Zoladex (goserelin acetate implant)

ZOLADEX - The Only LHRH-A with Proven Disease-free Survival Data in Locally Advanced Prostate Cancer1

ZOLADEX is indicated for use in combination with flutamide for the management of locally advanced Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with the combination should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Study Design

Combined androgen blockade (CAB) (ZOLADEX 3.6 mg every 4 weeks plus flutamide 250 mg tid for 2 months before and during external beam radiation therapy [EBRT]) (n=226) vs external beam radiation therapy (EBRT) alone (n=230).2-4

Study Results

CAB with ZOLADEX and Radiotherapy - Estimated Results
  • There was no significant difference in overall survival (n=456)2-4
  • Based on an analysis of centrally read Gleason scores (total n=429), estimated 8-year results showed4:
    • In patients with Gleason scores 2-6 (n=129), CAB + RT significantly improved disease-free survival, local control, and distant metastases vs RT alone
    • This benefit was not present in patients with Gleason scores 7-10 (n=300)
Estimated 8-year disease-free survival (CAB+RT vs RT alone)

Kaplan-Meier Estimate-adapted from Pilepich et al.4

  • There was no significant difference in overall survival (n=456)2-4
  • Based on an analysis of centrally read Gleason scores (total n=429), estimated 8-year results showed4:
    • In patients with Gleason scores 2-6 (n=129), CAB + RT significantly improved disease-free survival, local control, and distant metastases vs RT alone
    • This benefit was not present in patients with Gleason scores 7-10 (n=300)

Important Safety Information for ZOLADEX

References:

  1. Data on file. DA-ZOL-04, AstraZeneca Pharmaceuticals LP, Wilmington, Delaware.
  2. ZOLADEX® (goserelin acetate implant) 10.8 mg Depot, Prescribing Information, AstraZeneca Pharmaceuticals LP, Wilmington, Delaware.
  3. Data on File. DA-ZOL-05, AstraZeneca Pharmaceuticals LP, Wilmington, Delaware.
  4. Pilepich MV, Winter K, John MJ, et al. Phase III Radiation Therapy Oncology Group (RTOG) Trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001;50:1243-1252.

Zoladex