Midline involvement as a risk factor for vulvar cancer recurrence.

OBJECTIVE: This observational study was to identify risk factors for vulvar cancer recurrence. MATERIALS AND METHODS: In the study 107 patients with primary vulvar cancer were analyzed. Surgical treatment consisted of radical excision of the primary tumor in combination with unilateral or bilateral superficial and deep inguinofemoral lymphadenectomy through separate incisions. Patients with deeper tumor invasion >1 mm or wider than 2 cm and/or groin lymphnode metastases were referred for adjuvant radiotherapy. Those with large primary vulvar tumors received neoadjuvant radiotherapy of 30 Gy followed by surgical treatment and adjuvant radiotherapy. RESULTS: Most of patients had only primary radiotherapy to the vulva and inguinal lymph nodes and only 34.5% of patients were eligible for surgical treatment. In 5 year follow-up period 25.2% (27) patients were alive without the disease, 15.0% (16) were alive with the disease and 59.8% (64) were dead. 60.7% (65) patients experienced local recurrence and 2.8% (3) patients had distant metastases. Median survival for patients without recurrent disease was 38.9 ± 3.2 months and 36.0 ± 2.6 months with no statistically significant difference. Patients with early stage vulvar cancer had longer mean survival rates-for stage I 53.1 ± 3.4 months, 38.4 ± 4.4 months for stage II and 33.4 ± 2.6 and 15.6 ± 5.2 months for patients with stage III and stage IV vulvar cancer, respectively. The only significant prognostic factor predicting vulvar cancer recurrence was involvement of the midline. CONCLUSIONS: Patients having midline involvement of vulvar cancer has lower recurrence risk, probably because of receiving more aggressive treatment. There is a tendency for lower vulvar cancer recurrence risk for patients over 70 years of age and patients who are receiving radiotherapy as an only treatment without surgery, but tendency for higher risk of recurrence in patients with multifocal vulvar cancer.

Urinary concentrations of human epidydimis secretory protein 4 (He4) in the diagnosis of ovarian cancer: a case--control study.

OBJECTIVE: To analyze differential diagnostic accuracy of urinary human epidydimis secretory protein 4 (HE4) in patients with ovarian tumors. MATERIALS AND METHODS: In the case-control study 23 patients with ovarian cancer, 37 patients with benign ovarian tumors and 18 women in the control group were included. Serum CA125 values and urinary concentrations of HE4were assessed quantitatively. Urinary creatinine concentrations and glomerular filtration rate were also determined and used to calculate ratios to HE4. RESULTS: Higher urinary HE4 concentrations were observed in patients with late stage ovarian cancer (p=0.001) and also in patients with early stage ovarian cancer when compared to patients with benign ovarian tumors (p=0.044). On analysis where all ovarian cancer patients were included, higher diagnostic accuracy was observed with calculated ratio of HE4 to glomerular filtration rate (GFR) to unchanged urinary HE4 concentrations -AUC 0.861 vs. 0.858. When discriminatory accuracy was calculated for urinary HE4/GFR ratio and unchanged urinary HE4 concentrations, the last demonstrated a higher area under the curve - 0.701 vs. 0.602. The urinary HE4/creatinine ratio had lower discriminatory characteristics than unchanged concentrations of urinary HE4. However, HE4 serum concentration was more accurate for discrimination of patients with benign and malignant ovarian tumors when compared to urinary HE4 and CA125 in sera (AUCs were 0.868 for serum HE4 and 0.856 and 0.653 for urinary HE4 and CA125, respectively). CONCLUSIONS: Ovarian cancer patients have higher urinary concentrations of human epidydimis secretory protein 4 than patients with benign ovarian tumors. Urinary HE4 has comparable discriminatory accuracy with serum HE4 for benign and malignant ovarian tumors and can be recommended as a non-invasive ovarian cancer risk assessment method.

An ovarian cancer malignancy risk index composed of HE4, CA125, ultrasonographic score, and menopausal status: use in differentiation of ovarian cancers and benign lesions.

A case-control study included 83 ovarian cancer patients, 76 patients with benign ovarian tumors, and 79 healthy control subjects in the control group. Objective of the study is to analyze biomarker concentrations included in the two novel ovarian tumor differential diagnostic tests (risk of ovarian malignancy algorithm and OVA1) approved by food and drug administration in patients with ovarian tumors and to establish a new ovarian cancer risk assessment algorithm in conjunction with ultrasound score and menopausal status. Ovarian cancer diagnostic tests, developed in the training setting, were evaluated in the independent validation settings of Asian Pacific ovarian cancer biomarker research group study population and Denmark Pelvic Mass project population. Results show that mean serum concentrations of cancer antigen 125 (CA125), human epididymis secretory protein 4 (HE4), and beta-2-microglobulin were upregulated, but apolipoprotein A1, transferrin, and transthyretin were downregulated among ovarian cancer patients. When only one biomarker was introduced in the logistic regression analysis, together with ultrasonographic score and menopausal status, HE4 (area under the curve (AUC) = 0.930; 95 % confidence interval (CI) 0.891-0.969) was more accurate than CA125 (AUC = 0.902; 95 % CI 0.855-0.949) in ovarian cancer diagnostic, but when both biomarkers were included in the logistic regression analyses, ovarian cancer diagnostic accuracy was increased (AUC = 0.939; 95 % CI 0.902-0.977). In conclusions, human epididymis secretory protein 4 and CA125 in combination with ultrasonographic features and menopausal status has high accuracy in ovarian tumor differentiation.