Not immune to inequity: minority under-representation in immunotherapy trials for breast and gynecologic cancers.

OBJECTIVE: To describe the participation of minority women in clinical trials using immunologic agents for breast and gynecologic cancers. METHODS: A retrospective review of completed clinical trials involving immunotherapy for breast and gynecologic cancers was performed. Completed trials were examined for data on race, tumor type, and start year. Minority enrollment was stratified by tumor site. Based on Center for Disease Control and Prevention age-adjusted incidence for race, expected and observed ratios of racial participation were calculated and compared using Χ2 testing, p≤0.05. RESULTS: A total of 53 completed immunotherapy clinical trials involving 8820 patients were reviewed. Breast cancer trials were most common (n=24) and involved the most patients (n=6248, 71%). Racial breakdown was provided in 41 studies (77%) for a total of 7201 patients. Race reporting was lowest in uterine (n=4, 67%) and cervical cancer trials (n=6, 67%), and highest in ovarian cancer trials (n=12, 86%). White patients comprised 70% (n=5022) of all the patients included. Only 5% of patients involved were black (n=339), and 83% of these patients (n=282) were enrolled in breast cancer trials. Observed enrollment of black women was 32-fold lower for ovarian, 19-fold lower for cervical, 15-fold lower for uterine, and 11-fold lower for breast cancer than expected. While all trials reported race between 2013 and 2015, no consistent trend was seen towards increasing race reporting or in enrollment of black patients over time. CONCLUSION: Racial disparities exist in clinical trials evaluating immunologic agents for breast and gynecologic cancers. Recruitment of black women is particularly low. In order to address inequity in outcomes for these cancers, it is crucial that significant attention be directed towards minority representation in immuno-oncologic clinical trials.

Acute pyelonephritis during pregnancy: a systematic review of the aetiology, timing, and reported adverse perinatal risks during pregnancy.

We performed a comprehensive systematic review of acute pyelonephritis in pregnancy using PubMed, SCOPUS, ClinicalTrials.gov, and Ovid from inception to April 2018. About 7796 references were screened for inclusion, and 52 references from 1908 to 2017 were included. One hundred seven cases of acute pyelonephritis in pregnant women were reviewed. Gestational age at diagnosis was reported as 2 (2%), 43 (40%), and 51 (52%) during the first, second, and third trimesters, respectively. Maternal complications included sepsis (49%), acute respiratory distress syndrome (47%), anaemia (33%), acute kidney injury (10%), renal abscess (6%), and death (6%). 25 preterm deliveries (23%), 6 intrauterine foetal demises (6%), 4 spontaneous abortions (4%), and 8 neonatal intensive care unit admissions (7%) were reported. Microorganisms cultured included Escherichia coli (51%), Klebsiella (8%), Proteus (5%), Staphylococcus aureus (5%), Streptococcus (4%), and Enterococcus (3%). Early diagnosis and management led to fewer complications.Impact statementWhat is already known on this subject? Acute pyelonephritis during pregnancy can lead to adverse pregnancy outcomes and in this article, we highlight the most common outcomes previously reported. Previous studies have reported maternal adverse outcomes and only very few stressed on fetal/neonatal outcomes.What do the results of this study add? The results add that not only is maternal morbidity/mortality is increased, but also increases adverse outcomes for the fetus/neonate, such as preterm delivery and fetal/neonatal demise.What are the implications of these findings for clinical practice and/or further research? The implications from this article serve to increase a medical providers knowledge on how to appropriately counsel pregnant women with acute pyelonephritis. In addition, future research can aim to understand why pregnant women are more prone to morbidity and mortality compared to nonpregnant women.

Intraperitoneal (IP) port cytology after completion of primary therapy for advanced stage ovarian cancer: A novel approach to a "second look".

OBJECTIVE: To determine whether IP port cytology predicts early recurrence and/or poor prognosis in patients with ovarian cancer who have completed primary therapy. METHODS: A prospective study of patients with advanced stage ovarian cancer undergoing IP port removal after debulking followed by IV/IP chemotherapy was performed. Ports were flushed with 10 cc of normal saline into ThinPrep fixative to be analyzed for cytology. Results were correlated with clinical factors and cancer outcomes. Survivals were calculated using Kaplan-Meier curves and compared using log-rank analysis. RESULTS: Effluent from 53 IP ports was analyzed, and patients were followed for a median of 62 months. Mean age was 58.5, with the majority of patients being white (90%), with stage 3 (62%), serous histology (87%). Seven (13.2%) patients had positive IP cytology. POS and NEG groups were similar with regard to age, BMI, stage, grade, and GOG status. Patients with POS results had increased risk of recurrence HR 3.2 (95%CI 0.4, 28.9), and death HR 6.5 (95%CI 0.7, 58.8), and were more likely to recur before 12 months, 71% vs. 22% (p = 0.007). Compared to NEG, POS conferred a shorter median survival with PFS of 32 vs. 7 months (p = 0.02) and OS of 84 vs. 42 months (p = 0.04). CONCLUSIONS: IP port cytology is predictive of recurrence and survival in patients with ovarian cancer. This inexpensive test may serve as an adjunct to imaging and tumor markers to determine disease status at the completion of treatment. Further study should investigate how this may impact management.