Long-term Toxicity, Swallow Function, and Quality of Life on MC1273, a Phase II Study of Dose De-escalation for Adjuvant Chemoradiation in HPV-Positive Oropharyngeal Cancer (HPV-OPC)
Mené sur 79 patients atteints d'un cancer de l'oropharynx lié au papillomavirus humain et présentant des antécédents de tabagisme (89,9 % d'hommes), cet essai de phase II évalue la toxicité, la fonction de déglutition et la qualité de vie à 1, 2 et 3 ans après une stratégie de réduction de doses de radiothérapie et de chimiothérapie adjuvantes
Background: Patients with HPV-OPC are highly curable but risk significant long-term toxicity with standard therapy. This study investigated a de-escalation strategy of decreased adjuvant radiotherapy (RT) and chemotherapy after transoral robotic surgery, and reports on long-term functional and quality of life (QOL) outcomes. Methods: Eligible patients had a p16-positive OPC and ≤10 pack-year smoking history and underwent surgery followed by treatment with either 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks with weekly docetaxel (15 mg/m2) if they had intermediate pathologic risk factors or 36 Gy in 1.8-Gy fractions twice per day over 2 weeks with the same chemotherapy if they had extranodal extension. Toxicity, swallow function, and QOL were measured longitudinally. Results: Seventy-nine patients (89.9% male) were treated and eligible for toxicity and functional evaluation. Dry mouth was the most common grade 1 toxicity at 1 year (55.6%), 2 years (53.3%) and 3 years (49.2%). The cumulative rates of grade 2 toxicities at 1, 2, and 3 years, were 1.4%, 6.7%, and 6.8%. There were only two grade 3 toxicities at ≥ 1 year, including a grade 3 fatigue at 2 ½ years, and a grade 3 superficial soft tissue fibrosis at 4 years. There were no grade 4-5 toxicities. No patients were PEG dependent. Swallow function improved by 12 months post-treatment. QOL improved over time by all measurement tools and most patients returned to baseline level of function and QOL. Conclusion: De-escalated adjuvant therapy for select patients with HPV-OPC resulted in low rates of long-term toxicity, excellent swallow outcomes, and preservation of global and xerostomia-related QOL.
International Journal of Radiation Oncology, Biology, Physics