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.
OBJECTIVE
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.
Armstrong
Deborah K
DK
Assistant Professor, Oncology, Gynecology, and Obstetrics, Johns Hopkins Oncology Center, Baltimore, MD 21231, USA. darmstro@jhmi.edu
Blessing
John A
JA
Rader
Janet
J
Sorosky
Joel I
JI
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D054713:Bryostatins; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D016001:Confidence Intervals; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007783:Lactones / Q000008:administration & dosage* / Q000009:adverse effects; D018942:Macrolides; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
D054713:Bryostatins; D007783:Lactones; D018942:Macrolides; C046785:bryostatin 1