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Larynx preservation studies should consider treatment impact

Sat, May 21, 2011

Oral Cancer News

Source: www.internalmedicinenews.com
Author: Sara Freeman, Internal Medicine News Digital Network

Almost one-quarter of patients who had been given induction chemotherapy before radiotherapy for head and neck cancer experienced long-term swallowing difficulties, with another 15% experiencing voice disabilities that correlated with the mobility of the vocal cords.

Long-term data from the GORTEC (Groupe Oncologie Radiothérapie Tête et Cou) 2000-01 larynx preservation trial also show that approximately two-thirds of long-term head and neck cancer survivors experienced severe problems with sticky saliva and dry mouth, which were in turn linked to nutritional problems.

These findings, reported May 9 at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference, further confirm that studies looking at the effects of chemoradiotherapy on the larynx in head and neck cancer need to consider prospective assessment of laryngeal function, rather than just looking at anatomical preservation, according to a French radiation oncologist.

Dr. Gilles Calais of the Centre Hôpitalier Régional et Universitaire de Tours (France) presented data from a prospective analysis of 61 patients who had participated in the original 213-patient GORTEC 2000-01 trial. He also presented updated results from the trial using a recently developed composite end point.

“Larynx preservation can be achieved for most of our [head and neck] patients by using three different strategies: induction chemotherapy, concomitant [chemoradiotherapy], or alternating chemoradiotherapy,” Dr. Calais observed. Indeed, larynx preservation is a possibility in approximately 80% of patients, he said.

However, anatomical preservation does not mean that laryngeal function is maintained, especially with respect to the ability to speak or to swallow normally. This realization recently resulted in the development of new end points for clinical trials that included both survival and laryngeal function. The new end points are laryngoesophageal dysfunction-free survival (LED-FS) and freedom from laryngoesophageal dysfunction (FF-LED).

“So the purpose of this study was to go back to our data of the GORTEC 2000-01 study and evaluate the results according to these new composite end points,” Dr. Calais explained. “In parallel,” he added, “we performed a prospective analysis of voice and swallowing function for long-term surviving patients.”

Published in 2009, the GORTEC 2000-01 study showed that induction chemotherapy with TPF (docetaxel, cisplatin, and 5-fluorouracil) was superior to pf (cisplatin and 5-FU) in terms of 3-year larynx preservation rates (J. Natl. Cancer Inst. 2009;101:498-506). In all, 110 patients had been treated with TPF and 103 with PF, and the published larynx preservation rates were 70.3% and 57.5%, respectively. Anatomical preservation of the larynx was a possibly in 66 patients, and these patients were assessed for voice and swallowing function.

Recalculating survival curves according to the two new end points showed much lower overall values, compared with the anatomical-only end points, Dr. Calais noted. Considering all patients, the 5-year LED-FS was just 28% and the 5-year FF-LED was 50%.

Patients who were treated with the taxane-containing regimen fared better than those who received the cisplatin and 5-FU chemotherapy. The 5-year LED-FS rates were 36% in the TPF arm vs. 21% for the PF arm (P = .007). The 5-year FF-LED rates were 60% and 39%, respectively (P = .005).

“These data can be used as a reference for comparison with future larynx preservation studies,” Dr. Calais said. He noted that it was important to bear in mind that the best treatment to preserve the larynx is not known, referring to the FF-LED rate of 60% with the TPF regimen.

“Of course, [the] patient’s quality of life measure[s used] should be conducted in every future larynx preservation study.”

Dr. Calais declared no financial conflicts of interest.

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