Post-therapy change in prostate-specific antigen levels as a clinical trial endpoint in hormone-refractory prostatc cancer: A trial with 10-ethyl-deaza-aminopterin Journal Article


Authors: Schultz, P. K.; Kelly, W. K.; Begg, C.; Liebertz, C.; Cohen, L.; Scher, H. I.
Article Title: Post-therapy change in prostate-specific antigen levels as a clinical trial endpoint in hormone-refractory prostatc cancer: A trial with 10-ethyl-deaza-aminopterin
Abstract: Objectives: Serial changes in prostate-specific antigen (PSA) correlate with disease status in all stages of prostatic cancer. For hormone-refractory disease, post-therapy declines of 50% and 80% from baseline are associated with an improved survival. This study sought to evaluate edatrexate, a synthetic antifolate, in hormone-refractory prostatic cancer using post-therapy PSA change as the initial endpoint. Methods: Fourteen patients with progression of disease despite castrate levels oftestosterone received edatrexate. Serial changes in PSA were monitored and correlated with other parameters of outcome. Results: Stabilization of a rising PSA level in parallel with clinical stabilization of diseasewas observed in one patient; disease in all others progressed. Toxic reactions were acceptable. Conclusions: With no objective evidence for antitumor activity as assessed by post-therapy PSA changes in any of the patients treated, edatrexate seems a poor candidate for future study. The use of post-therapy PSA change as the initial screening modality allows treatments to be evaluated rapidly in patients without measurable disease. The methodology proposed will require validation in prospective phase III investigations using survival as the endpoint. © 1994.
Keywords: adult; cancer survival; clinical article; human tissue; treatment outcome; aged; human cell; cancer growth; antineoplastic agents; follow-up studies; prostate specific antigen; mucosa inflammation; cancer screening; antineoplastic activity; prostate cancer; prostate-specific antigen; prostatic neoplasms; antigen detection; diagnosis; testosterone; aminopterin; intravenous drug administration; hormone resistance; middle age; edatrexate; human; male; priority journal; article; support, u.s. gov't, p.h.s.
Journal Title: Urology
Volume: 44
Issue: 2
ISSN: 0090-4295
Publisher: Elsevier Science, Inc.  
Date Published: 1994-08-01
Start Page: 237
End Page: 242
Language: English
DOI: 10.1016/s0090-4295(94)80138-x
PROVIDER: scopus
PUBMED: 7519382
DOI/URL:
Notes: Urology -- Cited By :6 -- Export Date: 14 January 2019 -- Article -- CODEN: URGYA C2 - 7519382 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Colin B Begg
    241 Begg
  2. William K Kelly
    112 Kelly
  3. Howard Scher
    848 Scher