Neoadjuvant triplet chemotherapy enables radiotherapy avoidance in human papillomavirus–associated oropharyngeal cancer: a multicentre Phase II trial
Mené sur 32 patients atteints d'un carcinome épidermoïde de l'oropharynx lié au papillomavirus humain (âge médian : 56,5 ans), cet essai multicentrique de phase II évalue l'intérêt, du point de vue du taux de réponse complète, d'un triplet de chimiothérapie (docétaxel, cisplatine et 5-fluorouracile) pour éviter une radiothérapie et une chimioradiothérapie postopératoires
Background: This prospective Phase 2 trial assessed a novel de-escalation strategy for upfront neoadjuvant chemotherapy with docetaxel, cisplatin, and 5-fluorouracil (NAC-TPF) to avoid postoperative radiotherapy (PORT) and chemoradiotherapy (POCRT) for human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC).
Methods: Patients with HPV-associated resectable OPSCC were enrolled. Invasive surgery or PORT/POCRT was an inclusion criterion if upfront surgery was performed. Treatment started with three cycles of NAC-TPF, followed by surgery. The primary endpoint was the centrally reviewed pathological complete response (pCR) rate after NAC-TPF. Levels of high-risk HPV RNA in tumor specimens and plasma circulating tumor (ct) HPV DNA, and quality of life (QOL) scores were assessed.
Results: Of 32 eligible patients, 30 patients underwent transoral surgery after NAC-TPF. R0 resection was confirmed in 31 patients. pCR and virological complete response rate at both the primary site and lymph nodes were 65.6% and 64.5%, respectively. No PORT/POCRT was performed in 91%. All QOL scores recovered to baseline values or improved within 1 year. Twenty-three patients showed undetectable ctHPV DNA levels after NAC-TPF.
Conclusion: Although the primary endpoint was not met, NAC-TPF in HPV-associated resectable OPSCC achieved clinically meaningful pCR, enabling avoidance of PORT/POCRT in the majority of patients.
British Journal of Cancer , article en libre accès, 2026