Photodynamic therapy trials with lutetium texaphyrin (Lu-Tex) in patients with locally recurrent breast cancer

摘要

Abstract: Photodynamic therapy (PDT) of locally recurrent breastcancer has been limited to treatment of small lesionsbecause of non- selective necrosis of adjacent normaltissues in the treatment field. Lutetium Texaphyrin(PCI-0123, Lu-Tex) is a photosensitizer with improvedtumor localization that is activated by 732 nm light,which can penetrate through larger tumors. We haveevaluated Lu-Tex in a Phase I trial and in an ongoingPhase II trial in women with locally recurrent breastcancer with large tumors who have failed radiationtherapy. Patients received Lu-Tex intravenously byrapid infusion 3 hours before illumination of cutaneousor subcutaneous lesions. In Phase I, Lu-Tex doses wereescalated from 0.6 to 7.2 mg/kg in 7 cohorts. Sixteenpatients with locally recurrent breast cancer lesionswere treated. Dose limiting toxicities above 5.5 mg/kgwere pain in the treatment field during therapy, anddysesthesias in light exposed areas. No necrosis ofnormal tissues in the treated field was noticed.Responses were observed in 60% of evaluable patients$LB@n equals 15, 27% complete remission (CR), 33%partial remission (PR)$RB@, with 63% of lesionsresponding (n equals 73: 45% CR, 18% PR). In Phase II,25 patients have been studied to date, receiving twotreatments ranging from 1.0 to 3.0 mg/kg at a 21 dayinterval. Treatment fields up to 480 cm$+2$/ in sizewere treated successfully and activity has beenobserved. Patients have experienced pain at thetreatment site but no tissue necrosis. These studiesdemonstrate the feasibility of Lu-Tex PDT to largechest wall areas in women who have failed radiationtherapy for the treatment of locally recurrent breastcancer. Treatment conditions are currently beingoptimized in the ongoing Phase II trials. !8