A randomized, double-blind, placebo-controlled phase II study of vandetanib plus docetaxel/prednisolone in patients with hormone-refractory prostate cancer.

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Horti, József (author)

A randomized, double-blind, placebo-controlled phase II study of vandetanib plus docetaxel/prednisolone in patients with hormone-refractory prostate cancer.

Article/chapterEnglish2009

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Mary Ann Liebert Inc,2009
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LIBRIS-ID:oai:DiVA.org:umu-22453
https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-22453URI
https://doi.org/10.1089/cbr.2008.0588DOI

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Language:English
Summary in:English

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Vandetanib (ZACTIMA) is a once-daily oral anticancer drug that selectively inhibits vascular endothelial growth factor receptor, epidermal growth factor receptor, and rearranged during transfection signaling. This randomized (1:1), double-blind study evaluated vandetanib (100 mg/day) or placebo in combination with docetaxel (D; 75 mg/m(2) every 3 weeks) and prednisolone (P; 2 x 5 mg/day) in 86 patients with metastatic hormone-refractory prostate cancer (mHRPC). The primary assessment was prostate-specific antigen (PSA) response (confirmed reduction of >or=50% from baseline) and a greater number of patients showed a PSA response with placebo + DP (67%) versus vandetanib + DP (40%); hazard ratio = 2.23 (one-sided 80% confidence limit = 2.90; one-sided p = 0.99). More patients experienced progression events (disease progression or death from any cause) with vandetanib + DP (65%) versus placebo + DP (60%); hazard ratio = 1.13 (one-sided 80% confidence limit = 1.44; one-sided p = 0.67). The overall incidence of adverse events was similar in both groups, although more patients experienced adverse events, leading to permanent discontinuation with vandetanib + DP (28%) versus placebo + DP (12%). However, the safety and tolerability profile for vandetanib was similar to that previously reported; adverse events that occurred more frequently in the vandetanib + DP arm were hypertension (14% vs. 2%), erythematous rash (14% vs. 2%), and exfoliative rash (12% vs. 2%). In this study of patients with mHRPC, vandetanib + DP did not demonstrate any efficacy benefit, compared with placebo + DP.

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Widmark, AndersUmeå universitet,Onkologi(Swepub:umu)anwi0004 (author)
Stenzl, Arnulf (author)
Federico, Miriam H (author)
Abratt, Raymond P (author)
Sanders, Nick (author)
Pover, Gillian M (author)
Bodrogi, István (author)
Umeå universitetOnkologi (creator_code:org_t)

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In:Cancer biotherapy & radiopharmaceuticals: Mary Ann Liebert Inc24:2, s. 175-801557-88521084-9785

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By the author/editor: Horti, József; Widmark, Anders; Stenzl, Arnulf; Federico, Miriam ...; Abratt, Raymond ...; Sanders, Nick; show more...; Pover, Gillian M; Bodrogi, István; show less...

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