Hadi Erfani

PURPOSE: Despite a shift toward targeted therapies and immunotherapies, enrollment to phase I clinical trials for patients with solid tumor remains challenging. Historically, racial and ethnic minority populations are under-represented in clinical trial enrollment in the United States. Multiple barriers exist, including geographic distance from academic centers, restrictive eligibility criteria, and provider or patient factors. The University of Southern California (USC) Norris Comprehensive Cancer Center (USC Norris) clinical sites include both a private hospital and a safety-net hospital. In this report, we describe demographics and outcomes of patients enrolled to phase I clinical trials based on site of care. METHODS: Patients enrolled to early-phase clinical trials at USC Norris between January 1, 2015, and December 31, 2022, were included in this study. Patient demographics and outcomes were recorded in a database. RESULTS: Between January 1, 2015, and December 31, 2022, there were 611 patients enrolled. In all, 43.2% of patients enrolled were non-Hispanic White, followed by 26.2% Hispanic White, 20.6% Asian, 4.9% unknown, 3.9% non-Hispanic Black, and <1% each of American Indian/Alaskan Native or Native Hawaiian/Pacific Islander. The median overall survival was 6.5 months. The median progression-free survival was 2.3 months. The best response was complete response in 1.0%, partial response in 6.4%, stable disease in 36.8%, progression of disease in 44.5%, and not evaluable in 11.3%. The overall response rate was 7.4%. CONCLUSION: Enrollment of patients into early-phase clinical trials for solid tumors is challenging, but it is feasible to enroll patients both in a private hospital setting and in a safety-net hospital. Patient outcomes are similar regardless of enrollment site, and racial/ethnic diversity is increased compared with historic national averages in the United States.

In this review, we aim to evaluate the current literature on reproductive and oncologic outcomes after fertility-sparing surgery for early-stage cervical cancer (stage IA1-IB1). This is a systematic review of the existing literature using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist to report on fertility-sparing surgery and its outcomes in early-stage cervical cancer. Outcomes of interest were subsequent clinical pregnancy rate, reproductive outcomes, and cancer recurrence outcomes. Included in this systematic review were 68 studies encompassing 3,592 patients who underwent fertility-sparing surgery. Of these, reproductive outcomes were reported in 1096 pregnancies. The mean clinical pregnancy rate was 53.2%. Those who underwent vaginal radical trachelectomy had the highest clinical pregnancy rate (67.5%). The mean live birth rate was 67.8% in our study. Twenty-one percent of pregnancies after fertility-sparing surgery required assisted reproductive technology. The mean cancer recurrence rate was 3.2%, and the cancer death rate was 0.6% after a median follow-up period of 40.1 months with no statistically significant difference across surgical approaches. Offering fertility-sparing surgery in early-stage cervical cancer is reasonable. Highest clinical pregnancy rate is associated with vaginal radical trachelectomy. Moreover oncologic outcomes of minimally invasive approaches were comparable with abdominal approaches. We encourage detailed preoperative counseling and multidisciplinary approach to achieve best outcomes.

Objective: To evaluate whether elective preterm delivery (ED) at 34 weeks is of postnatal benefit to infants with isolated gastroschisis compared with routine obstetric care (RC).Methods: Between May 2013 and September 2015, all women with a sonographic diagnosis of fetal gastroschisis referred to a single tertiary center, before 34 weeks' gestation, were invited to participate in this study. Eligible patients were randomized to ED (induction of labor at 34 weeks) or RC (spontaneous labor or delivery by 37–38 weeks, based on standard obstetric indications). The primary outcome measure was length of time on total parenteral nutrition (TPN). Secondary outcomes were time to closure of gastroschisis and length of stay in hospital. Outcome variables were compared using appropriate statistical methods. Analysis was based on intention‐to‐treat.Results: Twenty‐five women were assessed for eligibility, of whom 21 (84%; 95% CI, 63.9–95.5%) agreed to participate in the study; of these, 10 were randomized to ED and 11 to RC. The trial was stopped at the first planned interim analysis due to patient safety concerns and for futility; thus, only 21 of the expected 86 patients (24.4%; 95% CI, 15.8–34.9%) were enrolled. Median gestational age at delivery was 34.3 (range, 34–36) weeks in the ED group and 36.7 (range, 27–38) weeks in the RC group. One patient in the ED group delivered at 36 weeks following unsuccessful induction at 34 weeks. Neonates of women who underwent ED, compared to those in the RC group, showed no difference in the median number of days on TPN (54 (range, 17–248) vs 21 (range, 9–465) days; P = 0.08), number of days to closure of gastroschisis (7 (range, 0–15) vs 5 (range, 0–8) days; P = 0.28) and length of stay in hospital (70.5 (range, 22–137) vs 31 (range, 19–186) days; P = 0.15). However, neonates in the ED group were significantly more likely to experience late‐onset sepsis compared with those in the RC group (40% (95% CI, 12.2–73.8%) vs 0%; P = 0.03).Conclusion: This study demonstrates no benefit of ED of fetuses with gastroschisis when postnatal gastroschisis management is similar to that used in routine care. Rather, the data suggest that ED is detrimental to infants with gastroschisis. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.