Practice Update: Oncology

NewData on theManagement of HCC

Interview with Arndt Vogel

by Jennifer N. Caudle

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

(HCC) 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 noninfe-

riority was shown for lenvatinib compared

to sorafenib in first-line treatment. And

there were some efficacy endpoints that

were clearly improved with lenvatinib com-

pared to sorafenib, including TTP and PFS

and response rates. Another question, of

course, was whether these efficacy end-

points were somehow correlated with the

worst outcome for the patient, and there-

fore 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 diar-

rhea, 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, effi-

cacy 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 III

study comparing lenvatinib to sorafenib in

patients with hepatocellular carcinoma. So

what were the main findings and implica-

tions 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 care-

ful. 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 dur-

ing treatment with lenvatinib and sorafenib,

there’s not really one marker that could

predict which group of patients would ben-

efit 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 under-

stand 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 hepatocellu-

lar 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 pro-

gressed 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 bio-

markers 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.

Dr Vogel is Professor,

Gastrointestinal Oncology;

Managing Senior Consultant,

Department of

Gastroenterology, Hepatology

and Endocrinology, Hannover

Medical School, Hannover,

Germany

www.practiceupdate.com/c/58080

ESMO 2017

VOL. 1 • NO. 3 • 2017