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- Title
Prospective study evaluating dynamic changes of cell-free HPV DNA in locoregional viral-associated oropharyngeal cancer treated with induction chemotherapy and response-adaptive treatment.
- Authors
Rosenberg, Ari J.; Izumchenko, Evgeny; Pearson, Alexander; Gooi, Zhen; Blair, Elizabeth; Karrison, Theodore; Juloori, Aditya; Ginat, Daniel; Cipriani, Nicole; Lingen, Mark; Sloane, Hillary; Edelstein, Daniel L.; Keyser, Kirsten; Fredebohm, Johannes; Holtrup, Frank; Jones, Frederick S.; Haraf, Daniel; Agrawal, Nishant; Vokes, Everett E.
- Abstract
<bold>Background: </bold>Human papillomavirus (HPV)-associated oropharyngeal cancer (OPC) has a favorable prognosis which has led to efforts to de-intensify treatment. Response-adaptive de-escalated treatment is promising, however improved biomarkers are needed. Quantitative cell-free HPV-DNA (cfHPV-DNA) in plasma represents an attractive non-invasive biomarker for grading treatment response and post-treatment surveillance. This prospective study evaluates dynamic changes in cfHPV-DNA during induction therapy, definitive (chemo)radiotherapy, and post-treatment surveillance in the context of risk and response-adaptive treatment for HPV + OPC.<bold>Methods: </bold>Patients with locoregional HPV + OPC are stratified into two cohorts: High risk (HR) (T4, N3, [Formula: see text] 20 pack-year smoking history (PYH), or non-HPV16 subtype); Low risk (LR) (all other patients). All patients receive induction chemotherapy with three cycles of carboplatin and paclitaxel. LR with ≥ 50% response receive treatment on the single-modality arm (minimally-invasive surgery or radiation alone to 50 Gy). HR with ≥ 50% response or LR with ≥ 30% and < 50% response receive treatment on the intermediate de-escalation arm (chemoradiation to 50 Gy with cisplatin). All other patients receive treatment on the regular dose arm with chemoradiation to 70 Gy with concurrent cisplatin. Plasma cfHPV-DNA is assessed during induction, (chemo)radiation, and post-treatment surveillance. The primary endpoint is correlation of quantitative cfHPV-DNA with radiographic response.<bold>Discussion: </bold>A de-escalation treatment paradigm that reduces toxicity without compromising survival outcomes is urgently needed for HPV + OPC. Response to induction chemotherapy is predictive and prognostic and can select candidates for de-escalated definitive therapy. Assessment of quantitative cfHPV-DNA in the context of response-adaptive treatment of represents a promising reliable and convenient biomarker-driven strategy to guide personalized treatment in HPV + OPC.<bold>Trial Registration: </bold>This trial is registered with ClinicalTrials.gov on October 1st, 2020 with Identifier: NCT04572100 .
- Subjects
INDUCTION chemotherapy; OROPHARYNGEAL cancer; LONGITUDINAL method; SURVIVAL rate; PAPILLOMAVIRUSES; PILOT projects; RESEARCH; DNA; CARBOPLATIN; CLINICAL trials; RESEARCH methodology; ANTINEOPLASTIC agents; PROGNOSIS; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; PAPILLOMAVIRUS diseases; DRUG monitoring; CISPLATIN; RESEARCH funding; PACLITAXEL
- Publication
BMC Cancer, 2022, Vol 22, Issue 1, p1
- ISSN
1471-2407
- Publication type
journal article
- DOI
10.1186/s12885-021-09146-z