IngentaConnect Phase I Trial of Pegylated Liposomal Doxorubicin with Hyperthermi...

Abstract:

Cytoreduction coupled with hyperthermic intraperitoneal chemotherapy (HIPEC) is an attractive treatment option for a select group of patients with abdominal-only malignancy. The present phase I study examined the safety and pharmacokinetics of intraperitoneal pegylated liposomal doxorubicin (PLD) used in the context of HIPEC in patients with advanced abdominal-only malignancies.

Patients with advanced abdominal malignancies underwent maximal cytoreduction and HIPEC with escalating doses of PLD (15-100 mg/m²). Perfusate, serum, and tissue doxorubicin levels were measured in five patients undergoing HIPEC at the maximum tolerated dose.

Twenty-one patients were enrolled in this trial. The maximum dose evaluated in this trial was 100 mg/m² and was well tolerated. The most common grade 3/4 complications were superficial wound infection and prolonged ileus. One patient developed an anastomotic leak in the postoperative period, requiring re-exploration. The median postoperative length of stay was 7 days (range, 4-29 days), three patients required readmissions within 30 days, and there were no operative mortalities The median follow-up time for was 13.7 months (range, 3-38 months). The median overall survival was 30.6 months with a median disease-free survival of 25 months.

We report that HIPEC with PLD following maximal cytoreduction in patients with advanced abdominal-only gastrointestinal or gynecologic malignancies is well tolerated. Encouraging survival after cytoreduction and HIPEC with PLD suggest that a phase II trial to verify activity is indicated.

Keywords: Phase I; Doxorubicin; Hyperthermia; Cytoreduction; Liposomal

Document Type: Research article

DOI: 10.1245/s10434-007-9718-8

Affiliations: 1: Division of Surgical Oncology, UMDNJ—New Jersey Medical School, 185 South Orange Ave, Newark, NJ, 07103, USA, Email: L.Harrison@umdnj.edu 2: Medical Oncology, UMDNJ—New Jersey Medical School, 185 South Orange Ave, Newark, NJ, 07103, USA

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Phase I Trial of Pegylated Liposomal Doxorubicin with Hyperthermic Intraperitoneal Chemotherapy in Patients Undergoing Cytoreduction for Advanced Intra-abdominal Malignancy