Paclitaxel/carboplatin versus topotecan/paclitaxel/carboplatin in patients with FIGO suboptimally resected stage III-IV epithelial ovarian cancer a multicenter, randomized study.

OBJECTIVE: The objective of this prospective randomized phase III trial was to compare paclitaxel plus carboplatin (PC) versus topotecan plus carboplatin and paclitaxel (TPC) in women with suboptimal stage III (residual tumour >1cm) or stage IV ovarian cancer to evaluate the survival rate and toxicities. METHODS: Eligible for the study were patients aged at least 18 years old with histological/cytological diagnosis of FIGO stages III (residual tumour ≥1 cm after primary surgery)--IV epithelial ovarian cancer. Patients were randomized to iv PC on day 1, every 21 days or iv topotecan daily for three days and PC on day 3, every 21 days. RESULTS: The intention to treat population was made of 326 patients in total, 170 in the PC group and 156 in the TPC group. The life table estimates of survival probabilities at one, three and five years were, respectively, 0.94 (95% CI: 0.88-0.97), 0.53 (95% CI: 0.44-0.62) and 0.32 (95%CI: 0.23-0.42) in the PC group, and 0.92 (95% CI: 0.86-0.95), 0.52 (95% CI: 0.42-0.61), and 0.32(95%CI: 0.22-0.43) in the TPC group (log-rank test at 5 years: ns). The results of the survival analysis based on Cox regression model showed no statistically significant differences between groups (p-value: ns). The number of subjects with at least one event with possible relationship to study medication was 151 (88.8%) in the PC group and 139 (89.1%) in the TPC group (p=ns). In the PC group, 79 patients (23.6%) experienced at least one Adverse Event (AE) graded as severe and 16 patients (4.8%) at least one life-threatening AE, whilst in the TPC group, the number of patients who presented at least one severe or life-threatening AE was 86 (24%) and 37 (10.3%), respectively. CONCLUSION: The results of the present study show that the addition of topotecan to a standard paclitaxel/carboplatin regimen in the treatment of advanced epithelial ovarian cancer did not result in significant advantages in terms of survival rate. A slightly worse toxicity profile for TPC was observed.

Serum cholesterol levels and mood symptoms in the postpartum period.

During pregnancy, the total serum cholesterol concentration rises up to 43%, followed by a rapid fall after delivery. Mild depressive symptoms ('postpartum blues') are a common complication of the puerperium and affect 30-85% of women in the early postpartum period. Based on these observations, it has been suggested that the sudden fall in cholesterol levels after delivery could serve as a 'natural model' to test the suggested association between cholesterol and mood. The present study was designed to expand the database concerning the association between cholesterol levels and mood in the postpartum period and to address some methodological problems raised by previous studies. Forty-seven healthy primiparous women were interviewed with a structured clinical interview on two occasions: during late pregnancy (median: day -20 before the expected delivery) and during the early postpartum period (median: day 32 after delivery). On both occasions, serum concentrations of total and HDL cholesterol were measured and mood symptoms were assessed with the state form of Spielberger's State-Trait Anxiety Index (STAI), the state form of the State-Trait Anger Scale (STAS), and the Beck Depression Inventory (BDI). We found significant, albeit moderate, relationships between serum cholesterol levels and mood symptoms in the postpartum period that were not present during late pregnancy. Lower postpartum levels of total cholesterol were associated with symptoms of anxiety (r=-0.30, P=0.04), anger/hostility (r=-0.31, P=0.04), and depression (r=-0.35, P=0.02), and lower postpartum levels of HDL cholesterol were associated with symptoms of anxiety (r=-0.34, P=0.02). This study confirms that the physiological fall in blood lipids in the postpartum period can be a useful model to test the relationship between serum cholesterol levels and mood.