13-cis-Retinoic Acid or All-trans-Retinoic Acid plus Interferon-α in Recurrent Cervical Cancer: A Southwest Oncology Group Phase II Randomized Trial |
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| Authors: | Geoffrey R. Weiss M.D. P.Y. Liu Ph.D. David S. Alberts M.D. Yei-Mei Peng Ph.D. Emily Fisher M.S. Min Jian Xu M.D. Sidney A. Scudder M.D. Laurence H. Baker D.O. Dennis F. Moore Jr. M.D. Scott M. Lippman M.D. |
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| Affiliation: | aUniversity of Texas Health Science Center at San Antonio, San Antonio, Texas;bSouthwest Oncology Group Statistical Center, Seattle, Washington;cUniversity of Arizona Cancer Center, Tucson, Arizona;dUniversity of California, Davis, Sacramento, California;eUniversity of Michigan Medical Center, Ann Arbor, Michigan;fWichita CCOP, Wichita, Kansas;gM.D. Anderson Cancer Center, Houston, Texas |
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| Abstract: | Purpose.Preclinical and clinical data support the study of retinoids and interferon-α (IFN-α) in advanced squamous cell carcinoma of the uterine cervix (SCC). This phase II randomized trial of the Southwest Oncology Group sought to estimate the response rate for IFN-α plus either 13-cis-retinoic acid (13cRA) or all-trans-retinoic acid (ATRA) in women with recurrent cervical SCC.Patients and Methods.Eligibility for this trial required bidimensionally measurable locally recurrent or metastatic squamous or adenosquamous carcinoma of the uterine cervix; SWOG performance status of ≤2; no prior interferon, retinoids, or chemotherapy (except as radiation sensitization). All but two patients were previously treated with surgery, radiation therapy, or both. After randomization, patients received IFN-α-2A (subcutaneous injection; 3 × 106units/m2/day) plus either 13cRA (1 mg/kg/day orally) or ATRA (150 mg/m2/day orally) in two equally divided doses.Results.Total enrollment was 63 patients, 21 in the ATRA arm, 42 in the 13cRA arm. Three patients were ineligible, 1 in the ATRA arm, 2 in the 13cRA arm. Each arm had 1 patient who received no assigned treatment and was not evaluated for response or toxicity. The ATRA/IFN-α response rate was 5% (1/19; 95% confidence interval = 0.1–26%), consisting of 1 partial response lasting 4 weeks. The 13cRA/IFN-α response rate was 8% (3/39; 95% confidence interval = 2–21%), consisting of 3 partial responses lasting 17, 22, and 24 weeks, respectively. All confirmed responses were partial. One additional unconfirmed partial response occurred in the 13cRA arm. Both regimens were generally well-tolerated and produced toxicities (principally malaise and fatigue) associated with each constituent agent's known single-agent side effects.Conclusion.Based upon the results of this study, neither regimen can be recommended for further study in patients previously treated with radiation therapy. |
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