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).

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.

• Authors: R T Morris, R N Joyrich, R W Naumann, N P Shah, A H Maurer, H W Strauss, J M Uszler, J T Symanowski, P R Ellis, W A Harb
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 25 Issue 4 Pg. 852-858 (Apr 2014) ISSN: 1569-8041 [Electronic] England
• PMID: 24667717 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

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