Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study.

OBJECTIVE: To evaluate whether locally applied vaginal estrogen affects prolapse-associated complaints compared with placebo treatment in postmenopausal women prior to surgical prolapse repair. DESIGN: Randomised, double-masked, placebo-controlled, multicentre study. SETTING: Urogynaecology unit at the Medical University of Vienna and University Hospital of Tulln. POPULATION: Postmenopausal women with symptomatic pelvic organ prolapse and planned surgical prolapse repair. METHODS: Women were randomly assigned local estrogen cream or placebo cream 6 weeks preoperatively. MAIN OUTCOME MEASURES: The primary outcome was differences in subjective prolapse-associated complaints after 6 weeks of treatment prior to surgery, assessed with the comprehensive German pelvic floor questionnaire. Secondary outcomes included differences in other pelvic floor-associated complaints (bladder, bowel or sexual function). RESULTS: Out of 120 women randomised, 103 (86%) remained for the final analysis. After 6 weeks of treatment the prolapse domain score did not differ between the estrogen and the placebo groups (4.4 ± 0.19 versus 4.6 ± 0.19; mean difference, -0.21; 95% CI -0.74 to 0.33; P = 0.445). Multivariate analysis, including only women receiving the intervention, showed that none of the confounding factors modified the response to estradiol. CONCLUSIONS: These results demonstrate that preoperative locally applied estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse. TWEETABLE ABSTRACT: Preoperative local estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with pelvic organ prolapse.

Different surgical approaches for stress urinary incontinence in women.

Stress urinary incontinence (SUI) constitutes involuntary voiding as a consequence of rising intra-abdominal pressure caused by sphincter weakness. In recent years studies were published according to surgical SUI management evaluating and comparing therapy options and outcomes. Therapy options were evaluated using a Medline search, including only publications in English between 2000-2012. Key words used were: SUI, conservative and surgical treatment, midurethral sling, colposuspension. Surgical treatment options demonstrate significantly better results than conservative treatment. MUS demonstrate better subjective and objective cure rates than colposuspension; it is less invasive and more cost-effective. First line SUI therapy such as RP MUS and TVT seem to be favored when compared to transobturator techniques. Retropubic and transobturator MUS showed equivalent objective and subjective success rates. Open colposuspension is an effective treatment possibility for recurrent SUI after failed MUS. TVT, compared with other MUS, seems to show slightly better cure rates. but perioperative complications appear to be similar. Long-term results (>10 years) of repeated SUI surgery showed that the Burch procedure had the lowest 9-year cumulative incidence of repeat SUI surgery. Mini-sling techniques may be underestimated but long-time results are pending and closer monitoring of the adverse event profile must be carried out. MUS are first choice in the treatment of SUI, of which TVT, has the best cure rate. Colpussupension continues to have its place in recurrent SUI. The new mini-MUS needs a longer follow-up for final evaluation.

[Measurement of the infrapubic angle using 3D perineal ultrasound and its relationship to obstetrical parameters]. / Die Messung des infrapubischen Winkels in der 3-D-Perineal-Sonografie und seine Beziehung zu geburtshilflichen Parametern.

PURPOSE: Ultrasound has achieved an indispensable role in urogynecology. The introduction of 3 D technology has enabled sonographers to visualize structures in the axial plane. The angle of the infrapubic arc may enable us to presume the shape of the pelvis. Our aim was to describe a method for measuring the infrapubic angle and the interpubic space with 3 D perineal ultrasound through 3 D rotation, correlating them with the length of the 2nd stage of labor and the rate of levator defects. MATERIALS AND METHODS: Women after vaginal delivery were recruited and underwent a 3 D perineal ultrasound on 2nd - 3 rd day postpartum. Volume datasets were analyzed to measure the infrapubic angle and the interpubic space independently by 2 urogynecologists. The interobserver reliability and the correlation between infrapubic arc angle and the length of the 2nd stage of labor and the occurrence of levator defects were calculated. RESULTS: 110 women were enrolled. With a correlation coefficient of 0.76, the relationship between the infrapubic angle measurements of the two observers was very good. A moderate to good correlation was found for the assessment of the interpubic gap, with r = 0.69. Between the infrapubic angle and length of the 2nd stage of labor, no statistical correlation for both observer measurements (p = 0.31; p = 0.78, respectively) was found. Also the correlation between the infrapubic arc angle and the occurrence of levator avulsions was not significant (p = 0.59; p = 0.39, respectively). CONCLUSION: 3 D ultrasound technology enables us to identify and evaluate the interpubic gap and the infrapubic arc with a high inter-observer reproducibility. However, from our data, the infrapubic angle does not seem to influence the length of the 2nd stage of labor and the occurrence of levator defects.

Patient goals after incontinence procedures: does the single-incision sling satisfy them?

OBJECTIVE: This study was undertaken to describe short-term postoperative achievement of subjective preoperative goals for single-incision MiniArc slings, in comparison with tension-free vaginal tape (TVT). METHOD: Patients submitted to mid-urethral sling (TVT and MiniArc) procedures for stress urinary incontinence (SUI) in two centers were included in this prospective study. Before surgery, the patients completed a preoperative open-ended questionnaire, in which they described their personal outcomes goals for SUI surgery and the degree of severity of their symptoms. At the first postoperative check, they were asked to assess the degree to which their goals had been met and the degree of postoperative incontinence symptoms; their grade of satisfaction was evaluated with IIQ-7, UDI-6 and a 0-10 visual analog scale. RESULTS: One hundred and eight patients (TVT n=51, MiniArc n=57) were included in this study. Incontinence symptom relief and improvement of quality of life were the most commonly described preoperative goals. Six to eight weeks after surgery, 47 patients (92.1%) after TVT and 53 (92.9%) women after single-incision slings were objectively cured (P=1). After surgery, more than 90% of the patients in both groups achieved their preoperative goals. Symptom scores improved significantly and were comparable in both groups. CONCLUSION: Our results show that self-reported achievement of preoperative goals of patients submitted to single-incision slings are comparable at the first follow-up with patients who have undergone the classic mid-urethral sling.

Adjuvant chemotherapy in early breast cancer.

Despite living in an era of progressively improved molecular characterization of breast cancer with novel prognostic and predictive tests as well as increased use of targeted therapies, adjuvant chemotherapy is still a cornerstone in the treatment of early breast cancer. Numerous clinical trials of adjuvant chemotherapy without trastuzumab have clearly shown that the effectiveness depends not only on the mere application of new substances (e.g., taxanes) but at least equally important on the way to utilize them. At present, standard adjuvant chemotherapy should include anthracyclines, taxanes and cyclophosphamide. Docetaxel is best used in three weekly intervals, while paclitaxel should be delivered either weekly or dose-dense every two weeks with G-CSF support. In high risk breast cancer patients with more than three involved axillary lymph nodes, an intensified dose-dense and sequential approach leads to significantly improved survival. Other approaches to improve the efficacy of adjuvant chemotherapy employ the incorporation of additional substances like capecitabine. Conversely, investigators trying to de-escalate adjuvant chemotherapy implemented taxane-containing but anthracycline-free chemotherapy. Altogether, these new approaches are awaiting further confirmatory clinical trials before they should be regarded as standard of care in early breast cancer.

Impact of mode of delivery on levator morphology: a prospective observational study with three-dimensional ultrasound early in the postpartum period.

OBJECTIVE: To evaluate morphology and integrity of the levator ani muscle (LAM) with three-dimensional ultrasound early in the postpartum period. DESIGN: Prospective cross-sectional observational study. SETTING: University hospital in Germany. POPULATION: Women after vaginal delivery and caesarean section with no previous vaginal delivery. METHODS: Three-dimensional perineal ultrasound was performed between 48 and 72 hours postpartum. The axial plane at the level of minimal hiatal dimension and tomographic ultrasound imaging were used to determine LAM biometry and defect. MAIN OUTCOME MEASURES: Primary outcome was to compare hiatal dimensions and levator defect following vaginal delivery or caesarean section. For secondary outcomes, we evaluated the role of caesarean section in protecting levator integrity, and the possible involvement of the first stage of labour in LAM changes. RESULTS: In all, 157 women participated: 81 (51.6%) following vaginal delivery (70 spontaneous and 11 operative deliveries) and 76 (48.4%) following caesarean section (55 elective and 21 emergency caesarean sections). All biometric indices of the levator were higher after vaginal delivery (P<0.001), except for LAM thickness. LAM defects were found to be significantly associated with vaginal delivery, with relative risk 7.5 (P<0.001). Following vaginal delivery, 32 (39.5%) levator defects were found: 27 (38.5%) after spontaneous delivery and five (45.4%) after operative delivery. Four (5.2%) women had a levator defect following emergency caesarean section. CONCLUSION: Vaginal delivery modifies and damages the LAM: the risk of levator defect after vaginal delivery is more than seven times higher than after caesarean section. Despite this, emergency caesarean section seems to have no complete preventive effect on LAM trauma.

The IUGA/ICS classification of complications of prosthesis and graft insertion: a comparative experience in incontinence and prolapse surgery.

INTRODUCTION AND HYPOTHESIS: This is a presentation of case series after the use of alloplasic material in urogynaecology. METHODS: From 2004 to 2010, a total 179 patients with complications have been referred directly after the use of alloplastic material in incontinence and prolapse surgery. Of this total, 125 patients had a previous vaginal sling plasty because of urinary stress incontinence, while 54 patients underwent a prolapse surgery with mesh use. Symptoms and findings are expressed by the recently introduced International Urogynecological Association/International Continence Society (IUGA/ICS) terminology. RESULTS: The most frequent findings after vaginal sling plasty were bladder outlet obstruction, pain and tape exposure. The most frequent findings after prolapse surgery were pain and mesh erosion. The IUGA/ICS classification does not give the possibility to express functional disorders. Most revisions were done more than 2 months after surgery. After incontinence surgery, mostly the vaginal area of suture line was affected; after prolapse surgery, the vagina and the trocar passage were affected. CONCLUSIONS: Mesh complication and affected site after prolapse surgery do differ from those after incontinence surgery. The IUGA/ICS classification of mesh complication facilitates the comparison of mesh complication.

A new algorithm for improving fetal weight estimation from ultrasound data at term.

OBJECTIVE: The purpose of this retrospective study was to find a method of improving the accuracy of fetal birth weight estimation on the basis of traditional ultrasonographic measurements of the head, thorax, and femur at term. In this context, we analyzed a novel regression method comparing to existing algorithms. METHODS: The delivery records of two hospitals were searched for women who delivered macrosomic infants, and the patients' medical records were retrospectively reviewed in order to derive clinical and ultrasonographic data at term. A total of 223 patients with macrosomic infants (birth weight > 4,000 g) were identified. These patients were complemented by data for 212 women who had ultrasound fetal assessments of less than 4,000 g. We used the method of isotonic regression to construct a birth weight prediction function that increases monotonically with each of the input variables and which minimizes the empirical quadratic loss. RESULTS: A suspicion of macrosomia was based on a history of macrosomia, fundal height, and sonographic weight estimation >4,000 g. The mean period between ultrasound weight estimation and delivery was 7.2 days. The ability of the biometric algorithms developed to predict fetal weight at term ranged between a mean absolute error of 312 and 344 g, given a confidence interval of 95%. We demonstrate that predictions of birth weight on the basis of ultrasound data can be improved significantly, if an isotonic regression model is used instead of a linear regression model. CONCLUSIONS: This study demonstrates that ultrasound detection of macrosomia can be improved using the isotonic regression method.

New prognostic and predictive factors in breast cancer.

There are two major questions regarding systemic therapy of breast cancer: Firstly, which patients should be treated, and secondly, how should these patients be treated? Prognostic factors aim to foresee the outcome of patients irrespective of treatment while predictive factors intend to assess the outcome of patients receiving a certain systemic therapy and thus are intimately associated with sensitivity or resistance to therapy. Ideally, a predictive factor is also a therapeutic target as it is the case with estrogen receptor (ER) or HER-2. In order to avoid over- as well as under-treatment, it is advisable to select the appropriate treatment strategy on the basis of a careful risk assessment for each individual patient. Additionally to time-honoured clinicopathological factors additional prognostic factors like urokinase-type plasminogen activator (uPA)/plasminogen activator inhibitor 1 (PAI-1) or multiparameter gene-expression analyses have shown promising results especially in node-negative breast cancer. These multigene profiles offer new insights in breast cancer biology, like the important role of the tumor-associated immune system. ER, HER-2 and potentially newer prognostic factors like epithelial cell adhesion molecule (Ep-CAM) bridge the gap from prognosis to prediction and serve as therapeutic targets. This should allow us to quantify the risk of progression in each individual patient and tailor treatment accordingly, leading to a more personalized treatment recommendation.

Neutron cross-sections for next generation reactors: new data from n_TOF.

In 2002, an innovative neutron time-of-flight facility started operation at CERN: n_TOF. The main characteristics that make the new facility unique are the high instantaneous neutron flux, high resolution and wide energy range. Combined with state-of-the-art detectors and data acquisition system, these features have allowed to collect high accuracy neutron cross-section data on a variety of isotopes, many of which radioactive, of interest for Nuclear Astrophysics and for applications to advanced reactor technologies. A review of the most important results on capture and fission reactions obtained so far at n_TOF is presented, together with plans for new measurements related to nuclear industry.

Epirubicin and cyclophosphamide versus epirubicin and docetaxel as first-line therapy for women with metastatic breast cancer: final results of a randomised phase III trial.

BACKGROUND: This randomised phase III trial was carried out to compare the efficacy and safety of epirubicin and cyclophosphamide (EC) with epirubicin and docetaxel (Taxotere) (ED) as first-line chemotherapy for metastatic breast cancer. PATIENTS AND METHODS: Patients (n = 240) were randomly assigned to receive either ED (epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2)) or EC (epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2)). The primary end point was objective response rate (ORR). Secondary end points were progression-free survival (PFS), overall survival (OS), and safety. RESULTS: ORR for patients randomly assigned to receive EC and ED were 42% and 47%, respectively (P = 0.63). Median PFS [10.1 versus 10.3 months; hazard ratio (HR) 0.98; log-rank P = 0.38] and OS (19.9 versus 30.0 months; HR 0.663; log-rank P = 0.21) were comparable in both arms. Although grade 3/4 leucopenia occurred more frequently with ED (81% versus 73%; P = 0.01), there were no significant differences in the incidence of febrile neutropenia and grade 3/4 infections. Grade 3/4 non-haematologic toxicity was infrequent in both arms. Congestive heart failure was observed in one patient in each arm. CONCLUSION: In this randomised trial, no differences in the efficacy study end points were observed between the two treatment arms.

Pelvic organ prolapse and overactive bladder.

AIMS: In this review we try to shed light on the following questions: *How frequently are symptoms of overactive bladder (OAB) and is detrusor overactivity (DO) present in patients with pelvic organ prolapse (POP) and is there a difference from women without POP? *Does the presence of OAB symptoms depend on the prolapsed compartment and/or stage of the prolapse? *What is the possible pathophysiology of OAB in POP? *Do OAB symptoms and DO change after conservative or surgical treatment of POP? METHODS: We searched on Medline and Embase for relevant studies. We only included studies in which actual data about OAB symptoms were available. All data for prolapse surgery were without the results of concomitant stress urinary incontinence (SUI) surgery. RESULTS: Community- and hospital-based studies showed that the prevalence of OAB symptoms was greater in patients with POP than without POP. No evidence was found for a relationship between the compartment or stage of the prolapse and the presence of OAB symptoms. All treatments for POP (surgery, pessaries) resulted in an improvement in OAB symptoms. It is unclear what predicts whether OAB symptoms disappear or not. When there is concomitant DO and POP, following POP surgery DO disappear in a proportion of the patients. Bladder outlet obstruction is likely to be the most important mechanism by which POP induces OAB symptoms and DO signs. However, several other mechanisms might also play a role. CONCLUSIONS: There are strong indications that there is a causal relationship between OAB and POP.

Pregnancy outcome in maternal Crigler-Najjar syndrome type II: a case report and systematic review of the literature.

OBJECTIVE: To report a case of maternal Crigler-Najjar syndrome (CNS) type II in pregnancy, systematically review the literature for similar case reports, and to evaluate whether pregnancy is safe in patients with the disease. Data sources included the PubMed and up to date databases. RESULTS: A 37-year-old mother with CNS type II was treated with phenobarbital during her pregnancy and her bilirubin levels were monitored. Her newborn had mild direct hyperbilirubinemia, did not require any treatment and his postnatal follow-up showed normal growth and development as well as normal hearing. CONCLUSION: CNS type II is rare, and only a few pregnancies with this condition have been reported. Maternal treatment with phenobarbital lowers the unconjugated bilirubin and avoids fetal and newborn sequelae.

Quality of life and adjuvant tamoxifen treatment in breast cancer patients.

About two-thirds of all breast cancer patients are treated with adjuvant hormonal therapy. Side effects of tamoxifen and their effects on physical, emotional and social functioning have been shown to impair the quality of life. Aim of this paper was to evaluate the side effects and level of influence on the physical, emotional and social functioning caused by tamoxifen treatment. For assessment of quality of life an own questionnaire was designed. Between January 2001 and December 2003, 136 women with breast cancer and adjuvant tamoxifen therapy were included in this study. Data of side effects, physical and mental health and patients' self-evaluation identified detrimental effects on patients' quality of life. Prevalence and severity of symptoms were not influenced by length of tamoxifen treatment. Patients were damaged in their constitution in respect to previous chemotherapy and pre-existing diseases; no influence was found by age or histopathological tumour characteristics. Our survey determines that breast cancer patients experience significant influence on quality of life by the negative impact on the physical, emotional and social functioning caused by tamoxifen treatment. Explicit attention to changes in quality of life should be considered as part of the standard care for women receiving adjuvant tamoxifen treatment.

Long-term outcome prediction by clinicopathological risk classification algorithms in node-negative breast cancer--comparison between Adjuvant!, St Gallen, and a novel risk algorithm used in the prospective randomized Node-Negative-Breast Cancer-3 (NNBC-3) trial.

BACKGROUND: Defining risk categories in breast cancer is of considerable clinical significance. We have developed a novel risk classification algorithm and compared its prognostic utility to the Web-based tool Adjuvant! and to the St Gallen risk classification. PATIENTS AND METHODS: After a median follow-up of 10 years, we retrospectively analyzed 410 consecutive node-negative breast cancer patients who had not received adjuvant systemic therapy. High risk was defined by any of the following criteria: (i) age <35 years, (ii) grade 3, (iii) human epithelial growth factor receptor-2 positivity, (iv) vascular invasion, (v) progesterone receptor negativity, (vi) grade 2 tumors >2 cm. All patients were also characterized using Adjuvant! and the St Gallen 2007 risk categories. We analyzed disease-free survival (DFS) and overall survival (OS). RESULTS: The Node-Negative-Breast Cancer-3 (NNBC-3) algorithm enlarged the low-risk group to 37% as compared with Adjuvant! (17%) and St Gallen (18%), respectively. In multivariate analysis, both Adjuvant! [P = 0.027, hazard ratio (HR) 3.81, 96% confidence interval (CI) 1.16-12.47] and the NNBC-3 risk classification (P = 0.049, HR 1.95, 95% CI 1.00-3.81) significantly predicted OS, but only the NNBC-3 algorithm retained its prognostic significance in multivariate analysis for DFS (P < 0.0005). CONCLUSION: The novel NNBC-3 risk algorithm is the only clinicopathological risk classification algorithm significantly predicting DFS as well as OS.

The influence of macrosomia on the duration of labor, the mode of delivery and intrapartum complications.

OBJECTIVE: This study assessed the perinatal outcome in a series of macrosomic fetuses with mothers from a general obstetric population in whom vaginal delivery was planned. METHODS: In all, 215 women with macrosomic infants were included from a total of 2,622 deliveries. The pattern of maternal weight gain in pregnancy, the influence of fetal macrosomia on the duration of labor and the delivery outcome were investigated in this group. The main issues studied were the impact of fetal weight on the mode of delivery, the duration of the two stages of delivery and the incidence of intrapartum complications in fetuses larger than 4,000 g in comparison with normal-weight fetuses. RESULTS: Complete data were obtained for 594 patients, including 215 macrosomic infants and 379 randomly assessed normal-weight infants. With regard to the mode of delivery, a direct correlation was observed between maternal weight gain and the incidence of secondary cesarean section (P<0.014) when vaginal delivery was initially planned. There was also a direct correlation between increasing birth weight and a higher incidence of secondary cesarean section and assisted vaginal delivery (P<0.002). In the first stage of labor, there was a statistically significant difference for obstructed labor between the two groups (P<0.03). The rate of perineal injuries and the incidence of postpartum hemorrhage were similar in the two groups. CONCLUSIONS: As some of the risk factors identified are known prior to delivery, every woman in whom there is a suspicion that the fetus may weigh up to 4,500 g should receive individual guidance regarding special intrapartum and perinatal conditions.

Fetal urogenital sinus with consecutive hydrometrocolpos because of labial fusion: prenatal diagnostic difficulties and postpartal therapeutic management.

OBJECTIVE: To elucidate the differential diagnoses of tumorous dilations in the fetal pelvic region detected by prenatal ultrasound and the postnatal management demonstrated on a fetus with 29 weeks of gestation with a retrovesical located bottle-like cystic structure measuring 54 x 31 x 27 mm within the pelvis. Postnatal findings were a labial fusion and a consecutive hydrometrocolpos due to a urethrovaginal fistula. METHOD: Case report of a fetus affected by an intricate cloacal anomaly. RESULTS: The long-term prognosis for this nonsyndromic form of hydrometrocolpos without any other structural defects or organic failures after operative sanitation is excellent. Final reconstruction is planned at about 12 months of age. CONCLUSION: Prenatal diagnosis of tumorous dilations in the fetal pelvic region often involves difficulties because of numerous differential diagnoses and possible presentation in late pregnancy. Magnetic resonance imaging could be a useful complementary tool for assessing these anomalies when ultrasonography is inconclusive. In some cases, the final diagnosis cannot be confirmed until after delivery.

Role of urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (PAI-1) for prognosis in endometrial cancer.

BACKGROUND: Urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (PAI-1) contribute to the invasiveness of many carcinomas. Here, we studied a possible association between cytosolic uPA and PA-1 concentrations in tumor tissue with prognosis in patients with endometrial cancer. METHODS: Cytosolic concentrations of uPA and PAI-1 were determined in 69 primary endothelial adenocarcinomas using an enzyme-linked immunoassay (ELISA). A possible influence of uPA and PAI-1 was studied by multivariate Cox regression adjusting for the established clinical prognostic factors FIGO-stage, grading, depth of invasion, diabetes mellitus and age. RESULTS: Both uPA (p=0.011) and PAI-1 (p=0.003) were associated with relapse free time using the multivariate proportional hazards model. Association with overall survival was less pronounced with p=0.021 for uPA and p=0.358 for PAI-1. Concentrations of PAI-1 increased with FIGO stage (p=0.003) and with histological grading (p=0.005). Both uPA and PAI-1 concentrations were negatively correlated with estrogen and progesterone receptor levels. CONCLUSION: The combination of high cytosolic concentrations of uPA (>5 ng/mg total protein) and high PAI-1 (>20 ng/mg total protein) may reveal a group of patients with increased risk of progression.

Effects of anemia correction with epoetin beta in patients receiving radiochemotherapy for advanced cervical cancer.

Patients with cervical cancer frequently suffer from anemia. This two-stage, adaptive-design study investigated the effect of anemia correction with epoetin beta on treatment outcomes. Patients with stage IIB-IVA cervical cancer received radiochemotherapy (RCT) and were randomized to epoetin 150 IU/kg three times weekly (n = 34) or standard care (control; n = 40) for up to 12 weeks. Primary end point for stage 1 aimed to establish a correlation between anemia correction and treatment failure (no complete response or relapsing within 6 months after RCT initiation) as a proof of concept before moving into stage 2. Secondary end points included progression/relapse-free survival, overall survival, response to RCT, hemoglobin (Hb) response, and safety. Median baseline Hb was 11.4 and 11.6 g/dL in epoetin and control groups, respectively. At treatment end point, median Hb increased by 1.3 g/dL with epoetin, but decreased by 0.7 g/dL in the control group (P < 0.0001). No significant correlation between Hb increase and treatment failure was demonstrated. There were no significant differences between epoetin and control groups in progression/relapse-free survival (29.4% vs 32.5% patients with events; P = 0.96), overall survival (23.5% vs 12.5% patients with events; P = 0.22) or overall complete response (53% vs 58%; P = 0.86). Adverse events were well matched between groups. This study shows that epoetin beta rapidly, effectively, and safely increases Hb levels in patients with cervical cancer receiving RCT. No positive correlation of Hb increase and improvement in clinical outcomes could be demonstrated.