In many countries, combinations of VEGFR TKI anti-cancer mediations plus immunotherapies are the standard of care as the first anti-cancer treatments for patients with advanced/metastatic kidney cancer due to increased response to treatment, longer progression-free survival and longer overall survival times compared to VEGFR TKI alone. It is known that most of the side effects from these combinations of anti-cancer medications are due to the VEGFR TKI.

Combinations of treatments continue to be of interest. But there remains the question of which combination of treatments is best for an individual patient with advanced/metastatic kidney cancer? Does temporarily stopping treatment with VEGFR TKI improve the tolerability of these combinations while keeping survival benefits?

In this phase 2 study, metastatic kidney cancer patients were treated with a combination of avelumab infusions every 2 weeks plus axitinib tablets daily for 36 weeks. At 36 weeks, the patients who had a response to treatment and their cancer got smaller stopped axitinib and continued with avelumab until their cancer started growing again (disease progression) or they couldn’t tolerate the side effects. If their cancer got worse, they re-started axitinib for 24 weeks. If they had another response to treatment, axitinib was stopped again and treatment with avelumab was continued. Patients with stable disease at 36 weeks continued the combination until their cancer started growing again or they couldn’t tolerate the side effects.

75 patients were assessed for the effectiveness of this treatment schedule. Nearly 4 in 10 patients stopped treatment with axitinib at 36 weeks. Three quarters of patients responded to treatment and their cancer got smaller and nearly one fifth of patients had stable disease. The time to when the treatment stopped working and the cancer started growing again was nearly 2 years, and for 7 in 10 patients their cancer did not grow for at least 18 months. The average length of the first axitinib break was 16 weeks. Of the 29 patients who stopped treatment with axitinib, 9 are still ongoing. For the other 20 patients, their cancer got worse. Of these, 19 re-started treatment with axitinib.

More than 9 in 10 patients had at least one side effect to treatment, and 4 in 10 had a serious or life-threatening side effect. There were no treatment-related deaths. A third of all patients reported side effects to axitinib, and 1 in 10 of all patients reported serious or life-threatening side effects to axitinib.

The TIDE-A study shows that for patients who responded to treatment with the avelumab plus axitinib combination as a first anti-cancer medication, it is safe to stop treatment with axitinib. Having a break from axitinib treatment reduces side effects while keeping the possibility of benefiting from axitinib treatment if it is re-started.

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