Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis: results from a French prospective multicentre study including 60 patients.

STUDY QUESTION: Is increasing the intensity of high-intensity focused ultrasound (HIFU) by 30% in the treatment of rectal endometriosis a safe procedure? SUMMARY ANSWER: This study demonstrates the safety of a 30% increase in the intensity of HIFU in the treatment of rectal endometriosis, with no Clavien-Dindo Grade III complications overall, and namely no rectovaginal fistulae. WHAT IS KNOWN ALREADY: A feasibility study including 20 patients with rectal endometriosis demonstrated, with no severe complications, a significant improvement in digestive disorders, dysmenorrhoea, dyspareunia, and health status, although the volume of the endometriosis nodule did not appear to be reduced. STUDY DESIGN, SIZE, DURATION: A prospective multicentre cohort study was conducted between 2020 and 2022 with 60 patients with symptomatic rectal endometriosis. Following the failure of medical treatment, HIFU treatment was offered as an alternative to surgery. PARTICIPANTS/MATERIALS, SETTING, METHODS: As the main objective of this study was to examine safety, all adverse events observed during the 6 months of follow-up were analysed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and Clavien-Dindo classifications. Secondary objectives included evaluating the evolution of symptoms using validated questionnaires: gynaecological and digestive pain symptoms with a visual analogue scale, health status with the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire, average post-operative daily pain level, and analgesic medication required in the 10 days following treatment. MRI was also performed at Day 1 to detect early complications. Finally, we performed a blinded MRI review of the evolution of the nodule at 6 months post-treatment. MAIN RESULTS AND THE ROLE OF CHANCE: The procedure was performed under spinal anaesthesia for 30% of the patients. The median duration of treatment was 32 min. Fifty-five patients left the hospital on Day 1. MRI scans performed on Day 1 did not highlight any early-onset post-operative complication. Using the Clavien-Dindo classification, we listed 56.7% Grade I events, 3.4% Grade II events, and no events Grade III or higher. At 1, 3, and 6 months, all gynaecologic, digestive and general symptoms, as well as health status, had significantly improved. The evolution of the nodule was also significant (P < 0.001) with a 28% decrease in volume. LIMITATIONS, REASONS FOR CAUTION: The main objective was safety and not effectiveness. The study was not randomized and there was no control group. WIDER IMPLICATIONS OF THE FINDINGS: HIFU treatment for rectal endometriosis results in an improvement of symptoms with low morbidity; as such, for selected patients, it could be a valuable alternative to surgical approaches following the failure of medical treatment. STUDY FUNDING/COMPETING INTEREST(S): The study was funded by the company EDAP TMS. Professors Dubernard and Rousset are consultants for EDAP TMS. Dubernard received travel support from EDAP-TMS. Dr F. Chavrier received industrial grants from EDAP-TMS. He has developed a device for generating focused ultrasonic waves with reduced treatment time. This device has been patented by EDAP-TMS. Dr Lafon received industrial grants from EDAP-TMS; he declares that EDAP-TMS provided funding directly to INSERM to support a young researcher chair in therapeutic ultrasound, which is unrelated to the current study. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT04494568.

Evaluation of online text-based information resources of gynaecological cancer symptoms.

BACKGROUND: Gynaecological cancer symptoms are often vague and non-specific. Quality health information is central to timely cancer diagnosis and treatment. The aim of this study was to identify and evaluate the quality of online text-based patient information resources regarding gynaecological cancer symptoms. METHODS: A targeted website search and Google search were conducted to identify health information resources published by the Australian government and non-government health organisations. Resources were classified by topic (gynaecological health, gynaecological cancers, cancer, general health); assessed for reading level (Simple Measure of Gobbledygook, SMOG) and difficulty (Flesch Reading Ease, FRE); understandability and actionability (Patient Education Materials Assessment Tool, PEMAT, 0-100), whereby higher scores indicate better understandability/actionability. Seven criteria were used to assess cultural inclusivity specific for Aboriginal and Torres Strait Islander people; resources which met 3-5 items were deemed to be moderately inclusive and 6+ items as inclusive. RESULTS: A total of 109 resources were identified and 76% provided information on symptoms in the context of gynaecological cancers. The average readability was equivalent to a grade 10 reading level on the SMOG and classified as 'difficult to read' on the FRE. The mean PEMAT scores were 95% (range 58-100) for understandability and 13% (range 0-80) for actionability. Five resources were evaluated as being moderately culturally inclusive. No resource met all the benchmarks. CONCLUSIONS: This study highlights the inadequate quality of online resources available on pre-diagnosis gynaecological cancer symptom information. Resources should be revised in line with the recommended standards for readability, understandability and actionability and to meet the needs of a culturally diverse population.

Tamoxifen related side effects and their impact on breast cancer incidence: A retrospective analysis of the randomised IBIS-I trial.

BACKGROUND: Studies in the adjuvant setting have shown that endocrine therapy related side effects predict breast cancer recurrence risk. Here, we assess the relationship between early reported side effects and incidence of breast cancer in women randomised to tamoxifen for cancer prevention in the International Breast Intervention Study (IBIS)-I trial. METHODS: Women randomised to tamoxifen in the IBIS-I trial and for whom side effect status was known at the 6-month follow-up visit were included in this analysis. Side effects included in this analysis were hot flushes, vaginal discharge, and vaginal dryness. The primary endpoint was all breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer. Cox proportional hazard models were used to investigate breast cancer incidence in the tamoxifen group with and without side effects reported within 6 months of randomisation. RESULTS: Women randomised to tamoxifen and reporting hot flushes at the 6-month follow-up visit had a non-statistically significant increase in breast cancer compared to those without hot flushes (HR = 1.26 (0.98-1.62), P = 0.08). A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01). A higher risk was observed for ER-positive breast cancer in postmenopausal women (HR = 1.81 (1.19-2.74), P = 0.01). No significant associations between gynaecological side effects and breast cancer occurrence was observed. CONCLUSIONS: Overall, no association between side effects reported at 6 months and subsequent breast cancer occurrence was observed. Some side effects might be useful markers for breast cancer occurrence in postmenopausal women.

Improved health-related quality of life in the first year after laparoscopic niche resection: a prospective cohort study.

OBJECTIVE: To evaluate changes in health-related quality of life (HRQOL) the first year after laparoscopic niche resection. STUDY DESIGN: Prospective cohort study in women with a large niche (residual myometrium thickness <3.0 mm) after caesarean section who underwent laparoscopic niche resection between May 2010 and January 2018. Women were included consecutively. 36-Item Short Form Survey (SF-36) was sent at baseline, three and twelve months postoperatively. All participants that filled out the questionnaire at baseline were included. Physical (PCS) and mental component summary scores (MCS) and scores for subdomains were calculated. Scores were analysed over time using Wilcoxon signed rank test. RESULTS: 146 participants responded to the SF-36 at baseline, of which 129 (88.4 %) responded at three or twelve months follow-up. After three months, median PCS and MCS improved, compared to baseline (p = 0.014 and p = 0.008, respectively). Subdomains physical functioning, bodily pain, general health, vitality, mental health and social functioning improved significantly. At twelve months follow-up, improvement in PCS and MCS did not reach statistical significance (p = 0.053 and p = 0.063, respectively). Subdomains bodily pain (77.6-89.8, p < 0.001), mental health (76-80, p = 0.004) and social functioning (75-87.5, p = 0.016) improved significantly. Women with symptom relief as main goal of the intervention showed larger improvement in PCS than women with distorted anatomy and to restore anatomy as main goal for the intervention (p = 0.001). CONCLUSION: Laparoscopic niche resection improves HRQOL in women with a large niche in physical and mental domains three and twelve months postoperatively.

Cytology in the diagnosis of cervical cancer in symptomatic young women: a retrospective review.

BACKGROUND: Cervical cancer in young women presents a diagnostic challenge because gynaecological symptoms are common but underlying disease is rare. AIM: To explore the potential for using cytology as a diagnostic aid for cervical cancer in young women. DESIGN AND SETTING: Retrospective review of primary care records and cytology data from the national cervical screening database and national audit of cervical cancers. METHOD: Four datasets of women aged 20-29 years in England were examined: primary care records and national screening data from an in-depth study of cervical cancers; cytology from the national audit of cervical cancers; whole-population cytology from the national screening database; and general-population primary care records from the Clinical Practice Research Datalink. The authors explored the sensitivity and positive predictive value (PPV) of symptomatic cytology (earliest <12 months before diagnosis) to cervical cancer. RESULTS: The estimated prevalence of cervical cancer among symptomatic women was between 0.4% and 0.9%. The sensitivity of moderate dyskaryosis (high-grade squamous intraepithelial lesion [HSIL]) or worse in women aged 20-29 years was 90.9% to 96.2% across datasets, regardless of symptom status. The PPV was estimated to be between 10.0% and 30.0%. For women aged 20-24 years, the PPV of '?invasive squamous carcinoma' was 25.4%, and 2.0% for severe or worse cytology. CONCLUSION: Cytology has value beyond screening, and could be used as a diagnostic aid for earlier detection of cervical cancer in young women with gynaecological symptoms by ruling in urgent referral.