e18024 Background: Head and neck cancer (HNC) is one of the most common cancers in Pakistan. Advanced stage is the most common presentation due to illiteracy and lack of optimum health care facilities. Concurrent chemoradiation is most commonly used treatment modality in these patients. We tested relatively less toxic systemic therapy using low dose capecitabine and afatinib in patients with locally advanced HNC combined with Quad-shot radiation therapy (QRT). Methods: A total of 93 patients with biopsy proven HNC with performance status of 2 or lower were included. Patients with primary tumor in oral cavity (41), oropharynx (19), hypopharynx (21) and larynx (12) with TNM stage III to IVB were selected. The patients were planned for low dose therapy (LDT) comprising capecitabine 500 mg twice daily and afatinib 40 mg daily. During this treatment, patients were planned for QRT. A total dose of 14 Gray (Gy) was planned with 3.5 Gy per fraction and two fractions a day at least six hours apart for two consecutive days. This protocol was repeated after a gap of one month. A maximum of three QRT sessions were planned. LDT was continued during this period until either patient progressed or develop toxicity. Response was assessed at the end of each month before delivering next QRT. Hematological, mucosal and skin toxicity were also assessed monthly during the treatment time. Progression free survival (PFS) and Overall survival (OS) were calculated at 3 years from randomization. Results: Out of total ninety-three patients, eighty-four patients completed at least two months of treatment. A total of 9 patients (11%) progressed during the treatment and were shifted to other treatment options. A total of 12 patients (14%) had complete response, 43 patients (51%) had partial response and 20 patients (24%) had stable disease. A total of 31 patients (37%) developed grade 1/2 anemia, 18 patients (21%) developed grade 1/2 neutropenia, and 13 patients (15%) developed grade 1/2 thrombocytopenia. A total of 46 patients (55%) developed grade 1/2 oral mucosal toxicity and 13 patients (15%) developed grade 3/4 oral mucosal toxicity. A total of 35 patients (42%) developed grade 1/2 skin toxicity and 9 patients (11%) developed grade 3/4 skin toxicity. Three-year PFS and OS were 31% and 44% respectively. Mean and median PFS (years) were 2.07±0.19 (95% confidence interval CI 1.69 to 2.45) and 1.18±013 (95% CI 0.92 to 1.44) respectively. Mean and median OS (year) were 2.57±0.20 (95% CI 2.17 to 2.97) and 2.11±0.15 (CI 1.81 to 2.41) respectively. Conclusions: Low dose systemic treatment in combination with QRT is a reasonable option in locally advanced HNC. However, a larger randomized trial is warranted to define its role before being routinely recommended.
Mateen et al. (Thu,) studied this question.