The investigators secondary analysis included 2,688 patients and the median overall follow up for surviving patients was 5.2 years (range 0.01 to 20.3).

The median overall follow-up was 14.1 years in RTOG 9003, 7.9 years in RTOG 0129, and 4.6 years in RTOG 0522. The analysis showed that patients 70 or older were more likely to be female with poorer PS, heavier smoking history, and p16-negative status.

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The investigators adjusted for covariates and found patients age 70 or older had worse survival regardless of smoking or p16 status.

The study demonstrated that adverse events in patients older than 70 may have been worse in p16-positive patients (HR 2.07 compared to 1.30). While the maximum grade stomatitis and other toxicities were similar by age cohort and treatment arms on RTOG 9003, that was not the case in the DDP-based studies.

In those studies, the patients over 70 experienced more grade 3 to 5 thrombocytopenia, anemia, nephrotoxicity and possibly ototoxicity but also experienced less mucositis.

“It’s an area of extreme importance as the population is aging and head and neck cancer has new developments in terms of HPV,” Dr. Kish told Cancer Therapy Advisor. She said future trials need to closely examine causes of death and treatment compliance among patients 70 and older.

Jochen Lorch, MD, who is a medical oncologist in the Head and Neck Treatment Center at Dana-Farber Cancer Institute in Boston, MA, said the problem is that in any study older patients are under-represented and are often not considered poor candidates for aggressive therapy.

“In head and neck cancer, the data are particularly sparse, partly due to the relative rarity of the disease, partly because of the aggressiveness of the treatment which is particularly demanding.”

Dr. Lorch said there are no prospective long-term data addressing this question. He said Dr. Kish and her colleagues undertook a massive analysis of data from three RTOG trials in which HPV status was available. He noted that the size of this data set is impressive.

“Although the authors do not provide absolute numbers of cases especially in the older patient category, it appears that they were able to adjust for HPV status and other covariates and found that survival, along with some severe side effects of chemoradiotherapy, were worse in the older age group,” Dr. Lorch told Cancer Therapy Advisor.

“I think this study is important as it shows for the first time that elderly patients may be at higher risk for poor outcomes when treated aggressively.”

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Anurag K. Singh MD, of the Roswell Park Cancer Institute in Buffalo, NY, said previous studies analyzing the use of chemotherapy and radiation in older patients with head and neck cancer showed that there was limited benefit and perhaps a decrement in survival when chemotherapy was added to radiation in patients older than 70. 

“However, there was anecdotal evidence of acceptable outcomes in good performing patients and so there was a question about what to do with this age group of patients,” Dr. Singh told Cancer Therapy Advisor.

“Given that outcomes in this age group are still worse, the decision regarding chemo in this population will need to individualized.”