Annals of surgical oncology · 2026
Efficacy and Safety of Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy for Recurrent Uterine Leiomyosarcoma: Results of a Phase 2 Study.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Sun Beatrice J, Zhou Maggie Y, Lohman Marti, Mokhtari Ryan, Siy Amanda, Cunanan Kristen, Ganjoo Kristen N, Lee Byrne
Аннотация
BACKGROUND: Uterine leiomyosarcoma (uLMS) is an aggressive malignancy with high rates of peritoneal recurrence and poor survival. Although surgery for recurrent uLMS has shown encouraging results, addition of hyperthermic intraperitoneal chemotherapy (HIPEC) is not well described. We evaluate safety and efficacy of cytoreductive surgery (CRS)-HIPEC with gemcitabine followed by systemic dacarbazine for recurrent uLMS.
PATIENTS AND METHODS: This was an open-label, single-arm phase 2 study of patients with recurrent uLMS who underwent CRS-HIPEC at a single tertiary center (March 2021-May 2025). HIPEC was performed for 60 min with gemcitabine (1000 mg/m2), followed by six doses of adjuvant dacarbazine (1000 mg/m2). Primary study objective was 1-year progression-free survival. Secondary outcomes were adverse events, intraperitoneal recurrence, and quality of life.
RESULTS: A total of 17 patients underwent CRS-HIPEC with gemcitabine for recurrent uLMS (median 55 years). Most patients had received prior systemic therapy (76%) and undergone at least two operations for uLMS (65%). Median PFS was 11 months, significantly longer than historical control of 3 months (p < 0.001). Median OS was not reached at follow up time over 3 years. The study was closed early due to slow accrual: at time of closure, two patients remained without evidence of disease recurrence. Median PCI was 7; all patients achieved CCR 0. There were no Clavien-Dindo grade 3 complications, and median postoperative stay was 7 days. Two patients experienced grade 4 toxicities (hypokalemia and neutropenia).
CONCLUSIONS: CRS with gemcitabine HIPEC and adjuvant systemic chemotherapy is feasible without increased morbidity and has potential to improve outcomes and achieve long-term survival in patients with recurrent uLMS.
PATIENTS AND METHODS: This was an open-label, single-arm phase 2 study of patients with recurrent uLMS who underwent CRS-HIPEC at a single tertiary center (March 2021-May 2025). HIPEC was performed for 60 min with gemcitabine (1000 mg/m2), followed by six doses of adjuvant dacarbazine (1000 mg/m2). Primary study objective was 1-year progression-free survival. Secondary outcomes were adverse events, intraperitoneal recurrence, and quality of life.
RESULTS: A total of 17 patients underwent CRS-HIPEC with gemcitabine for recurrent uLMS (median 55 years). Most patients had received prior systemic therapy (76%) and undergone at least two operations for uLMS (65%). Median PFS was 11 months, significantly longer than historical control of 3 months (p < 0.001). Median OS was not reached at follow up time over 3 years. The study was closed early due to slow accrual: at time of closure, two patients remained without evidence of disease recurrence. Median PCI was 7; all patients achieved CCR 0. There were no Clavien-Dindo grade 3 complications, and median postoperative stay was 7 days. Two patients experienced grade 4 toxicities (hypokalemia and neutropenia).
CONCLUSIONS: CRS with gemcitabine HIPEC and adjuvant systemic chemotherapy is feasible without increased morbidity and has potential to improve outcomes and achieve long-term survival in patients with recurrent uLMS.