ArticleThe Lancet regional health. Southeast Asia2026
Low-dose nivolumab with neoadjuvant chemotherapy and oral metronomic therapy in borderline resectable oral cavity squamous cell carcinoma: a phase II trial.
Article in The Lancet regional health. Southeast Asia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
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24 authors.
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Abstract
Background: Non-surgical management of oral cavity squamous cell carcinoma (OSCC) has poorer outcomes compared to surgery. In borderline resectable tumors, historical neoadjuvant chemotherapy achieves surgical conversion in only about 40%. Combining low-dose immunotherapy and oral metronomic therapy (OMT) with chemotherapy may enhance resection rate and survival. Methods: Between April 2023 and April 2024, patients deemed 'borderline resectable' OSCC based on predefined criteria by a multidisciplinary tumor board were prospectively offered this Phase II single-arm interventional trial setting. Patients received two 21-day cycles of carboplatin, nab-paclitaxel, low-dose nivolumab, and six weeks of erlotinib, methotrexate, celecoxib, with additional cycle(s) if needed. Primary endpoint was R0 resection rate. Secondary endpoints were objective response rate, pathologic response, safety, event-free survival (EFS), and overall survival (OS). Immune biomarkers and Volumetric assessment were exploratory endpoints. The trial was prospectively registered in the Clinical Trial Registry of India (CTRI/2023/04/051617). Findings: Of 34 patients, all except one completed planned neoadjuvant therapy. After 2 cycles, 22 (66·6%) had partial response and 11 had stable disease; none progressed. Twenty six underwent surgery; 25 achieved R0 resection (25/33-75·7% conversion). Four of seven remaining patients received additional cycle(s); three subsequently achieved R0 resection. Overall conversion rate was 90·3% (28/31) excluding 2 patients who refused further treatment. Major pathological response occurred in 12 patients (41·4%), including four with pathological complete response. Grade ≥3 toxicities occurred in 5 of 34 patients (14·7%), with no treatment-related deaths. One patient had grade 4 diarrhea with grade 4 acute kidney injury. Interpretation: The NeoLOCUS regimen offers an affordable, outpatient chemo-immunotherapy approach that improves surgical conversion and pathological response in borderline resectable OSCC. Funding: Fluid Research Grant- Christian Medical College, Vellore, India.
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