A prospective comparative randomized study to asses local control and toxicity in patients with intermediate risk oral cavity squamous cell carcinoma with post-operative adjuvant radiotherapy with or without cetuximab
DOI:
https://doi.org/10.71152/ajms.v16i11.4843Keywords:
Oral cavity cancer; Post-operative; Intermediate risk factors; Cetuximab; RadiotherapyAbstract
Background: Treatment of oral cavity cancer includes surgery, radiotherapy (RT), chemotherapy, and immunotherapy. Surgery followed by adjuvant RT plays an important role in patients with intermediate risk factors but many studies showed locoregional failure following adjuvant RT alone. Elevated epidermal growth factor receptor (EGFR) expression is detected in 90% of patients with head and neck squamous cell carcinoma (SCC).
Aims and Objectives: The objective of this study was locoregional disease control, toxicities, disease-free survival (DFS), and OS between post-operative only RT and concurrent cetuximab (CP) with RT in oral cavity SCC with intermediate risk factors.
Materials and Methods: Arm A received adjuvant RT at a dose of 60 Gy by 30 fractions, total 6 weeks duration. In study arm B received the same dose of adjuvant RT as study arm A along with concomitant injection of cetuximab at a dose of 400 mg/m2 prior to start of RT and then 250 mg/m2 weekly.
Results: In arm A, 14 (56.0%) and arm B, 14 (56.0%) patients had anterior 2/3rd of tongue and buccal mucosa cancer, respectively. In arm A, 15 (60.0%) and arm B, 12 (48.0%) patients had pT2 status, respectively. There was no rash in arm A but 9 (36%) patients developed rash in arm B. DFS at 12 months was higher in CP arm B compared to arm A but not statistically significant.
Conclusion: This study showed addition of CP to RT improved LRC with increased and manageable adverse effects.
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