CeTeG
Lomustine-temozolomide combination therapy versus standard temozolomide therapy in newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09)
Phase 3N = 141NCT01149109
- Population
- Patients aged 18 to 70 years with newly diagnosed glioblastoma with methylated MGMT promoter and Karnofsky Performance Score of 70% or higher; 141 randomly assigned, 129 in the modified intention-to-treat population (patients who started their allocated chemotherapy)
- Design
- Open-label, randomised (1:1) phase 3 trial at 17 German university hospitals: standard temozolomide chemoradiotherapy (75 mg/m2 daily with radiotherapy 59 to 60 Gy, then six courses of temozolomide 150 to 200 mg/m2 on days 1 to 5 of 4-week courses) versus radiotherapy 59 to 60 Gy plus up to six 6-week courses of lomustine 100 mg/m2 on day 1 and temozolomide 100 to 200 mg/m2 on days 2 to 6; primary endpoint overall survival in the modified intention-to-treat population
- Primary endpoint
- OS
- Arms
- Standard temozolomide chemoradiotherapy (control, n = 63): Radiotherapy 59 to 60 Gy with daily temozolomide 75 mg/m2, then six courses of temozolomide 150 to 200 mg/m2 on days 1 to 5 of a 4-week course
- Lomustine plus temozolomide (experimental, n = 66): Radiotherapy 59 to 60 Gy plus up to six 6-week courses of lomustine 100 mg/m2 on day 1 and temozolomide 100 to 200 mg/m2 on days 2 to 6
- People
- Herrlinger U, senior author Glas M, Neurooncology Working Group of the German Cancer Society
OSHR 0.60 (95% CI 0.35–1.03)Δ median OS+16.7 monthsOSHR 0.60 (95% CI 0.35–1.03)
Show the numbers
| Endpoint | Analysis | Lomustine plus temozolomide | Standard temozolomide chemoradiotherapy | Effect |
|---|---|---|---|---|
| OSModified ITT: all randomised patients who started allocated chemotherapy (n=129: 63 temozolomide, 66 lomustine-temozolomide) | primaryHerrlinger 2019 | median 48.1 months | median 31.4 months (27.7–47.1) | HR 0.60 (95% CI 0.35–1.03)P=0.0492The 95% confidence interval for the lomustine-temozolomide median runs from 32.6 months to not assessable, so it is not stored as a numeric interval. The hazard ratio confidence interval includes 1 while the log-rank p value is below 0.05, as printed in the abstract. |
| OSITT (n=141) | exploratoryHerrlinger 2019 | — | — | HR 0.60 (95% CI 0.35–1.03)P=0.0432Secondary analysis of the intention-to-treat population. |
| Endpoint | Analysis | Lomustine plus temozolomide | Standard temozolomide chemoradiotherapy | Effect |
|---|---|---|---|---|
| OSModified ITT: all randomised patients who started allocated chemotherapy (n=129: 63 temozolomide, 66 lomustine-temozolomide) | primaryHerrlinger 2019 | median 48.1 months | median 31.4 months (27.7–47.1) | HR 0.60 (95% CI 0.35–1.03)P=0.0492The 95% confidence interval for the lomustine-temozolomide median runs from 32.6 months to not assessable, so it is not stored as a numeric interval. The hazard ratio confidence interval includes 1 while the log-rank p value is below 0.05, as printed in the abstract. |
| OSITT (n=141) | exploratoryHerrlinger 2019 | — | — | HR 0.60 (95% CI 0.35–1.03)P=0.0432Secondary analysis of the intention-to-treat population. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.6 | 0.35–1.03 |
| OS | 0.6 | 0.35–1.03 |
- Standard temozolomide chemoradiotherapy (control)
- Lomustine plus temozolomide (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Standard temozolomide chemoradiotherapy | Lomustine plus temozolomide |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 30 | 51.6% | 64.9% |
| 60 | 26.6% | 42.1% |
| 90 | 13.7% | 27.3% |
| 120 | 7.1% | 17.7% |
Appears in
Sources
Herrlinger U, Tzaridis T, Mack F, Steinbach JP, Schlegel U, Sabel M, et al. Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial. Lancet. 2019;393(10172):678-688.