The Absolute Effect / Evidence / EORTC 30992
Penile Cancer · Medical Oncology · Neoadjuvant/Locally Advanced
EORTC 30992
Clinical question
Can irinotecan plus cisplatin produce clinically meaningful responses in locally advanced or metastatic penile cancer?
Trial context
Population
28 patients with T3/T4, N1–N3 or M1 cisplatin-advanced penile carcinoma
Intervention
Irinotecan + cisplatin
Key endpoint
Objective response rate
Time horizon / follow-up
During treatment
Absolute Effect
What changes for patients?
Irinotecan plus cisplatin produced 8 responses among 26 eligible patients, an objective response rate of 30.8%. The study was designed to exclude a response rate below 30% but did not demonstrate that threshold statistically. There were 3 grade 3 diarrhoeas and 2 grade 4 neutropenic fevers. NNT is not applicable because this was single-arm.
NNT: Not applicable; single-arm phase II
Treatment burden / harm
Grade 3–4 selected toxicity
NNH: Not applicable; single-arm study
Relative effect
ORR: 8/26 eligible patients responded
80% CI 18.8–45.1%; prespecified threshold >30% not demonstrated
Clinical interpretation
The response signal is from a small single-arm phase II study and cannot establish comparative survival benefit or a standard regimen for advanced penile cancer.
Primary publication
- Pizzocaro G, et al. Ann Oncol. 2008;19:1304–1307.
- Primary publication / source