Salvage Surgery Shows More Prosthesis-Related Complications

PHOENIX-Performing salvage surgery after chemoradiation or radiation treatment for laryngeal cancer patients, rather than just performing primary surgery right away, appears to lead to more complications with patients’ tracheoesophageal voice prostheses, according to a retrospective study reported by researchers here.

Patients who were first treated either with radiotherapy or chemoradiation, then had salvage surgery performed later, had significantly more leakage around their prostheses, among other problems, than those who had primary surgery performed, researchers from Johns Hopkins University found during an examination of all the total laryngectomies performed at the Johns Hopkins Medical Center from 1998 to 2008.

When we looked at the number of leaks around the voice prostheses, we did find a significant difference between the groups, said Heather Starmer, MA, a speech-language pathologist who presented the findings at the American Head and Neck Society Meeting, conducted as part of the Combined Otolaryngology Spring Meeting.

A movement away from the practice of having a total laryngectomy, and then radiation therapy, prompted the study, Ms. Starmer said. For many years, the primary treatment for patients who had end-stage laryngeal cancer was total laryngectomy followed by radiation therapy, she said.

Then the tide started to change.

The Rise of Chemoradiation

In a 2006 study of the National Cancer Database, Chen et al. found that, from 1985 to 2001, use of chemoradiation as primary treatment for advanced cancer of the larynx increased from 8.3% to 20.8%. In another 2006 study of the same database, Hoffman et al. found that primary chemoradiation for all cancer of the larynx increased from 2% to 13.2%.

Studies on the effectiveness of chemoradiotherapy seem to have fueled the change in strategy.

The 1994 Veterans Affairs Laryngeal Cancer Study Group concluded that 64% of patients getting induction chemotherapy and definitive radiation therapy had retained their larynx after two years, with no decrement in two-year survival, compared with patients receiving a total laryngectomy.

The 2003 RTOG 91-11 study concluded that patients getting chemoradiation had significantly better laryngeal preservation than patients getting either just radiotherapy or induction chemoradiation therapy and then radiotherapy.

There has been a real change toward chemoradiation for treatment of these patients, Ms. Starmer said. At the same time period when we’ve seen this change in practice, we’ve also started to see, clinically, patients having an increased number of complications regarding tracheoesophageal voice prostheses [TEP], she continued. And so the question that we posed was: Could the problems that we’re seeing clinically be related to salvage surgery in comparison to the patients having primary surgery?

The Hopkins Study

A total of 174 patients were included in the Johns Hopkins analysis, including 81 who had primary surgery performed, 61 who had primary radiotherapy, and 32 who had primary chemoradiotherapy. Those who did not receive complete oncologic treatment, those who didn’t receive follow-up TEP care at Johns Hopkins, and those with a follow-up period of less than six months were excluded from the study.

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.

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.

But he said the study ignored the fact that, more often than not, chemoradiation does not lead to total laryngectomy, and that it is a risk that comes with the potential upside of preserving the voice. He said he was puzzled about the point of the study.

For those patients who don’t have to go to total laryngectomy, they can maintain their voice. They can maintain their quality of life, he said. So there is no comparison.

About two-thirds of patients who are treated with chemoradiation do not have to have a total laryngectomy.

The reason why people are going to be treated with chemoradiation is to preserve their larynxes, Dr. Persky said.

He said patients should be fully informed of the potential complications related to chemoradiation. But those complications are generally worth it, he said. That’s okay, he said. At least you’ve subjected them to some form of therapy that could have potentially saved their larynx.

©2009 The Triological Society