Minimizing Toxicity While Maintaining Efficacy in RCC - Episode 9

Case Study: Observation in Metastatic RCC

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Brian I. Rini, MD, presents a case study focused on the treatment of a 64 year-old male who presented with recurrent lung nodules 9 years after a left radical nephrectomy for a clear-cell renal cell carcinoma (RCC). The length of time between the primary surgery and recurrence illustrates the long natural history of the disease, Rini points out. Given the slow progression and low tumor volume, the patient opted for observation.

After 2 years of observation, the patient developed new lymph node involvement, including a paratracheal lesion. At this point, systemic therapy was initiated with 50-mg sunitinib using the 4 weeks on, 2 weeks off schedule. After a total of 14 months of therapy, the patient developed progressive disease and was treated with axitinib at 5 mg twice daily, which was empirically escalated after 4 weeks to 7 mg twice daily, Rini notes.

Occasionally, patients present with very indolent disease and may not require initial treatments, notes Robert A. Figlin, MD. The identification of these patients can be challenging, as can knowing when to initiate therapy.

To help answer these questions, a prospective study was conducted to explore observation prior to the initiation of systemic therapy in patients with metastatic RCC. In total, 52 patients with ECOG performance status 0 and a median baseline tumor burden of 3.2 cm were enrolled in the trial. Patients with a tumor burden ≤1.5 cm could safely be observed for 31.6 months prior to the initiation of systemic therapy compared with 13.8 months for patients with >1.5 cm disease.

The main triggers to begin therapy were signs of rapid progression, new sites of disease, and symptoms, Rini notes. Additionally, anxiety could be a good reason to start therapy; however, Rini notes, most patients preferred not being treated.