NEW YORK (Reuters Health) – In patients with locoregionally advanced squamous-cell carcinoma of the head and neck (LASCCHN), the survival benefit of adding cetuximab to radiotherapy is still apparent at 5 years, new research shows.

Treatment with cetuximab plus radiotherapy is associated with a 9% absolute survival advantage at 5 years compared with radiotherapy alone, lead author Dr. James A. Bonner, from the University of Alabama, Birmingham, and colleagues note.

The results, which appear in the November 7th online issue of The Lancet Oncology, also indicate that the development of a prominent cetuximab-induced rash is predictive of improved survival.

The phase III trial involved 424 patients who were randomized to receive radiotherapy for 6 to 7 weeks with or without cetuximab (400 mg/m2 initial dose, followed by seven weekly doses of 250 mg/m2). The subjects had LASCCHN of the oropharynx, hypopharynx, or larynx. Enrollment was completed early in 2002, and the median follow-up for the current analysis was 60 months.

Updated median survival for the cetuximab group was about 20 months longer than for the control group: 49.0 vs. 29.3 months (p = 0.018). The corresponding overall survival rates at 5 years were 45.6% and 36.4%.

The presence of an acneiform rash of at least grade 2 severity following cetuximab therapy was associated with improved overall survival relative to no rash or a grade 1 rash (68.8 vs. 25.6 months, HR 0.49, p = 0.002).

“These findings,” the authors conclude, “provide additional support for the recent inclusion of cetuximab in the National Comprehensive Cancer Network Guidelines as an accepted standard systemic therapy for patients with locoregionally advanced head and neck cancer.”

Reference:
Lancet Oncol 2009.