Tolerability and efficacy of anti-androgen manipulation versus taxotere and anti-androgen manipulation in patients with hormone-naive, high-risk/metastatic prostate cancer: A phase II, open-labeled, randomized study.

• DOI: 10.1200/jco.2011.29.7_suppl.147
• Publication Date: 2017-02-23T18:54:21Z
• Authors: I. D. Pedley; J. A. Frew; J. M. Wilson; A. R. Abdul Razak; A. Azzabi; R. McMenemin; J. Stockley; N. Soomro; G. Durkan; H. Leung
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

147 Background: Anti-androgen manipulation (AA) is considered the standard initial therapy for high-risk/metastatic prostate cancer. The role of chemotherapy and anti-androgen manipulation (TAA) is still undefined in this group. GenTax is a phase II trial investigating clinical outcome and gene profiling in prostate cancer before and after AA or TAA. Here we present the clinical outcome data. Methods: Patients with T3/4 disease, PSA ≥ 50 ng/ml or Gleason score ≥ 8, or metastatic disease were enrolled. Patients were randomised at histological diagnosis to AA or TAA (goserelin 3.6 mgs q28 ± taxotere 75 mg/m2 q21 for 6 cycles). TRUS biopsies were taken at randomisation and 22 weeks after treatment initiation. Clinical assessment including KPS, QOL using QLQ-C30, bloods/PSA were measured 3 weekly until 22 weeks then 3 monthly. Data was analysed for PFS, OS, toxicities and QOL. Results: 30 patients were recruited with 15 patients in each arm from 10/13/2005 to 12/02/2009. The median age was 62.2 yrs (range 48.9-75.1). All patients had a KPS of ≥ 90%. 12 (40%) and 18 (60%) of patients had stage 3 and 4 disease respectively. At randomization 10 patients had bone and 4 had visceral metastases. 29 had a Gleason score of ≥ 7. There were no statistical differences for age, KPS, disease stage or Gleason score between the two arms. Treatment was well tolerated in both groups with no G3-4 toxicity in the AA arm. In the TAA arm, 4 patients had dose delays or reductions; with one G3 incidence of neutropenia. G3-4 non-hematological toxicities were infrequent; fatigue and one episode of anaphylaxis occurring in separate patients. Median PFS and OS between the two treatments have not been reached at median follow up of 25 months. The 2-year PFS rate was not significantly different, (50% vs 60% p = 0.788) between the AA and TAA groups. There were no significant differences in QOL measures. Conclusions: Combination therapy of taxotere and anti-androgen manipulation is safe and well tolerated. The gene profiling results may provide important information in selecting patients who will benefit from more aggressive initial therapy. [Table: see text]