Purpose: Malignant ascites in ovarian carcinoma patients is associated with poor prognosis and reduced quality of life. The trifunctional antibody catumaxomab (anti-EpCAM × anti-CD3) enhances the antitumor activity by redirecting T cells and Fcγ receptor I/III–positive accessory cells to the tumor. This multicenter phase I/II dose-escalating study investigated tolerability and efficacy of i.p. catumaxomab application in ovarian cancer patients with malignant ascites containing epithelial cell adhesion molecule (EpCAM)–positive tumor cells. Experimental Design: Twenty-three women with recurrent ascites due to pretreated refractory ovarian cancer were treated with four to five i.p. infusions of catumaxomab in doses of 5 to 200 μg within 9 to 13 days. Results: The maximum tolerated dose was defined at 10, 20, 50, 200, and 200 μg for the first through fifth doses. Side effects included transient fever (83%), nausea (61%), and vomiting (57%), mostly CTCAE (Common Terminology Criteria for Adverse Events) grade 1 or 2. A total of 39 grade 3 and 2 grade 4 treatment-related adverse events (AE), 9 of them after the highest dose level (200 μg), were observed in 16 patients. Most AEs were reversible without sequelae. Treatment with catumaxomab resulted in significant and sustained reduction of ascites flow rate. A total of 22/23 patients did not require paracentesis between the last infusion and the end of study at day 37. Tumor cell monitoring revealed a reduction of EpCAM-positive malignant cells in ascites by up to 5 log. Conclusion: I.p. immunotherapy with catumaxomab prevented the accumulation of ascites and efficiently eliminated tumor cells with an acceptable safety profile. This suggests that catumaxomab is a promising treatment option in ovarian cancer patients with malignant ascites.

Objective: The aim of our study was the evaluation of sonographic fetal weight estimation taking into consideration 9 of the most important factors of influence on the precision of the estimation. Methods: We analyzed 820 singleton pregnancies from 22 to 42 weeks of gestational age. We evaluated 9 different factors that potentially influence the precision of sonographic weight estimation (time interval between estimation and delivery, experts vs. less experienced investigator, fetal gender, gestational age, fetal weight, maternal BMI, amniotic fluid index, presentation of the fetus, location of the placenta). Finally, we compared the results of the fetal weight estimation of the fetuses with poor scanning conditions to those presenting good scanning conditions. Results: Of the 9 evaluated factors that may influence accuracy of fetal weight estimation, only a short interval between sonographic weight estimation and delivery (0–7 vs. 8–14 days) had a statistically significant impact. Conclusion: Of all known factors of influence, only a time interval of more than 7 days between estimation and delivery had a negative impact on the estimation.

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Clinical data, demographic, diagnostic and treatment information were primarily collected from the patients' charts. Patients were seen at 3-month intervals after initial diagnosis for a 2year period, thereafter at 6-month intervals for another 2 years and then once a year to evaluate for sonographic and clinical signs of relapse. The patients' data were further reviewed for the surgical procedure performed. Radicality varying from unilateral adnexectomy, in this study referred to as fertility sparing surgery, to hysterectomy with bilateral adnexectomy, omentectomy and lymphadenectomy were recorded. Bilateral adnexectomy, hysterectomy, omentectomy, cytology, and several peritoneal biopsies were regarded as full staging. Tumor typing and staging were performed by the department of pathology according to the criteria of the International Federation of Gynaecologists and Obstetricians (FIGO) and the International Union against Cancer (IUCC).The following parameters were registered for each patient: age at primary diagnosis, menopausal stage, age at menopause, surgical procedure performed, tumor type and stage. Also, the presence of BOT cells in ascites was recorded. In follow-up, the occurrence of relapse, time to relapse, death and survival time were registered. The main outcomes assessed were disease recurrence and survival.Statistical analysis was performed using MedCalc (Version 8.1; MedCalc Software, Mariakerke, Belgium). All values are given as mean and standard deviation. To test differences between continuous variables for statistical significance, the Mann-Whitney test for unpaired variables was applied. For categorical data, the chi-square test was used. For the comparison of survival times, Kaplan-Meier curves were drawn for different patient groups. The chi-square statistic of the logrank test was calculated to test differences between survival curves for significance. p values less than 0.05 were considered as statistically significant. ResultsAltogether, 113 patients could be identified, including 19 women with fertility sparing surgery. Mean follow-up time was 9.6 AE 6.6 years (minimum 6 months, maximum 23.5 years, median 7.9 years). Mean age at primary diagnosis was 51.2 AE 16.6 years; altogether 36 women (32%, 36/113) were under the age of 40. About half of the patients were premenopausal (56/113). Histology revealed a serous tumor in 73 women (64.6%), mucinous in 39 (34.5%) and endometrioid in one case (0.9%). 63 patients (55.8%) were diagnosed at FIGO stage Ia, 13 (11.5%) at stage Ib, 18 (15.9%) at stage Ic, 7 (6.3%) at stage II and 12 (10.6%) at stage III (Table 1). Cytology was positive for tumor cells in five cases (4.4%, 5/113). Implants were found in 19 patients: 11 were invasive (57.9%) and 8 non-invasive implants (42.1%). Localization of implants was the omentum (42.1%), the peritoneum (31.6%), diaphragm (10.5%) and bladder (10.5%). The mesosalpinx, uterus, umbilicus and kidney were affected in less than 10%.An adjuvant platinum-based chemotherapy was recommended to 11 patients diagnosed wi...

We present a rare case of giant fibroadenoma in pregnant young women. Because of the progressive structural damage of the breast immediate surgical enucleation was indicated. Safety of the fetus was provided by perioperative monitoring. The pre-operative differentiation from phyllodes tumor is still challenging.