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Original Investigation |

Cetuximab and Radiotherapy in Laryngeal Preservation for Cancers of the Larynx and Hypopharynx A Secondary Analysis of a Randomized Clinical Trial

James Bonner, MD1; Jordi Giralt, MD2; Paul Harari, MD3; Sharon Spencer, MD1; Jeltje Schulten, MD, MBA4; Anwar Hossain, MS5; Shao-Chun Chang, MD5,6; Steve Chin, MD5; José Baselga, MD, PhD7
[+] Author Affiliations
1Department of Radiation Oncology, University of Alabama at Birmingham, Birmingham
2Hospital General Vall d’Hebron, Barcelona, Spain
3Department of Human Oncology, University of Wisconsin at Madison, Madison
4Merck Serono, Darmstadt, Germany
5Eli Lilly and Company, Indianapolis, Indiana
6currently with AstraZeneca, Gaithersburg, Maryland
7Memorial Sloan Kettering Cancer Center, New York, New York
JAMA Otolaryngol Head Neck Surg. 2016;142(9):842-849. doi:10.1001/jamaoto.2016.1228.
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Importance  The appropriate use of surgery or radiotherapy-based approaches for organ preservation has been the subject of much debate. Unfortunately, there has been a lack of improvement in overall survival for patients with laryngeal carcinoma in the last 30 years.

Objective  To assess the rates of laryngeal preservation and laryngectomy-free survival in patients receiving cetuximab and radiotherapy (CRT) and patients receiving radiotherapy alone.

Design, Setting, and Participants  Patients were enrolled in a multicenter, open-label, stratified, randomized, phase 3 study from April 1, 1999, through March 31, 2002, from 73 centers in the United States and 14 other countries. A secondary subgroup analysis of patients with hypopharyngeal and laryngeal carcinoma was undertaken. Rates of laryngeal preservation and laryngectomy-free survival were estimated by the Kaplan-Meier method. The hazard ratios (HRs) were calculated using a Cox proportional hazards regression model. Quality of life was evaluated using the European Organization for Research and Treatment of Cancer core questionnaire and head and neck module.

Main Outcomes and Measures  Laryngeal preservation and laryngectomy-free survival.

Results  Of the 424 patients included in the trial, 168 treated patients with cancer of the larynx or hypopharynx were included in this analysis (90 in the CRT group and 78 in the radiotherapy alone group). The median (range) age of the patients was 59 (40-80) years in the CRT group and 61 (35-81) years in the radiotherapy alone group. In the CRT group, 72 patients (80.0%) were male and 18 (20.0%) were female. In the radiotherapy alone group, 62 (79.5%) were male and 16 (20.5%) were female. The rates of laryngeal preservation at 2 years were 87.9% for CRT vs 85.7% for radiotherapy alone, with an HR of 0.57 (95% CI, 0.23-1.42; P = .22). Similarly, the HR for laryngectomy-free survival comparing CRT vs radiotherapy alone was 0.78 (95% CI, 0.54-1.11; P = .17). This study was not powered to assess organ preservation. Median overall survival was 27 (95% CI, 20-45) vs 21 (95% CI, 17-35) months for the CRT and radiotherapy alone groups, respectively, with an HR of 0.87 (95% CI, 0.60-1.27). No differences between treatments were reported regarding overall quality of life, need for a feeding tube, or speech.

Conclusions and Relevance  The results of a possible cetuximab-related laryngeal preservation benefit for patients with hypopharyngeal or laryngeal cancer are intriguing; these results need to be interpreted in the context of a retrospective subset analysis with limited sample size.

Trial Registration  clinicaltrials.gov Identifier: NCT00004227

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Figure 1.
Trial Profile for the Subpopulation of Patients With Hypopharyngeal or Laryngeal Carcinoma

aData are from Bonner et al.22

bData are from Bonner et al.23

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Figure 2.
Kaplan-Meier Plots

CRT indicates cetuximab plus radiotherapy; NE, not estimable.

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Figure 3.
Mean Changes in Quality of Life

Categorical quality-of-life scores were linearly transformed to 0- to 100-point scales according to the European Organization for Research and Treatment of Cancer scoring manual. Change was calculated as the postbaseline score minus the baseline score. A positive value indicates an improvement.

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