MP53-01: Toxicity of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Pediatric Patients with Rhabdomyosarcoma: Early Experience and Results of a Phase 1 Trial
Introduction: Soft-tissue sarcomas as a group comprise the most common type of extra-cranial solid tumor type in children. Most soft-tissue sarcomas diagnosed in children are rhabdomyosarcoma (RMS). Rapid growth and aggressive metastatic spread are major factors in severely decreasing the prognosis of patients with this condition, and current therapies for recurrence of intraperitoneal malignancies have not provided an increase in survival over several decades. HIPEC has been demonstrated to improve survival in several adult peritoneal malignancies. Similarly, in children cytoreduction and HIPEC have been applied to some pediatric malignancies with promising results. We aim to evaluate toxicities of pediatric RMS patients treated with continuous perfusion of hyperthermic intraperitoneal cisplatin + doxorubicin Methods: This is a single-arm feasibility and safety study. Pediatric patients with resectable primary refractory or recurrent intra-abdominal RMS tumors treated with HIPEC (CIS+DOXO) from June of 2019 to June of 2022 were included in the analysis. Patients with mets not limited to peritoneum, prior HIPEC, active infection or systemic illness were excluded from the study. Clinical and demographic variables, adverse events within 30 days post-Op, recurrence free survival (RFS) and overall survival (OS) were compiled and stratified Results: A total of n=6 participants were included in the analysis. The cohort was comprised mostly of female patients (83%), Bladder was the most common primary tumor location (50%) and Embryonal was the most common subtype (83%). Median OS of the cohort was 20.4±6.6 months, non-deceased patients have had a median survival of 36±7.5 months and mean RFS of 14 months. 50% of the cohort evolve without a grade =3 adverse event [CTCAE v4]. Table Conclusions: We conclude that the study technique is reasonably well tolerated in pediatric patients with refractory or recurrent intra-abdominal RMS tumors. The efficacy of Cytoreductive Surgery and HIPEC in pediatric RMS patients needs further evaluation with a larger cohort of patients SOURCE OF Funding: None
