Luigi Selvaggi

A prospective study in 132 women undergoing in vitro fertilization was performed in order to assess whether lower doses of gonadotropin releasing hormone agonists (GnRH-a) may ensure adequate oocyte retrieval and pregnancy rate, without pituitary oversuppression. Forty-five patients received subcutaneous tryptorelin depot (Decapeptyl 3.75, IPSEN SpA), 41 received subcutaneous tryptorelin acetate daily (Decapeptyl 0.1 mg, IPSEN SpA) and 46 received 0.05 mg tryptorelin acetate daily from day 21 of the cycle. From day 3 of the new cycle, if the estradiol levels were < 30 pg/ml, patients received two or three ampules of gonadotropin daily. In the group receiving subcutaneous tryptorelin acetate depot, the mean number of total gonadotropin ampules was significantly higher (p < 0.05), otherwise estradiol levels and the number of oocytes retrieved, fertilized and cleaved were significantly lower (p < 0.05). Pituitary oversuppression induced by GnRH-a causes an increase in the gonadotropin requirement for assisted reproductive techniques (ART) and a reduction in the number of oocytes retrieved and fertilized. There is a high risk of oversuppression in normal-weight or underweight women, because there is greater bioavailability of the peptide, hence elevated circulating levels of GnRH-a. Thus, ovarian stimulation in ART cycles depends on many factors, not least the identification of the best GnRH-a dose.

Ehlers-Danlos syndrome is a heterogeneous group of diseases, where connective tissue laxity is the main feature. Several pregnancy and delivery complications, mainly related to vascular and uterine rupture or to soft tissue tears, are described. A case of a full term pregnancy is reported and the clinical value of obstetrical management is discussed.

A quantitative study of the circulating immune complexes (IC) was carried out on women during normal pregnancy (286) and the post-partum period (20) and women with pre-eclampsia (30). Furthermore, the behaviour of the complement (C) system was followed. Results showed that IC were low in the first trimester of normal pregnancy (25.3%) and decreased in the following trimesters, whereas they were always present in pre-eclampsia. A very significant difference (p less than 0.0001) was seen when we compared the incidence of IC in normal pregnancy at the third trimester and the pre-eclamptic patients. The follow-up study of the IC, carried out on 4 pre-eclamptic women, showed an increase in the IC levels associated with the exacerbation of the pre-eclamptic picture and a decrease after delivery. The study of complement in normal pregnancy showed a decrease in C1-INH, C1s and C1q, whereas C3, C5, C9 and the properdin factor B increased during the following weeks of gestation; CH50 did not vary excepting during the 1st trimester. In the puerperium all values increased. There was no significant difference between the serum levels of the C components in the 3rd trimester of normal pregnancy and pre-eclampsia. High levels of C3d were observed in normal pregnancy at the 3rd trimester and in pre-eclampsia. The study of this split product of C3 showed that there is activation of the C system, but, since the synthesis of the C components is increased, activation could be masked. Alloantibodies and circulating IC could be the factors responsible for this activation in normal pregnancy and in pre-eclampsia, respectively.

The aim of our study was to clarify the question, to what extent the anxiety of the gravida during gestation is capable to influence the fetal condition.--For that reason, besides of a statistical analysis of a standardized interview the basal heart frequency and the reaction in a non-stress CTG over 20 min has been examined. The data of 101 women between the 36th and 42nd week of gestation were included. The age of our patients ranged from 20 to 30 years.--For assessment of the degree of anxiety we used the STAI X-1 test (questionnaire for self-assessment of anxiety as condition and characteristically personal property, resp.). Cases of pathologic gestation were excluded by history and a carefully clinical examination. No significant correlations between the level of anxiety and fetal condition could be demonstrated. We detected only a slight tendency of decreasing heart-rate variability and increasing frequency of accelerations in the CTG, as well as an increase of active fetal movements with a raising maternal level of anxiety.

Sonographic and postmortem findings of left visceral isomerism associated with polysplenia are reviewed. Particular stress is given to pathologic data, which could prospectively suggest some specific ultrasonic features in order to characterize this complex syndrome.

We examined mononuclear cell subsets in cord blood of normal newborns by surface marker analysis. The percentages of T lymphocytes (E-rosetting and T3+ cells) were lower in cord blood than in peripheral blood (PB) from adults, while the percentage and absolute number of T6+ cells were higher in cord blood. As the sum of T4+ and T8+ cells exceeded the values of E-rosetting lymphocytes in cord blood, we suggest that immature lymphocytes with the phenotype of 'common' thymocytes (T6+, T4+, T8+) are present in cord blood of full-term newborns. Higher percentage and absolute number of B lymphocytes were detected in cord blood. More than 50% of B cells in cord blood formed rosettes with mouse erythrocytes, a surface marker of functional immaturity. Finally, cells bearing receptors for IgG-Fc fragments or C3 and expressing Ia-like and M1 antigens were uniformly increased in cord blood, suggesting higher percentages of cells of the monocytic lineage.

We report the case of an unsuspected G.I. cancer in a patient with no clinical signs other than ascites and positive PAP-smear on admission. Histologically, neither endometrium nor cervix were involved. To date, only 2 cases of primary gastrointestinal (gastric) cancers with no metastases to the cervix, suspected by PAP-smear, have been reported in medical literature. A few more have been reported with cervical metastases. The suspicion of intraabdominal adenocarcinoma was based on the evidence of signet ring cells found in the smear with negative cervical biopsies and negative fractional curettage. A postmortem examination confirmed the absence of genital involvement. Our aim is to remind the clinician that an abnormal PAP-smear, due to non gynecological malignancies, can, on rare occasions, be observed. In order to obtain a positive cervico-vaginal PAP-smear by a non gynecologic intraabdominal exfoliating cancer, both previous literature and our case suggest peritoneal effusion to be of major importance.

Central nervous system (CNS) involvement is considered an uncommon complication in patients with ovarian carcinoma. The aim of this study was to evaluate prognostic factors for survival following surgical resection of brain metastases in patients with ovarian carcinoma. A retrospective chart review was conducted on 22 patients who had been submitted to neurosurgical resection of a solitary brain metastasis from ovarian carcinoma. Eighteen lesions were cerebral, 4 were cerebellar. CNS was the only site of disease in 9 patients, 9 patients had CNS and abdominopelvic disease, and 4 also had concomitant extraperitoneal dissemination. Following surgery, 17 received whole-brain radiotherapy and 5 received systemic chemotherapy. Median survival from diagnosis of cerebral metastasis for the entire series was 16 months (range, 4-41 months). Extracranial disease at the time of CNS metastasis and time interval between diagnosis of ovarian cancer and CNS involvement manifestation were the only factors significantly affecting survival. Neurosurgical resection of brain metastasis from ovarian carcinoma is indicated in solitary lesions in the absence of systemic disease. The role of chemotherapy and stereotactic radiosurgery should be investigated.

Central nervous system (CNS) involvement is considered an uncommon complication in patients with ovarian carcinoma. The aim of this study was to evaluate prognostic factors for survival following surgical resection of brain metastases in patients with ovarian carcinoma. A retrospective chart review was conducted on 22 patients who had been submitted to neurosurgical resection of a solitary brain metastasis from ovarian carcinoma. Eighteen lesions were cerebral, 4 were cerebellar. CNS was the only site of disease in 9 patients, 9 patients had CNS and abdominopelvic disease, and 4 also had concomitant extraperitoneal dissemination. Following surgery, 17 received whole-brain radiotherapy and 5 received systemic chemotherapy. Median survival from diagnosis of cerebral metastasis for the entire series was 16 months (range, 4-41 months). Extracranial disease at the time of CNS metastasis and time interval between diagnosis of ovarian cancer and CNS involvement manifestation were the only factors significantly affecting survival. Neurosurgical resection of brain metastasis from ovarian carcinoma is indicated in solitary lesions in the absence of systemic disease. The role of chemotherapy and stereotactic radiosurgery should be investigated.

Central nervous system (CNS) involvement is considered an uncommon complication in patients with ovarian carcinoma. The aim of this study was to evaluate prognostic factors for survival following surgical resection of brain metastases in patients with ovarian carcinoma. A retrospective chart review was conducted on 22 patients who had been submitted to neurosurgical resection of a solitary brain metastasis from ovarian carcinoma. Eighteen lesions were cerebral, 4 were cerebellar. CNS was the only site of disease in 9 patients, 9 patients had CNS and abdominopelvic disease, and 4 also had concomitant extraperitoneal dissemination. Following surgery, 17 received whole-brain radiotherapy and 5 received systemic chemotherapy. Median survival from diagnosis of cerebral metastasis for the entire series was 16 months (range, 4-41 months). Extracranial disease at the time of CNS metastasis and time interval between diagnosis of ovarian cancer and CNS involvement manifestation were the only factors significantly affecting survival. Neurosurgical resection of brain metastasis from ovarian carcinoma is indicated in solitary lesions in the absence of systemic disease. The role of chemotherapy and stereotactic radiosurgery should be investigated.

Reliability of hysteroscopy in diagnosing endometrial hyperplasia in women with abnormal uterine bleeding. Out of 105 patients with abnormal uterine bleeding 47 showed structural abnormalities. Comparative analysis between hysteroscopic and histological results in 58 women without gross abnormalities has been performed in order to verify sensitivity and specificity of hysteroscopy in the diagnosis of endometrial hyperplasia. Specificity of hysteroscopy in diagnosing endometrial hyperplasia was 84.7% while sensitivity resulted to be 80%. Women with abnormal uterine bleeding and normal uterine cavity has a low rate (3.4%) of false negative endometrial hyperplasia. On the contrary findings of endometrial hyperplasia at hysteroscopy has a high incidence of false positive (25.8%). In conclusion, abnormal uterine bleeding could cause an increased thickness in endometrium, appearing as hyperplasia on hysteroscopic examination.

There is increasing evidence that autoimmune phenomena, including auto-antibody production, may affect fertility in women with endometriosis. The aims of this study are to evaluate anti-laminin-1 antibody (aLN-1) presence in sera and in follicular fluids (FF) of women with endometriosis undergoing IVF and its impact on oocyte maturation and IVF outcome. aLN-1 were measured by a home-made enzyme linked immunosorbent assay in sera and FF obtained from 35 infertile women with endometriosis and in sera from 50 fertile controls and 27 infertile women without endometriosis (IWWE). aLN-1 serum levels were significantly higher in women with endometriosis in comparison with both fertile controls and IWWE (P<0.001 and P<0.05, respectively) and a positive correlation was found between serum- and FF-aLN-1 (r=0.47, P=0.004). According to the cut-off (mean+3 SD of fertile controls), 31% of women with endometriosis were aLN-1 positive. Metaphase II oocyte counts showed inverse correlation wi...

To assess the learning curve associated with tele-assisted surgery. We performed a training box-based study, describing speed and accuracy in volunteers performing basic and complex laparoscopic tasks, to assess performance and in the skill acquisition of inexperienced users, using the Telelap Alf X system. Ten surgeons in gynaecology who had never received formal instruction on this new surgical device, completed four modules during a consecutive 3 day training programme. All the participants completed the training programme with a good learning curve. Use of the TELELAP Alf X advanced surgical robotic system is associated with a rapid learning curve among experienced surgeons. Copyright © 2015 John Wiley & Sons, Ltd.

The insulin-like growth factors (IGFs) and their receptors are implicated in pre- and postnatal growth and development. It is believed that the alteration in their activity may contribute to intrauterine growth restriction (IUGR). The aim of this experimental study was to relate some metabolic alterations, involving insulin-like growth factor pathway, in the placenta of pregnancies complicated by intrauterine growth restriction. Placental samples were obtained from six uncomplicated pregnancies and four pregnancies complicated by IUGR. These samples were then stained by immunohistochemical technique, using monoclonal antibodies. Our data have not shown a significant difference in the IR, the Shc isoforms and Akt levels between normal and IUGR placentas. The IUGR placentas had significantly lower levels of IRS-2 expression and higher levels of p85 transcription. IGF-I receptor binds to its ligand and activates two intracellular processes mainly a Shc-mediated pro-mitotic pathway and ...

... 1 Bega G, Wapner R, Lev-Toaff A, Kuhlman K. Diagnosis of conjoined twins at 10 weeks using three-dimensional ultrasound ... Dr. Marco Scioscia Dipartimento di Scienze Chirurgiche Generali e Specialistiche Sezione A - Ostetricia e Ginecologia Policlinico di Bari Piazza Giulio ...

This prospective single-institutional clinical trial sought to assess the safety and feasibility of laparoscopic benign ovarian cyst enucleation with a novel robot-assisted laparoscopic system. In this study, we report a series of 10 cases treated using Telelap ALF-X in the first clinical application on patients at the Division of Gynaecologic Oncology, Catholic University of the Sacred Heart of Rome. The primary inclusion criterion was the presence of monolateral ovarian cyst without a preoperative assessment suspicious for malignancy. Intra-operative data such as docking time, operative time, estimated blood loss, intra and peri-operative complications, and conversion to either standard laparoscopy or laparotomy were collected. The cysts were removed using the ovary sparing technique with respect to conservative surgical principles. The median operative time was 46,3 min, and patients without post-operative complications were discharged either 1 or 2 days after the procedure. Tele...

To evaluate the safety and feasibility of the new robotic TELELAP ALF-X platform in a heterogeneous series of gynecological procedures. Between September 2013 and May 2014, 146 patients were enrolled in this Phase II study trial. Patients with presumed benign or borderline adnexal disease, and benign and early stage malignant uterine disease were prospectively included. Median age was 52 years (range 19-79 years), and median BMI was 23.7 (range 17.3-34.0 kg/m(2)). Sixty-two patients (32.5 %) underwent mono/bilateral salpingo-oophorectomy or cyst removal (Group A), four patients (2.7 %) myomectomy (Group B), 46 patients (31.5 %) total hysterectomy (Group C), and 34 (23.3 %) endometrial cancer staging (Group D). Median docking time was 7 min (range 3-36). Median OT was 35 min (range 17-145) in the Group A, 40 min (range 10-50) in the Group B, 133 min (range 58-320) in the Group C, and 160 min (range 69-290) in the Group D. Reduction in OT over the study period for hysterectomy (p <...

To evaluate the activity and toxicity of the combination of cisplatin (80 mg/m2 day 1) and vinorelbine (25 mg/m2 days 1 and 8) in patients with carcinoma of the uterine cervix that has not been previously treated with chemotherapy. Fifty patients with cervical cancer were enrolled onto this study (27 stage IB-III, 23 stage IVB-recurrent). A two-stage optimal Simon design was applied. Thirteen responders of 29 treated patients were required to proceed beyond the first stage, and 28 responders were needed overall. Hematologic toxicity was mild, with neutropenia being the most frequent side effect. Nonhematologic toxicity was frequent but never severe; one patient had grade 3 peripheral neurotoxicity. Objective responses were recorded for 32 patients (64%): 11 patients (22%) achieved a complete response (CR) and 21 patients (42%) achieved a partial response (PR). The response rate was 81.5% in patients with IB-III stage (25.9% CR rate) and 43.5% in patients with IVB-recurrent disease (...

To evaluate efficacy and safety of a neoadjuvant treatment with irinotecan and cisplatin [cis-diamminedichloroplatinum(II); CDDP] in patients with locally advanced cervical cancer. A phase 2 study was conducted at 13 centers located in Italy. Eighty-seven were enrolled between 2000 and 2003. Patients received irinotecan 175 mg/m2 on day 1 every 3 weeks followed by CDDP 80 mg/m2. Each patient was to receive 3 cycles of treatment. Tumor response was to be evaluated by magnetic resonance imaging 3 weeks after the end of the third cycle. At the end of therapy, all patients were to be examined for radical surgery. Of 71 patients included in the primary analysis, 9 (12.7%) showed a complete response; and 43 (60.6%), a partial response for an overall response rate of 73.2% (95% confidence interval [CI], 61.4%-83.1%). Complete pathological responses were observed in 13.6% of the patients (95% CI, 7.0%-23.0%). Overall survival rate at 4 years was 87.0% (95% CI, 79.5%-94.5%).There were no stu...

Polycystic ovary syndrome (PCOS) is still a complex and heterogeneous disorder that presents a challenge for clinical investigators. It is the most common endocrine and metabolic disorder of reproductive-aged women that presents with varied symptoms such as hyperinsulinemia, anovulatory dysfunction, hirsutism, obesity and elevated incidence of cardiac problems. For these reasons, this syndrome is considered by some physicians as an endocrine and for others as a metabolic syndrome. This article will focus on the disorder of the PCOS. It will be based on an understanding of the physiopathology in order to present therapeutic recommendations.

An adverse effect of leukocytospermia in seminal fluid on motility and fertilizing power of spermatozoa has been described. This detrimental effect could be mediated by radical oxygen species (ROS). Recently, a direct effect on nuclear DNA of sperm induced by ROS has been described, although the chance of fertilization did not seem altered during ICSI procedure. Aim of this prospective case-control study was to compare the outcome of results in term of fertilization rate and embryo quality in patients with and without idiopathic leukocytospermia during IVF and ICSI cycles. Seventy-two patients selected for a program of IVF and ICSI were admitted in the study. Fourty-two patients underwent IVF procedure, 14 with idiopathic leukocytospermia and 28 without, and thirty underwent ICSI procedure, 16 with leukocytospermia and 14 without leukocytospermia. Statistical significant differences on cleavage rate of embryos between leukocytospermia and control group in IVF cycles were observed. I...

Previous reports indicate depression of cellular immunity during pregnancy. In order to get a deeper insight into the immunoregulatory subsets of mononuclear cells in pregnant women, we analyzed the percentages of T and B lymphocytes, T cell subsets and cells expressing IgG-Fc and C3 receptors, and M1- and Ia-like antigens in venous blood samples from healthy women and pregnant women at different gestational ages and after delivery. Even if a trend toward a progressive decrease of T lymphocytes and T4+ helper subset was observed throughout pregnancy, along with a slight increase in the percentages of cells bearing C3 receptors, M1, and Ia-like antigens in the second trimester of gestation, analysis of variance of our data did not demonstrate statistical significance in the observed changes. Therefore we conclude that the pregnancy-induced suppression of maternal responsiveness towards alloantigens and/or mitogens is not reflected by significant changes in the distribution of circula...

Lissencephaly (agyria) is a cortical dysplasia associated with a disturbance in the migration of neocortical neurons. Because of abnormal sonographic findings in the brain of a 24-week fetus, we carried out serial magnetic resonance imaging (MRI) examinations which raised the suspicion of isolated lissencephaly. In the second trimester, an area of damage depicted as low-intensity signals was identified by MRI inside the cortical parenchyma. In the same cortical area, agyria was detected later in pregnancy, and postnatally calcification was observed by computerized tomography (CT) scan. We believe that ultrasound and targeted MRI examination can improve our understanding of some disorders of neuronal migration and that earlier diagnosis is feasible if both methods are employed and interpreted by sound criteria.

Many hormones such as insulin, insulin-like growth factors, and the glucocorticoids are involved in regulating fetal growth. Inositol phosphoglycans (IPGs), a family of putative second messengers of insulin, are reported to exert several of insulin's metabolic effects. A prospective cross-sectional study was carried out to investigate IPG P-type (P-IPG) in human amniotic fluid and in adult urine under physiological conditions. An amniotic fluid sample was taken from 78 women undergoing early amniocentesis and a mid-stream urine specimen was collected from 109 healthy pregnant and 66 non-pregnant women. All samples were assessed using a polyclonal antibody-based ELISA. The P-IPG content was a thousand times higher in the amniotic fluid than in the urine (p < 0.0001). Urinary specimens showed a four-fold higher P-IPG content during pregnancy than in healthy non-pregnant women (p < 0.001). Under physiological conditions, human amniotic fluid was found to be enriched in P-IPG compared with maternal urine, suggesting a possible fetal origin. Therefore, IPGs may play a role in insulin sensitivity and fetal growth and, perhaps, be involved in some of its abnormalities such as macrosomia and intrauterine growth restriction.

The prenatal diagnosis of Robinow's syndrome was accomplished in our case by measuring the length of the long bones and the ulna/humerus ratio. Although the prenatal sonographic appearance did not show the typical 8-week fetal face, pathological findings confirmed this particular feature. In view of the strongly suggestive family history, the authors consider the possible mechanisms of genetic inheritance.

It has been proposed that extending the platinum-free interval with intervening non-platinum therapy increases the efficacy of a later re-treatment with platinum in platinum-sensitive recurrent ovarian cancer. This hypothesis is based on data from small series and although it has not been validated prospectively, this strategy has entered general practice in Italy in the last years. The SOCRATES study retrospectively assessed the pattern of care of a cohort of patients with recurrent platinum-sensitive ovarian cancer observed in the years 2000-2002 in 37 Italian centres. Data were collected between April and September 2005. Patients with recurrent ovarian cancer with a platinum-free interval >6 months were eligible. 493 patient files were collected and 428 were eligible and analyzed. The interval from the end of the 1st line to relapse was 6-12 months in 164 patients (39.5%) and >12 months in 251 cases (60.5%). Patients received a 2nd (100%), 3rd (80.1%), 4th (50.2%), 5th (28.3%), and 6th (11.9%) line of chemotherapy. At 2nd line 282 (65.9%) received platinum (group A), while 146 (34.1%) received non-platinum chemotherapy (group B). In the latter group, 67 patients received platinum at later progression (group B1), while 79 never received platinum (group B2). Median time to platinum re-treatment was 20 and 23.1 months in patients of groups A and B1, respectively. The response rate to the first platinum received was 74.4 and 57.4% in groups A and B1, respectively (p = 0.02). Group B2 was characterized by the worst response rate and survival. At multivariate analysis time of first platinum re-treatment (2nd line vs. later; p = 0.0132; OR = 2.34) and age (p = 0.0029; OR = 2.41) was independently associated with a higher possibility of response to platinum. With the limits of a retrospective study, our data question the hypothesis that extending the platinum-free interval with an intervening non-platinum therapy in patients with recurrent platinum-sensitive ovarian cancer improves the response rate of a further platinum re-treatment.

We examined mononuclear cell subsets in cord blood of normal newborns by surface marker analysis. The percentages of T lymphocytes (E-rosetting and T3+ cells) were lower in cord blood than in peripheral blood (PB) from adults, while the percentage and absolute number of T6+ cells were higher in cord blood. As the sum of T4+ and T8+ cells exceeded the values of E-rosetting lymphocytes in cord blood, we suggest that immature lymphocytes with the phenotype of 'common' thymocytes (T6+, T4+, T8+) are present in cord blood of full-term newborns. Higher percentage and absolute number of B lymphocytes were detected in cord blood. More than 50% of B cells in cord blood formed rosettes with mouse erythrocytes, a surface marker of functional immaturity. Finally, cells bearing receptors for IgG-Fc fragments or C3 and expressing Ia-like and M1 antigens were uniformly increased in cord blood, suggesting higher percentages of cells of the monocytic lineage.

Carboplatin plus paclitaxel administered every 3 weeks is standard first-line chemotherapy for patients with advanced ovarian cancer. A weekly paclitaxel schedule combined with carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial. The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks. We did a multicentre, randomised, phase 3 study at 67 institutions in Italy and France. Women with FIGO stage IC-IV ovarian cancer, an ECOG performance status of 2 or lower, and who had never received chemotherapy were randomly allocated in a 1:1 ratio to receive either carboplatin (AUC 6 mg/mL per min) plus paclitaxel (175 mg/m(2)) every 3 weeks for six cycles or carboplatin (AUC 2 mg/mL per min) plus paclitaxel (60 mg/m(2)) every week for 18 weeks. Randomisation was done by computer-based minimisation, stratified by centre, residual disease after surgery, and ECOG performance status. The study was not blinded. Coprimary endpoints were progression-free survival and quality of life (assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index [FACT-O/TOI] score), and analysis was by modified intention to treat. This report presents the final analysis. The study is registered with ClinicalTrials.gov, number NCT00660842. 822 patients were enrolled into the study between Nov 20, 2008, and March 1, 2012; 12 withdrew their consent immediately after randomisation and were excluded, and 810 were eligible for analysis. 404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule. After median follow-up of 22·3 months (IQR 16·2-30·9), 449 progression-free survival events were recorded. Median progression-free survival was 17·3 months (95% CI 15·2-20·2) in patients assigned to treatment every 3 weeks, versus 18·3 months (16·8-20·9) in women allocated to the weekly schedule (hazard ratio 0·96, 95% CI 0·80-1·16; p=0·66). FACT-O/TOI scores differed significantly between the two schedules (treatment-by-time interaction p<0·0001); with treatment every 3 weeks, FACT-O/TOI scores worsened at every cycle (weeks 1, 4, and 7), whereas for the weekly schedule, after transient worsening at week 1, FACT-O/TOI scores remained stable. Fewer patients assigned to the weekly group than those allocated treatment every 3 weeks had grade 3-4 neutropenia (167 [42%] of 399 patients vs 200 [50%] of 400 patients), febrile neutropenia (two [0·5%] vs 11 [3%]), grade 3-4 thrombocytopenia (four [1%] vs 27 [7%]), and grade 2 or worse neuropathy (24 [6%] vs 68 [17%]). Three deaths during the study were attributed to chemotherapy; two women died who were allocated treatment every 3 weeks and one death was recorded in the group assigned the weekly regimen. A weekly regimen of carboplatin and paclitaxel might be a reasonable option for first-line treatment of women with advanced ovarian cancer. None.