No available data support the potential response of relapsed recurrent renal cell carcinoma (RCC) patients treated with systemic targeted therapies (TT) after completion of adjuvant sunitinib. In this study, we aimed to assess the efficacy and tolerability of rechallenge with sunitinib and other TT in advanced setting.
In this multi-institutional retrospective study, relapsed RCC patients were re-challenged with sunitinib or other systemic TT as first-line therapeutic approach after failed sunitinib adjuvant treatment. Patient characteristics, treatments and clinical outcomes were recorded. The primary end point was progression-free survival (PFS). Secondary end points were objective response rate (ORR) and overall survival (OS).
34 relapses were recorded, 25 patients (73.5%) were male. 25 patients were treated with systemic TT: 65% of patients received TT against Vascular Endothelial Growth Factor pathway (VEGF-TT, including sunitinib), 21.7% received mTOR inhibitors and 13%, immunotherapy. Median time to relapse was 20.3 months (IQR 5.2-20.4) from diagnosis, and 7.5 months (IQR 1.0-8.5) from adjuvant suntinib (AS) ending. At a median follow-up of 23.5 months, 24/25 patients had progressed on first-line systemic therapy. Median PFS was 12.0 months (95% CI: 5.78-18.2). There were no statistical differences in PFS between different treatments or sunitinib rechallenge. PFS was not statistically different in patients relapsing on or after AS (≤ 6 or > 6 months after AS ending). ORR was 20.5%. Median OS was 29.1 months (95% CI: 16.4-41.8).
Rechallenge with sunitinib or other systemic therapies is still a feasible therapeutic option that provides advanced or metastastic RCC patients with additional clinical benefits on PFS and OS after failed response to adjuvant sunitinib.