The average follow-up was 5.67 years, and there was no difference between groups in either age or gender. Seventy-eight percent of the patients in the 10-year study period had stage 3 or stage 4 tumors.
Explore This IssueSeptember 2009
The average patient who had primary surgery experienced about 0.5 leaks around the prosthesis during the follow-up period. But those who underwent salvage surgery did considerably worse. Those who received primary chemoradiotherapy experienced 1.2 leaks, on average, and those in the primary radiotherapy group had about 1.4 leaks. (p = 0.04).
Similar results were seen when it came to dislodgments. About 0.3 dislodgments occurred, on average, among those who had received primary surgery, compared to 0.5 in the primary chemoradiotherapy group and about 0.6 in the primary radiotherapy group (p = 0.02).
The most pronounced risk for complication was seen in the need for size changes. Patients receiving primary chemoradiotherapy had double the risk of a size change in their prostheses compared with those in the primary surgery group. They required about 2.5 size changes, compared with just one size change per patient in the primary surgery group. And the radiotherapy group had triple the risk, requiring more than three size changes, on average (p = 0.006).
Patients who received salvage surgery after chemoradiotherapy were also found to be at significantly higher risk of needing extended laryngectomies and reconstruction, the researchers found.
What to Tell Patients
Ms. Starmer said that the findings should be used to give patients more information as they decide their paths for treatment. We have to think about how this may change our TEP management for these patients, she said. Specifically, patient education may be paramount, and [we should] educate our patients that they may be at higher risk for such complications.
She said that patients should also be told what risk factors to look for, so that they can be followed more closely. She added, We may also want to think about changes in surgical techniques and perioperative management of these patients.
She said researchers at Hopkins are now starting to examine some of the rehabilitative techniques and whether they may help to lower the risk of TEP complications in these patients.
Mark Persky, MD, Chairman of the Department of Otolaryngology at Beth Israel Medical Center in New York, said that it is true that patients who must have salvage surgery are more prone to complications because of the effects of chemoradiation treatment.