title: A phase II trial of intraperitoneal photodynamic therapy for patients with peritoneal carcinomatosis and sarcomatosis.
abstract: OBJECTIVE
  A previous phase I trial of i.p. photodynamic therapy established the maximally tolerated dose of Photofrin (Axcan Pharma, Birmingham, AL)-mediated photodynamic therapy and showed encouraging efficacy. The primary objectives of this phase II study were to determine the efficacy and toxicities of i.p. photodynamic therapy in patients with peritoneal carcinomatosis and sarcomatosis.
  
  
  METHODS
  Patients received Photofrin 2.5 mg/kg i.v. 48 hours before debulking surgery. Intraoperative laser light was delivered to the peritoneal surfaces of the abdomen and pelvis. The outcomes of interest were (a) complete response, (b) failure-free survival time, and (c) overall survival time. Photosensitizer levels in tumor and normal tissues were measured.
  
  
  RESULTS
  One hundred patients were enrolled into one of three strata (33 ovarian, 37 gastrointestinal, and 30 sarcoma). Twenty-nine patients did not receive light treatment. All 100 patients had progressed by the time of statistical analysis. The median failure-free survival and overall survival by strata were ovarian, 2.1 and 20.1 months; gastrointestinal cancers, 1.8 and 11.1 months; sarcoma, 3.7 and 21.9 months. Substantial fluid shifts were observed postoperatively, and the major toxicities were related to volume overload. Two patients died in the immediate postoperative period from bleeding, sepsis, adult respiratory distress syndrome, and cardiac ischemia.
  
  
  CONCLUSIONS
  Intraperitoneal Photofrin-mediated photodynamic therapy is feasible but does not lead to significant objective complete responses or long-term tumor control. Heterogeneity in photosensitizer uptake and tumor oxygenation, lack of tumor specificity for photosensitizer uptake, and the heterogeneity in tissue optical properties may account for the lack of efficacy observed.
authors.affiliation: Department of Radiation Oncology, Division of Gynecologic Oncology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Hahn
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Fraker
authors.forename: Rosemarie
authors.initials: R
authors.lastname: Mick
authors.forename: James
authors.initials: J
authors.lastname: Metz
authors.forename: Theresa M
authors.initials: TM
authors.lastname: Busch
authors.forename: Debbie
authors.initials: D
authors.lastname: Smith
authors.forename: Timothy
authors.initials: T
authors.lastname: Zhu
authors.forename: Carmen
authors.initials: C
authors.lastname: Rodriguez
authors.forename: Andreea
authors.initials: A
authors.lastname: Dimofte
authors.forename: Francis
authors.initials: F
authors.lastname: Spitz
authors.forename: Mary
authors.initials: M
authors.lastname: Putt
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Rubin
authors.forename: Chandrakala
authors.initials: C
authors.lastname: Menon
authors.forename: Hsing-Wen
authors.initials: HW
authors.lastname: Wang
authors.forename: Daniel
authors.initials: D
authors.lastname: Shin
authors.forename: Arjun
authors.initials: A
authors.lastname: Yodh
authors.forename: Eli
authors.initials: E
authors.lastname: Glatstein
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D017323:Dihematoporphyrin Ether / Q000009:adverse effects / Q000627:therapeutic use*; D004487:Edema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D013471:Sunburn / Q000209:etiology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D017323:Dihematoporphyrin Ether