GETUG 13
GETUG 13 showed that men with the worst-risk testicular cancers whose tumour markers fall too slowly after the first cycle of chemotherapy do better if treatment is intensified: 59 percent were free of progression at three years against 48 percent with standard BEP, and fewer needed high-dose salvage chemotherapy.
Overview
GETUG 13 was a phase 3 trial of the French GETUG group with MD Anderson and Slovak centres in 263 patients with poor-prognosis (IGCCCG) non-seminomatous germ cell tumours. After one cycle of bleomycin, etoposide and cisplatin, the 203 patients with an unfavourable decline in alpha-fetoprotein and hCG were randomised to three further BEP cycles or a dose-dense regimen (paclitaxel-BEP-oxaliplatin followed by cisplatin, ifosfamide and bleomycin with growth factor support); the 51 with a favourable decline continued BEP. The primary endpoint was progression-free survival.
Three-year progression-free survival was 59 percent with dose-dense chemotherapy against 48 percent with BEP (hazard ratio 0.66, p 0.05), with more grade 3 to 4 neurotoxicity and haematological toxicity but no difference in toxic deaths, and fewer patients needed salvage high-dose chemotherapy (6 against 16 percent). Marker-guided intensification became the approach for poor-prognosis disease, which is how the corpus's testicular cancer page cites the trial.
- 59 vs 48 out of 100 alive without the cancer growing at 3 years with Dose-dense chemotherapy (T-BEP-oxaliplatin then cisplatin, ifosfamide, bleomycin) compared with Standard BEP; 11 more per 100.
- Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 34 percent lower chance of the event at any given time (hazard ratio 0.66, likely range 0.44 to 1).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 70 out of 100 people alive without the cancer growing at 3 years with BEP after favourable marker decline.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 6 vs 16 out of 100 reached this endpoint with Dose-dense chemotherapy compared with Standard BEP; 10 fewer per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 7 vs 1 out of 100 reached this endpoint with Dose-dense chemotherapy compared with Standard BEP; 6 more per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Poor-prognosis disseminated non-seminomatous germ cell tumours in France, the United States and Slovakia: after one cycle of BEP, patients with an unfavourable tumour marker decline were randomised to continue BEP or switch to dose-dense chemotherapy (paclitaxel-BEP-oxaliplatin then cisplatin, ifosfamide and bleomycin), with progression-free survival as the primary endpoint. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
263 enrolled.
95% CI 49 to 68 · 95% CI 38 to 59
Source95% CI 57 to 81
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 3 years, unfavourable marker declineprimary | Dose-dense chemotherapy (T-BEP-oxaliplatin then cisplatin, ifosfamide, bleomycin) | 105 | 59% | 0.66 (0.44 to 1) | 0.05 | link |
| Standard BEP | 98 | 48% | ||||
| Progression-free survival at 3 years, favourable marker decline (continued BEP, not randomised) | BEP after favourable marker decline | 51 | 70% | - | - | link |
| Salvage high-dose chemotherapy with stem cell transplant required | Dose-dense chemotherapy | 105 | 6% | - | - | link |
| Standard BEP | 98 | 16% | ||||
| Grade 3 to 4 neurotoxicity | Dose-dense chemotherapy | 105 | 7% | - | - | link |
| Standard BEP | 98 | 1% |
Similar pages
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