The Absolute Effect / Evidence / EORTC 30994
Bladder Cancer · Medical Oncology · Adjuvant
EORTC 30994
Clinical question
Does immediate adjuvant chemotherapy improve outcomes compared with deferred chemotherapy after radical cystectomy?
Trial context
Population
284 patients with pT3–pT4 and/or N+ M0 urothelial carcinoma after radical cystectomy
Intervention
Immediate adjuvant cisplatin-based chemotherapy vs deferred chemotherapy at relapse
Key endpoint
5-year progression-free survival
Time horizon / follow-up
5 years
Absolute Effect
What changes for patients?
Immediate chemotherapy increased 5-year progression-free survival from 31.8% to 47.6%, an absolute improvement of 15.8 points (NNT 7). Overall survival was not significantly improved: 5-year OS 53.6% vs 47.7%, HR 0.78, P=.13. The trial closed early and was underpowered for OS.
NNT: 7
Treatment burden / harm
Grade 3–4 myelosuppression
NNH: Not applicable; toxicity comparisons are confounded by more patients receiving deferred treatment at relapse
Relative effect
HR: 0.54
95% CI 0.40–0.73; P<.0001
Clinical interpretation
Immediate adjuvant cisplatin-based chemotherapy improved progression-free survival after cystectomy, but the trial was underpowered to prove an overall-survival benefit.
Primary publication
- Sternberg CN, et al. Lancet Oncol. 2015;16:76–86.
- Primary publication / source