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| June 11, 2010 |
RTOG 0129 HPV Analysis Reported in NEJM
Presence of Human Papillomavirus (HPV) Predicts Survival for Patients with Oropharyngeal Cancer
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Philadelphia, PA - June 7, 2010 Oropharyngeal cancer patients whose tumors test positive for the human papillomavirus live longer after treatment than patients whose tumors test negative according to research from the Radiation Therapy Oncology Group (RTOG) being published today by the New England Journal of Medicine (NEJM) and presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. RTOG is a National Cancer Institute-funded national clinical trials group and is administered by the American College of Radiology.
RTOG researchers led by K. Kian Ang, M.D., Ph.D. of the University of Texas M.D. Anderson Cancer Center, who is the lead author of the study being published in the NEJM, and Maura L. Gillison, M.D., Ph.D. of The Ohio State University, who directed the HPV analysis, found that oropharyngeal cancer patients with HPV-positive tumors had a survival rate 25 percentage points higher at three years (82.4% vs. 57.1%) than patients on the study with HPV-negative tumors. This survival benefit was seen irrespective of the assigned cancer treatment and traditional prognostic factors such as tumor stage and age. The researchers also found that tobacco smoking was independently associated with survival for both groups of patients and the risk of death and cancer progression increased by 1% for each pack-year of tobacco smoking.
Dr. Gillison reports that, "Our data reveal that the biologic behavior of an HPV-positive tumor may be altered by tobacco use. It appears that genetic alterations induced by tobacco-associated carcinogens may make HPV-positive tumors less responsive to cancer therapy. Our data show that as the pack-years for tobacco smoking increased survival decreased."
The published results are based on an analysis of study data from RTOG 0129, a prospective randomized phase III trial evaluating the value of accelerated radiotherapy combined with cisplatin chemotherapy as compared to cisplatin and standard radiotherapy for patients with stage III-IV head and neck cancer. Utilizing specimens collected at the time of patient entry into the study, the investigators were able to complete a retrospective analysis of the HPV status of the oropharyngeal tumors based on in-situ hybridization. Using a recursive partitioning analysis the researchers were able to classify the patients as having a low, intermediate, or high risk of death based on four factors: HPV status, pack-years of tobacco smoking, tumor stage, and nodal stage.
Study data being presented at ASCO on a second study, RTOG 9003, confirms the correlation of HPV status (via its surrogate, p16) and pack-years of tobacco smoking to survival. In this study of 1068 head and neck patients enrolled over seven years to a randomized phase III trial evaluating four different radiotherapy schedules, 60% had oropharynx cancer and HPV status was able to be determined for 29% (190) of those patients. Once again the investigators found that HPV status and tobacco pack-years were independent predictors of patient survival.
According to Dr. Ang, "On the basis of our data, we believe that future clinical trials, and indeed future treatment decisions, should be designed on the basis of the patient's HPV status as it may be possible to achieve good survival rates for HPV-positive patients without the long-term complications of intensive multi-modality therapy."
HPV status has been correlated with survival in other smaller studies but this is the first analysis of a patient cohort of sufficient size to show the correlation irrespective of treatment and other favorable prognostic factors. "RTOG has been a leader in head and neck cancer research since the 1970's. Our unique database of outcome results and biospecimen resources allow us to quickly test and validate new hypotheses in biomarker research," said Walter J. Curran, Jr., M.D., the RTOG Group Chair, and the Executive Director of the Winship Cancer Institute of Emory University. "This type of research exemplifies the value of the NCI-funded cancer cooperative groups in answering questions that need rigorously collected multicenter data."
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