BACKGROUNDNiraparib, an inhibitor of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of BRCA mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to firstline platinum-based chemotherapy is unknown. METHODSIn this randomized, double-blind, phase 3 trial, we randomly assigned patients with newly diagnosed advanced ovarian cancer in a 2:1 ratio to receive niraparib or placebo once daily after a response to platinum-based chemotherapy. The primary end point was progression-free survival in patients who had tumors with homologousrecombination deficiency and in those in the overall population, as determined on hierarchical testing. A prespecified interim analysis for overall survival was conducted at the time of the primary analysis of progression-free survival. RESULTSOf the 733 patients who underwent randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. Among the patients in this category, the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred. CONCLUSIONSAmong patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency. (Funded by GlaxoSmithKline; PRIMA/ENGOT-OV26/GOG-3012 ClinicalTrials.gov number, NCT02655016.) a bs tr ac t

5503 Background: Adjuvant therapy for early stage high-risk endometrial cancer remains controversial. Methods: Patients with surgical stage I, II, IIIA (positive peritoneal fluid cytology only), or IIIC (positive pelvic lymph nodes only) were eligible if they, according to departmental guidelines, had a sufficiently high risk for micrometastatic disease to qualify for adjuvant therapy. Most patients had two or more of the risk factors: grade 3, deep myometrial invasion, or DNA non-diploidy, while some patients had only one of these. Patients with serous, clear cell, or anaplastic carcinomas were eligible regardless of risk factors. Patients with para-aortic metastases were not eligible. Lymph node exploration at staging surgery was optional. Pelvic RT ± vaginal brachytherapy was given to a dose =44 Gy. CT was given before or after RT. Before August 2004 CT consisted of four courses of cisplatin =50 mg/m2 + doxorubicin 50 mg/m2 or epirubicin 75 mg/m2 (AP). Thereafter several CT regimens were allowed, of which AP, paclitaxel 175 mg/m2 + epirubicin 60 mg/m2 + carboplatin AUC 5, and paclitaxel 175 mg/m2 + carboplatin AUC 5–6 were used. Progression-free survival (PFS) was the primary end-point. The study was terminated before the aimed goal of 400 patients because of slow recruitment. We decided to make an early analysis since new studies on endometrial cancer are presently discussed. Results: 372 patients were entered between May 1996 and Oct 2006. Of 367 evaluable patients 190 were randomized to RT and 177 to RT+CT. Risk factors were well balanced between the randomization arms. The median follow-up time was 3.5 years. The hazard ratio for PFS was 0.58 in favor of RT+CT (95 % confidence interval (CI) 0.34 - 0.99; p=0.046). This translates to an estimated 7 % absolute difference in 5-year PFS from 75 % (95 % CI 67 % - 82 %) to 82 % (95 % CI 73 % - 88 %). Conclusion: RT+CT was better than RT alone. Next question is if RT+CT is better than CT alone. No significant financial relationships to disclose.

PurposeTo determine the impact of socioeconomic position (SEP) and distance to provider on outpatient mental health care utilization among incident users of antidepressants.MethodA nationwide register-based cohort study of 50,374 person-years.ResultsPersons in low SEP were more likely to have outpatient psychiatrist contacts [odds ratio (OR) 1.25; confidence interval (CI) 1.17–1.34], but less likely to consult a co-payed psychologist (OR 0.49; CI 0.46–0.53) and to get mental health service from a GP (MHS-GP) (OR 0.81; CI 0.77–0.86) compared to persons in high SEP after adjusting for socio-demographics, comorbidity and car ownership. Furthermore, persons in low SEP who had contact to any of these therapists tended to have lower rates of visits compared to those in high SEP. When distance to services increased by 5 km, the rate of visits to outpatient psychiatrist tended to decrease by 5% in the lowest income group (IRR 0.95; CI 0.94–0.95) and 1% in the highest (IRR 0.99; CI 0.99–1.00). Likewise, contact to psychologists decreased by 11% in the lowest income group (IRR 0.89; CI 0.85–0.94), whereas rate of visits did not interact.ConclusionPatients in low SEP have relatively lower utilization of mental health services even when services are free at delivery; co-payment and distance to provider aggravate the disparities in utilization between patients in high SEP and patients in low SEP.Electronic supplementary materialThe online version of this article (doi:10.1007/s00127-017-1437-2) contains supplementary material, which is available to authorized users.

NCT00598156.

Collaboration within the recently established Network for Research on Spirituality and Health (NERSH) has made it possible to pool data from 14 different surveys from six continents. All surveys are largely based on the questionnaire by Curlin "Religion and Spirituality in Medicine, Perspectives of Physicians" (RSMPP). This article is a methodological description of the process of building the International NERSH Data Pool. The larger contours of the data are described using frequency statistics. Five subscales in the data pool (including the already established DUREL scale) were tested using Cronbach's alpha and Principal Component Analysis (PCA) in an Exploratory Factor Analysis (EFA). 5724 individuals were included, of which 57% were female and the mean age was 41.5 years with a 95% confidence interval (CI) ranging from 41.2 to 41.8. Most respondents were physicians (n = 3883), nurses (n = 1189), and midwives (n = 286); but also psychologists (n = 50), therapists (n = 44), chaplains (n = 5), and students (n = 10) were included. The DUREL scale was assessed with Cronbach's alpha (α = 0.92) and PCA confirmed its reliability and unidimensionality. The new scales covering the dimensions of "Religiosity of Health Professionals (HPs)" (α = 0.89), "Willingness of Physicians to Interact with Patients Regarding R/S Issues" (α = 0.79), "Religious Objections to Controversial Issues in Medicine" (α = 0.78), and "R/S as a Calling" (α = 0.82), also proved unidimensional in the PCAs. We argue that the proposed scales are relevant and reliable measures of religious dimensions within the data pool. Finally, we outline future studies already planned based on the data pool, and invite interested researchers to join the NERSH collaboration.