Longitudinal Evaluation of Trial Outcome Index Scores in Patients With Esophageal Cancer.

BACKGROUND

The purpose of this study was to use the Trial Outcome Index (TOI) to longitudinally assess the effects of treatment for esophageal cancer.

METHODS

Patients with esophageal cancer treated with curative intent therapy (N = 84) were evaluated with Functional Assessment of Cancer Therapy-Esophageal Cancer subscale (FACT-E) questionnaires, which were scheduled at baseline and at 1, 3, 6, 9, 12, 18, 24, and 36 months after completion of treatment. Patients treated with preoperative therapy also completed questionnaires 6 to 8 weeks after starting treatment and after completion of induction treatment (12-14 weeks) just before the operative procedure. Physical and functional well-being subscales and the esophageal specific concerns that comprise the TOI were used for the analysis. A linear mixed-effects model with identity link function was used for longitudinal TOI scores. Tukey-Kramer adjustment for multiple comparisons was used for pairwise comparisons.

RESULTS

TOI scores differed over time (p < 0.0001), with a significant decrease in TOI from baseline to 6 to 8 weeks after chemotherapy or chemoradiation (p < 0.0001; median, 95 versus 68). At 1 month after treatment (esophagectomy or definitive chemoradiation), median TOI scores were 79 (p = 0.0011 compared with baseline). However by 3 months after treatment, median scores were 90, not significantly different from baseline (p = 0.23). Beyond 3 months, TOI scores either increased or stabilized. Single patients have TOI scores 12 points lower than patients with partners (p = 0.0015).

CONCLUSIONS

TOI is a useful tool to assess the physical and functional effects of treatment in patients with esophageal cancer and may provide an efficient index for the comparison of different types of treatment, particularly in the context of clinical trials.