Dr. Ornstein on Toxicity Concerns for Neoadjuvant Therapy in Localized RCC

Moshe Ornstein, MD, MA, Department of Hematology and Medical Oncology, Cleveland Clinic, discusses toxicity concerns when treating renal cell carcinoma (RCC).

A phase 2 trial (NCT03341845) examined the use of neoadjuvant avelumab (Bavencio) and axitinib (Inlyta) in patients with RCC who were at high risk of relapse after nephrectomy.

When considering neoadjuvant therapy for patients who have localized RCC, toxicity and efficacy of the treatment should be considered in the scope of an individual patient’s disease, Ornstein says. For a patient who has metastatic RCC, there is a lower likelihood of treatment leading to a cure, so clinicians and patients should have a higher bar for acceptable toxicities.

However, for patients with localized RCC, even if some will experience recurrence, many will be cured without treatment outside of surgery, Ornstein continues. Therefore, the bar for acceptable toxicities should be lower in patients with localized disease, Ornstein says.

In this phase 2 trial, the combination of neoadjuvant avelumab and axitinib was well tolerated, and there did not appear to be any notable surgical complications stemming from adverse effects of the combination therapy, Ornstein explains. Although it is not standard to give this combination prior to surgery for patients with localized RCC, the results of the trial do establish a setting where the agents can be administered effectively, Ornstein concludes.