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Background: With an expectation of excellent locoregional control, ongoing efforts to de-intensify therapy for patients with human papillomavirus-associated squamous cell oropharyngeal cancer necessitate a better understanding of the metastatic risk for patients with this disease. The objective of this study was to determine what factors affect the risk of metastases in patients with squamous cell cancers of the oropharynx., Methods: Under a shared use agreement, 547 patients from Radiation Therapy Oncology Group 0129 and 0522 with nonmetastatic oropharyngeal squamous cell cancers who had a known p16 status and smoking status were analyzed to assess the association of clinical features with the development of distant metastases. The analyzed factors included the p16 status, sex, T stage, N stage, age, and smoking history., Results: A multivariate analysis of 547 patients with a median follow-up of 4.8 years revealed that an age ≥ 50 years (hazard ratio [HR], 3.28; P = .003), smoking for more than 0 pack-years (HR, 3.09; P < .001), N3 disease (HR, 2.64; P < .001), T4 disease (HR, 1.63; P = .030), and a negative p16 status (HR, 1.60; P = .044) were all factors associated with an increased risk of distant disease., Conclusions: Age, smoking, N3 disease, T4 disease, and a negative p16 status were associated with the development of distant metastases in patients with squamous cell cancers of the oropharynx treated definitively with concurrent chemoradiation., (© 2018 American Cancer Society.)

The comparison of overall survival curves between treatment arms will always be of interest in a randomized clinical trial involving a life-shortening disease. In some settings, the experimental treatment is only expected to affect the deaths caused by the disease, and the proportion of deaths caused by the disease is relatively low. In these settings, the ability to assess treatment-effect differences between Kaplan-Meier survival curves can be hampered by the large proportion of deaths in both arms that are unrelated to the disease. To address this problem, frequently displayed are cause-specific survival curves or cumulative incidence curves, which respectively censor and immortalize events (deaths) not caused by the disease. However, the differences between the experimental and control treatment arms for these curves overestimate the difference between the overall survival curves for the treatment arms and thus could result in overestimation of the benefit of the experimental treatment for the patients. To address this issue, we propose new estimators of overall survival for the treatment arms that are appropriate when the treatment does not affect the non-disease-related deaths. These new estimators give a more precise estimate of the treatment benefit, potentially enabling future patients to make a more informed decision concerning treatment choice. We also consider the case where an exponential assumption allows the simple presentation of mortality rates as the outcome measures. Applications are given for estimating overall survival in a prostate-cancer treatment randomized clinical trial, and for estimating the overall mortality rates in a prostate-cancer screening trial., (Copyright © 2014 John Wiley & Sons, Ltd.)