title: Phase II study of treatment of advanced ovarian cancer with folate-receptor-targeted therapeutic (vintafolide) and companion SPECT-based imaging agent (99mTc-etarfolatide).
abstract: BACKGROUND
  This report examines (99m)Tc-etarfolatide imaging to identify the presence of folate receptor (FR) on tumors of women with recurrent/refractory ovarian or endometrial cancer and correlates expression with response to FR-targeted therapy (vintafolide).
  
  
  METHODS
  In this phase II, single-arm, multicenter study, patients with advanced ovarian cancer were imaged with (99m)Tc-etarfolatide before vintafolide treatment. Up to 10 target lesions (TLs) were selected based on Response Evaluation Criteria In Solid Tumors criteria using computed tomography scans. Single-photon emission computed tomography images of TLs were assessed for (99m)Tc-etarfolatide uptake as either FR positive or negative. Patients were categorized by percentage of TLs positive and grouped as FR(100%), FR(10%-90%), and FR(0%). Lesion and patient response were correlated with etarfolatide uptake.
  
  
  RESULTS
  Forty-nine patients were enrolled; 43 were available for analysis. One hundred thirty-nine lesions were (99m)Tc-etarfolatide evaluable: 110 FR positive and 29 FR negative. Lesion disease control rate (DCR = stable or response) was observed in 56.4% of FR-positive lesions versus 20.7% of FR-negative lesions (P < 0.001). Patient DCR was 57%, 36%, and 33% in FR(100%), FR(10%-90%), and FR(0%) patients, respectively. Median overall survival was 14.6, 9.6, and 3.0 months in FR(100%), FR(10%-90%), and FR(0%) patients, respectively.
  
  
  CONCLUSIONS
  Overall response to FR-targeted therapy and DCR correlate with FR positivity demonstrated by (99m)Tc-etarfolatide imaging.
  
  
  BACKGROUND
  NCT00507741.
authors.affiliation: Barbara Ann Karmanos Cancer Institute. Electronic address: rmorris@med.wayne.edu.
authors.forename: R T
authors.initials: RT
authors.lastname: Morris
authors.affiliation: Detroit Medical Center, Wayne State University, Detroit.
authors.forename: R N
authors.initials: RN
authors.lastname: Joyrich
authors.affiliation: Levine Cancer Institute.
authors.forename: R W
authors.initials: RW
authors.lastname: Naumann
authors.affiliation: Charlotte Radiology, Carolinas Medical Center, Charlotte.
authors.forename: N P
authors.initials: NP
authors.lastname: Shah
authors.affiliation: Temple University Hospital, Philadelphia.
authors.forename: A H
authors.initials: AH
authors.lastname: Maurer
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York.
authors.forename: H W
authors.initials: HW
authors.lastname: Strauss
authors.affiliation: Saint John's Health Center, Santa Monica.
authors.forename: J M
authors.initials: JM
authors.lastname: Uszler
authors.affiliation: Levine Cancer Institute.
authors.forename: J T
authors.initials: JT
authors.lastname: Symanowski
authors.affiliation: Endocyte, Inc., Indianapolis.
authors.forename: P R
authors.initials: PR
authors.lastname: Ellis
authors.affiliation: Horizon Oncology Research, Lafayette, USA.
authors.forename: W A
authors.initials: WA
authors.lastname: Harb
mesh_terms: D000328:Adult; D000368:Aged; D003952:Diagnostic Imaging; D005260:Female; D058975:Folate Receptor 1 / Q000378:metabolism*; D005492:Folic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008875:Middle Aged; D058990:Molecular Targeted Therapy; D009367:Neoplasm Staging; D015609:Organotechnetium Compounds / Q000008:administration & dosage*; D010051:Ovarian Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D011859:Radiography; D015899:Tomography, Emission-Computed, Single-Photon; D014748:Vinca Alkaloids / Q000008:administration & dosage*
chemical_list: C520389:EC145; D058975:Folate Receptor 1; D015609:Organotechnetium Compounds; D014748:Vinca Alkaloids; C000588984:technetium 99m etarfolatide; D005492:Folic Acid
keywords: 99mTc-etarfolatide imaging; recurrent ovarian cancer; vintafolide