Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study.

BACKGROUND: Improvement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence. METHODS/DESIGN: Multicentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat. DISCUSSION: Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer.

Seroprevalence and placental transportation of maternal antibodies specific for Neisseria meningitidis serogroup C, Haemophilus influenzae type B, diphtheria, tetanus, and pertussis.

BACKGROUND: Maternal antibodies contribute to the protection of neonates from infectious diseases during the first months of life. The seroprevalence of antibodies specific for polysaccharide or protein antigens from vaccine-preventable pathogens was determined in paired maternal delivery and cord blood serum samples. METHODS: Antibody concentrations specific for Neisseria meningitidis serogroup C polysaccharide, Haemophilus influenzae type B polysaccharide, diphtheria toxin, tetanus toxin, and pertussis toxin, filamentous hemagglutinin, and pertactin from Bordetella pertussis were determined by enzyme-linked inmmunosorbent assay (ELISA), fluorescent multiplex immunoassay, or serum bactericidal assay. RESULTS: We investigated 197 paired maternal delivery and cord blood samples. The mean maternal age was 30.8 years, and the mean gestational age was 39.3 weeks. Cord geometric mean concentrations (GMCs) were 0.23 microg/mL for N. meningitidis serogroup C and 0.53 microg/mL for H. influenzae type B. Cord GMCs to diphtheria and tetanus were 0.16 and 1.06 IU/mL, respectively, and cord GMCs to pertussis toxin, filamentous hemagglutinin, and pertactin were 16.2, 34.8, and 17.7 ELISA U/mL (by ELISA), respectively. Cord GMCs to polysaccharide were, in general, 107% identical to maternal GMCs, whereas cord GMCs to proteins were a mean of 157% of maternal concentrations. In addition, the levels of anti-N. meningitidis serogroup C immunoglobulin G1 and G2 in cord blood were 145% and 109% of maternal concentrations, respectively. CONCLUSIONS: Antibody concentrations directed toward polysaccharide were equal in maternal and cord blood, whereas antibody concentrations to proteins were 1.6 times higher in cord blood than in maternal blood. This is probably attributable to the less-active transportation of immunoglobulin G2 antibodies elicited by polysaccharide. Despite proper placental transfer, cord antibody concentrations are low, possibly placing neonates at risk before they receive their primary vaccinations. CLINICAL TRIALS REGISTRATION: ISRCTN14204141 .