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


Authors: Morris, R. T.; Joyrich, R. N.; Naumann, R. W.; Shah, N. P.; Maurer, A. H.; Strauss, H. W.; Uszler, J. M.; Symanowski, J. T.; Ellis, P. R.; Harb, W. A.
Article 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 99mTc-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 99mTc-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 99mTc-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 99mTcetarfolatide 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 99mTcetarfolatide imaging. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Keywords: adult; clinical article; controlled study; protein expression; aged; overall survival; constipation; drug tolerability; fatigue; advanced cancer; drug efficacy; anorexia; computer assisted tomography; controlled clinical trial; multiple cycle treatment; ovary cancer; phase 2 clinical trial; nausea; neuropathy; multicenter study; drug response; nausea and vomiting; cancer control; single photon emission computer tomography; molecularly targeted therapy; recurrent ovarian cancer; folate receptor; exploratory research; human; female; priority journal; article; vintafolide; etarfolatide tc 99m
Journal Title: Annals of Oncology
Volume: 25
Issue: 4
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2014-01-01
Start Page: 852
End Page: 858
Language: English
DOI: 10.1093/annonc/mdu024
PROVIDER: scopus
PUBMED: 24667717
DOI/URL:
Notes: Export Date: 1 May 2014 -- Art. No.: mdu024 -- CODEN: ANONE -- Source: Scopus
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  1. Harry W Strauss
    164 Strauss