Patient Reported Outcomes, Physician-Reported Toxicity and Dosimetry in Cervix Cancer Patient Treated With Chemo-Radiation and MR-Guided Brachytherapy

Abstract

Vaginal and sexual function is an important, yet often neglected, survivorship issue for cervical cancer patients. Our objective was to evaluate patient-reported outcomes (PROs), physician-reported vaginal toxicity and dosimetry in cervical cancer patients treated with definitive chemo-radiation (CRT) and brachytherapy (BT). Cervical cancer patients treated with definitive CRT and MR-guided HDR BT who were disease-free for > 3 months and attending routine follow-up were eligible. Consenting patients completed the following validated PROs: Female Sexual Distress Scale-Revised (FSDS-R; cut-off for distress >11)), Female Sexual Function Index (FSFI; cut-off for sexual dysfunction <26), EuroQol Group EQ-5D (index value range: 0 (death) to 1 (perfect health)), and Menopause Rating Scale (MRS; range: 0 (asymptomatic) to 44 (highest symptoms)), as well as a socio-demographics questionnaire. Oncologists scored vaginal toxicity using the CTCAE v4.0. Pt, treatment and dosimetric characteristics were collected and summarized using descriptive statistics. The association between PROs and dichotomized dosimetric characteristics were assessed using the Mann-Whitney test for continuous PROs and using Fisher’s exact test for categorical. The association between PROs and continuous dosimetric characteristics was tested using linear regression. The association between PROs and physician assessed toxicities were assessed using Fisher’s exact test. Between August 2018 and January 2020, 51 consenting patients were eligible for analysis. Median age at diagnosis was 46 (range: 23-73), 43% were FIGO 2B, 42% were lymph node positive and 50% had vaginal involvement clinically. Seventy-three percent were partnered, 76% were sexually active and 87% used a vaginal dilator post-treatment. The median HRCTV D90 was 92.1Gy (81-106.4), ICRU recto-vaginal (RV) point was 63.1Gy (52.6-85.8) and vaginal D2cc was 76.3Gy (54.5-133). Median FSDS-R score was 13 (0-48); 58% met criteria for sexual distress, median FSFI score was 15.6 (2-33.6); 83% met criteria for sexual dysfunction, median EQ5D index value was 0.8 (0.4-1) and median MRS score was 16 (0-33). There was a negative association between the ICRU RV point and EQ-5D (p = 0.02) and a positive correlation with MRS (p = 0.0027). A positive correlation was seen for FSDS-R (p = 0.021) when ICRU RV point was >65Gy. There was no significant correlation between PROs and physician assessed toxicity. Cervical cancer patients self-report high rates of sexual distress and dysfunction as well as menopausal symptoms. No association existed between PROs and physician-assessed toxicity, raising the possibility that physicians under-estimate the impact of patient symptoms. The patient experience was significantly correlated to dose, further validating the importance of the ICRU RV point as a surrogate for toxicity and quality of life.