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Ann Surg Oncol. 2011 Sep;18(9):2599-603. doi: 10.1245/s10434-011-1651-1. Epub 2011 Mar 19.

Closed abdomen hyperthermic intraperitoneal chemotherapy with irinotecan and mitomycin C: a phase I study.

Author information

1
Department of Digestive Surgery, Centre Hospitalo-Universitaire Lyon Sud, Hospices Civils de Lyon, Pierre Bénite cedex, France. eddy.cotte@chu-lyon.fr

Abstract

PURPOSE:

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is now a recognized treatment for peritoneal carcinomatosis (PC). The objective of this phase I study is to determine the maximum tolerated dose of irinotecan (CPT-11) when used with mitomycin C (MMC) for closed abdomen HIPEC.

METHODS:

Patients with PC fulfilling the inclusion criteria were studied. All underwent cytoreductive surgery and closed abdomen HIPEC with 0.7 mg/kg MMC and an escalating dose of irinotecan. Grade 4 (National Cancer Institute grading system) surgical and hematological complications were used to identify dose-limiting toxicity (DLT).

RESULTS:

12 patients were studied. At the first dose level of irinotecan (100 mg/m(2)), one patient developed a grade 4 hematological toxicity. Three other patients were included at the same level with no toxicity. Three patients were then included at the second dose level (150 mg/m(2) irinotecan), of whom one developed a grade 4 surgical complication. Three further patients were thus included at the second dose level. Of these three, two patients developed DLT [grade 4 neutropenia in one, grade 4 neutropenia and thrombocytopenia with an intra-abdominal lymphatic fistula requiring reoperation (grade 4 surgical complication) in the other]. Dose escalation was stopped at this level. The maximum tolerated dose of irinotecan was determined to be 100 mg/m(2).

CONCLUSION:

Closed HIPEC combining MMC and irinotecan is safe and feasible. For HIPEC, the maximum tolerated dose of irinotecan is 100 mg/m(2) when used with 0.7 mg/kg MMC.

PMID:
21424369
DOI:
10.1245/s10434-011-1651-1
[Indexed for MEDLINE]

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