📃 Paper Title: Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial
🧍 Author: Bolla
🕒 Year: 2002
📚 Journal: The Lancet
🌎 Country: France
ㅤContext to the study:
Can you tell me about a study that showed a benefit of androgen suppression in prostate cancer?
ㅤ✅ Take-home message of study:
In patients with locally advanced prostate cancer, androgen suppression (with LHRH analogues) during and after external radiation therapy for 3 years, improves patient outcomes
Disease free period improved from 40% to 74%
Overall survival improved from 62% to 78%
ㅤ Randomised Control Trial (Phase III results)
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Study participants:
Numbers included:
415, recruited between 1987-1995.
Two arms:
Radiotherapy alone or radiotherapy plus immediate androgen suppression.
Inclusion criteria:
Age < 80 years
Histologically proven T1-2 prostatic adenocarcinoma of WHO histological grade 3, or T3-4 N0-1 M- prostatic adenocarcinoma of any histological grade
Exclusion criteria:
History of previous malignant disease (patients with adequately treated basal-cell carcinoma of the skin were included)
Evidence of distant metastases (this includes involvement of common iliac or para-aortic lymph nodes as assessed by CT scan, bipedal lymphangiography, or extraperitoneal lymphadenectomy)
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Key study outcomes:
Primary Outcome
Disease Free Survival at 5 years (DFS)
Secondary Outcomes
Clinical disease-free interval (time to first clinical evidence of progression)
Clinical disease-free survival (time to first clinical progression or death from any cause)
Overall Survival
Results
5 year clinical DFS Radiotherapy alone: 40% (95% CI 32-48) vs combined treatment: 74% (67-81)
5 Year OS Radiotherapy alone: 62% (52-72) vs combined treatment 78% (72-84)
Locoregional control failure radiotherapy alone 16.4% (10.8-22.1) vs combined treatment 1.7% (0-3.7)
Distant metastases radiotherapy alone 29.2% (22.7-35.1) vs combined treatment 9.8% (5.4-14.2)
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Study Limitations:
Conventional radiotherapy technique was employed, as opposed to using three-dimensional conformal radiotherapy
No comparison group receiving hormone treatment only.
The period of 3 years of adjuvant hormonal treatment was chosen empirically, hence more trials with shorter period warranted to reduce related side-effects.
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