Results from the phase III NRG Oncology RTOG 0920 (NRG-RTOG 0920) Trial Assessing Postopervative Radiotherapy with or without Concurrent Cetuximab for Selected Patules The head and neck (scchn) showed that radiotherapy with cetuximab demonstrated superiority as measured by improved Disease-free survival, a secondary endpoint.

The study also showed no increase in long-term toxicity. The Trial Results, however, did not show a statistically significant improvement in overall survival, the primary endPoint. These results were Published in the Journal of Clinical Oncology.

“Currently, The outscotts with HPV-NEGATIVE SCCHN Remain Poor and Treatment is Associated With A High Rate of Locoregional Fail and Death, Despite Surgical Surgical APY, “Stated Mitchell Machtay, MD, of the Pennsylvania State University Cancer Institute and The lead author of the NRG-RTOG 0920 manuscript.

“Given that egfr is a common hallmark of scchnch, our hope was that adding cetuximab to postoporative radiotherapy un per help.

NRG-RTOG 0920 Enrollled 577 Eligible Patients with the Oral Cavity, Oropharynx, or Larynx, and with one or More Intermediate-Risk factors that Warranted Postoperative Raditoresy Ose cisplatin chemotherapy. Most tumors (85%) Had High Egfr Expression.

Patients were randomly assigned to receive eater imrt (60–6 gy) with weekly cetuximab (c+rt) or radiotherapy alone (RT). The primary objective of this trial was to determine if the addition of cetuximab to radiotherapy improved overall survival. Disease-free survival and toxicity was secondary endpoints.

Overall Survival at a Median Follow-up of 7.2 Years was not Significly Improved (Hazard Ratio (HR) 0.81; One-Sided P = 0.075; But-Yaar Estimates 76.5% for c+rt and 68.7% for. ease -Free survival was (hr 0.75; one-sided p = 0.017; Five-Year Estimates 71.7% for C+RT and 63.6% for RT Alone).

The benefits discovered with the addition of cetuximab was only seen in the hpv-negative subpopulation (80% of the patients in the trial). Grade 3-4 Acute Toxicity Rates Wi 39.7% (RT) and 70.3% (C+RT) (Two-Sided P <0.0001) And Late Grade 3-4 Toxicity Rates Were 29.0% (RT) and 33.2% (C+RT ) (two-sided p = 0.31). There was no grade 5 (fatal) toxicities in eater arm.

“These data would indicate that adding cetuximab to radiotherapy is an approves option for carefully selected patients with HPV-Negative Disease,” Machtay added, “Particularly there for whom cisplatin-based chemotherapy with radiation is not a good choice.”

Provided by NRG Oncology