Objectives To report on patterns of morbidity from the EMBRACE prospective study on MRI image-guided, adaptive brachytherapy in locally advanced cervical cancer, using a novel method to identify patients with LAte, PERsistent, Substantial treatment-related symptoms (LAPERS).
Methods EORTC QLQ-C30 + CX24 were analyzed in 657 patients out of 1416 patients within the EMBRACE study who had a valid baseline, 3 months’ assessment and at least 3 additional late follow-ups. A LAPERS event for an individual patient was defined when the median scoring over late follow-ups was “quite a bit” or “very much” (substantial symptoms). For organ-related symptoms baseline morbidity was taken into account by requiring the median to be worse than the minimum of baseline and 3 months scoring (treatment-related). In addition, crude incidences and median prevalence rates were calculated.
Results Median follow-up was 42 months (IQR 30–59). LAPERS, crude incidence and median prevalence rates of substantial symptoms are presented in table 1; and examples including prevalence rates in figure 1. LAPERS/crude incidence ratios lower than 0.1 indicate that <10% of symptomatic patients experience persisting substantial symptoms. LAPERS/median prevalence ratios close to 1 indicate that the proportion of patients experiencing substantial symptoms displayed in the prevalence over time are the same individual patients with persisting symptoms.
Conclusions LAPERS method provides complementary information to prevalence and incidence rates. LAPERS provides a more appropriate tool for a valid assessment of patients’ burden of substantial toxicity.
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