EORTC 22863
Phase III Randomized Comparison of Pelvic Radiotherapy Alone vs Pelvic Radiotherapy Plus the LHRH Analogue Goserelin and Cyproterone Acetate in Carcinoma of the Prostate at High Risk for Metastasis
Phase 3N = 415NCT00849082
- Population
- Patients with locally advanced prostate cancer: T1-2 tumours of WHO grade 3 or T3-4 N0-1 M0 tumours; median age 71 years (range 51 to 80)
- Design
- Open-label randomized trial, 1987 to 1995: 415 patients (208 radiotherapy alone, 207 combined treatment) with T1-2 tumours of WHO grade 3 or T3-4 N0-1 M0 tumours were assigned to radiotherapy alone or radiotherapy plus immediate goserelin. Radiotherapy: 50 Gy to the pelvis plus a 20 Gy prostatic boost. Goserelin 3.6 mg every 4 weeks from the first day of radiotherapy for 3 years, with cyproterone acetate 150 mg daily for the first month. Primary endpoint (2002 and 2010 reports): clinical disease-free survival.
- Primary endpoint
- DFS
- Arms
- Radiotherapy alone (control, n = 208): External radiotherapy: 50 Gy to the pelvis plus a 20 Gy prostatic boost
- Radiotherapy plus goserelin (experimental, n = 207): Same radiotherapy plus goserelin 3.6 mg every 4 weeks for 3 years, with cyproterone acetate in the first month
- People
- Bolla M, senior author Pierart M, EORTC
Δ 60-month OS+17 pointsΔ 60-month Surviving patients free of disease+37 pointsΔ 60-month DFS+34 pointsΔ 60-month OS+16 pointsDFSHR 0.42 (95% CI 0.33–0.55)Δ 120-month DFS+25 points
Show the numbers
| Endpoint | Analysis | Radiotherapy plus goserelin | Radiotherapy alone | Effect |
|---|---|---|---|---|
| OSPatients with data available for analysis (401 of 415) | primarymedian follow-up 45 monthsBolla 1997 | 79% at 5 y (72–86%) | 62% at 5 y (52–72%) | P=0.001First published analysis (1997). Kaplan-Meier estimates. The later reports state that the primary endpoint was clinical disease-free survival. |
| Surviving patients free of diseasePatients with data available for analysis (401 of 415)Proportion of surviving patients who were free of disease at 5 years | primarymedian follow-up 45 monthsBolla 1997 | 85% at 5 y (78–92%) | 48% at 5 y (38–58%) | P<0.001Among surviving patients only; not a disease-free survival rate. |
| DFSEvaluable patients (412 of 415); analyses were by intention to treat according to the abstractClinical disease-free survival (primary endpoint) | long term-updatemedian follow-up 66 monthsBolla 2002 | 74% at 5 y (67–81%) | 40% at 5 y (32–48%) | P=0.00012002 report, median follow-up 66 months (range 1 to 126). |
| OSEvaluable patients (412 of 415); analyses were by intention to treat according to the abstract | long term-updatemedian follow-up 66 monthsBolla 2002 | 78% at 5 y (72–84%) | 62% at 5 y (52–72%) | P=0.00022002 report. 5-year specific survival was 94% (90 to 98) with combined treatment and 79% (72 to 86) with radiotherapy alone. |
| DFSClinical disease-free survival (primary endpoint) | long term-updatemedian follow-up 9.1 yearsBolla 2010 | 47.7% at 10 y (39–56%) | 22.7% at 10 y (16.3–29.7%) | HR 0.42 (95% CI 0.33–0.55)P<0.0001 |
| OS | long term-updatemedian follow-up 9.1 yearsBolla 2010 | 58.1% at 10 y (49.2–66.0%) | 39.8% at 10 y (31.9–47.5%) | HR 0.60 (95% CI 0.45–0.80)P=0.0004 |
| Prostate cancer mortality10-year prostate-cancer mortality | long term-updatemedian follow-up 9.1 yearsBolla 2010 | 10.3% at 10 y (5.1–15.4%) | 30.4% at 10 y (23.2–37.5%) | HR 0.38 (95% CI 0.24–0.60)P<0.0001 |
| Endpoint | Analysis | Radiotherapy plus goserelin | Radiotherapy alone | Effect |
|---|---|---|---|---|
| OSPatients with data available for analysis (401 of 415) | primarymedian follow-up 45 monthsBolla 1997 | 79% at 5 y (72–86%) | 62% at 5 y (52–72%) | P=0.001First published analysis (1997). Kaplan-Meier estimates. The later reports state that the primary endpoint was clinical disease-free survival. |
| Surviving patients free of diseasePatients with data available for analysis (401 of 415)Proportion of surviving patients who were free of disease at 5 years | primarymedian follow-up 45 monthsBolla 1997 | 85% at 5 y (78–92%) | 48% at 5 y (38–58%) | P<0.001Among surviving patients only; not a disease-free survival rate. |
| DFSEvaluable patients (412 of 415); analyses were by intention to treat according to the abstractClinical disease-free survival (primary endpoint) | long term-updatemedian follow-up 66 monthsBolla 2002 | 74% at 5 y (67–81%) | 40% at 5 y (32–48%) | P=0.00012002 report, median follow-up 66 months (range 1 to 126). |
| OSEvaluable patients (412 of 415); analyses were by intention to treat according to the abstract | long term-updatemedian follow-up 66 monthsBolla 2002 | 78% at 5 y (72–84%) | 62% at 5 y (52–72%) | P=0.00022002 report. 5-year specific survival was 94% (90 to 98) with combined treatment and 79% (72 to 86) with radiotherapy alone. |
| DFSClinical disease-free survival (primary endpoint) | long term-updatemedian follow-up 9.1 yearsBolla 2010 | 47.7% at 10 y (39–56%) | 22.7% at 10 y (16.3–29.7%) | HR 0.42 (95% CI 0.33–0.55)P<0.0001 |
| OS | long term-updatemedian follow-up 9.1 yearsBolla 2010 | 58.1% at 10 y (49.2–66.0%) | 39.8% at 10 y (31.9–47.5%) | HR 0.60 (95% CI 0.45–0.80)P=0.0004 |
| Prostate cancer mortality10-year prostate-cancer mortality | long term-updatemedian follow-up 9.1 yearsBolla 2010 | 10.3% at 10 y (5.1–15.4%) | 30.4% at 10 y (23.2–37.5%) | HR 0.38 (95% CI 0.24–0.60)P<0.0001 |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 0.42 | 0.33–0.55 |
| OS | 0.6 | 0.45–0.8 |
| Prostate cancer mortality | 0.38 | 0.24–0.6 |
Appears in
Sources
Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, et al. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997;337(5):295-300.
Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, et al. 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. Lancet. 2002;360(9327):103-6.
Bolla M, Van Tienhoven G, Warde P, Dubois JB, Mirimanoff RO, Storme G, et al. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncol. 2010;11(11):1066-73.