Does change in health-related quality of life score predict survival? Analysis of EORTC 08975 lung cancer trial.

BACKGROUND: Little is known about whether changes in health-related quality of life (HRQoL) scores from baseline during treatment also predict survival, which we aim to investigate in this study. METHODS: We analysed data from 391 advanced non-small-cell lung cancer (NSCLC) patients enrolled in the EORTC 08975 study, which compared palliative chemotherapy regimens. HRQoL was assessed at baseline and after each chemotherapy cycle using the EORTC QLQ-C30 and QLQ-LC13. The prognostic significance of HRQoL scores at baseline and their changes over time was assessed with Cox regression, after adjusting for clinical and socio-demographic variables. RESULTS: After controlling for covariates, every 10-point increase in baseline pain and dysphagia was associated with 11% and 12% increased risk of death with hazard ratios (HRs) of 1.11 and 1.12, respectively. Every 10-point improvement of physical function at baseline (HR=0.93) was associated with 7% lower risk of death. Every 10-point increase in pain (HR=1.08) was associated with 8% increased risk of death at cycle 1. Every 10-point increase in social function (HR=0.91) at cycle 2 was associated with 9% lower risk of death. CONCLUSIONS: Our findings suggest that changes in HRQoL scores from baseline during treatment, as measured on subscales of the EORTC QLQ-C30 and QLQ-LC13, are significant prognostic factors for survival.

Effect of completion-time windows in the analysis of health-related quality of life outcomes in cancer patients.

BACKGROUND: We examined if cancer patients' health-related quality of life (HRQoL) scores on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 are affected by the specific time point, before or during treatment, at which the questionnaire is completed, and whether this could bias the overall treatment comparison analyses. PATIENTS AND METHODS: A 'completion-time window' variable was created on three closed EORTC randomised control trials in lung (non-small cell lung cancer, NSCLC) and colorectal cancer (CRC) to indicate when the QLQ-30 was completed relative to chemotherapy cycle dates, defined as 'before', 'on' and 'after'. HRQoL mean scores were calculated using a linear mixed model. RESULTS: Statistically significant differences (P<0.05) were observed on 6 and 5 scales for 'on' and 'after' comparisons in the NSCLC and two-group CRC trial, respectively. As for the three-group CRC trial, several statistical differences were observed in the 'before' to 'on' and the 'on' to 'after' comparisons. For all three trials, including the 'completion-time window' variable in the model resulted in a better fit, but no substantial changes in the treatment effects were noted. CONCLUSIONS: We showed that considering the exact timing of completion within specified windows resulted in statistical and potentially clinically significant differences, but it did not alter the conclusions of treatment comparison in these studies.

Regional cerebral blood velocity in infants. A real-time transcranial and fontanellar pulsed Doppler study.

To quantitate blood velocity while maintaining the real-time ultrasound image of the intracranial vessels in infants, we used a commercial phased-array pulsed Doppler scanner and developed a transcranial technique to measure the middle cerebral artery velocity, and a fontanellar approach to measure flow velocities in the basilar, internal carotid, anterior cerebral, and the pericallosal arteries. In 22 healthy term and 25 stable preterm infants, the peak spectral systolic velocities in the internal carotid and basilar arteries in term infants were 45 +/- 3.1, and 38.8 +/- 2.5 cm/sec, (mean +/- SEM), respectively. A hierarchical pattern of velocity variation was noted between the large and small intracranial vessels in both the term and preterm infants. The velocities were 30-40% higher in the proximal than in the smaller distal, anterior cerebral, and pericallosal arteries (P less than 0.05). Although the velocities in corresponding vessels were slightly lower in preterm infants than in the term, the differences were statistically not significant. In both groups, the end diastolic velocities did not change significantly among the large and small arteries; therefore, a significant variation in Pourcelot's index (PI, the ratio of maximum systolic-end diastolic difference to the systolic velocity) was noted between the internal carotid and the pericallosal arteries: 0.88 +/- 0.01 vs. 0.76 +/- 0.02, (P less than 0.05). A nearly parabolic velocity profile was documented in the vessels studied.