Patients were asked to complete a QOL form at baseline

Patients were asked to complete a QOL form at baseline http://www.selleckchem.com/products/Calcitriol-(Rocaltrol).html and weekly for the first 7 weeks, and subsequently before each administration of Gem for 24 weeks from random assignment. The forms were completed at the hospital and, with the exception of the baseline, before diagnostic procedures. For this analysis, we used the following global linear-analogue self-assessment (LASA) indicators sensitive to the wide spectrum of reactions seen in patients on chemotherapy: Physical well-being (Butow et al, 1991), mood (Butow et al, 1991; Hurny et al, 1996), coping effort (Butow et al, 1991; Hurny et al, 1993), and functional performance (Bernhard et al, 1999). The indicators for physical well-being, mood, coping effort, and functional performance were sensitive to tumour response in metastatic colorectal cancer (Borner et al, 2005).

The issue of high psychological distress in pancreatic cancer (Zabora et al, 2001) was covered by the mood and coping indicators, which are sensitive to mood disorders and psychosocial dysfunction (Bernhard et al, 2001). Specific LASA indicators were used for pain (Fishman et al, 1987) and tiredness (Bernhard et al, 1999). The restriction to a few key indicators instead of a standard assessment was based on feasibility considerations for the intensive longitudinal assessment schedule (Bernhard et al, 2008). Statistical analysis Quality of life forms filled in >3 days before or after day 1 of a cycle were excluded. We report means of untransformed data (scale range: 0�C100; higher scores: better condition).

A mean change of 8 points from baseline was defined as clinically meaningful (Sloan and Dueck, 2004). Associations among the stratification factors, baseline CA 19-9 and QOL scores (grouped by medians), and tumour response (Therasse et al, 2000) were investigated by ��2-tests, associations among the continuous QOL scores by Spearman correlations. We used R0.7 as criterion for multi-collinearity (Van Steen et al, 2002). A Cox model for overall survival was calculated with stratification factors, treatment arm, and baseline CA 19-9 as predictors. Then the QOL indicators were added individually to the model, first with continuous and second with grouped scores (cut-off points: 33 and 67% quantile of total sample, intermediate group as reference). The findings of the grouped scores were more consistent due to nonlinear effects, and are presented here.

A second Cox model was calculated for all QOL indicators without clinical factors and a third model with clinical factors and QOL indicators. Associations between QOL changes and maximum Cilengitide CA 19-9 decrease (both to baseline) were explored by Spearman correlations. The prognostic value of CA 19-9 baseline concentration and CA 19-9 maximal decrease for QOL during chemotherapy was investigated by a linear mixed-effects model for each indicator taking into account time effects on QOL, split by monthly treatment duration (Bernhard et al, 2008).

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