Penile Cancer · Medical · High-risk node-positive adjuvant therapy

Adjuvant Paclitaxel-Platinum vs 5-FU-Platinum

In high-risk node-positive penile SCC, does adjuvant paclitaxel-platinum provide similar efficacy with less toxicity than 5-FU-platinum?

Population49 men with resected node-positive penile SCC and ≥1 high-risk feature.InterventionFour 3-weekly cycles of paclitaxel-platinum.ComparatorFour 3-weekly cycles of 5-FU-platinum.Primary endpointDisease-free survival.

Absolute Effect

Disease-free survival

Median 19.6 vs 12.4 months

Paclitaxel-platinum versus 5-FU-platinum; HR 1.16, P=.686. Efficacy comparison was inconclusive.

Grade ≥3 toxicity

40.9% vs 77.3% (−36.4 points)

Absolute reduction with paclitaxel-platinum, P=.014.

Other toxicity

Grade ≥3 hematologic toxicity was 4.5% versus 54.5%; hospitalization for toxicity was 9.1% versus 45.5%. Completion of all planned cycles was 83.3% versus 48%.

Clinical interpretation

The trial provides randomized evidence of substantially lower toxicity with paclitaxel-platinum, but it was small and stopped early, so it cannot establish comparative efficacy.

This is particularly important in a rare cancer: a lower toxicity regimen may be attractive, but the efficacy uncertainty must remain explicit.

NNT / NNH

For grade ≥3 toxicity, the absolute reduction was 36.4 points, giving an approximate NNT of 3 to avoid one grade ≥3 event when choosing paclitaxel-platinum over 5-FU-platinum. For hospitalization, the absolute reduction was 36.4 points as well, also approximately NNT 3. No efficacy NNT is calculated.

Limitations

Only 49 patients were randomized. The trial was underpowered for DFS/OS and included subsequent cisplatin-based chemoradiotherapy. Results should not be generalized beyond the studied high-risk population.

Primary / authoritative sources

Randomized penile cancer trial — PubMed