocellular carcinoma treated with lenvatinib or sorafenib. Can you tell us a little bit about the study?
Dr. Vogel: Yes, of course. So, the study was the first study, the first positive study for more than 10 years for the systemic treatment of HCC, and in this study noninferiority was shown for lenvatinib compared to sorafenib in first-line treatment. And there were some efficacy endpoints that were clearly improved with lenvatinib compared to sorafenib, including TTP and PFS and response rates. Another question, of course, was whether these efficacy endpoints were somehow correlated with the worst outcome for the patient, and therefore this has reported outcomes from patients, I think, extremely important at the moment to decide which treatment would be best for our patients.
So, here in this study, there was really a large quality of life investigation and the compliance of all patients was very good, so we have reports from more than 98% of the patients, which is really extremely well and the data are very robust. And what we can see here is that overall during treatment, quality of life and health-related, global health declines during treatment, and the outcomes are very similar for both treatment arms sorafenib and lenvatinib. But there were a couple of key domains which were really in favor of lenvatinib compared to sorafenib, and these domains include pain, for example, nutrition, body image, and diarrhea, and these are, I think, outcomes which are also important for the patient. So, overall, I think these data indicate that we do have some improved secondary endpoints, efficacy endpoints, and we also have a safety profile and then quality of life profile, which is in favor of lenvatinib.
Dr. Caudle: That’s very interesting. Now, you were also involved in an analysis of serum biomarkers in patients from the phase 3 study comparing lenvatinib to sorafenib in patients with hepatocellular carcinoma. So what were the main findings and implications from this study?
Dr. Vogel: So, I think with the biomarker study, we need to be a little bit careful. So, first of all, this was...they were only derived from a small portion of patients, so really we do not have the tissue and the blood samples from all patients, so we need to be a little bit careful. We can just generate hypotheses with these results. So, I think, although the data are in line with what we expected, there are indeed some biomarkers that change during treatment with lenvatinib and sorafenib, there’s not really one marker that could predict which group of patients would benefit more from either treatment, lenvatinib or sorafenib. So, I think, we can use these data to better understand the mechanism of action and maybe also to better understand mechanism of resistance in the future.
Dr. Caudle: That’s interesting. You know, let’s stay on the topic of biomarkers a little longer, especially for hepatocellular carcinoma, but let’s shift our focus to regorafenib. An exploratory analysis of the RESOURCE trial is reported at ESMO this year related to biomarkers that might predict improved overall survival and time to progression for patients receiving regorafenib. So, how might these findings influence clinical practice moving forward?
Dr. Vogel: So, I think first of all, the RESOURCE study was a very important study because it was the first positive study in second-line treatment of HCC, and so far we do not really have an evidence-based second-line treatment for our patients that have progressed on sorafenib. So, this was very important and we now have the drug available for these patients that tolerated sorafenib and have progressed on it. So, now we have the biomarker analysis here, and again, I think, the data are interesting.
They will help us to better understand the mechanism of action in the future. In this trial, interestingly, there were some biomarkers that were predictive of treatment benefit with the regorafenib. They were not prognostic. They’re also predictive for a better TTP, and I think we might be able to use these data in the future to better select patients for treatment with regorafenib, but at the moment, I think we only have one approved second-line treatment, which is regorafenib, so it will not really immediately impact on our daily treatment decisions.