Head, neck cancer trial shows assessing HRQOL is valuable to patients, doctors

EORTC trial 24954 set out to compare two treatment schemes for patients with resectable hypopharyngeal and laryngeal cancers, and the results published in Cancer show that there is a trend towards worse HRQOL scores in patients receiving alternating chemoradiotherapy (Alternating arm) as opposed to those given sequential induction chemotherapy and radiotherapy (Sequential arm). However, very few differences reached the level of statistical significance, and most patients' HRQOL scores returned to baseline once treatment was completed.

Dr. Andrew Bottomley, EORTC Assistant Director and lead author of this study says, "Most clinical trials focus on clinical endpoints such as survival or disease-free survival, but not all undertake a detailed evaluation of HRQOL. In addition, there are few randomized controlled trials in the Head and Neck literature."

Dr. J.L. Lefebvre of the Centre Oscar Lambret in Lille, France, and member of the EORTC Head and Neck Cancer Group adds, "We saw this as something that needed to be addressed. Quality of Life is an important endpoint, and patients with head and neck cancers could suffer from debilitating problems with swallowing, speech, and hearing. They also have psychological effects from loss of function and changes in their body image. Assessing HRQOL of patients is of great value to both patients and their physicians."

From July 1996 through May 2004 this prospective phase III EORTC study randomized 450 patients between the ages of 35 and 76 years (WHO performance status less than or equal to two) with untreated, resectable advanced stage squamous cell carcinoma of the larynx (tumor stage T3-T4, lymph node stage N0-N2, distant metastasis stage M0) or hypopharynx (T2-4N0-2M0) into either the Sequential or Alternating arms. Patients in both arms were assessed for HRQOL at randomization, baseline, Day 42, and at Months 6, 12, 24, 36 and 48.

No differences were observed in the primary endpoint, fatigue, or a secondary endpoint, dyspnea. Significant differences were found in the swallowing and speech problems, both of which were secondary endpoints, at Day 42 in favor of patients in the Sequential Arm. Explanatory and sensitivity analysis revealed that the primary analysis favored the Sequential Arm, but most differences in HRQOL did not exist at the end of treatment and returned to baseline levels.