Abstract 433P
Background
Head and neck squamous cell carcinomas (HNSCC) are a major health concern in India, largely due to tobacco and areca nut use. This study examines the capecitabine and cyclophosphamide regimen’s effectiveness. Despite new standards set by the EXTREME and KEYNOTE-048 trials, access to these treatments is limited due to logistical and financial challenges. The paper proposes Oral Metronomic Chemotherapy (OMCT) as a cost-effective, sustainable solution. This regimen, which includes capecitabine and cyclophosphamide, can be administered in low, regular doses and has shown promising results in treating HNSCC.
Methods
This study, conducted from June 2023 to June 2024, evaluated the effectiveness and safety of a drug combination (Capecitabine 2000 mg and Cyclophosphamide 100 mg) in treating patients with advanced and metastatic head and neck squamous cell carcinomas. The drugs were administered orally in 3-weekly cycles for up to 6 cycles. The study included patients aged 18 and above with specific health parameters, excluding those with non-squamous histology, severe illnesses, or unwillingness to give written consent. The primary objective was to observe progression-free survival, with secondary objectives including overall survival, toxicity profile, and quality of life. Data was analyzed using SPSS software.
Results
In the study, 101 patients were enrolled, with a median age of 55. Most were male smokers and tobacco users. Tumors primarily originated from the oral cavity (63.6%), followed by the oropharynx, larynx, and hypopharynx. About 70% had received prior treatment, with 57.5% having received platinum. The median progression-free survival was 179 days, and overall survival was 302 days. No severe adverse reactions were documented, with most patients experiencing manageable Grade 1 mucositis.
Conclusions
Our study is the first report on the feasibility-safety and efficacy of a drug combination of two chemotherapeutic agents, cyclophosphamide and capecitabine (100 mg plus 2000mg). The fixed-dose combination is affordable, widely accessible, and suitable for outpatient treatment of patients in remote rural areas.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.