EORTC 22993-08993
Prophylactic cranial irradiation versus observation in extensive small-cell lung cancer after response to chemotherapy
Phase 3NCT00016211
- Population
- Patients aged 18-75 years with extensive small-cell lung cancer and a response to chemotherapy
- Design
- Randomised trial (the abstract does not state a phase; ClinicalTrials.gov lists phase 3) of prophylactic cranial irradiation versus no further therapy in patients aged 18 to 75 years with extensive small-cell lung cancer who had responded to chemotherapy. Primary endpoint: time to symptomatic brain metastases; CT or MRI of the brain was done when a predefined symptom suggesting brain metastases was present. The registry lists 287 enrolled; the paper's abstract gives 143 per group.
- Primary endpoint
- Time to symptomatic brain metastases
- Arms
- Prophylactic cranial irradiation (experimental, n = 143): Prophylactic cranial irradiation
- No further therapy (control, n = 143): No further therapy
- People
- Slotman B, EORTC Radiation Oncology Group and Lung Cancer Group
Time to symptomatic brain metastasesHR 0.27 (95% CI 0.16–0.44)Δ 12-month Cumulative incidence of brain metastasis−25.8 pointsΔ median OS+1.3 monthsΔ 12-month OS+13.8 points
Show the numbers
| Endpoint | Analysis | Prophylactic cranial irradiation | No further therapy | Effect |
|---|---|---|---|---|
| Time to symptomatic brain metastasesRandomised patients (143 per group) | primarySlotman 2007 | — | — | HR 0.27 (95% CI 0.16–0.44)P<0.001Hazard ratio for symptomatic brain metastases, PCI versus control. |
| Cumulative incidence of brain metastasisRandomised patients (143 per group) | primarySlotman 2007 | 14.6% at 12 mo (8.3–20.9%) | 40.4% at 12 mo (32.1–48.6%) | Cumulative risk of brain metastases within 1 year, as phrased in the abstract. |
| OSRandomised patients (143 per group) | primarySlotman 2007 | median 6.7 months; 27.1% at 12 mo (19.4–35.5%) | median 5.4 months; 13.3% at 12 mo (8.1–19.9%) | Median OS is 'after randomization' per the abstract. Overall survival is reported as a further outcome (the primary endpoint was time to symptomatic brain metastases); the abstract gives no hazard ratio or p value for OS. Median disease-free survival rose from 12.0 weeks to 14.7 weeks (weeks are not an allowed unit for the median field). |
| Endpoint | Analysis | Prophylactic cranial irradiation | No further therapy | Effect |
|---|---|---|---|---|
| Time to symptomatic brain metastasesRandomised patients (143 per group) | primarySlotman 2007 | — | — | HR 0.27 (95% CI 0.16–0.44)P<0.001Hazard ratio for symptomatic brain metastases, PCI versus control. |
| Cumulative incidence of brain metastasisRandomised patients (143 per group) | primarySlotman 2007 | 14.6% at 12 mo (8.3–20.9%) | 40.4% at 12 mo (32.1–48.6%) | Cumulative risk of brain metastases within 1 year, as phrased in the abstract. |
| OSRandomised patients (143 per group) | primarySlotman 2007 | median 6.7 months; 27.1% at 12 mo (19.4–35.5%) | median 5.4 months; 13.3% at 12 mo (8.1–19.9%) | Median OS is 'after randomization' per the abstract. Overall survival is reported as a further outcome (the primary endpoint was time to symptomatic brain metastases); the abstract gives no hazard ratio or p value for OS. Median disease-free survival rose from 12.0 weeks to 14.7 weeks (weeks are not an allowed unit for the median field). |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Time to symptomatic brain metastases | 0.27 | 0.16–0.44 |
- Prophylactic cranial irradiation (experimental)
- No further therapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Prophylactic cranial irradiation | No further therapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 4 | 66.1% | 59.8% |
| 8 | 43.7% | 35.8% |
| 13 | 26.1% | 18.8% |
| 17 | 17.2% | 11.3% |