Efficacy of Metronomic Oral Capecitabine, Methotrexate and Cyclophosphamide in Locally Advanced Operable Oral Cavity Squamous Cell Carcinoma - A Phase II Study

节拍式口服卡培他滨、甲氨蝶呤和环磷酰胺治疗局部晚期可手术口腔鳞状细胞癌的疗效——一项II期研究

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Abstract

BACKGROUND: Squamous cell carcinoma (SCC) of the oral cavity mostly presents with advanced disease. Though standard of care is surgery followed by radiation, there is a long wait time in many Indian centres during which some patients progress. We devised a simple, relatively non-toxic oral metronomic chemotherapy (OMCT) regimen aimed at preventing disease progression during the waiting period. METHODS: Patients with stage III and IV oral cavity SCC were prospectively included in the trial as per inclusion criteria. They received at least 1 cycle of OMCT unless progression of disease before completion. A maximum of 2 cycles were given, and patients with either stable disease or partial response were operated any time after completion of 1 cycle of OMCT. Progressive disease was managed either with surgery, concurrent chemoradiation or IV NACT f/b surgery or concurrent chemoradiation. Details of sociodemographic, diagnosis, treatment and follow up were collected. RESULTS: 81 patients received at least 1 cycle and were evaluable. The most common oral cavity subsite involved was the buccal mucosa (46%) with stage III (49%) and IVA (51%) equally distributed. 13 (16%) patients had developed grade I toxicities to OMCT. Among 81, 10 (12%) had partial response, and 57 (71%) had stable disease. 14 patients (17%) had disease progression. CONCLUSIONS: Oral metronomic chemotherapy in the form of Methotrexate, Capecitabine and Cyclophosphamide is an effective, safe and feasible option to bridge the waiting list period for surgery in locally advanced operable oral cavity squamous cell carcinoma. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13193-026-02596-6.

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