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Kidney cancer, the first early stage immunotherapy

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To date, there are no therapies for patients with kidney cancer at high risk of recurrence, and observation is the only possible strategy. But from the annual congress of the American Society of clinical Oncology comes a study destined to change clinical practice. For the first time, in fact, immunotherapy administered after surgery significantly increased the free time from disease recurrence, reducing the risk of recurrence and death by 32% in the two-year follow-up, compared to placebo.

More than a quarter of patients have a relapse

In 2020, 13,520 new diagnoses of kidney cancer were estimated in Italy. In general, about 25% present metastatic already at diagnosis, while the remaining 75% are operable. However, 25-30% of the operated patients relapse, most of them within two years. This percentage is even higher if only cases classified as intermediate or high risk are considered. The study (KEYNOTE-564, phase 3) evaluated pembrolizumab, an anti-PD-1 drug, as a potential adjuvant treatment (i.e. after surgery) in these patients at intermediate-high or high risk of relapse after nephrectomy ( surgical removal of a kidney) or after nephrectomy and resection of metastatic lesions.

The study of pembrolizumab as adjuvant therapy

“Immunotherapy with pembrolizumab, which has already achieved important results in advanced disease, opens up for the first time a new perspective for its use even at an earlier stage, immediately after surgery”, confirms Sergio Bracarda, Director of the Oncology Department and of the Complex Structure of Medical and Translational Oncology of the Santa Maria di Terni Hospital: “To date, for these patients, after surgery, there are no therapeutic options available other than careful observation with regular checks . There was a lack of studies that could support a concrete advantage in reducing the risk of relapse with pharmacological treatment that was effective and tolerable. In the KEYNOTE-564 study, pembrolizumab was shown to be effective in reducing the risk of relapse or death by 32% compared to placebo – an important result, with an acceptable tolerability profile and a favorable overall survival trend. To know the impact on overall survival we will have to wait for longer-term data, but already delaying the time to reappearance of the tumor could modify its natural history ”.

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To achieve this it took decades, as you recall Toni K. Choueiri, director of the Lank Center for Genitourinary Oncology, co-leader of the Kidney Cancer Center, Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School: “We hope to continue to provide new treatment options for patients with kidney cancer.” Studies are already underway for both the first line of treatment and the second and third: we are looking at combinations of two immunotherapies and these with angiogenesis inhibitors, very effective in kidney cancer.

Kidney cancer and the role of Italian research

The most common kidney cancer is renal cell carcinoma (RCC), which affects about nine out of 10 diagnoses. This cancer is twice as common in men than in women and, in most cases, is discovered by chance during diagnostic tests performed for other abdominal diseases. “In the past, kidney cancer was taken as an example of an orphan disease, today we have several possibilities for advanced disease and, finally, important results even at an earlier stage”, he concludes. Saverio Cinieri, elected president of the Italian Association of Medical Oncology (Aiom): “Italy has actively participated in this clinical study, bringing – as very often happens – high quality data”.

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