13 research outputs found
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
No full textA 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, 2020Purpose 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
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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.TL (2020
Safety, strength and simplicity of efavirenz in pregnancy
No full textThe WHO recommends starting lifelong ART for all pregnant women with a CD4 count at or below 350 cells/mm³, which recognises the important component of ‘when to start’ and the role that timing of initiation plays in reducing mortality and disease progression. The data on ‘what to start’ are conflicting, and options for resource-limited settings are limited. The choice of an ART regimen for pregnant women is complicated by the need to take into account the health and safety of both the mother and baby. Particularly contentious is whether to use a nevirapine- (NVP) or efavirenz- (EFV) based regimen. This review presents the latest evidence on the safety and efficacy of EFV and NVP in pregnancy and offers recommendations for improving maternal and child health outcomes and avoid mother-to-child transmission as South Africa moves toward turning back the tide on its HIV epidemic
Outcomes for efavirenz versus nevirapine-containing regimens for treatment of HIV-1 infection: a systematic review and meta-analysis.
No full textINTRODUCTION: There is conflicting evidence and practice regarding the use of the non-nucleoside reverse transcriptase inhibitors (NNRTI) efavirenz (EFV) and nevirapine (NVP) in first-line antiretroviral therapy (ART). METHODS: We systematically reviewed virological outcomes in HIV-1 infected, treatment-naive patients on regimens containing EFV versus NVP from randomised trials and observational cohort studies. Data sources include PubMed, Embase, the Cochrane Central Register of Controlled Trials and conference proceedings of the International AIDS Society, Conference on Retroviruses and Opportunistic Infections, between 1996 to May 2013. Relative risks (RR) and 95% confidence intervals were synthesized using random-effects meta-analysis. Heterogeneity was assessed using the I(2) statistic, and subgroup analyses performed to assess the potential influence of study design, duration of follow up, location, and tuberculosis treatment. Sensitivity analyses explored the potential influence of different dosages of NVP and different viral load thresholds. RESULTS: Of 5011 citations retrieved, 38 reports of studies comprising 114 391 patients were included for review. EFV was significantly less likely than NVP to lead to virologic failure in both trials (RR 0.85 [0.73-0.99] I(2) = 0%) and observational studies (RR 0.65 [0.59-0.71] I(2) = 54%). EFV was more likely to achieve virologic success than NVP, though marginally significant, in both randomised controlled trials (RR 1.04 [1.00-1.08] I(2) = 0%) and observational studies (RR 1.06 [1.00-1.12] I(2) = 68%). CONCLUSION: EFV-based first line ART is significantly less likely to lead to virologic failure compared to NVP-based ART. This finding supports the use of EFV as the preferred NNRTI in first-line treatment regimen for HIV treatment, particularly in resource limited settings
Outcome virologic failure in RCTs-subgroups by settings.
No full text<p>Outcome virologic failure in RCTs-subgroups by settings.</p
Baseline characteristics of patients on NVP and EFV by study design.
No full text1<p>These two studies compared NVP 400 mg once daily to EFV 600 mg once daily. All other studies compared NVP200 mg twice daily to EFV 600 mg once daily.</p>2<p>Studies in TB/HIV co-infected patients on TB treatment.</p>3<p>after July 2007, the definition of failure changed from more than 5000copies/ml to more than 400copies/ml.</p><p>Abbreviations: EFV efavirenz NVP nevirapine Dash (–) Not provided VS Virologic suppression VF Virologic failure Italics: Overall cohort characteristics not differentiated by NNRTI.</p
Outcome mortality in RCTs and observational studies.
No full text<p>Outcome mortality in RCTs and observational studies.</p
Outcome virologic success in RCTs and observational studies.
No full text<p>Outcome virologic success in RCTs and observational studies.</p
Outcome virologic failure in RCTs and observational studies.
No full text<p>Outcome virologic failure in RCTs and observational studies.</p
