Phase I study of debulking surgery and photodynamic therapy for disseminated intraperitoneal tumors

摘要: Abstract Purpose: Phase I study designed to determine the maximum tolerated dose of intraoperative photodynamic therapy (PDT) at laparotomy/debulking surgery in patients with refractory or recurrent, disseminated intraperitoneal tumors. Methods and Materials: Patients received dihematoporphyrin ethers (DHE) 1.5–2.5 mg/kg by i.v. injection prior surgery. resected ≤5 mm residual disease underwent laser light delivery all peritoneal surfaces. Results: Fifty-four entered study. Thirty-nine delivery/PDT. PDT was escalated increasing DHE from 1.5 2.5 mg/kg, shortening interval between 72 48 hr, dose. Initially, 630 nm red alone used. In this group, 2.8–3.0 J/cm 2 induced small bowel edema resulted 3 perforations after resection enterotomy. Further escalation, however, achieved switching less penetrating 514 green bowel/mesentery. later patients, whole supplemented boost doses 10–15 5–7.5 high risk areas. Small complications were not seen light. Dose limiting toxicities occurred highest 5.0 boost. These had pleural effusions that required thoracentesis postoperative respiratory support for 7–9 days, while one a gastric perforation. At potential follow-up times 3.8–43.1 months (median 22.1 months), 3039 are alive 939 free disease. Conclusion: The following debulking performed hr intravenous administration is 3.75 entire surface boosts 5.0–7.5 sites gross encountered