SAT-474 Gemcitabine Oxaliplatin Combination in Patients with Advanced Adrenocortical Carcinoma

Abstract Disclosure: L. Chen: None. V. Balderrama Brondani: None. L.P. Marcal: None. C. Jimenez: None. J. Varghese: None. A.Y. Shah: None. M.A. Habra: None. M.T. Campbell: None. Background: Adrenocortical cancer (ACC) is a rare and aggressive malignancy with high rates of recurrence and metastasis, with no highly effective systemic therapy available. The standard first-line chemotherapy regimen- etoposide, doxorubicin, and cisplatin (EDP) in combination with mitotane- has a response rate of 23% and a median progression-free survival (PFS) of approximately five months. Due to the rarity of ACC, there is no well-established second-line chemotherapy. While the gemcitabine-oxaliplatin (GemOx) regimen has been used in other malignancies, such as pancreatic carcinoma, its efficacy in ACC remains unreported. Here, we present the first case series evaluating GemOx as salvage therapy in patients with progressive, metastatic ACC. Objective: To assess the efficacy and safety of GemOx in heavily pretreated patients with advanced ACC. Methods: This retrospective case series includes patients with advanced ACC who received GemOx between April 2023 and April 2024. Patients were administered gemcitabine 1000 mg/m² intravenously on days 1 and 8, along with oxaliplatin 130 mg/m², every three weeks. The study protocol (PA 12-0933) was approved by the institutional review board. Baseline characteristics, toxicity profiles, PFS, and overall survival (OS) were reviewed. Tumor response was assessed using RECIST v1.1 criteria by a blinded, independent radiologist through central review. Results: Fourteen patients received GemOx. The median age was 54 years (range: 30-69), and 36% were female. Six patients (43%) had hormonally active ACC. The median number of prior systemic therapy lines was three (range: 1 - 10). Eleven patients (79%) had disease progression on prior immunotherapy, and six (43%) had progressed on prior multikinase inhibitors. The median follow-up was 10.7 months (95% CI: 8.7 - 12.6). The median PFS was 7.9 months (95% CI: 3.6 - 12.2), and the median OS was 13.0 months (95% CI: 4.7 - 21.4). Among the 12 patients evaluable for response, five (41.7%) achieved stable disease as their best response, while seven (58.3%) had progressive disease. Two patients lacked follow-up imaging. No treatment-related deaths occurred. Conclusion/Discussion: GemOx demonstrated promising efficacy as salvage therapy for advanced ACC, with a manageable and anticipated safety profile. Further prospective studies incorporating correlative analyses are warranted to identify predictors of response and explore additional treatment strategies for this challenging patient population. Presentation: Saturday, July 12, 2025