Findings showing similar health-related quality of life (HRQoL) scores in patients with advanced endometrial carcinoma undergoing combination therapy versus monochemotherapy could be significantly important, especially for disease that has not had a specifically approved treatment for 50 years, said Kirk Shepard. , MD, Chief Medical Officer, Senior Vice President and Head of Global Medical Affairs, Eisai.
Can you discuss what can be derived by measuring HRHL for a condition like endometrial cancer (CE), especially in its advanced stages (aEC)?
It is extremely important that we measure these parameters in patients, especially in endometrial carcinoma., advanced endometrial carcinoma. If you think about it, it’s been 50 years since a drug was specifically approved for endometrial carcinoma. It is therefore very important not to measure the effectiveness [and] the efficacy of a drug, but also the benefit-risk balance, and of course the quality of life is on the other side. So, using health-related quality of life measures, which have come a long way over the past two decades – 2 guidelines, at least, written since 2006, 2009, FDA, Europe, on health measures. how they can appropriately measure the quality of life in patients.
And this particular one that we used, which was the EORTC QLQ-C30, is the one that is probably used more than any other. It is a more general measure of the parameters of different domains. And it has been validated in over 100 validation studies and used in possibly a a few thousand studies over twenty years. It is therefore very important that we use these tools that we have now to measure the quality of life of patients.
The results indicate similar mean HRQoL scores for patients with aEC undergoing combination therapy versus chemotherapy. Can you tell us about the significance of this discovery?
So we were very happy with the results, as you can imagine, because we were comparing ourselves â Keytruda [pembrolizumab] and Lenvima [lenvatinib]-at mono-chemotherapy. And these are traditional chemotherapy drugs. So this would be called the doctor’s choice of treatment, which is either doxorubicin or paclitaxel.
So to come out, numerically, in fact, a better quality of life, even if it was not statistically important–but the same quality of life parameters as 2 mono drugs, while we are giving 2 drugs was very important.
As I said too, this is something very precious because it gives–especially healthcare physicians who have treated endometrial carcinoma for 50 years with the same drugs–a window into what happens when we come up with new advanced drugs, such as an OI [immuno-oncology] or a TKI [tyrosine kinase inhibitor], like Lenvima, and shows that, really, the quality of life is still quite good. So with the great results we’ve had, and I think you’re probably familiar with the 309 study that we have present at SGO [Society of Gynecologic Oncology], it is really a very acceptable risk / benefit ratio.
Were there any notable differences by patient subgroup in HRQoL for those undergoing combination therapy?
We haven’t done any subgroup analyzes yet, and that’s a great question, because that’s the right thing to do first. We wanted, of course, to get the first results for SGO as soon as we knew the results so that treating physicians would know that this was another group of drugs that they could use together to treat patients.
And then, of course, the quality of life is now also a bit topline. This gives the tool that I mentioned earlier, the results of that. But subgroup analysis, as long as the numbers don’t get too low when we look at the group, is the route we would like to take to the next step.
I can just say it’s been a pleasure working at a company like Eisai because they have human healthcare which you may or may not have heard of. Human healthcare is a platform that was launched 30 years ago, where we put the patient, caregiver and family first.
And so that fits very well with what we’ve done, not only with endometrial carcinoma, but in the same program at ASCO, we’re doing an HRQoL study, and it’s presented orally for renal cell carcinoma. . Again, Eisai is very keen not only to achieve good results when it comes to tumor reduction, but also to ensure that we always consider the quality of life of the patient.
Lorusso D, Colombo N, Herraez AC, et al. Health-related quality of life (HRQoL) in patients with advanced endometrial cancer (aEC) (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (PCT). J Clin Oncol. 2021; (suppl 15; abstr 5570). doi: 10.1200 / JCO.2021.39.15_suppl.5570