Английская Википедия:Early Prostate Cancer (clinical programme)

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The Early Prostate Cancer (EPC) programme was a large clinical trial programme of monotherapy with the nonsteroidal antiandrogen bicalutamide (Casodex) plus standard care versus standard care alone in men with early prostate cancer.[1][2][3] It was started in August 1995,[1] with the first analysis published in 2002[4] and the final follow-up published in 2010.[5] The programme consisted of three large randomized, double-blind, placebo-controlled trials in which a total of 8,113Шаблон:Nbspmen with localized or locally advanced prostate cancer were treated with 150Шаблон:Nbspmg/day bicalutamide plus standard care (watchful waiting, radical prostatectomy, or radiation therapy) (n=4052) or given placebo (standard care alone) (n=4061).[3][2] It constituted the largest clinical trial of prostate cancer treatment to have ever been conducted at the time.[1][3][6]

The three trials in the EPC programme were as follows:[2][7]

Several combined follow-up papers of the EPC programme results were published, including at median 3.0Шаблон:Nbspyears in August 2002,[4] median 5.4Шаблон:Nbspyears in November 2004,[16] median 7.4Шаблон:Nbspyears in February 2006,[17] and median 9.7Шаблон:Nbspyears in April 2010.[5]

The EPC programme found that bicalutamide was effective in treating locally advanced prostate cancer.[2] Conversely, it was not effective for localized prostate cancer, where there was instead a statistically insignificant trend toward reduced overall survival with bicalutamide therapy (at median 7.4Шаблон:Nbspyears follow-up: Шаблон:Abbrlink = 1.16; 95% Шаблон:Abbrlink = 0.99–1.37; Шаблон:Abbrlink = 0.07).[1][2] The increased mortality with bicalutamide in men with localized prostate cancer was however statistically significant at certain follow-ups in the Trial 25/SPCG-6 substudy of the EPC programme.[13][15] The preceding findings led to the withdrawal of pre-existing approval of bicalutamide for localized prostate cancer in the United Kingdom and Canada.[2]

Liver safety is an important concern with bicalutamide. In the first analysis of the EPC programme at median 3.0Шаблон:Nbspyears of follow-up, abnormal liver function tests had occurred in 3.4% of men treated with bicalutamide and 1.9% of men with placebo.[2][3][4] Clinically relevant increases in aspartate transaminase (AST), alanine transaminase (ALT), and bilirubin occurred in 1.6%, 1.6%, and 0.7% with bicalutamide and in 0.5%, 0.3%, and 0.4% with placebo.[2] However, liver changes with bicalutamide were usually transient and rarely severe.[2] Abnormal liver function tests led to treatment withdrawal in 1.4% with bicalutamide and 0.5% with placebo.[4] No cases of fatal hepatotoxicity occurred with bicalutamide in the SPCG-6 substudy of the EPC programme.[13]

References

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  1. ↑ 1,0 1,1 1,2 1,3 Шаблон:Cite journal
  2. ↑ 2,0 2,1 2,2 2,3 2,4 2,5 2,6 2,7 2,8 Шаблон:Cite journal
  3. ↑ 3,0 3,1 3,2 3,3 Шаблон:Cite journal
  4. ↑ 4,0 4,1 4,2 4,3 Шаблон:Cite journal
  5. ↑ 5,0 5,1 Шаблон:Cite journal
  6. ↑ Шаблон:Cite journal
  7. ↑ Шаблон:Cite journal
  8. ↑ Шаблон:Cite journal
  9. ↑ Шаблон:Cite journal
  10. ↑ Шаблон:Cite journal
  11. ↑ Шаблон:Cite journal
  12. ↑ Шаблон:Cite journal
  13. ↑ 13,0 13,1 13,2 Шаблон:Cite journal
  14. ↑ Шаблон:Cite journal
  15. ↑ 15,0 15,1 Шаблон:Cite journal
  16. ↑ Шаблон:Cite journal
  17. ↑ Шаблон:Cite journal
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