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If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects. Patients with T1–2 primary breast cancer and no palpable lymphadenopathy were enrolled in the randomised, multicentre, open-label, phase 3 non-inferiority EORTC 10981-22023 AMAROS trial. Patients were randomly assigned (1:1) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node, stratified by institution. The primary endpoint was non-inferiority of 5-year axillary recurrence, considered to be not more than 4% for the axillary radiotherapy group compared with an expected 2% in the axillary lymph node dissection group. Analyses were by intention to treat and per protocol. The AMAROS trial is registered with ClinicalTrials.gov, number NCT00014612. Between Feb 19, 2001, and April 29, 2010, 4823 patients were enrolled at 34 centres from nine European countries, of whom 4806 were eligible for randomisation. 2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy. Of the 1425 patients with a positive sentinel node, 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy; these patients constituted the intention-to-treat population. Median follow-up was 6·1 years (IQR 4·1–8·0) for the patients with positive sentinel lymph nodes. In the axillary lymph node dissection group, 220 (33%) of 672 patients who underwent axillary lymph node dissection had additional positive nodes. Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group. 5-year axillary recurrence was 0·43% (95% CI 0·00–0·92) after axillary lymph node dissection versus 1·19% (0·31–2·08) after axillary radiotherapy. The planned non-inferiority test was underpowered because of the low number of events. The one-sided 95% CI for the underpowered non-inferiority test on the hazard ratio was 0·00–5·27, with a non-inferiority margin of 2. Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year, 3 years, and 5 years. Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1–2 primary breast cancer and no palpable lymphadenopathy. Axillary radiotherapy results in significantly less morbidity. EORTC Charitable Trust.

Objective To assess and compare the accuracy of visual inspection with acetic acid (VIA), visual inspection with Lugol’s iodine (VILI), and human papillomavirus (HPV) testing as alternative standalone methods for primary cervical cancer screening in sub-Saharan Africa. Design Systematic review and meta-analysis of diagnostic test accuracy studies.Data sources Systematic searches of multiple databases including Medline, Embase, and Scopus for studies published between January 1994 and June 2014.Review methods Inclusion criteria for studies were: alternative methods to cytology used as a standalone test for primary screening; study population not at particular risk of cervical cancer (excluding studies focusing on HIV positive women or women with gynaecological symptoms); women screened by nurses; reference test (colposcopy and directed biopsies) performed at least in women with positive screening results. Two reviewers independently screened studies for eligibility and extracted data for inclusion, and evaluated study quality using the quality assessment of diagnostic accuracy studies 2 (QUADAS-2) checklist. Primary outcomes were absolute accuracy measures (sensitivity and specificity) of screening tests to detect cervical intraepithelial neoplasia grade 2 or worse (CIN2+).Results 15 studies of moderate quality were included (n=61 381 for VIA, n=46 435 for VILI, n=11 322 for HPV testing). Prevalence of CIN2+ did not vary by screening test and ranged from 2.3% (95% confidence interval 1.5% to 3.3%) in VILI studies to 4.9% (2.7% to 7.8%) in HPV testing studies. Positivity rates of VILI, VIA, and HPV testing were 16.5% (9.8% to 24.7%), 16.8% (11.0% to 23.6%), and 25.8% (17.4% to 35.3%), respectively. Pooled sensitivity was higher for VILI (95.1%; 90.1% to 97.7%) than VIA (82.4%; 76.3% to 87.3%) in studies where the reference test was performed in all women (P<0.001). Pooled specificity of VILI and VIA were similar (87.2% (78.1% to 92.8%) v 87.4% (77.1% to 93.4%); P=0.85). Pooled sensitivity and specificity were similar for HPV testing versus VIA (both P≥0.23) and versus VILI (both P≥0.16). Accuracy of VIA and VILI increased with sample size and time period.Conclusions For primary screening of cervical cancer in sub-Saharan Africa, VILI is a simple and affordable alternative to cytology that demonstrates higher sensitivity than VIA. Implementation studies are needed to assess the effect of these screening strategies on the incidence and outcomes of cervical cancer in the region.

World Health Organization guidelines for cervical cancer screening recommend HPV testing followed by visual inspection with acetic acid (VIA) for triage if HPV positive. In order to improve visual assessment and identification of cervical intraepithelial neoplasia grade 2 and worse (CIN2+), providers may use visual aids such as digital cameras. To determine whether combined examination by naked-eye and digital VIA (D-VIA) and VILI (D-VILI) improves detection of CIN2+ as compared to the conventional evaluation. Women (30-49 years) living in Dschang (West Cameroon) were prospectively invited to a cervical cancer screening campaign. Primary HPV-based screening was followed by VIA/VILI and D-VIA/VILI if HPV-positive. Health care providers independently defined diagnosis (pathological or non-pathological) based on naked-eye VIA/VILI and D-VIA/VILI. Decision to treat was based on combined examination (VIA/VILI and D-VIA/VILI). Cervical biopsy and endocervical curettage were performed in all HPV-positive participants and considered as reference standard. Diagnostic performance of individual and combined naked-eye VIA/VILI and D-VIA/VILI was evaluated. A sample size of 1,500 women was calculated assuming a prevalence of 20% HPV positivity and 10% CIN2+ in HPV-positive women. Due to the COVID-19 pandemic, the study had to terminate prematurely. A total of 1,081 women with a median age of 40 (IQR 35.5-45) were recruited. HPV positivity was 17.4% (n = 188) and 26 (14.4%) had CIN2+. Naked-eye VIA and D-VIA sensitivities were 80.8% (95% CI 60.6-93.4) and 92.0% (95% CI 74.0-99.0), and specificities were 31.2% (95% CI 24-39.1) and 31.6% (95% CI 24.4-39.6), respectively. The combination of both methods yielded a sensitivity of 92.3% (95% CI 74.9-99.1) and specificity of 23.2% (95% CI 16.8-30.7). A trend towards improved sensitivity was observed, but did not reach statistical significance. Addition of D-VIA/VILI to conventional naked-eye examination may be associated with improved CIN2+ identification. Further studies including a larger sample size are needed to confirm these results.

Background Polyploid giant cancer cells (PGCCs) have been observed in epithelial ovarian tumors. They can resist antimitotic drugs, thus participating in tumor maintenance and recurrence. Although their origin remains unclear, PGCC formation seems to be enhanced by conditions that trigger the unfolded protein response (UPR) such as hypoxia or chemotherapeutic drugs like paclitaxel. Hypoxia has been shown to promote the formation of ovarian PGCCs by cell fusion. We thus hypothesized that the UPR could be involved in EOC cell fusion, possibly explaining the occurrence of PGCCs and the aggressiveness of EOC. Methods The UPR was induced in two ovarian cancer cell lines (SKOV3 and COV318). The UPR activation was assessed by Western blot and polyploidy indexes were calculated. Then, to confirm the implication of cell fusion in PGCC formation, two populations of SKOV3 cells were transfected with plasmids encoding for two distinct nuclear fluorescent proteins (GFP and mCherry) associated with different antibiotic resistance genes, and the two cell populations were mixed in co-culture. The co-culture was submitted to a double-antibiotic selection. The resulting cell population was characterized for its morphology, cyclicity, and proliferative and tumorigenic capacities, in addition to transcriptomic characterization. Results We demonstrated that cell fusion could be involved in the generation of ovarian PGCCs and this process was promoted by paclitaxel and the UPR activation. Double-antibiotic treatment of PGCCs led to the selection of a pure population of cells containing both GFP- and mCherry-positive nuclei. Interestingly, after 3 weeks of selection, we observed that these cells were no longer polynucleated but displayed a single nucleus positive for both fluorescent proteins, suggesting that genetic material mixing had occurred. These cells had reinitiated their normal cell cycles, acquired an increased invasive capacity, and could form ovarian tumors in ovo . Conclusions The UPR activation increased the in vitro formation of PGCCs by cell fusion, with the newly generated cells further acquiring new properties. The UPR modulation in ovarian cancer patients could represent an interesting therapeutic strategy to avoid the formation of PGCCs and therefore limit cancer relapse and drug resistance.

Background The World Health Organization recommends thermal ablation as an alternative to cryotherapy to treat women with precancerous lesions in low-resource settings. However, limited data are available on women’s experience and adverse events (AEs) of the procedure in the context of Sub-Saharan Africa. The objective of this study was to evaluate the acceptability and safety of thermal ablation in women screened positive for precancerous cervical lesions. Methods Asymptomatic women aged 30–49 years old living in the Dschang Health District were invited to participate in a cervical cancer screening campaign termed “3 T-Approach” (for Test-Triage and Treat). Recruited women were asked to perform HPV self-sampling followed by triage with visual assessment and treatment with thermal ablation if required. After treatment and 4–6 weeks later, interviews were conducted to assess women’s experience on anxiety, discomfort, and pain during thermal ablation. AEs were recorded on pre-defined electronic forms 4–6 weeks after treatment to assess the procedure’s safety. Results Between September 2018 and December 2020, 399 HPV-positive women (18.7% of women screened) were recruited, 236 (59.1%) had a positive visual assessment, 234 were treated by thermal ablation and 198 (84.6%) received therapy in the same visit. Treatment was not considered as painful (score ≤ 4/10) by 209 (90.9%) patients while 5 (2.5%) reported high pain (score 8–10/10). During post-treatment interviews 4–6 weeks later, most reported AEs were graded mild or moderate (grade I-II). The most frequent symptoms reported as mild AEs (grade 1–2) were vaginal watery discharge (75.5%), vaginal bloody-stained discharge (21.5%) and malodourous discharge (14.5%). None of the participants experienced serious AEs (grade 3–4) or AEs requiring admission to hospital or emergency consultation. The vast majority of women (99.6%) would agree to repeat the procedure if necessary and (99.6%) would recommend it to friends or family. Conclusion Thermal ablation is widely accepted by women and appears as a safe procedure. It may contribute to improving the link between screening and treatment in a single visit and to optimizing cervical cancer control in low-resource settings. Trial registration The study was registered on clinicaltrials.gov ( NCT03757299 ) in November 2018 (28/11/2018).

Visual inspection with acetic acid (VIA) is one of the methods recommended by the World Health Organization for cervical cancer screening. VIA is simple and low-cost; it, however, presents high subjectivity. We conducted a systematic literature search in PubMed, Google Scholar and Scopus to identify automated algorithms for classifying images taken during VIA as negative (healthy/benign) or precancerous/cancerous. Of the 2608 studies identified, 11 met the inclusion criteria. The algorithm with the highest accuracy in each study was selected, and some of its key features were analyzed. Data analysis and comparison between the algorithms were conducted, in terms of sensitivity and specificity, ranging from 0.22 to 0.93 and 0.67 to 0.95, respectively. The quality and risk of each study were assessed following the QUADAS-2 guidelines. Artificial intelligence-based cervical cancer screening algorithms have the potential to become a key tool for supporting cervical cancer screening, especially in settings where there is a lack of healthcare infrastructure and trained personnel. The presented studies, however, assess their algorithms using small datasets of highly selected images, not reflecting whole screened populations. Large-scale testing in real conditions is required to assess the feasibility of integrating those algorithms in clinical settings.

Background The World Health Organization’s 90-70-90 goal aims to eliminate cervical cancer (CC) as a public health issue, with a target of up to 70% of women screened by 2030. However, many countries, including Cameroon, are far from achieving this goal. Home-based human papillomavirus (HPV) self-sampling is a promising approach to improve participation rates. The main objective of this study was to explore the acceptability and feasibility of home-based HPV self-sampling in the West region of Cameroon. Methods A quantitative, descriptive, cross-sectional study conducted between January 11 and February 05, 2024, was embedded in a cluster-randomised controlled trial comparing home- vs. hospital-based CC screening. Women eligible for CC screening, male partners or close relatives, community leaders, and healthcare professionals (HCPs) living in Dschang health district responded to a structured questionnaire. Simple and multivariate analyses were performed to assess the association between acceptability of home-based HPV self-sampling, CC screening practices, and sociodemographic factors such as education, professional status, residence, and income. Preferences for implementation (e.g., seasonal timing) were also explored. Results A total of 556 participants (300 women, 70 male partners, 153 HCPs, and 33 community leaders) were recruited. Overall, 77.5% of participants expressed favourable attitudes toward home-based HPV self-sampling, with acceptability rates of 73.7% for women, 65.7% for men, 90% for community leaders, and 87.6% for HCPs. Previous CC screening was reported by 33% of women, and was significantly associated with being over 40 years old (aOR = 2.1, p  = 0.007), with a monthly income of > 50,000 XAF (aOR = 2.2, p  = 0.049), and having good knowledge of CC (aOR = 2.6, p  = 0.001). Morning screening implementation was preferred by most participants, with 60% favouring year-round screening. More than 70% preferred face-to-face communication of HPV test results from SMS or phone calls, at hospitals for women (63%), men (50%), and HCPs (65.4%); while community leaders preferred home disclosure. Conclusion Home-based HPV self-sampling was highly accepted across all study groups and was unaffected by sociodemographic factors. Previous screening practices were associated with age, income, and knowledge. Home-based HPV self-sampling screening can address access disparities to CC screening. Community involvement in planning and implementing these programs is essential to ensure their success. Trial registration Ethical Cantonal Board of Geneva, Switzerland (CCER, N°202100085), (ClinicalTrials.govID NCT06166420 / 20231204) and the National Ethics Committee for Human Health Research in Cameroon (N°2023/09/1579/CE/CNERSH/SP).

Background Cervical cancer (CC) is a public health burden, particularly in low-and middle-income countries, but can be prevented by screening for Human Papillomavirus (HPV). Nevertheless, positive test results may have psychological and sexual impacts for women. This study aimed to assess the impact of HPV test results on anxiety and sexual dysfunction in Cameroonian women. Methods This prospective cohort study conducted from 2020 to 2022 in Cameroon, included women previously enrolled in the 3T-Approach trial. Participants underwent a same-day consultation, organized as follows: HPV screening, triage of HPV-positive women and treatment by thermal ablation or Large Loop Excision of the Transformation Zone (LLETZ), if necessary. They completed anxiety (STAI) and sexual function (ASEX) questionnaires at 1, 6, and 12 months post-screening. Results Among 273 women included in the study, 220 (80.6%) completed all time points. Upon inclusion, 24.5% were HPV-positive, of which 46.3% underwent treatment. Anxiety levels did not significantly differ by HPV status. Higher sexual dysfunction prevalence was observed in HPV-positive women at all intervals. Between 1 and 12 months HPV-positive women showed an increase in their mean sexual dysfunction score (+ 4.5, 95% CI: 0.5 to 8.4), which was not seen in HPV-negative women. This disparity persisted even after adjusting for socio-demographic factors. Conclusion HPV test results did not significantly impact anxiety levels in women in Cameroon. Nevertheless, HPV-positive women reported higher sexual dysfunction at one-year post-screening compared to HPV-negative women. Further research should focus on investigating the factors affecting sexual dysfunction, in order to propose strategies to maintain women’s well-being without compromising screening rates. Trial registration The protocol of the 3TApproach study was registered under ClinicalTrials.gov, (identifier NCT03757299) on 28, November, 2018.

IntroductionTransvaginal natural orifice transluminal endoscopic surgery (vNOTES) has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy without conversion. The results in terms of efficacy and safety are promising. However, we note a lack of medical literature and no specific randomised controlled trial assessing women’s sexual function after vNOTES for benign adnexal surgery. The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared with CAL on women’s sexual function. Secondary outcomes will evaluate vNOTES’s efficiency, morbidity and postoperative complications compared with CAL for benign adnexal surgery. The relationship between adnexal mass morcellation and the quality of the histological analysis will also be evaluated as secondary outcome.Methods and analysisWomen aged 18–70 years undergoing a benign adnexal surgery at the Geneva University Hospitals will be eligible and randomised with a 1:1 ratio to the CAL arm or the vNOTES arm, if inclusion criteria are met. Participants will complete the Female Sexual Function Index, the Couple Satisfaction Index-16 and a self-reported questionnaire on dyspareunia within 4 weeks prior to randomisation and at 3+6 months after surgery. General and clinical data will be collected when the patient is enrolled in the study, during hospitalisation and at 1 month postoperative to assess secondary outcomes.An absence of impairment on sexual function will be confirmed with a stability or an improvement of the evaluated scores in each group at 3 and 6 months postoperative compared with the preoperative scores. We expect to have no statistically significant difference in sexuality questionnaires scores between the two groups.Ethics and disseminationProtocol of this study was validated by the Cantonal Research Ethics Commission of Geneva, Switzerland, on 9 August 2022. We aim to publish the study’s results in peer-reviewed journals within 3 years.Trial registration numberNCT05761275.

Objectives The World Health Organization’s (WHO) global strategy for cervical cancer elimination has set the target of 70% of women screened in all countries by 2030. Community sensitization through media is often used, but community health workers’ (CHW) involvement may contribute to improving screening coverage. We aimed to assess effectiveness and costs of two cervical cancer screening recruitment strategies conducted in a low-resource setting. Methods The study was conducted in the West Region of Cameroon, in the Health District of Dschang, a community of 300,000 inhabitants. From September 2018 to February 2020, we recruited and screened women for cervical cancer in a single-visit prevention campaign at Dschang District Hospital. During the first 9 months, recruitment was only based on Community Information Channels (CIC) (e.g.. street banners). From the tenth month, participation of CHW was added in the community after training for cervical cancer prevention counselling. Population recruitment was compared between the two strategies by assessing the number of recruited women and direct costs (CHW costs included recruitment, teaching, certification, identification badge, flyers, transport, and incentives). The intervention’s cost-effectiveness was expressed using an incremental cost-effectiveness ratio (ICER). Results and discussion During the period under study, 1940 women were recruited, HPV positive rate was 18.6% ( n  = 361) and 39 cases of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) were diagnosed. Among included participants, 69.9% ( n  = 1356) of women were recruited through CIC as compared to 30.1% ( n  = 584) by CHW. The cost per screened woman and CIN2+ diagnosed was higher in the CHW group. The ICER was 6.45 USD or 16.612021Int’l$ per screened woman recruited by CHW. Recruitment in rural areas increased from 12.1 to 61.4% of all women included between CIC-led and CHW-led interventions. These outcomes highlight the importance of training, preparing, and deploying CHW to screen hard-to-reach women, considering that up to 45% of Cameroon’s population lives in rural areas. Conclusion CHW offer an important complement to CIC for expanding coverage in a sub-Saharan African region such as the West Region of Cameroon. CHW play a central role in building awareness and motivation for cervical cancer screening in rural settings.