Improvement in Patient-Reported Distress after Chemo-Radiation in Cervical Cancer Patients

Abstract

Curative treatment of cervical cancer with definitive chemo-radiotherapy (CRT) can be associated with significant morbidity impacting quality of life and causing distress. Our objective was to evaluate the clinical utility of prospectively collected patient-reported distress over time in cervical cancer patients treated with definitive CRT using the Edmonton Symptom Assessment System (ESAS) questionnaire. Between 2011 and 2016, consenting cervical cancer patients treated with definitive CRT who completed ≥ 2 questionnaires at routine clinical visits, including baseline, were included. The ESAS is a validated 10-item patient-reported symptom screening tool. Items are scored 0-10 and summed to a total score with higher scores indicating higher distress. Mean total scores were calculated at all time points and compared to baseline using a paired t-test. For each patient, a slope was created using linear regression. A one-sample t-test was performed on the slopes to determine whether the degree of change differed from zero. The minimal clinically important difference (MCID) for total ESAS score was defined as a change of 3-points for improvement and 4-points for deterioration. A mixed model was used to evaluate the longitudinal change in the MCID from baseline. Of the 98 patients initially identified, 68 met inclusion criteria. Median (range) follow-up was 16 mos (2-57) and compliance at 12 mos was 57% (39/68). The median (range) age at diagnosis was 46 years (30-77) and 32%, 53%, 15% were FIGO stages IB, IIA-B, and IIIA-B respectively. All patients received external beam radiation with concurrent cisplatin followed by MR-guided PDR (47%) or HDR (53%) brachytherapy with 59% intracavitary and 41% combined intracavitary/interstitial techniques. There was no difference in total score at baseline compared to end of treatment (p=0.50), but reductions in distress were observed at 6 weeks, 3 mos and 6 mos after treatment compared to baseline (p=0.03, p=0.008 and p=<0.001, respectively). There was a significant improvement in distress over time for each patient reflected in the change in slope (mean slope: -0.79; 95% confidence interval: -1.31, -0.27; p=0.004). There was also a significant improvement in the MCID for total score from baseline over time (p=0.04). Cervical cancer patients experience significant distress at diagnosis and during definitive CRT that significantly improves over time after treatment to an extent that is expected to be clinically meaningful for patients as defined by the MCID. Prospective collection of cervix cancer specific patient-reported outcomes should be incorporated into routine clinical practice to better inform areas of need and survivorship planning.