Phase II study of treatment of advanced ovarian cancer with folate-receptor-targeted therapeutic (vintafolide) and companion SPECT-based imaging agent (99mTc-etarfolatide)

Ann Oncol. 2014 Apr;25(4):852-858. doi: 10.1093/annonc/mdu024.

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).

Patients and 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.

Clinical trial number: NCT00507741.

Keywords: 99mTc-etarfolatide imaging; recurrent ovarian cancer; vintafolide.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Diagnostic Imaging
  • Female
  • Folate Receptor 1 / metabolism*
  • Folic Acid / administration & dosage
  • Folic Acid / analogs & derivatives*
  • Humans
  • Middle Aged
  • Molecular Targeted Therapy
  • Neoplasm Staging
  • Organotechnetium Compounds / administration & dosage*
  • Ovarian Neoplasms / diagnostic imaging
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / pathology
  • Radiography
  • Tomography, Emission-Computed, Single-Photon
  • Vinca Alkaloids / administration & dosage*

Substances

  • EC145
  • Folate Receptor 1
  • Organotechnetium Compounds
  • Vinca Alkaloids
  • technetium 99m etarfolatide
  • Folic Acid

Associated data

  • ClinicalTrials.gov/NCT00507741