The Absolute Effect / Penile Cancer / Medical
In men with bulky regional penile squamous cell carcinoma without distant metastases, can neoadjuvant paclitaxel, ifosfamide and cisplatin produce enough tumour response to enable consolidative surgery?
30 men with penile SCC and bulky regional nodal disease (cN2–cN3); prospective single-arm phase II study. This is not a randomized comparison.
Neoadjuvant TIP: paclitaxel, ifosfamide and cisplatin for four planned cycles, followed by surgical consolidation in eligible responders.
Objective response occurred in 15/30 (50%); 22/30 (73.3%) underwent surgery and 3/30 (10%) achieved a pathologic complete response. Median time to progression was 8.1 months and median OS 17.1 months.
NNT is not defensible: there was no randomized comparator and therefore no causal absolute treatment effect can be calculated.
Reported grade 3–4 toxicities included anemia, neutropenia, febrile neutropenia and peripheral neuropathy, each occurring in fewer than 5% in the published phase II report.
Pagliaro TIP is important benchmark evidence for multimodal management of bulky regional penile cancer, but its single-arm design means response and survival cannot be attributed causally to TIP.
For bulky cN2–cN3 penile SCC without distant metastases, neoadjuvant cisplatin-based combination chemotherapy followed by consolidative surgery in responders remains a multidisciplinary strategy for selected patients. Pagliaro TIP is phase II benchmark evidence rather than a randomized proof that TIP is superior to other regimens. Nodal resectability, performance status, renal function and likelihood of complete surgical consolidation are central to selection.
EAU penile-cancer guidance ↗ · Pagliaro TIP primary report ↗