INTRODUCTION
Renal cell carcinoma, DLTs, neutropenia, cellulitis, toxicities, toxicity, vascular kidney cancer, anemia, rash, mucositis, deaths, mRCC, Cancer
RENAL CELL CARCINOMA, NEUTROPENIA, CELLULITIS, METASTATIC RENAL CELL CARCINOMA, THROMBOCYTOPENIA, ANEMIA, SECONDARY, MUCOSITIS, KIDNEY CANCER, CANCER
Renal cell carcinoma is a highly vascular kidney cancer that is often asymptomatic until late stage, with one third of new cases presenting with metastatic renal cell carcinoma (mRCC). In 2023, the American Cancer Society estimates that approximately 81,800 new cases and 14,890 deaths will be attributed to kidney cancer.Due to the success of sunitinib and temsirolimus as single agents, studies were conducted to concomitantly combine the two therapies in an attempt to improve mRCC treatment. However, this combination was poorly tolerated due to observed dose‐limiting toxicities (DLTs) which included mucositis, neutropenia, anemia, thrombocytopenia, rash, and cellulitis.We therefore hypothesized that alternating sunitinib and temsirolimus therapy would be well tolerated and improve the combined PFS of the agents when used as monotherapy (11 + 4 months). To test this hypothesis we performed a single‐arm, phase II study with alternating 4‐weekly treatment cycles of sunitinib and temsirolimus with a 2‐week rest of no therapy in between each therapy type in patients with mRCC. The primary objective was to determine the PFS of this regimen of alternating therapy in mRCC patients, with secondary objectives including clinical response rate and characterizing the alternating regimen toxicity profile.