Clinical relevance of quality-of-life data in laryngectomized patients.

OBJECTIVES/HYPOTHESIS: Statistically significant differences in health-related quality of life (HRQL) are not always clinically relevant. It is also plausible that patients perceive other changes to be relevant than health professionals do. The objective of this study was to find thresholds for HRQL that laryngectomees consider to be clinically relevant 1 year after surgery, (i.e., the level of HRQL that patients rate as satisfactory). A second aim was to investigate how many laryngectomized patients reached those targets. STUDY DESIGN: Multicenter cross-sectional study. METHODS: A total of 28 patients 1 year following laryngectomy and 24 healthcare professionals (HCPs) defined target values for the QLQ-C30 and QLQ-H&N35. In another sample of 157 laryngectomized patients 1 year following laryngectomy, we determined what percentage of patients reached these thresholds. RESULTS: Patients are the most accepting of sensory impairments (56.5), coughing (53.6), and dyspnea (44.0), whereas constipation (9.1) and nausea/vomiting (10.7) were rated as being the most troublesome symptoms. HCPs assessed more of the studied complaints as being tolerable than patients did, especially in psychosocial domains. Between 34.5% (senses) and 86.5% (constipation) of the reference group hit the predefined targets at different scales. CONCLUSIONS: Symptoms caused by disease are easier for patients to live with than more general nonspecific symptoms. Taking into account that some adverse effects of disease or therapy are partially irreversible, target values additional to changes of HRQL can be helpful when interpreting data.

Recovery from sublethal damage during fractionated irradiation of human FaDu SCC.

BACKGROUND AND PURPOSE: The present study addresses whether recovery of sublethal damage in tumours may change during fractionated irradiation in FaDu human squamous cell carcinoma and whether such an effect might contribute to the pronounced time factor of fractionated irradiation previously found in this tumour. PATIENTS AND METHODS: FaDu tumours were transplanted s.c. into the right hind leg of NMRI nu/nu mice. Single doses or 2, 4, and 8 equal fractions in 3.5 days were applied in previously unirradiated tumours and after priming with 18 fractions of 3 Gy in 18 or 36 days. All irradiations were given under clamp hypoxic conditions. Experimental endpoints were tumour control dose 50% (TCD50) and alpha/ beta values without and after priming. RESULTS: Without priming TCD50 increased with increasing number of fractions from 38.8 Gy (95% CI 35;45) after single dose irradiation to 54.0 Gy (42;57) after 8 fractions. No increase in TCD50 when given in 1, 2, 4, or 8 fractions in 3.5 days was found after priming with 18 3-Gy fractions in 18 and 36 days. After priming with 18 fractions in 18 days TCD50 remained constant at 25 Gy and after priming with 18 fractions in 36 days at 42 Gy. The alpha/beta ratio without priming was 68 Gy (42;127). After fractionated irradiation with 18 3-Gy fractions in 18 and 36 days the alpha/beta ratio increased to 317 Gy (38; infinity) and to infinite, respectively. CONCLUSIONS: Our results indicate that clonogenic cells in FaDu tumours lose entirely their capacity to recover from sublethal radiation damage during fractionated irradiation. Therefore, an increased repair capacity as an explanation for the pronounced time factor of fractionated irradiation in this tumour can be ruled out.