Incidence of severe late toxicities and quality of life in patients with locally advanced cervical cancer treated with concurrent chemoradiotherapy at Charlotte Maxeke Johannesburg Academic Hospital South Africa, 2014-2017

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2020

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Pillay, Prinitha

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Purpose The purpose of this study was to determine the incidence of bladder and gastrointestinal (GIT) complications in patients with severe-late cervical cancer (≥Grade 3 and >90 days after treatment completion) bladder and gastrointestinal complications; and to describe both the complication--related and sexual-health related quality of life experienced by these patients treated with chemoradiation for locally advanced cervical cancer. Methods This is a retrospective analysis of prospectively collected study data from a Phase III randomised controlled trial (RCT). This RCT investigated the benefits of combining hyperthermia with chemoradiation in 76 patients with FIGO Stage IIB and III cervical cancer whom were selected from the control arm. The Kaplan Meier time-to-event analysis was used to determine actuarial probability of complications, while clinician reported morbidity was recorded using Radiation Therapy Oncology Group (RTOG) criteria and patient reported outcomes (PRO) were recorded using EORTC QLQ CX24 quality of life (QoL) questionnaires. These criteria were assessed at baseline, and then every three months post-treatment during the first year and every six months post-treatment in the second year. Results The mean age of the patients was 50 years (SD±10.6.). 50% were HIV positive with a mean age of 45.2 years (SD±9.3) and a median CD4 count of 518 (range 374-626). All patients completed the entire course of concurrent Cisplatin based chemotherapy and chemoradiation (CCRT) within 56 days. GIT complications were largely obstructive and appeared predominantly in the second year, and the risk of was similar independent of the presence of disease. Local rectal fistulas were more common in patients who ultimately died from disease progression. The predominant bladder complications were fistulas, where the highest risk of developing a fistula was in the first year and half as likely to develop in those with no evidence of disease (NED). In those with NED, 5.3% developed ≥Grade 3 bladder complications (Grade 3 n=1, Grade 4 n=2, Grade 5 fatality n=1) with an actuarial probability of 3.3% and V 12.5% in the first and second year respectively. 3.5% of patients with NED developed ≥Grade 3 GIT complications (Grade 3 n=2, Grade 4 n=0, Grade 5 fatality n=2) with 0% in the first year and 23.1% actuarial risk during the second year. The probability of being alive with or without severe complications was not statistically different (ChiSquare 0.788 p=0.375 Log Rank: Mantel-Cox). It was noted that those without complications lived longer and the median survival had not been yet reached. Further to this, patients with complications reported more severe symptoms than those without complications (bladder 20% vs. 5% and GIT 21% vs. 8%), which tended to be complication specific symptoms e.g. incontinence in fistulas or related obstructive symptoms. There was a large discordancy between clinician graded severe toxicity and PRO of toxicity in the GIT (7.9% vs.10%) and slightly different with bladder toxicity (9.2% vs. 7%). Clinician’s grading using the worst toxicity underestimated the duration and quality of life that patients endured with Grade 3/4 symptoms before a Grade 5 fatality. Sexual worry and poor body image, were present in 60% of patients at baseline and this remained constant for the first year post-treatment but decreased in those who survived beyond a year to 35-40%. 11% of patients reported being sexually active at baseline but this doubled by six months post–treatment and plateaued to 30% of patients after nine months post-treatment. 21% of women under 30 years, 22% of those aged 31-50 years and 10% of patients over 50 years of age reported having sex in the previous four weeks. Out of the 72 reports of sexual activity, pain during intercourse was reported in 65% of patients while 77% found intercourse enjoyable and 51% of the patients found it both enjoyable and painful. 26% of patients reported enjoying intercourse without pain and 14% who did not enjoy intercourse reported pain. The main vaginal symptom was discharge, which was almost twice as prevalent as vaginal discomfort throughout the first two years post-treatment (71% vs. 43% at baseline; 40% vs. 27% at 6 months; 23% vs. 14% at 18 months). However, there was a clear and noteworthy improvement over time. Conclusion There is a high risk of developing severe complications in patients who survive the first year; and their quality of life outlook is significantly worse than those without complications. Monitoring patterns of tell-tale symptoms and their intensities reported by patients is, currently, the best ‘early-warning system’ to detect severe late complications. In light of the high fatality rate, a comprehensive multidisciplinary approach is needed for patients reporting the severest symptoms in order to rapidly avert complications and to support those who suffer the harrowing effects once they have developed complications. Providing care on a daily basis, but without the indepth understanding of what is most meaningful to patients, only widens the gap in the care of patients. These findings can help health professionals to shape patient expectations by paying closer attention to concerns about their bodies and sexual function, and to reassure patients that there are improvements over time.

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A research submitted in partial fulfilment of the requirements for the degree of Master of Medicine in Radiation Oncology to the Faculty of Health Science, University of the Witwatersrand, Johannesburg, 2020

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