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Purpose/objective(s): The purpose of this study was to compare clinical outcomes between black and white females treated with curative intent for vulvar squamous cell carcinoma (VSCC) and identify factors that correlate with locoregional control (LRC) and survival.Materials/methods: Patients with VSCC treated with either adjuvant or definitive radiotherapy with curative intent from 2009-2020 within our multi-center academic medical system were retrospectively analyzed. Patient and treatment-specific factors were evaluated. Kaplan-Meier and Univariate Cox proportional hazards models were used to estimate and assess factors correlated with LRC, progression free survival (PFS) and overall survival (OS). Comparisons between groups were performed using the log-rank test.Results: We identified 39 patients with VSCC treated with curative intent; 43% (n = 17) received adjuvant RT and 56% (n = 22) received definitive RT to a median dose of 59.4 Gy and 64.4 Gy, respectively. Thirty-four patients received external beam radiation therapy (EBRT) alone, 5 pts received EBRT plus brachytherapy and 22 patients received concurrent chemotherapy. The cohort was comprised of 22 black patients (BP) and 17 white patients (WP) with a median age of 62 (range: 32-93) and 68 (38-98), respectively. Median follow up for the entire cohort was 12.5 months (Q1-Q3: 2.8-31.3mos) for all patients and 14.9 months (3.8-33.2) for alive patients. BP were significantly more likely to present with clinical FIGO stage I/II (73% vs 24%, P = 0.002), undergo surgical resection (68% vs 18%, P = 0.002) and to have HPV-positive tumors (55% versus 29%, P = 0.012). 6 BP were HIV-positive versus 0 WP. There was no difference between the groups in relation to smoking status (P = 0.72). The complete response rate was 86% (n = 19) among BP (FIGO stage I; n = 9, II; n = 4, III; n = 4, IVA; n = 2) versus 59% (n = 10) among WP (I; n = 1, II; n = 1, III; n = 6, IVA; n = 2), (P = 0.51). One-year estimated LRC, PFS and OS were 100% versus 66% (P = 0.001), 100% versus 50% (P < 0.001) and 95% versus 70% (P = 0.04) for BP versus WP, respectively. On univariate analysis, only complete response to treatment (P < 0.001) and race were significantly associated with LRC and survival.Conclusion: This data demonstrates high response rates and local control for early stage VSCC, which primarily included BP in this cohort. Further exploration is needed to understand the etiology behind these differences. These data suggest a potential role for therapeutic stratification to optimize outcomes and decrease late toxicity.Author Disclosure: J.S. Remick: None. N.S. McCall: Honoraria; PrecisCA.N. Khanna: None. J.W. Shelton: None. S. Hanasoge: None. P.R. Patel: None. A.B. Patel: Honoraria; American College of Radiology. T. Cole: None. A. McCook: None. A.N. Gordon: None. C. Han: None. K. Starbuck: None. J. Switchenko: None. T.Y. Eng: Stock; Amgen. [ABSTRACT FROM AUTHOR]

Purpose/objective(s): Definitive or adjuvant radiotherapy (RT) for vulvar squamous cell carcinoma (VSCC) is associated with significant toxicity that can negatively impact a patient's health-related quality of life (HRQoL). Given the rarity of this disease, data on the incidence of acute and late severe toxicity as well as the real-world late-symptom burden from a modern cohort are lacking.Materials/methods: Patients with VSCC treated with adjuvant or definitive radiotherapy with curative intent from 2009-2020 within our multi-center academic medical system were retrospectively analyzed. Treatment-related acute and late (≥3 months after RT) grade 3 or greater toxicities assessed by CTCAE version 5.0 were recorded. All provider-reported subjective symptoms (PRSS) documented from the date of RT completion to the date of last follow up were recorded. Kaplan-Meier model was used to estimate one-year overall survival (OS) and progression-free survival (PFS).Results: Thirty-nine patients received either definitive (n = 22, 56.4%) or adjuvant (n = 17, 43.6%) RT to a median dose of 64.4 Gy and 59.4 Gy, respectively. Five patients (3 definitive, 2 adjuvant) received a brachytherapy boost with a median total EQD2 of 84.3 Gy. Intensity-modulated or volumetric-modulated arc RT was used in 34 (87.2%) of patients, and 22 patients (56.4%) received concurrent chemotherapy. Median follow up time was 12.5 months (Q1-Q3: 2.8-31.3 months) for all patients and 14.9 months (3.8-33.2) for alive patients. Seventy-four percent of patients (FIGO Stage I; n = 10, II; n = 5, III; n = 10, IVA; n = 4) had a complete response based on clinical (n = 26) or pathologic (n = 3) criteria, including 16 treated with adjuvant RT and 13 treated with definitive RT. The 1-year estimated OS and PFS were 90.4% and 90.5%, respectively. The incidence of acute grade ≥3 toxicity was 35.9% (n = 14). Acute grade ≥3 skin toxicity was most common (n = 10, 25.6%), followed by urinary (n = 1, 2.6%), gastrointestinal (n = 1, 2.6%), hematologic (n = 1, 2.6%), and fatigue (n = 1, 2.6%). Five (12.8%) patients experienced late grade ≥3 toxicity, including 2 patients (5.1%) with grade 3 dermatologic toxicity, 2 patients (5.1%) with grade 4 skin toxicity, and 1 patient (2.6%) with grade 3 gastrointestinal toxicity. Among the 32 patients with PRSS data available, 6 (15.3%) reported dyspareunia or inability to have sexual intercourse, 5 (12.8%) noted skin discoloration or fibrosis, 11 (28.2%) reported long-term vaginal pain or irritation, and 8 (20.5%) required long-term opiate pain medication.Conclusion: RT for VSCC is associated with considerable rates of severe acute and late toxicity as well as PRSS that affect both a patient's physical functioning and HRQoL. Taken together with the high rates of disease control and survival, these data argue for improved patient-reported outcome measures and investigation of therapeutic de-escalation strategies.Author Disclosure: N.S. McCall: Honoraria; PrecisCA.T.Y. Eng: Stock; Amgen. J.W. Shelton: None. S. Hanasoge: None. P.R. Patel: None. A.B. Patel: Honoraria; American College of Radiology. A. McCook: None. J. Switchenko: None. T. Cole: None. N. Khanna: None. C. Han: None. A.N. Gordon: None. K. Starbuck: None. J.S. Remick: None. [ABSTRACT FROM AUTHOR]