Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study (2021)

Type of publication:
Randomised controlled trial

Author(s):
Jason Yap, Daniel Slade, Harriet Goddard, Christopher Dawson, Raji Ganesan, Shireen Velangi, *Banchhita Sahu, Baljit Kaur, Ana Hughes, David Luesley

Citation:
BJOG 2021 May;128(6):1047-1055

Abstract:
Objective To compare the safety and efficacy of Veregen® ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). Design A Phase II randomised control trial. Setting A tertiary gynaecological oncology referral center. Population All women diagnosed with primary and recurrence uVIN. Methods Eligible patients were randomised to receive either Veregen® or placebo ointment (applied 3 times daily for 16 weeks), and were followed up at 2, 4, 8, 16, 32 and 52 weeks. Main outcome measures Outcome measures, recorded at 16 and 32 weeks, were histological (HR) and clinical (CR) response (as measured by ≥30% reduction in the sum of the longest diameter of all lesions when compared to baseline), toxicity and changes in quality of life and pain scores. Results 26 patients were randomised and all 13 patients who received Veregen® showed either complete (n=5) or partial (n=8) CR with a trend towards an improvement in baseline symptoms. In placebo group, 3 patients had complete CR, 2 had partial CR and 6 had stable disease. Patients in the Veregen® group showed a significant improvement in CR as compared to the placebo group (P=0.0026). There was no evidence of difference in HR and toxicity reported in both groups. Conclusion Our study indicates that Veregen application is safe and leads to at least a partial clinical resolution of uVIN lesions and symptoms improvement, thus warranting a phase III multi-centre RCT.

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Perivascular epitheloid cell tumor and mesonephric adenocarcinoma of the uterine cervix: an unknown co-existence (2019)

Type of publication:
Journal article

Author(s):
*Dimitrios Papoutsis, *Banchhita Sahu, *Joanna Kelly, Angeliki Antonakou

Citation:
Oxford Medical Case Reports, Volume 2019, Issue 1, January 2019

Abstract:
A 67-year-old woman with post-menopausal bleeding and a suspicious endocervical mass was referred to gynaecology outpatients’ for diagnosis and management. Cervical punch biopsies taken showed a benign cervical perivascular epithelioid cell tumour (PEComa), with MRI imaging and PET-CT scan indicating a 3–4 cm endocervical tumour with malignant features. The patient underwent radical hysterectomy with lymph node dissection and the surgical specimen histopathology demonstrated a residual benign PEComa and a stage IIB mesonephric adenocarcinoma (MNA) of the cervix. There is no disease recurrence 12 months after surgery. Cervical PEComas are extremely rare tumours of mesenchymal origin deriving from the perivascular epithelioid cells with only 14 cases described so far. Cervical MNAs are rare tumours originating from the remnants of the mesonephric duct of Wolff with only 40 cases reported. Our case adds to the existing literature and highlights the challenges with regard to preoperative diagnosis, treatment and prognosis.

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Risk factors for treatment failure following cold coagulation cervical treatment for CIN pathology: a cohort-based study (2015)

Type of publication:
Journal article

Author(s):
*Papoutsis D., *Underwood M ., *Parry-Smith W., *Panikkar J.

Citation:
Archives of Gynecology and Obstetrics, May 2015, vol./is. 292/6(1329-1337)

Abstract:
Purpose: To determine any risk factors for cytology recurrence in women after cold coagulation ablative treatment for cervical intraepithelial neoplasia (CIN). Methods: This was a retrospective observational study of a cohort of women having had cold coagulation between 2001 and 2011 in the colposcopy unit of an NHS hospital. We retrospectively collected data from our colposcopy unit database. Women with previous cervical treatment were excluded. Results: 559 eligible women we re identified with a mean age of 28.7 +/- 6.2 years. Nulliparous women were 66.3 % with smokers involving 35.3 %. Referral cytology, pretreatment cervical punch biopsies and colposcopy were high grade in 51.9, 71.9 and 45.8 % of women. Endocervical crypt involvement (ECI) on pretreatment cervical punch biopsy involved 9.7 % of women. Mean follow-up was 3.1 +/- 2.4 years. Overall cytology recurrence (mild/moderate/severe dyskaryosis) at 6 and 12 months follow-up was 7.4 and 5 %. High-grade cytology recurrence (moderate/severe dyskaryosis) involved 2.7 % of women over the entire follow-up period . Multiple regression analysis showed that ECI on pretreatment cervical pun ch biopsy was a risk factor for high-grade cytology recurrence (HR 3.72; 95 %CI 1.18-11.71; p = 0.024). There were no risk factors identified for overall cytology recurrence. However, when cytology tests with borderline nuclear changes at follow-up were pooled with mild/moderate/severe dyskaryosis cytology tests, then parity >2 was a risk factor for abnormal cytology (HR 1.71; 95 %CI 1.08-2.69; p = 0.022). Conclusions: Endocervical crypt involvement on pretreatment cervical punch biopsy and multiparity >2 are risk factors that increase the likelihood of abnormal cytology following cold coagulation. These two risk factors should be taken in consideration when performing cold coagulation cervical treatment for CIN pathology.