Detection of Residual Peritoneal Metastases Following Cytoreductive Surgery Using Pegsitacianine, a pH-Sensitive Imaging Agent: Final Results from a Phase II Study.

BACKGROUND: For patients with peritoneal carcinomatosis, extent of disease and completeness of cytoreductive surgery (CRS) are major prognostic factors for long-term survival. Assessment of these factors could be improved using imaging agents. Pegsitacianine is a pH-sensitive polymeric micelle conjugated to the fluorophore indocyanine green. The micelle disassembles in acidic microenvironments, such as tumors, resulting in localized fluorescence unmasking. We assessed the utility of pegsitacianine in detecting residual disease following CRS. PATIENTS AND METHODS: NCT04950166 was a phase II, non-randomized, open-label, multicenter US study. Patients eligible for CRS were administered an intravenous dose of pegsitacianine at 1 mg/kg 24-72 h before surgery. Following CRS, the peritoneal cavity was reexamined under near-infrared (NIR) illumination to evaluate for fluorescent tissue. Fluorescent tissue identified was excised and evaluated by histopathology. The primary outcome was the rate of clinically significant events (CSE), defined as detection of histologically confirmed residual disease excised with pegsitacianine or a revision in the assessment of completeness of CRS. Secondary outcomes included acceptable safety and pegsitacianine performance. RESULTS: A total of 53 patients were screened, 50 enrolled, and 40 were evaluable for CSE across six primary tumor types. Residual disease was detected with pegsitacianine in 20 of 40 (50%) patients. Pegsitacianine showed high sensitivity and was well tolerated with no serious adverse events (SAEs). Transient treatment-related, non-anaphylactic infusion reactions occurred in 28% of patients. CONCLUSIONS: Pegsitacianine was well tolerated and facilitated the recognition of occult residual disease following CRS. The high rate of residual disease detected suggests that the use of pegsitacianine augmented surgeon assessment and performance during CRS.

Transvaginal ureteroneocystostomy.

Ureteral injury is a known complication of gynecologic surgery with potential long-term sequelae. Traditional management of significant ureteral injury recognized at the time of transvaginal pelvic organ prolapse repair is a transabdominal re-implantation procedure using a transabdominal open or laparoscopic approach. We present a case describing a transvaginal approach for ureteroneocystostomy. During a transvaginal pelvic organ prolapse repair, a ureteral transection was noted. A transvaginal ureteroneocystostomy was performed. There was primary healing of the ureteroneocystostomy without sequelae during a 6-month follow-up period.

Take me to your leader: Reporting structures and equity in academic gynecologic oncology.

OBJECTIVE: Gynecologic oncology includes increasing percentages of women. This study characterizes representation of faculty by gender and subspecialty in academic department leadership roles relevant to the specialty. METHODS: The American Association of Medical Colleges accredited schools of medicine were identified. Observational data was obtained through institutional websites in 2019. RESULTS: 144 accredited medical schools contained a department of obstetrics and gynecology with a chair; 101 a gynecologic oncology division with a director; 98 a clinical cancer center with a director. Women were overrepresented in academic faculty roles compared to the US workforce (66 vs 57%, p < 0.01) but underrepresented in all leadership roles (p < 0.01). Departments with women chairs were more likely to have >50% women faculty (90.2 vs 9.8%, p < 0.01); and have larger faculties (80.4 vs 19.6% >20 faculty, p = 0.02). The cancer center director gender did not correlate to departmental characteristics. A surgically focused chair was also associated with >50% women faculty (85.7 vs 68.3%, p = 0.03); faculty size >20 (85.7 vs 61.4%, p < 0.01); and a woman gynecologic oncology division director (57.6 vs 29.4%, p < 0.01; 68.4 vs 31.7%, p < 0.01) and gynecologic oncology fellowship (50 vs 30.4%, p < 0.01; 59.1 vs 32%, p < 0.01). Gynecologic oncology leadership within cancer centers was below expected when incidence and mortality to leadership ratios were examined (p < 0.01, p < 0.01). CONCLUSION: Within academic medical schools, women remain under-represented in obstetrics and gynecology departmental and cancer center leadership. Potential benefits to gynecologic oncology divisions of inclusion women and surgically focused leadership were identified.