Prospective randomized controlled trial to compare 3-dimensional conformal radiotherapy to intensity-modulated radiotherapy in head and neck squamous cell carcinoma: Long-term results

Background Grade ≥2 acute xerostomia between 3D conformal radiotherapy (RT) and intensity-modulated radiotherapy (IMRT) was evaluated in patients with head and neck squamous cell carcinomas (HNSCCs) treated radically. Methods Between 2005 and 2007, 59 patients with HNSCC (T1-3, N0-2b) were randomized to IMRT or 3D-RT. On RT, weekly xerostomia, dysphagia, dermatitis, and mucositis were graded by Radiation Therapy Oncology Group (RTOG) acute toxicity criteria. Patients underwent examination under anesthesia, positron emission tomography (PET)-CT, and toxicity assessments per protocol (NCT00652613) thereafter. Results Incidence of grade ≥2 xerostomia at 8 weeks posttreatment was significantly lower with IMRT compared with 3D conformal RT (24% vs 53%; p =.024). At subsequent follow-up, significantly fewer patients receiving IMRT had grade ≥2 xerostomia. Long-term weight loss was higher in patients in the 3D conformal RT arm compared to IMRT (50% vs 21%; p =.038). Disease-related outcomes between arms (median follow-up, 70 months) were similar. Conclusion IMRT significantly reduces incidence of acute and late grade ≥2 xerostomia in patients with HNSCC.