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Purpose: Platinum-refractory or relapsed squamous cell carcinoma of the head and neck (SCCHN) is considered to have poor prognosis. Although cetuximab is currently recommended as category 1 in this group of patients, the use of it is hampered in low- and middle-income countries (LMICs) like Pakistan due to nancial constraints. Further, majority of the population of these countries is unable to tolerate toxicity related to other intravenous chemotherapeutic agents due to lower socioeconomic background with poor nutrition status. The aim of this study is to evaluate the response rate and toxicity of oral methotrexate (MTX) in platinum-refractory or relapsed SCCHN. Methods: Between June 2008 and December 2012, 71 patients received palliative oral MTX either due to recurrent or persistent disease. With a median age of 51 years (range 22–75), there were 68% of males and 32% of females. Site distribution was as following; oral cavity 58%, nasopharynx 25%, hypopharynx 7%, paranasal sinuses 6%, larynx 3%, Oropharynx 1%. Patterns of recurrence; local 32%, regional 07%, loco regional 10%, distant 15% and persistent disease in 36% of the patients. All the patients received oral MTX 10 mg once a day, 4 days a week. To contain the possible side effects associated with MTX, folinic acid 15 mg per oral every 6 hourly on day 5 was prescribed. Response assessment was done on two monthly basis. Response, toxicity, mean response time and mean time to progression were determined. Results: Response to MTX was as following; complete response 3%, partial response 4%, stable disease 11% and progressive disease in 82% of the patients respectively. Toxicity related to oral MTX includes neutropenia Grade III in 1% while mucositis Grade III in 10% of the patients, respectively. None of the patient had Grade IV mucositis or haematological toxicity. Treatment was stopped in 13% of the patients due to poor compliance. Mean response time was 4 months (range 1 – 20) and mean time to progression was 5 months (range 1–23). Conclusion: Oral MTX is a simple, cost-effective and well-tolerated regimen to be used on outpatient basis for palliation in platinum refractory or relapsed SCCHN in LMICs and debilitated patients. This treatment merits further evaluation in large-scale clinical trials. Key words: Oral methotrexate, platinum refractory, relapsed squamous cell carcinoma of head and neck

ORAL METHOTREXATE AS SECOND LINE CHEMOTHERAPY IN PLATINUM-REFRACTORY OR RELAPSED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK