A randomized phase II evaluation of bryostatin-1 (NSC #339555) in persistent or recurrent squamous cell carcinoma of the cervix: A Gynecologic Oncology Group Study. Invest New Drugs 2003 Nov;21(4):453-7
Date
10/31/2003Pubmed ID
14586213DOI
10.1023/a:1026255403046Scopus ID
2-s2.0-1642452915 (requires institutional sign-in at Scopus site) 20 CitationsAbstract
OBJECTIVES: The Gynecologic Oncology Group performed a randomized phase II study to determine the antitumor activity and toxicity of two different schedules of administration of bryostatin-1 in patients with persistent or recurrent squamous cell carcinoma of the cervix.
METHODS: Eligible patients were randomized to receive either bryostatin-1 25 mug/m(2) as a 1-h infusion weekly for 3 weeks followed by a 1-week rest (Regimen I) or bryostatin-1 120 mug/m(2) as a 72-h continuous infusion every 2 weeks (Regimen II).
RESULTS: A total of 70 patients were enrolled on this study. There were 32 eligible patients on Regimen I and 33 eligible patients on Regimen II; all but 4 had had prior chemotherapy. There were two partial responses (one on each treatment arm) among the 65 eligible patients (response rates = 3.1 and 3.0%, respectively). Ten patients on each regimen had stable disease. The most common adverse event was myalgia; 8 of 32 patients (25%) on Regimen I and 16 of 33 patients (48%) on Regimen II had any grade of myalgia. There was no significant myelosuppression on either treatment arm.
CONCLUSIONS: Both of these schedules and doses of bryostatin-1 are inactive as single agents in the second-line treatment of squamous cell carcinoma of the cervix.
Author List
Armstrong DK, Blessing JA, Rader J, Sorosky JI, Gynecologic Oncology Group StudyAuthor
Janet Sue Rader MD Chair, Professor in the Obstetrics and Gynecology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultAged
Anemia
Bryostatins
Carcinoma, Squamous Cell
Confidence Intervals
Drug Administration Schedule
Female
Humans
Infusions, Intravenous
Lactones
Macrolides
Middle Aged
Neoplasm Recurrence, Local
Uterine Cervical Neoplasms
