TPF versus a novel regimen of paclitaxel, carboplatin, and oral metronomic chemotherapy as neoadjuvant treatment for technically unresectable oral cancers: Multicentric phase III randomized non-inferiority study

PCm vs TPF neoadjuvant oral cancer

Paciente / Población Intervención / Exposición Comparación Desenlace

In patients with technically unresectable oral cancers, neoadjuvant weekly paclitaxel and carboplatin with triple oral metronomic chemotherapy was non-inferior for overall survival, with less toxicity, compared with TPF.

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475pacientes

Diseño

Multicentric, open-label, randomised (1:1) phase III non-inferiority study in patients with ECOG PS 0-1 and technically unresectable oral cancers, comparing neoadjuvant TPF every 3 weeks for 2-4 cycles with weekly paclitaxel-carboplatin plus triple oral metronomic chemotherapy (methotrexate, celecoxib, erlotinib) for 6-9 cycles, followed by surgery if resectable (CTRI/2023/08/056693).

Desenlace

Overall survival, with a hazard ratio of 1.3 for non-inferiority.

ResultadoMedian OS 13.31 months with paclitaxel-carboplatin plus metronomic chemotherapy (PCm) vs 13.99 months with DCF; HR 0.826 (one-sided 95% CI 0.668-1.021; non-inferiority P=0.0002). Grade >3 toxicities 43.2% vs 86.4% (P<0.001). ORR 45.6% vs 23.4% (P<0.001). Disease deemed resectable after NACT in 137 (57.3%) vs 80 (33.9%), and surgery done in 109 (45.6%) vs 61 (26%) patients (P<0.001). Pathologic CR in 6 (5.5%) vs 4 (6.6%). Growth factors given to 20.5% vs 100%.

Noronha V, Thiagarajan S, Menon NS, et al. Presented at ESMO Congress 2026, abstract LBA44, 25 October. Not yet published.

Discusión y crítica

This open-label phase III trial shows overall survival with the paclitaxel-carboplatin metronomic regimen non-inferior to TPF, with fewer severe toxicities, a higher response rate and more patients reaching surgery. Median survival was short in both arms, and the abstract gives no median follow-up or number of deaths, so maturity cannot be judged. The open-label design may have influenced toxicity reporting and decisions on resectability, and the abstract reports no quality of life or per-protocol analysis. The two regimens also differ in number of cycles and growth factor use, and the results call the comparator DCF while the methods name TPF.