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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

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Abstract

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 μg/m2 as a 1-h infusion weekly for 3 weeks followed by a 1-week rest (Regimen I) or bryostatin-1 120 μg/m2 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.

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Authors and Affiliations

  1. Oncology, Gynecology, and Obstetrics, Johns Hopkins Oncology Center, Baltimore, MD, 21231

    Deborah K. Armstrong (Assistant Professor)

  2. Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY, 14263

    John A. Blessing (Executive Director)

  3. Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Washington University School of Medicine, St. Louis, MO, 63110

    Janet Rader (Associate Professor)

  4. Division of Gynecologic Oncology, University of Iowa Hospitals and Clinics, Iowa City, IA, 52242

    Joel I. Sorosky (Professor)

Authors
  1. Deborah K. Armstrong
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  2. John A. Blessing
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  3. Janet Rader
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  4. Joel I. Sorosky
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Correspondence to Deborah K. Armstrong.

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Armstrong, D.K., Blessing, J.A., Rader, J. et al. 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 21, 453–457 (2003). https://doi.org/10.1023/A:1026255403046

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  • DOI: https://doi.org/10.1023/A:1026255403046

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