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• W2227609670 abstract "5100 Background: Bevacizumab and sunitinib both have activity in metastatic renal cell carcinoma (mRCC). Combining bevacizumab and sunitinib may increase antitumor efficacy by maximizing inhibition of the VEGF pathway. The safety and maximum tolerated dose (MTD) of sunitinib in combination with bevacizumab was assessed in this Phase I trial. Methods: Cohorts of 3–6 patients (pts) with mRCC received escalating doses of sunitinib (dose levels: 25, 37.5, and 50 mg po) daily for 4 weeks (wks) followed by 2 wks off with fixed-dose bevacizumab (10 mg/kg iv) every 2 wks continuously. Pre- determined dose-limiting toxicities (DLTs) were assessed in the first 6-wk cycle. Results: Of 26 pts (median age 57) enrolled, 25 were treated including 7 (1 replaced) in cohort 1 (sunitinib 25 mg, bevacizumab 10 mg/kg), 6 in cohort 2 (sunitinib 37.5 mg, bevacizumab 10 mg/kg) and 12 (6 for MTD, additional 6 for safety) in cohort 3 (sunitinib 50 mg, bevacizumab 10 mg/kg). Two DLTs of G4 hemorrhage occurred (1 cohort 2, 1 cohort 3). Therefore, the MTD was sunitinib 50 mg plus bevacizumab 10 mg/kg. However, with chronic treatment, additional toxicities were observed, many overlapping, including G3/4 HTN (14/25 overall, 9/12 cohort 3), G3/4 proteinuria (6/25 overall, 4/12 cohort 3), G3 thrombocytopenia (6/12 cohort 3), G3 RPLS (2/12 cohort 3) and G3 microangiopathic hemolytic anemia (2/12 cohort 3). One pt in cohort 2 died of an MI; autopsy showed tumor involvement of the myocardium. Other toxicities were reversible. In total, 10/25 (40%) pts required sunitinib dose reductions (2/6 cohort 2, 8/12 cohort 3) and 11/25 (44%) pts were withdrawn for toxicity (2/7 cohort 1, 2/6 cohort 2, 7/12 cohort 3). The median number of treatment cycles received was 7 for cohort 1 (range 1–14), 3 for cohort 2 (range 1–9) and 4 for cohort 3 (range 1–8). Of 25 pts, 13 (52%) had a confirmed objective response (1 complete response and 12 partial responses). Conclusions: While active, the combination of bevacizumab plus sunitinib in this phase I trial was poorly tolerated at full doses. Chronic therapy resulted in a high proportion of pts experiencing toxicity requiring sunitinib dose reductions and/or study discontinuation. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genentech™ BioOncology, Pfizer Oncology" @default.
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• W2227609670 date "2008-05-20" @default.
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• W2227609670 title "Phase I trial of bevacizumab plus sunitinib in patients with metastatic renal cell carcinoma" @default.
• W2227609670 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.5100" @default.
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