gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

Ketokonazol/hydrocortisone versus estramustinphosphate in the management of PSA progression following primary androgen deprivation for metastatic prostate cancer

Meeting Abstract

  • corresponding author presenting/speaker Carsten Ohlmann - Bereich Urologische Onkologie Universitätsklinikum, Köln, Deutschland
  • Igor Cordia - Bereich Urologische Onkologie Universitätsklinikum, Köln
  • Udo H. Engelmann - Bereich Urologische Onkologie Universitätsklinikum, Köln
  • Axel Heidenreich - Bereich Urologische Onkologie Universitätsklinikum, Köln

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO305

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dkk2006/06dkk415.shtml

Published: March 20, 2006

© 2006 Ohlmann et al.
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Outline

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Objectives: Although the majority of patients with metastatic prostate cancer (PCA) initially respond to androgen deprivation, most will ultimately fail and require further therapy. Currently, no standard therapy exists for these patients with androgen-refractory but hormone-sensitive PCA. Second-line hormonal therapy with estramustinphosphat (EMP) or ketokonazol/hydrocortisone (KHC) have been described to produce response rates of 30 to 60%. It was the purpose of this prospective randomized phase-II trial to compare both clinical efficacy and side effects of both regimens in a cohort of 65 patients.

Patients & Methods: To become eligible for second line hormonal therapy, all patients had to show (1) PSA-progression at 2 consecutive measurements 2 weeks apart, (2) PSA progression following antiandrogen withdrawal and castration levels of testosterone. In 35 patients, EMP was applied at 300 – 350 mg/die as continuous intravenous infusion on 7 consecutive days followed by oral medication with 3x 280 mg/day until PSA progression. In 30 patients, K consisted of 800 mg/day and replacement HC at 30 mg/day until PSA progression. On the EMP and KHC group, 10 and 6 patients underwent antiandrogen withdrawal, all other patients had received LHRH therapy or orchiectomy. Primary endpoint was PSA response; PSA was measured at 6 weeks intervalls, treatment associated side effects were documented.

Results: Of the 35 patients in the EMP group, 8 (23%) demonstrated a PSA decrease > 50% with a median duration of 3 (2-12) months. Of the 30 patients in the KHC group, 18 (61%) patients exhibited a PSA decrease > 50% with a median duration of 7.5 (3-34) months. Response rates were higher in patients with LHRH or orchiectomy as compared to patients with PSA progression following antiandrogen withdrawal. Differences in PSA response and response duration were statistically significant between both groups. In the EMP group, 12 (34%) patients discontinued therapy due to significant side effects; 3 (9%) patients developed deep venous thrombosis. In the KHC group, no WHO grade III/IV side effects were observed, none of the patients discontinued treatment.

Conclusion: KHC appears to be an effective therapeutic approach in patients with hormone-sensitive PCA after primary androgen deprivation. EMP, however, is a toxic regimen with minimal therapeutic response. Currently, phase-II protocols are initiated comparing KHC versus growth factor antagonists in order to further optimize second line hormonal therapy.