e., absolute value) or maximum (i.e., relative) decrease of CA 19-9. In the total sample (N=319), the median time to progression (TTP) was 4.3 and 3.9 months in patients randomly assigned to GemCap or Gem, respectively (Herrmann et al, 2007); that selleck products is, the majority of patients failed during our observation period of 6 months. In a Cox model with stratification factors, treatment arm and baseline CA 19-9 >1 �� ULN (N=247; TTP GemCap and Gem: 4.4 and 3.9 months), the strongest effect was present for CA 19-9, followed by physician-rated KPS and pain requiring analgesic medication, as shown in Table 3. After adding the QOL indicators separately, tiredness (good vs intermediate) was additionally prognostic, with less tiredness resulting in a better survival (HR: 0.68, 95% CI: 0.48-0.96, P<0.05).
Similarly, patients who reported less pain (good vs intermediate) had a better survival (HR: 0.69, 95% CI: 0.48�C0.98, P<0.05). It is important to note that these effects were not linear but discriminated patients with low symptom burden from the others. The remaining indicators were not associated with survival. Pain and tiredness (borderline effect) were also the only prognostic indicators in the model without clinical factors (Table 3). Table 3 Prognostic value of baseline factors for overall survival in patients with an increased tumour marker concentration Finally, a Cox model was calculated including both the clinical factors and QOL indicators (Table 3). Patient-rated pain intensity was more prognostic than pain requiring analgesic medication according to the treating physician.
In contrast, patient-rated functional performance remained unprognostic after exclusion of KPS. Survival according to tiredness and pain intensity is shown in Figure 1. A univariate analysis of all available patients (including CA 19-9 1 �� ULN) showed similar findings. Figure 1 Overall survival by baseline scores of tiredness (cut-off points: 50, 77) and pain (cut-off points: 71, 92). Both indicators have a range from 0 to 100, with higher scores indicating a better condition. P-values are based on log-rank test. Associations between CA 19-9 and QOL during chemotherapy Mean changes in physical QOL domains across the whole observation period were marginally correlated with the maximum CA 19-9 decrease, ranging from R=0.15 (P<0.05) for functional performance to R=0.28 (P<0.
001) for physical well-being. To investigate the role of CA 19-9 in estimating palliation, we first explored the prognostic GSK-3 value of CA 19-9 baseline concentration and of maximal decrease for QOL during chemotherapy by mixed-effects models using all available data until failure (N=231). The only, but not relevant, difference by baseline CA 19-9 was present in pain: Patients with baseline CA 19-9 below the median indicated marginally less pain on treatment (average score: 8.5 vs 8.3 P<0.05).