Table 6. Averaged months of TOX, TWiST, and REL accumulated within 72 months of randomisation, with Q-TWiST calculated for patient-derived utility coefficients (N=324a).
|
Treatment group
|
||||
|---|---|---|---|---|
| DI-EC | SD-CT | |||
| Average months | Average months | Difference | 95% CI | |
| Components of Q-TWiST | ||||
| TOXb | 2.32 (0.57) | 0.32 (0.06) | — | — |
| TWiST | 47.25 (2.11) | 44.55 (2.07) | — | — |
| REL | 9.44 (1.25) | 12.28 (1.25) | — | — |
| Q-TWiST=ut × TOX+utwist × TWiST+ur × REL | ||||
| All available scores: (ut=0.77, utwist=0.91, ur=0.77) | 52.05 (1.55) | 50.24 (1.53) | 1.81 (2.21) | (−2.51–6.14) |
| Grade 3 or higher toxicity: (ut=0.70, utwist=0.91, ur=0.77) | 51.89 (1.55) | 50.22 (1.53) | 1.67 (2.21) | (−2.66–6.00) |
| All available scores, adjusted for ‘less than perfect’: (ut=0.85, utwist=1.00, ur=0.85) | 57.25 (1.71) | 55.26 (1.68) | 1.99 (2.43) | (−2.77–6.74) |
| Grade 3 or higher toxicity, adjusted for ‘less than perfect’: (ut=0.77, utwist=1.00, ur=0.85) | 57.06 (1.71) | 55.23 (1.68) | 1.83 (2.43) | (−2.93–6.58) |
Abbreviations: CI=confidence interval; DI-EC=dose-intensive epirubicin cyclophosphamide; SD-CT=standard dose chemotherapy (ACx4-CMFx3).
Note: standard errors are shown in parentheses. Standard errors do not factor in the variability of the patient-derived utility coefficients.
Excluding 20 patients who did not receive any of their prescribed treatment (6 in the SD-CT group and 14 in the DI-EC group).
One month was assigned to TOX for any reversible subjective toxic effect (i.e., does not include objective laboratory measures, e.g., blood counts) of grade 3 reported during a cycle. Three additional months were included after last report of grade 3 or higher alopecia or weight gain. For 13 DI-EC cases and 1 SD-CT case that experienced subjective toxicities of grade 3 or higher following chemotherapy, TOX includes the additional months attributable to these late toxicities. See Appendix A for a complete definition of subjective toxicity.