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Report from ASCO – CARMENA Trial

Report from ASCO – CARMENA Trial

KCCure recently attended ASCO – the world’s largest cancer research conference. Learn more below on why everyone in the kidney cancer world is talking about CARMENA.

What is CARMENA?

It may sound like an Italian operetta – but CARMENA is actually a French led clinical trial for kidney cancer patients.  Data from CARMENA was presented as part of the plenary session during ASCO 2018 – which is the world’s largest cancer research conference.  As a result, the trial has been getting a lot of attention and discussion in the kidney cancer world.

How was the trial conducted and what were the conclusions?

From 2009 to 2017, 450 patients with metastatic kidney cancer at diagnosis agreed to participate in this clinical trial.  Patients were randomized into two arms.

When a nephrectomy is conducted to remove a primary kidney tumor on a patient that already has metastatic cancer, it is referred to as a cytoreductive nephrectomy.  In one arm, patients received an upfront cytoreductive nephrectomy. Following the cytoreductive nephrectomy, patients were started on sunitinib (Sutent) (50 mg. 4 weeks on, 2 weeks off).

In the second arm, patients did not receive a cytoreductive nephrectomy and the primary tumor was left in place.  Instead, they were immediately started on systemic therapy which also consisted of sunitinib (50 mg. 4 weeks on, 2 weeks off).

The trial was designed to determine whether cytoreductive nephrectomy would improve overall survival for patients.  The results of the trial, which were reported at the ASCO plenary session, found that there was no statistical difference between the two groups.  In other words, under-going a cytoreductive nephrectomy did not improve the outcome for patients with primary metastatic disease.

What does this mean for Kidney Cancer Patients?

The results of the CARMENA trial go against what was previously thought to be true – that cytoreductive nephrectomy prolongs overall survival.  That assumption was based on previous trials that involved the use of interferon alpha, an immunotherapy treatment that’s no longer routinely used in RCC, as well as analyses looking back through patient records to establish patterns.

With the introduction of targeted therapies that were more successful at treating metastatic disease, such as targeted therapies like sunitinib, researchers began to question again whether cytoreductive nephrectomy before systemic therapy was the best course of action for patients with advanced metastatic disease. As a result, doctors decided to conduct the CARMENA trial.

The results of this study force us all to reconsider standard practice guidelines for RCC patients. When should patients be given a cytoreductive nephrectomy?  Should we defer or delay nephrectomy in patients or should they only be given systemic therapy?

Over the next few months, we could begin to see changes in recommendations and guidelines that influence and direct how practitioners treat patients diagnosed with metastatic kidney cancer.  We expect this could lead to more multi-disciplinary discussions between urologists and medical oncologists about how to best standardize care.

What does this mean for patients who previously had a cytoreductive nephrectomy?

It’s important to note that the trial found that not doing a cytoreductive nephrectomy was not inferior to doing a cytoreductive nephrectomy.  In other words, there is no benefit for either arm – so if you were a patient diagnosed with metastatic disease who underwent cytoreductive nephrectomy, there’s no reason to fear that the course of action you took was detrimental.

And while CARMENA likely will change and influence practice, we expect that many patients diagnosed with metastatic disease will still be candidates for cytoreductive nephrectomy for reasons such as palliation (relieving pain due or symptoms) for large tumors or for patients where a complete response or near complete response of disease could be achieved through surgery or surgery combined with systemic therapy.

What is KCCure doing in response to CARMENA?

In addition to educating patients about the trial data and potential changes in practice, we’re also gathering patient preferences through a brief survey.  Knowing patient views related to surgical practices and treatment of cancer is important.

Once completed, we’ll aggregate responses into a way that can be useful for providers and stakeholders in the field as they consider guidelines and recommendations.

When it comes to cancer treatment and management of the disease, we believe the patient voice should always be part of the process.  We hope you’ll take a minute to share your views – your voice matters!

If you’d like to read the publication related to the CARMENA trial, click here to read more in the New England Journal of Medicine.

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