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Abstract

PURPOSE:

We conducted a retrospective evaluation of the IMCL-9815 study to examine the association of human papillomavirus (HPV) and p16 protein expression status with outcomes in patients with oropharyngeal carcinoma (OPC) receiving radiotherapy (RT) plus cetuximab or RT alone.

PATIENTS AND METHODS:

In the IMCL-9815 study, patients were randomly allocated to receive RT plus weekly cetuximab or RT alone. A subpopulation of patients with p16-evaluable OPC was retrospectively evaluated on the basis of locoregional control (LRC), overall survival (OS), and progression-free survival (PFS). Evaluable samples from patients with p16-positive OPC were also tested for HPV DNA.

RESULTS:

Tumor p16 status was evaluable in 182 patients with OPC enrolled in the IMCL-9815 study; 41% were p16 positive. When treated with RT alone or RT plus cetuximab, p16-positive patients had a longer OS than p16-negative patients (hazard ratio, 0.40; 95% CI, 0.21 to 0.74 and hazard ratio, 0.16; 95% CI, 0.07 to 0.36, respectively). The addition of cetuximab to RT increased LRC, OS, and PFS in both patients with p16-positive OPC and those with p16-negative disease. Interaction tests for LRC, OS, and PFS did not demonstrate any significant interaction between p16 status and treatment effect (P = .087, .085, and .253, respectively). Similar trends were observed when patients with p16-positive/HPV-positive OPC (n = 49) and those with p16-positive/HPV-negative OPC (n = 14) were compared.

CONCLUSION:

p16 status was strongly prognostic for patients with OPC. The data suggest that the addition of cetuximab to RT improved clinical outcomes regardless of p16 or HPV status versus RT alone. 

Author information

Rosenthal DI1, Harari PM1, Giralt J1, Bell D1, Raben D1, Liu J1, Schulten J1, Ang KK1, Bonner JA2.​

1David I. Rosenthal, Diana Bell, and Kian K. Ang, The University of Texas MD Anderson Cancer Center, Houston, TX; Paul M. Harari, University of Wisconsin, Madison, WI; Jordi Giralt, Hospital Vall d'Hebron, Barcelona, Spain; David Raben, University of Colorado School of Medicine, Aurora, CO; Joyce Liu, Merck Serono, Beijing, People's Republic of China; Jeltje Schulten, Merck KGaA, Darmstadt, Germany; and James A. Bonner, University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL.

2David I. Rosenthal, Diana Bell, and Kian K. Ang, The University of Texas MD Anderson Cancer Center, Houston, TX; Paul M. Harari, University of Wisconsin, Madison, WI; Jordi Giralt, Hospital Vall d'Hebron, Barcelona, Spain; David Raben, University of Colorado School of Medicine, Aurora, CO; Joyce Liu, Merck Serono, Beijing, People's Republic of China; Jeltje Schulten, Merck KGaA, Darmstadt, Germany; and James A. Bonner, University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL. jabonner@uabmc.edu.