{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,11]],"date-time":"2026-11-11T15:56:00Z","timestamp":1794412560536,"version":"4.9.0"},"reference-count":39,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2024,7,1]]},"abstract":"\n Importance<\/jats:title>\n \n Immune checkpoint inhibitors improve survival in recurrent and\/or metastatic head and neck cancer, yet their role in curative human papillomavirus\u2212positive oropharyngeal cancer (HPV\n +<\/jats:sup>\n OPC) remains undefined. Neoadjuvant nivolumab and chemotherapy followed by response-adaptive treatment in HPV\n +<\/jats:sup>\n OPC may increase efficacy while reducing toxicity.\n <\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n To determine the deep response rate and tolerability of the addition of neoadjuvant nivolumab to chemotherapy followed by response-adapted locoregional therapy (LRT) in patients with HPV\n +<\/jats:sup>\n OPC.\n <\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n This phase 2 nonrandomized clinical trial conducted at a single academic center enrolled 77 patients with locoregionally advanced HPV\n +<\/jats:sup>\n OPC from 2017 to 2020. Data analyses were performed from February 10, 2021, to January 9, 2023.\n <\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n \n Addition of nivolumab to neoadjuvant nab-paclitaxel and carboplatin (studied in the first OPTIMA trial) followed by response-adapted LRT in patients with HPV\n +<\/jats:sup>\n OPC stages III to IV.\n <\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Primary outcome was deep response rate to neoadjuvant nivolumab plus chemotherapy, defined as the proportion of tumors with 50% or greater shrinkage per the Response Evaluation Criteria in Solid Tumors 1.1. Secondary outcomes were progression-free survival (PFS) and overall survival (OS). Swallowing function, quality of life, and tissue- and blood-based biomarkers, including programmed death-ligand 1 (PD-L1) expression and circulating tumor HPV-DNA (ctHPV-DNA), were also evaluated.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The 73 eligible patients (median [range] age, 61 [37-82] years; 6 [8.2%] female; 67 [91.8%] male) started neoadjuvant nivolumab and chemotherapy. Deep responses were observed in 51 patients (70.8%; 95% CI, 0.59-0.81). Subsequent risk- and response-adaptive therapy was assigned as follows: group A, single-modality radiotherapy alone or transoral robotic surgery (28 patients); group B, intermediate-dose chemoradiotherapy of 45 to 50 Gray (34 patients); and group C, regular-dose chemoradiotherapy of 70 to 75 Gray (10 patients). Two-year PFS and OS were 90.0% (95% CI, 0.80-0.95) and 91.4% (95% CI, 0.82-0.96), respectively. By response-adapted group, 2-year PFS and OS for group A were 96.4% and 96.4%, and group B, 88.0% and 91.0%, respectively. Lower enteral feeding rates and changes in weight, as well as improved swallowing, were observed among patients who received response-adapted LRT. Pathologic complete response rate among patients who underwent transoral robotic surgery was 67.0%. PD-L1 expression was nonsignificantly higher for deeper responses and improved PFS, and ctHPV-DNA clearance was significantly associated with improved PFS.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n \n This phase 2 nonrandomized clinical trial found that neoadjuvant nivolumab and chemotherapy followed by response-adapted LRT is feasible and has favorable tolerability, excellent OS, and improved functional outcomes in HPV\n +<\/jats:sup>\n OPC, including among patients with high-risk disease. Moreover, addition of nivolumab may benefit high PD-L1 expressors, and sensitive dynamic biomarkers (eg, ctHPV-DNA) are useful for patient selection.\n <\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT03107182<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamaoncol.2024.1530","type":"journal-article","created":{"date-parts":[[2024,6,6]],"date-time":"2024-06-06T11:33:10Z","timestamp":1717673590000},"page":"923","source":"Crossref","is-referenced-by-count":64,"title":["Neoadjuvant Nivolumab Plus Chemotherapy Followed By Response-Adaptive Therapy for HPV\n +<\/sup>\n Oropharyngeal Cancer"],"prefix":"10.1001","volume":"10","author":[{"given":"Ari J.","family":"Rosenberg","sequence":"first","affiliation":[{"name":"Section of Hematology and Oncology, Department of Medicine, University of Chicago, Chicago, Illinois"},{"name":"University of Chicago Comprehensive Cancer Center, Chicago, 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