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Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma

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Motzer R.J., Barrios C.H., Kim T.M., Falcon S., Cosgriff T., Harker W.G., Srimuninnimit V., Pittman K., Sabbatini R., Rha S.Y., Flaig T.W., Page R., Bavbek S., Beck J.T., Patel P., Cheung F.-Y., Yadav S., Schiff E.M., Wang X., Niolat J., Sellami D., Anak O., Knox J.J.

Journal of Clinical Oncology 2014 32:25 (2765-2772)

Purpose A multicenter, randomized phase II trial, RECORD-3, was conducted to compare first-line everolimus followed by sunitinib at progression with the standard sequence of first-line sunitinib followed by everolimus in patients with metastatic renal cell carcinoma. Patients and Methods RECORD-3 used a crossover treatment design. The primary objective was to assess progression-free survival (PFS) noninferiority of first-line everolimus compared with first-line sunitinib. Secondary end points included combined PFS for each sequence, overall survival (OS), and safety. Results Of 471 enrolled patients…(ver más)

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