The every woman study™ low- and middle-income countries edition protocol: A multi-country observational study to assess opportunities and challenges to improving survival and quality of life for women with ovarian cancer.

BACKGROUND: Ovarian cancer is a challenging disease to diagnose and treat effectively with five-year survival rates below 50%. Previous patient experience research in high-income countries highlighted common challenges and opportunities to improve survival and quality of life for women affected by ovarian cancer. However, no comparable data exist for low-and middle-income countries, where 70% of women with the disease live. This study aims to address this evidence gap. METHODS: This is an observational multi-country study set in low- and middle-income countries. We aim to recruit over 2000 women diagnosed with ovarian cancer across multiple hospitals in 24 countries in Asia, Africa and South America. Country sample sizes have been calculated (n = 70-96 participants /country), taking account of varying national five-year disease prevalence rates. Women within five years of their diagnosis, who are in contact with participating hospitals, are invited to take part in the study. A questionnaire has been adapted from a tool previously used in high-income countries. It comprises 57 multiple choice and two open-ended questions designed to collect information on demographics, women's knowledge of ovarian cancer, route to diagnosis, access to treatments, surgery and genetic testing, support needs, the impact of the disease on women and their families, and their priorities for action. The questionnaire has been designed in English, translated into local languages and tested according to local ethics requirements. Questionnaires will be administered by a trained member of the clinical team. CONCLUSION: This study will inform further research, advocacy, and action in low- and middle-income countries based on tailored approaches to the national, regional and global challenges and opportunities. In addition, participating countries can choose to repeat the study to track progress and the protocol can be adapted for other countries and other diseases.

Role of molecular biomarker human papilloma virus (HPV) E6 oncoprotein in cervical cancer screening.

OBJECTIVE: The Onco E6™ Cervical Test, based on detection of the E6 oncoprotein of HPV 16 and 18 genotypes is evaluated as a screen for the early detection cervical neoplasia in resource-limited countries. METHODS: This prospective study from June 2018 to June 2019 evaluated 235 women aged 21-65 years, who came to Gynaecological Oncology Outpatient Department by VIA, cytology, E6 oncoprotein test and by colposcopy. Screen-positive women by any of the tests or women with suspicious findings were further evaluated by biopsy at colposcopy. The McNemar test was used to compare the performance of E6 oncoprotein test with other screening tests. RESULTS: The E6 oncoprotein positivity rate was 6.8% (n = 16) with 81.25% HPV 16 positive and 18.75% HPV 18 positive. Among VIA positive cases (n = 100), E6 oncoprotein was positive in 9% (p < .001). In histopathology confirmed chronic cervicitis, CIN I, CIN II, CIN III and invasive cervical cancer, E6 test was positive for 2.8%, 4.7%, 25%, 50% and 100% respectively. E6 oncoprotein test had the highest specificity and Positive Predictive Value (PPV; 97% and 75%) compared to VIA (42% and 18%), cytology (95% and 46%) and colposcopy (94% and 59%). Sensitivity of the E6 oncoprotein test for detection of CIN3+ was significantly higher than that of cytology (52% VS 25%) but lower than that of VIA (52% VS 74%). CONCLUSIONS: The HPV E6 oncoprotein test is highly specific and is an effective triage test to reduce colposcopy referrals for the large number of false positive test outcomes seen with VIA.

Adjuvant Hysterectomy in Patients With Residual Disease After Radiation for Locally Advanced Cervical Cancer: A Prospective Longitudinal Study.

PURPOSE: The aim of the study was to evaluate the efficacy of hysterectomy in the control of pelvic disease in patients with post-irradiated residual cervical cancer. PATIENTS AND METHODS: Forty patients were treated at either National Institute of Cancer Research and Hospital (NICRH) or Delta Cancer Hospital in Dhaka, Bangladesh, with International Federation of Gynecology and Obstetrics stage IIB to IIIB disease with residual disease after the following: either concurrent chemoradiation with or without brachytherapy, induction chemotherapy and external-beam radiotherapy (EBRT) with or without brachytherapy, or only EBRT. Patients were treated by either radical hysterectomy or extrafascial hysterectomy. RESULTS: From 2009 to June 2013, 55 patients were evaluated for central residual disease on their presentations to NICRH or Delta Hospital. Patients with distant recurrences after primary radiation were excluded. Forty patients had invasive cancer on biopsy and underwent either radical hysterectomy or extrafascial hysterectomy. Surgery was performed 14 to 18 weeks after the initial treatment. Of the 29 women who underwent extrafascial hysterectomy, four (13.8%) developed recurrent disease, and one died; none of the 11 patients treated by radical hysterectomy experienced recurrences during the study period. Morbidity was increased in patients who underwent radical hysterectomy. Overall 90% of patients (36 of 40 patients) who underwent surgery had no evidence of disease at 5 years of follow-up. CONCLUSION: Surgery is a viable treatment option for patients with residual cervical cancer after radiation. Radical hysterectomy after radiation is more morbid but has better tumor control than extrafascial hysterectomy.