gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Randomized study of docetaxel (D) and dexamethasone (DX) with low or high dose estramustine (E) for patients with advanced hormon-refractory prostate cancer (HRPC)

Meeting Abstract

  • corresponding author presenting/speaker Thomas Nelius - Otto-von-Guericke-Universität Magdeburg, Urologische Klinik, 39120 Magdeburg, Deutschland
  • Tobias Klatte - Otto-von-Guericke-Universität Magdeburg, Urologische Klinik, 39120 Magdeburg
  • Frank Reiher - Otto-von-Guericke-Universität Magdeburg, Urologische Klinik, 39120 Magdeburg
  • Tobias Lindenmeir - Otto-von-Guericke-Universität Magdeburg, Urologische Klinik, 39120 Magdeburg
  • Ron Yap - Northwestern University Chicago, Chicago, 60611, USA
  • Ernst Peter Allhoff - Otto-von-Guericke-Universität Magdeburg, Urologische Klinik, 39120 Magdeburg

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO297

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dkk2006/06dkk407.shtml

Veröffentlicht: 20. März 2006

© 2006 Nelius et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Background: D-based chemotherapy is a burgeoning option for men with advanced HRPC. Alone or in combination with E, D has been shown to improve median survival. In this study we tested the combination of D with two different doses of E in patients (pts) with HRPC to improve response rates and to lower side effects.

Methods: 72 metastatic HRPC pts were randomly assigned to receive D (70mg/m2 IV, d2, q3w) and E (3 x 280 mg/d PO starting 1 day prior to D, for 5 consecutive days) for arm A or E (3 x 140 mg/d PO starting 1 day prior to D, for 3 consecutive days) for arm B. Premedication with oral DX at a total daily dose of 16 mg, in divided doses two times a day was administered in arm A on day 1 to 5 and in arm B on day 1 to 3. Initially, 6 cycles were administered. Chemotherapy was restarted after significant PSA rise. Pts were monitored for measurable PSA response, time to progression (TTP), survival and toxicity.

Results: PSA declines of ≥75%, ≥50% and ≤50% were 36.8%, 55.3% and 44.7% in arm A and 38.2%, 67.6% and 32.4% in arm B, respectively (P=.442). TTP in Arm A and Arm B were 11 months (95% CI, 7-14) versus 14 months (95% CI, 8-19), P=.6911) and overall survival 21 months (95% CI, 6-35) versus 22 months (95% CI, 18-27) , respectively, (P=.4149). The primary treatment-related side effects observed in arm A and arm B were granulocytopenia (34% and 29%, P=.663) and thrombotic complications caused by E (four pts (11%) and one pt (3%), respectively, P=.206). Associated baseline factors with overall survival in univariate analysis were ECOG performance status (P<.001), hemoglobin (Hb) level (P<.001), bone pain (P<.001), and PSA (P<.097) and in multivariate analysis ECOG performance status (95% CI, 2.9-13.9) and bone pain (95% CI, 3.2-20.1), (P<.001). The cut-off value for the baseline Hb was 7,4 mmol/l. Patients with a Hb >7,4 mmol/l had a median survival of 33 months compared to 16 months for patients with a Hb <7,4 mmol/l.

Conclusions: In this randomized phase II study the combination of D and E had substantial activity in HRPC. We did not find a statistically significant difference of higher dose of E in combination with D compared to a lower dose of E and D regarding PSA response, TTP and survival. However, there was a tendency of higher toxicity in the high dose E group. These treatment-related toxicities were mainly hematologic and manageable. Our data support the use of D/E low dose scheme as first line therapy for HRPC. Anemia was an independent prognostic variable, as was shown by other studies. These findings make the hemoglobin level a new target for combination therapies with recombinant human erythropoietin. This may enhance the effectiveness of D based chemotherapy in HRPC and improve quality of life.