Phase II trial of sunitinib for the therapy of progressive metastatic castration-refractory prostate cancer after previous docetaxel chemotherapy.
Effective options are lacking for progressive castration-refractory prostate cancer (CRPC) after conventional chemotherapy. Sunitinib is an orally administered multitargeted tyrosine kinase inhibitor that is approved multinationally for renal cell carcinoma and gastrointestinal stromal tumors. A phase II trial was conducted to examine the efficacy and toxicities of sunitinib in metastatic CRPC progressing after 1-2 previous chemotherapy regimens including docetaxel. The primary objective was clinical progression-free survival (PFS) with a 12-week PFS > or = 30% assumed to be of interest. Secondary objectives included prostate-specific antigen (PSA) response, modulation of PSA kinetics, objective response, quality of life, pain, survival, and toxicities. Sunitinib 50 mg daily was administered orally on days 1-28 of each 6-week cycle. Patients were treated to a maximum of 8 cycles or until clinically progressive disease or intolerable toxicity.
Sonpavde
Guru
G
Texas Oncology and Baylor Sammons Cancer Center, Dallas, TX, USA. guru.sonpavde@usoncology.com
Hutson
Thomas E
TE
Berry
William R
WR
Boehm
Kristi A
KA
Asmar
Lina
L
D000230:Adenocarcinoma / Q000188:drug therapy*; D000726:Androgen Antagonists / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D002369:Castration; D018572:Disease-Free Survival; D006801:Humans; D007211:Indoles / Q000627:therapeutic use* / Q000633:toxicity; D008297:Male; D009362:Neoplasm Metastasis; D017430:Prostate-Specific Antigen / Q000032:analysis; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D011758:Pyrroles / Q000627:therapeutic use* / Q000633:toxicity; D011788:Quality of Life; D000077210:Sunitinib
D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D017430:Prostate-Specific Antigen; D000077210:Sunitinib