title: Prolonged complete responses and near-complete responses to sunitinib in metastatic renal cell carcinoma.
abstract: Sunitinib is a tyrosine kinase inhibitor with activity against vascular endothelial growth factor (VEGF) receptor and platelet-derived growth factor receptor recently approved by the FDA for the treatment of advanced renal cell carcinoma (RCC). Complete responses (CRs) to sunitinib have been documented in the literature. However, a detailed description and analysis of these patients is lacking. Seventy-four patients receiving sunitinib at the Cleveland Clinic in first-, second-, and third-line clinical trials were reviewed to determine the number of patients with Response Evaluation Criteria in Solid Tumors (RECIST)-defined CRs and patients who have achieved near CRs (nCRs) with a > 90% reduction in composite tumor volume or residual disease of <or= 1 cm only. Two patients (2.7%) achieved investigator-assessed, RECIST-defined CRs and have had prolonged responses lasting > 22 months while on maintenance sunitinib. The patients who obtained CRs had nonbulky pulmonary metastases, had favorable or intermediate Memorial Sloan-Kettering Cancer Center risk profiles, were treated with sunitinib in the first-line setting, and had a significant reduction in composite tumor measurements within the first 2 cycles. Two additional patients achieved nCRs, including a patient who had previously progressed on bevacizumab. Finally, 1 patient achieved sufficient downstaging and reduction of tumor volume such that the remaining lesion could be excised to produce a surgical CR. Sunitinib is capable of producing durable CRs in patients with cytokine-naive, metastatic RCC who have nonbulky pulmonary metastases. Additionally, nCRs can be seen despite nonpulmonary metastatic sites and previous VEGF-targeted therapy.
authors.affiliation: Cleveland Clinic Taussig Cancer Center, Cleveland, OH 44195, USA.
authors.forename: Daniel Y C
authors.initials: DY
authors.lastname: Heng
authors.forename: Brian I
authors.initials: BI
authors.lastname: Rini
authors.forename: Jorge
authors.initials: J
authors.lastname: Garcia
authors.forename: Laura
authors.initials: L
authors.lastname: Wood
authors.forename: Ronald M
authors.initials: RM
authors.lastname: Bukowski
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008175:Lung Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011758:Pyrroles / Q000627:therapeutic use*; D000077210:Sunitinib; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib