PMID-9233866 – Goserelin Plus Radiotherapy Improves Prostate Cancer Survival
Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997;337(5):295-300.
Quick Reference
| Property | Value |
|---|---|
| PMID | 9233866 |
| DOI | 10.1056/NEJM199707313370502 |
| Year | 1997 |
| Journal | New England Journal of Medicine |
| Study Type | RCT |
| Evidence Level | I |
| Sample | 415 patients with locally advanced prostate cancer |
| Peptide(s) Studied | Goserelin |
Key Findings
- Five-year overall survival was significantly higher with combined radiotherapy + goserelin: 79% vs 62% with radiotherapy alone (P=0.001)
- Disease-free survival at 5 years: 85% vs 48% (P<0.001)
- Adjuvant goserelin started simultaneously with external irradiation significantly improved local control
- The combined approach reduced both local recurrence and distant metastases
- Benefits observed across multiple endpoints including clinical disease-free survival and overall survival
Study Design
Prospective, randomized, multicenter trial (EORTC 22863) of 415 patients with locally advanced (T1-2 grade 3, or T3-4) prostate cancer. Patients were randomized to external beam radiotherapy alone versus radiotherapy plus goserelin 3.6 mg SubQ every 4 weeks starting on day 1 of radiation and continuing for 3 years.
Limitations
- Open-label design (no blinding possible due to nature of intervention)
- Single goserelin dose/schedule studied
- No comparison with other LHRH agonists or GnRH antagonists
- Quality-of-life data limited in the initial publication
Clinical Relevance
This landmark NEJM trial fundamentally changed the standard of care for locally advanced prostate cancer by demonstrating that adding goserelin to radiotherapy significantly improves survival. It established combined androgen deprivation therapy with radiation as the standard approach and remains one of the most cited studies supporting long-term GnRH agonist use in prostate cancer management.
Related
#research #RCT #peptide #sexual-health #evidence-level-I