Faculty Bibliography

Background Dostarlimab is a humanized programmed death 1 (PD-1) receptor monoclonal antibody that blocks interaction with the ligands PD-L1 and PD-L2. Dostarlimab is approved as a monotherapy in adult patients (pts) with mismatch repair deficient (dMMR; US) or dMMR/microsatellite-instability high (EU) recurrent or advanced endometrial cancer that has progressed progressing on or following prior treatment with a platinum-containing regimen. GARNET is a phase 1 study assessing antitumor activity and safety of dostarlimab monotherapy in pts with solid tumors. Methods Pts with dMMR solid tumors, mismatch repair proficient endometrial cancer, and non-small cell lung cancer that progressed on or after prior therapy received 500 mg of dostarlimab IV every 3 weeks (Q3W) for 4 cycles, then 1000 mg IV every 6 weeks (Q6W) for up to 2 years or until disease progression or discontinuation. Here, we report TRAEs by cycle. Results A total of 515 pts were included. Of these pts, 60 (11.7%) experienced TRAEs leading to treatment interruption, and 25 (4.9%) experienced TRAEs leading to discontinuation. TRAEs of any grade with overall incidence of >=10% of pts are shown (table 1). The majority of TRAEs occurred during cycles 1-3, with highest incidence during cycle 1. Grade 3 or 4 TRAEs were rare; those seen in >=1% of pts are shown. Immune-related (ir) TRAEs of any grade with overall incidence of >=2% of pts are shown. Most cases (96.9%) of irTRAEs occurred during cycles 1-8. The peak incidence of hypothyroidism occurred during cycle 4; in addition, frequency was increased during cycles 5-8, compared with cycles 1-4. No deaths were attributed to dostarlimab. Abstract 370 Table 1 Time course of adverse events in the GARNET trial Conclusions No new safety signals were detected with dostarlimab compared to other anti-PD-1 inhibitors. Most TRAEs were low grade. The majority of TRAEs and grade >=3 TRAEs occurred in the first 3 cycles (first 12 weeks), but some cases occurred later, suggesting a need for ongoing monitoring. Few increases in the incidence of TRAEs were seen during cycle 5 following the transition to the 1000-mg Q6W dosing schedule; the TRAEs with increased incidence after the transition were fatigue and lipase increased. An increase in the frequency of the irTRAE hypothyroidism was seen after transitioning to the 1000-mg Q6W schedule

OBJECTIVES/OBJECTIVE:We evaluated the incidence of breast cancer and overall survival in a multi-center cohort of ovarian cancer patients carrying BRCA1/2 mutations in order to assess risks and formulate optimal preventive interventions and/or surveillance. METHODS:Medical records of 502 BRCA1/2 mutation carriers diagnosed with ovarian cancer between 2000 and 2018 at 7 medical centers in Israel and one in New York were retrospectively analyzed for breast cancer diagnosis. Data included demographics, type of BRCA mutations, surveillance methods, timing of breast cancer diagnosis, and family history of cancer. RESULTS:The median age at diagnosis of ovarian cancer was 55.8 years (range, 23.9-90.1). A third (31.5%) had a family history of breast cancer and 17.1% of ovarian cancer. Most patients (67.3%) were Ashkenazi Jews, 72.9% were BRCA1 carriers. Breast cancer preceded ovarian cancer in 17.5% and was diagnosed after ovarian cancer in 6.2%; an additional 2.2% had a synchronous presentation. Median time to breast cancer diagnosis after ovarian cancer was 46.0 months (range, 11-168). Of those diagnosed with both breast cancer and ovarian cancer (n = 31), 83.9% and 16.1% harbored BRCA1 and BRCA2 mutations, respectively. No deaths from breast cancer were recorded. Overall survival did not differ statistically between patients with an ovarian cancer diagnosis only and those diagnosed with breast cancer after ovarian cancer. CONCLUSION/CONCLUSIONS:The low incidence of breast cancer after ovarian cancer in women carrying BRCA1/2 mutations suggests that routine breast surveillance, rather than risk-reducing surgical interventions, may be sufficient in ovarian cancer survivors.

Background/UNASSIGNED:Medical marijuana (MM) use is common among cancer patients, but relatively little is known about the usage patterns and efficacy of MM used by gynecologic cancer patients. Methods/UNASSIGNED:Demographic and clinical data were collected for gynecologic cancer patients prescribed MM between May 2016 and February 2019. The electronic medical record was used to query formulation prescribed, usage patterns, length of use, symptom relief, and side effect profile. Descriptive statistics were calculated. Results/UNASSIGNED:Of 45 gynecologic cancer patients prescribed MM, 89% were receiving chemotherapy; 56% were undergoing primary treatment. MM was used for a median of 5.2 months (range 0.6-25.4). Over 70% of patients reported improvement in nausea/vomiting, compared to 36% of patients using MM for pain relief (p = 0.02). Of 41 patients with follow-up information, 71% found MM improved at least one symptom. Conclusions/UNASSIGNED:Among a small sample of gynecologic cancer patients prescribed MM for symptom management, self-reported follow-up indicated symptom relief for the majority of patients and minimal therapy-related side effects. This data can prove useful for counseling gynecologic cancer patients on the efficacy and side effects of MM.

Objectives: Minimally invasive surgery (MIS) is the standard of care for gynecologic and gynecologic oncology conditions. For large specimen retrieval, morcellation is a controversial option due to concerns of undetected malignancy and dissemination. Our objective was to compare safety and discharge outcomes for patients with mini-laparotomy (ML) versus morcellation for large specimen retrieval during robotic cases.
Method(s): In this retrospective cohort study of patients who underwent robotic gynecologic surgery (RGS) from January 2013 to June 2016, we compared intraoperative and postoperative outcomes for patients undergoing ML or morcellation. Mode of specimen delivery was at the discretion of the surgeon. The ML group consisted of patients who at the completion of RGS underwent an abdominal ML incision and the morcellation group consisted of patients who underwent manual or power morcellation for specimen delivery. Outcomes were analyzed using Mann-Whitney U test, Chi-squared/Fisher's exact tests, and multivariate logistic models.
Result(s): Of the 2,126 patients undergoing RGS, 154 (7.2%) underwent a ML for specimen retrieval and 834 (39.2%) underwent specimen removal with morcellation. Median age was greater for the ML compared to morcellation (45 [IQR 37.1-52.8] vs 40 [IQR 35.0-46.0]; p<0.001), but median body mass index (26.1 [IQR 22.6-32.2] vs 25.7 22.6-30.2]; p=0.31) and proportion of patients with >=3 comorbidities (9.1% vs 6.5%; p=0.32) were similar between groups. Twenty-one (13.6%) patients with ML were undergoing surgery for cancer diagnosis, compared to 1 (0.1%) patient with morcellation (p<0.001). Patients with ML had significantly heavier specimen weights, (median 386.3 g [IQR 245.0-641.0] vs 280.0 g [IQR 114.0-510.0]; p<0.001), estimated blood loss (EBL, median 122.5 mL [IQR 50.0-250.0] vs 100.0 mL [IQR 50.0-250.0]; p=0.03), and longer operative time (median 211.0 min [IQR 162.3-67.0] vs 178.0 min [IQR 135.0-233.7]; p<0.001). Both groups had similar times to discharge (median 7.5 hour [IQR 4.9-17.4] vs 7.5 hour [IQR 5.5-11.0]; p=0.81), but patients with ML were less likely to have same day discharge (67.5% vs 77.0%; p=0.02). Complications (13.6% vs 9.7%; p=0.19), wound infection (1.9% vs 1.9%; p=1.00), post-operative blood transfusion (0.6% vs 0.5%; p=0.57), and re-admission (1.3% vs 1.1%; p=0.69) were similar between ML and morcellation groups. In multivariable analysis, there was no difference in same day discharge between ML and morcellation groups after controlling for age, cancer diagnosis, and operative time (odds ratio=0.94; 95% CI (0.59-1.46); p=0.78). [Formula presented]
Conclusion(s): Despite increased EBL and operative time, ML for specimen retrieval does not affect postoperative outcomes such as time to discharge, wound infection, complications, need for blood transfusion, or re-admission rates. These results highlight that ML may play an important role when removing large specimens while still enabling patients to have a successful MIS procedure and same day discharge.
Copyright

The GOG Foundation, Inc. (GOG-F) is a non-profit 501(c)(3) organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. GOG Partners (GOG-P) is a program of the GOG-F and is positioned alongside NRG Oncology under the GOG-F organizational umbrella. GOG-P operates outside of the federally funded NCI NRG Oncology, a key distinguishing feature. By functioning as a site management organization (SMO), GOG-P provides an additional platform for clinical trial development, mentorship opportunities, patient accrual, and site infrastructure support yielding an expanded gynecologic oncology clinical trials infrastructure in the US. GOG-P has a consistent track record of conducting high quality clinical trials that lead to bringing novel FDA approved treatments for gynecologic cancer. This manuscript summarizes the history and organizational structure of the GOG-P. In addition, we outline the other key supportive programs within the GOG-F that help support the GOG-P effort to perform transformative gynecologic cancer research.

BACKGROUND:Mounting evidence suggests disproportionate coronavirus disease 2019 (COVID-19) hospitalizations and deaths because of racial disparities. The association of race in a cohort of gynecologic oncology patients with severe acute respiratory syndrome-coronavirus 2 infection is unknown. METHODS:Data were abstracted from gynecologic oncology patients with COVID-19 infection among 8 New York City area hospital systems. A multivariable mixed-effects logistic regression model accounting for county clustering was used to analyze COVID-19-related hospitalization and mortality. RESULTS:Of 193 patients who had gynecologic cancer and COVID-19, 67 (34.7%) were Black, and 126 (65.3%) were non-Black. Black patients were more likely to require hospitalization compared with non-Black patients (71.6% [48 of 67] vs 46.0% [58 of 126]; P = .001). Of 34 (17.6%) patients who died from COVID-19, 14 (41.2%) were Black. Among those who were hospitalized, compared with non-Black patients, Black patients were more likely to: have ≥3 comorbidities (81.1% [30 of 37] vs 59.2% [29 of 49]; P = .05), to reside in Brooklyn (81.0% [17 of 21] vs 44.4% [12 of 27]; P = .02), to live with family (69.4% [25 of 36] vs 41.6% [37 of 89]; P = .009), and to have public insurance (79.6% [39 of 49] vs 53.4% [39 of 73]; P = .006). In multivariable analysis, among patients aged <65 years, Black patients were more likely to require hospitalization compared with non-Black patients (odds ratio, 4.87; 95% CI, 1.82-12.99; P = .002). CONCLUSIONS:Although Black patients represented only one-third of patients with gynecologic cancer, they accounted for disproportionate rates of hospitalization (>45%) and death (>40%) because of COVID-19 infection; younger Black patients had a nearly 5-fold greater risk of hospitalization. Efforts to understand and improve these disparities in COVID-19 outcomes among Black patients are critical.

INTRODUCTION/BACKGROUND:In 2014, the Society of Gynecologic Oncology's Clinical Practice Committee published a clinical update reviewing the treatment of women with endometrial cancer. At that time, there had been significant advances in the diagnosis, work-up, surgical management, and available treatment options allowing for more optimal care of affected women. Despite these advances, the incidence of endometrial cancer as well as the deaths attributable to the disease have continued to rise; from 1987 to 2014 there has been a 75% increase in cases and almost 300% increase in endometrial cancer deaths. Fortunately, since then, there has been progress in the treatment of patients with endometrial cancer with increased utilization of molecular pathology, greater understanding of genetic predisposition, enhanced methods for lymph node assessment, a broader understanding of the efficacy of radiation and chemotherapy, and a more efficient approach to survivorship and surveillance. The purpose of this document is to present a comprehensive review of this progress. MANUSCRIPT DEVELOPMENT PROCESS/UNASSIGNED:The authors reviewed the available evidence, contributed to the development of this manuscript, provided critical review of the guidelines, and finalized the manuscript recommendations. The review was also presented to and approved by the Society of Gynecologic Oncology (SGO) Clinical Practice Committee, SGO Publications Committee, and the SGO board members prior to submission for publication. The recommendations for this manuscript were developed by a panel of gynecologic oncologists who were members of the SGO Clinical Practice and Education Committees. Panelists reviewed and considered evidence from current uterine cancer literature. The terminology used in these guidelines was adopted from the ASCCP management guidelines [1] using a two-part rating system to grade the strength of recommendation and quality of evidence (Table 1). The rating for each recommendation is given in parentheses.

In 2014, the Society of Gynecologic Oncology's Clinical Practice Committee published a clinical update reviewing the treatment of women with endometrial cancer. At that time, there had been significant advances in the diagnosis, work-up, surgical management, and available treatment options allowing for more optimal care of affected women. This manuscript, Part II in a two-part series, includes specific recommendations on treatment of recurrent disease, post treatment surveillance and survivorship, considerations for younger women, and special situations. Part I covered histopathology and molecular pathology, risk factors, presentation and diagnostic approach, surgical approach and adjuvant therapy.

Despite the impact of the COVD-19 pandemic and public health crisis on health care delivery, the GOG-Foundation has continued to prioritize the delivery of novel and state-of-the-science treatment options to patients via clinical trials.