Cetuximab might enhance laryngeal preservation


By Will Boggs MD

NEW YORK (Reuters Health) - The addition of cetuximab to radiotherapy might increase laryngeal preservation rates in patients with cancer of the larynx or hypopharynx, according to a secondary analysis of a randomized clinical trial.

Primary analysis of the trial found locoregional control and survival advantages associated with the addition of cetuximab to radiotherapy, but the trial was not sufficiently powered to assess laryngeal preservation rates.

Dr. James Bonner, of the University of Alabama at Birmingham, and colleagues undertook a secondary analysis of 168 patients to compare laryngeal preservation rates of patients with locoregionally advanced laryngeal and hypopharyngeal cancers who were treated with cetuximab and radiotherapy (n=90) versus radiotherapy alone (n=78).

The treatment groups did not differ significantly in the rates of two-year locoregional control or three-year survival, according to the July 7 JAMA Otolaryngology - Head and Surgery online report, although rates were numerically higher in both cases for patients treated with cetuximab and radiotherapy.

Similarly, the rates of laryngeal preservation were numerically better in the cetuximab and radiotherapy group at two and three years (87.9%) than in the radiotherapy alone group at two years (85.7%) and three years (76.8%), but these differences fell short of statistical significance.

The only adverse events that occurred with greater frequency in the combined-therapy group were chills, fever, and headache.

"Although the difference in the rates of laryngeal preservation between the two groups did not reach statistical significance, the initial trial was not powered to assess this subgroup question," the researchers reiterate. "The hazard ratio (HR) of 0.57 is a strong indicator that cetuximab, when added to radiotherapy, may improve laryngeal preservation."

"This treatment approach warrants further evaluation in larger populations to fully assess the potential value of cetuximab or other molecular targeting agents to augment laryngeal preservation rates," they add.

Dr. Nabil F. Saba, of Emory University School of Medicine, Atlanta, Georgia, who coauthored an accompanying editorial, told Reuters Health by email, "Clearly these findings ought to influence our future design for laryngeal preservation trials; perhaps we ought to examine a cetuximab radiation arm in a prospective study; at the present, however, the standard of care for larynx preservation at least in the U.S. remains concurrent cisplatin-based therapy."

"Our success in treating larynx cancer depends on larynx preservation but also on avoiding excessive toxicities incurred from concurrent therapy, which could translate into worsened overall survival," Dr. Saba said. "Patient selection is therefore of primary importance."

Dr. Bonner did not respond to a request for comments.

Eli Lily and Company funded this research, employed two coauthors, and had relationships with two other coauthors.

SOURCE: http://bit.ly/29vFpRN and http://bit.ly/29PIpcV

JAMA Otolaryngol Head Neck Surg 2016.

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