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Background: Mucin 1 antigen, highly expressed by epithelial ovarian cancer (EOC), is a potential target for immunotherapy. A previous successful phase 1 trial was conducted in patients with adenocarcinoma who were injected with Cvac, autologous monocyte-derived dendritic cells (DCs) incubated with mannosylated mucin 1 protein (M-FP). The present study was a phase 2 trial of Cvac in patients with advanced EOC. Method(s): Eligible patients had EOC with progressive disease, defined as an increase in CA125 of >= 25% in 1 month. The primary endpoint was CA125 response or stabilization. Peripheral blood mononuclear cells were collected by leukapheresis and cultured to generate DCs. The DC were incubated with M-FP, and after washing were prepared for injection into the patient intradermally every 4 weeks for 3 doses, then every 10 weeks for up to 12 months. Result(s): All 28 patients recruited were evaluable for safety and 26 for efficacy. All had undergone surgery and platinum-based chemotherapy, and 57% of patients received >= 3 chemotherapy regimens. There were no Grade 3 or 4 toxicities considered related to Cvac. Four patients showed CA125 response or stabilization (2 patients with major responses, 1 minor response, 1 stabilization) of median duration 10.3 months (5.3-16.3 months). An additional patient had > 25% CA125 reduction (not confirmed). Conclusion(s): Cvac immunotherapy was well tolerated. Clinical activity in EOC was evident based on decline or stabilization of CA125 in some patients, supporting ongoing development of Cvac in ovarian carcinoma and planning of additional trials of patients in remission is currently underway.Copyright © 2014 Mitchell et al.; licensee BioMed Central Ltd.

Background: Gynaecological cancers of several pathological subtypes express estrogen and/or progesterone hormone receptors (ER/PR). Previous studies, [all or mostly] retrospective, have reported variable rates of tumour response and clinical benefit. Prospective studies are needed to determine the activity of aromatase inhibitors in women with potentially hormone responsive recurrent gynaecological cancers, and to determine possible predictors of response. Method(s): PARAGON is a Gynecologic Cancer InterGroup phase 2 trial lead by the Australia New Zealand Gynaecological Oncology Group and NHMRC Clinical Trials Centre, in collaboration with Cancer Research UK and the Belgian Gynaecological Oncology Group. The study is designed to facilitate research in rare tumours. The protocol enrols postmenopausal women with recurrent gynaecological cancers of 7 different subtypes: epithelial ovarian cancer (EOC) with only rising CA125 after first line chemotherapy; platinum resistant/refractory EOC; low grade EOC; endometrial carcinomas; endometrial stromal sarcomas; miscellaneous sarcomas; and, granulosa cell and other sex cord stromal tumours. ER/PR positivity must be demonstrated by immunohistochemistry. Each subgroup will enrol 25-50 patients with defined stopping rules based on response and reviewed by an independent data monitoring committee (IDMC). Study treatment is anastrozole 1 mg daily until disease progression or unacceptable toxicity. The primary endpoint is clinical benefit (complete response, partial response, or stable disease at x months). Secondary endpoints include progression free survival, response duration, aspects of QoL, toxicity. Blood and tumour samples are being collected for translational studies and confirmation of ER/PR positivity. Recruitment commenced in 2011 in Australia, New Zealand and the United Kingdom. 236 of 350 planned patients have been enrolled to February 2014. Accrual to the platinum resistant/refractory subgroup closed on 9 December 2

Mucin 1 (MUC1) is highly expressed as a cancer-related protein variant by ovarian carcinoma and is thus a potential antigen for immunotherapy. In this phase II trial of CVac, patients received autologous dendritic cells (DC) pulsed with mannan-MUC1 fusion protein (MFP). Eligible patients had incurable disease and rising CA125 levels (>=25% in 1 mth, confirmed). The primary endpoint was CA125 response (major >=50%, minor >=25%) or stabilisation (>=3 mths). PBMC were collected by leukapheresis, cultured with IL-4 and GM-CSF to generate DC, and pulsed with MFP on d5. DC were reinjected 4-weekly x 3, then 10-weekly to 12 mths. Result(s): 28 patients recruited (26 evaluable; 21 evaluable for efficacy (received >=3 vaccinations). Characteristics: serous histology 22 (85%) patients; median age 58yrs; >=3 lines systemic therapy 15 pts (57%). Following ex vivo culture, the mean viable DC recovery was 19+/-2x107. There was no grade >=3 therapy-related toxicity. Of 21 patients, 4 (19%) showed CA125 response or stabilisation (duration 5.3-16.4 months) with 2 major and 1 minor response, and 1 stable disease. Two of these patients had received >=3 chemotherapy regimens. An additional patient had an unconfirmed minor response. CT scan results were generally concordant with CA125 status. Conclusion(s): Study treatment was well tolerated. In this mostly heavily pre-treated group of patients with progression, some showed clear evidence of CA125 response or stabilisation. A multi-centre randomised phase II trial of CVac in patients with ovarian carcinoma is currently recruiting and a phase III trial is planned for 2011.

1 december 2011, Item does not contain fulltext, BACKGROUND: There is a growing interest to apply the sentinel node (SN) procedure in the treatment of vulvar cancer. Previous vulvar surgery might disrupt lymphatic patterns and thereby decrease SN detection rates, lengthen scintigraphic appearance time (SAT), and increase SN false-negative rate. The aims of this study were to evaluate the SN detection rates at the Mercy Hospital for Women in Melbourne and to investigate whether previous vulvar surgery affects SN detection rates, SAT, and SN false-negative rate. METHODS: Data on all patients with vulvar cancer who underwent an SN procedure (blue dye, technetium, or combined technique) from November 2000 to July 2010 were retrospectively collected. RESULTS: Sixty-five SN procedures were performed. Overall detection rate was 94% per person and 80% per groin. Detection rates in the group of patients who underwent previous excision of the primary tumor were not lower compared with the group without previous surgery or with just an incisional biopsy. There was no statistical significant difference in SAT between the previous excision group and the other patients. None of the patients with a false-negative SN had undergone previous excision. CONCLUSIONS: Results indicate that previous excision of a primary vulvar malignancy does not decrease SN detection rates or increase SN false-negative rate. Therefore, the SN procedure appears to be a reliable technique in patients who have previously undergone vulvar surgery. Previous excision did not significantly lengthen SAT, but the sample size in this subgroup analysis was small.