Chemotherapy or targeted therapy?: Real-world comparative outcomes in advanced and recurrent head and neck cancer in resource-limited settings.

e18013 Background: Head and neck cancer (HNC) poses a significant global health burden, with 1.43 million new cases and 0.51 million deaths reported in 2020, over 90% of which are squamous cell carcinomas. Early-stage disease is typically managed with surgery, radiation, chemotherapy, or combinations thereof. For unresectable or advanced HNC, treatment options are expanding to include immunotherapy-based regimens; however, access to these therapies is often limited in resource-constrained settings due to financial burden. In this context, affordable and effective alternatives remain essential. Our study evaluates the safety and efficacy of Cisplatin plus 5-fluorouracil versus the EGFR inhibitor gefitinib in advanced HNC in a resource-limited setting. Methods: After institutional review board approval, 180 patients (>18 years) with advanced HNC were enrolled between May and December 2022. Patients with stage I/II disease, pregnancy, lactation, medical unfitness for chemotherapy, or allergies to study drugs were excluded. Participants were randomized to receive either CF (n=96) every 3 weeks for 6 cycles or gefitinib 250 mg BID daily for 3 months. Tumor response was assessed by CT scans at baseline and every 8 weeks. Toxicities were recorded each cycle. Comparisons were made using chi-square or Fisher’s exact tests; p<0.05 was significant. Results: A total of 180 patients were included, with 53.3% receiving CF and 46.7% receiving Gefitinib. Overall response rates were similar between groups, with 50% achieving complete or partial responses. Complete responses occurred in 7.3% of CF patients versus 4.8% with Gefitinib, and partial responses in 42.7% versus 48.8%, respectively. Progressive disease was seen in 51.5% of CF patients versus 48.5% with Gefitinib, while stable disease was reported in 64.6% versus 42.6%. There was no statistically significant difference in overall response. Treatment discontinuation was higher in the CF group (34.4% vs. 22.6%), and adverse events including vomiting, renal insufficiency, fever, bone marrow suppression, hearing loss, and skin rashes were more frequent with CF. Conclusions: Our study showed that both palliative care approaches effectively halted disease progression in the majority of patients with advanced HNC. Adverse effects from chemotherapy remain a significant concern, affecting both treatment adherence and quality of life. Gefitinib monotherapy demonstrated a favorable safety profile with fewer adverse events and represents a practical therapeutic option due to its oral administration. Further multi-center, long-term studies are needed to fully establish its efficacy in patients who have difficult access to immunotherapy.