Opdivo plus Cabometyx prolonged survival with minimal effects to their health status, which may highlight the need for patients to advocate for their quality of life when making treatment decisions.
Patients with advanced renal cell carcinoma may have maintained or improved quality of life when treated with Opdivo (nivolumab) plus Cabometyx (cabozantinib) compared with Sutent (sunitinib), according to findings from a recent trial.
Findings from this trial, which were published in Lancet Oncology, highlight the importance of focusing on quality of life when making treatment decisions, especially as more options become available for patients with advanced renal cell carcinoma.
“Very often, it's not clear that one or another option will produce a better outcome in any given person, so to be able to make an informed decision about which option you want to take, we need information about the patient experience to be able to give to people who are facing this decision about a new therapy,” said David Cella, professor in the Department of Medical Social Sciences at Northwestern University Feinberg School of Medicine in Chicago, in an interview with CURE®. “It used to be there weren't as many options and you went with the existing standard of care. And there very often was one standard of care. Now, there can be three or four (options) in a given disease. We need more information to feed to people so that they can make that decision.”
Findings from this trial were previously reported and demonstrated that patients with advanced renal cell carcinoma treated with first-line Opdivo plus Cabometyx had significant improvements in overall survival and in progression-free survival (the time when a patient with cancer lives without worsening disease) compared with those treated with Sutent.
“The (CheckMate 9ER) trial itself was important because immunotherapy has made a very big impact in diseases like advanced kidney cancer in terms of the possibility of extending survival time,” Cella explained. “Previous advances in kidney cancer had not extended survival time but had improved progression-free survival time. This is an opportunity to see if we could actually help people live longer — not just live longer without the progression of their disease but live longer overall.”
In this study, researchers focused on patient-reported outcomes (information on a patient’s health reported from the patient themselves pertaining to symptoms and well-bring) in those enrolled in the CheckMate 9ER trial. In particular, 323 patients with previously untreated advanced renal cell carcinoma were assigned treatment with Opdivo plus Cabometyx and 328 patients were assigned to Sutent.
Patient-reported outcomes were assessed at the start of the trial and every six weeks and included disease-related symptoms and health status. This allowed researchers to monitor for changes in quality of life and potential deterioration events. Patients were followed-up for a median of 23.5 months.
At the beginning of the trial, patients from both treatment groups reported low symptom burden. Changes in patient-reported outcomes from the start of the study demonstrated that Opdivo plus Cabometyx was linked with more favorable outcomes compared with Sutent. Treatment with Opdivo and Cabometyx was also associated with a lower risk for symptom deterioration versus Sutent.
“What we showed — which was why I was so excited about it — is that this (Opdivo)/(Cabometyx) combination not only extended survival relative to sunitinib (Sutent), but people also had fewer problems with symptoms and functions. They didn't just live longer, they lived better,” Cella said.
He added that this is somewhat different from what is normally observed in oncology. Oftentimes, when a new treatment involves adding a drug to an existing regimen or a new combination regimen, it may extend survival but at the cost of worse quality of life.
“(This is) either because it's being compared to a placebo, so you (are) just adding more adverse events or toxicity, or because it's more potent against the cancer, but also is more destructive to the normal tissues in a person's body,” Cella mentioned. “What we typically see in cancer trials is worse quality of life while you're getting the treatment but better survival. Then the question becomes, ‘Was it worth it?’ Usually, the answer is yes, but the patient has to make a trade-off and say, ‘I'll accept more risk of toxicity in exchange for an increased chance of living longer.’ That's a gamble most people will take.”
This increased focus on quality of life in patients enrolled in clinical trials may be a result of a more patient-centered approach to cancer care, which has been influenced by the federal government including the creation of the Patient-Centered Outcomes Research Institute under the Affordable Care Act.
“There has been an increased sense in our society about being more patient centered, patient focused, giving people the information they need in order to make decisions,” Cella said. “And parallel to that, the U.S. (Food and Drug Administration) has taken a major initiative on a more patient-centered approach. That's part of the 21st Century Cures Act, which … has really increased explicit attention paid to the patient perspective in clinical trials.”
As more information becomes available on patient experiences on cancer treatments, Cella advised patients to ask more questions related to quality of life when making treatment decisions.
“Most oncologists welcome questions,” he explained. “They have a lot of information. They want to be able to answer those questions. Ask questions not just about what's the prospect of cure or what's the prospect of getting a complete or partial response, which isn't necessarily a cure, but does show a sign that your disease is responding to the treatment. … Those are the standard questions, but also ask what's the experience of going through the treatment? What are the symptoms that I should anticipate? Will I be tired? Will I have pain? Will I have mouth sores, nausea, vomiting? Sometimes those conversations actually happen with the treating nurse after therapy is recommended, but it really would be better to ask (the cancer team) right up front while you're making that choice, particularly if there is a choice to be made.”
Cella also highlighted the importance of gathering all the information they can about their cancer experience, even if that involves getting a second opinion.
“It can be a very confusing time and a very disorienting time,” he said. “I really encourage people to try to do the best they can to take stock of the facts that are known about their cancer, about its stage, risks associated with it and what those treatment options are. And don't hesitate to get a second opinion unless you're really, totally comfortable with the opinion that you're getting. Getting a second opinion shouldn't offend anyone and can equip you with the right kind of tools to make the best decision for you. And then don't be afraid to change course along the way if things don't go as expected.”
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