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Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressive AIDS-Related Kaposi’s Sarcoma: An AIDS Clinical Trials Group Clinical Study

From the Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard School of Public Health, and Sections of Hematology and Oncology, Department of Medicine, Boston Medical Center and Boston School of Medicine, Boston, MA; Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY; and Department of Medicine, Northwestern University Medical School and The Robert H. Lurie Comprehensive Cancer Center, Chicago, IL.

Address reprint requests to Jamie H. Von Roenn, MD, Department of Medicine, Division of Hematology and Medical Oncology, Northwestern University Medical School, 676 N Saint Clair St, Suite 850, Chicago, IL 60611; email: j-vonroenn{at}northwestern.edu

PURPOSE: Liposomal anthracyclines and paclitaxel are considered the best available cytotoxic therapies for Kaposi’s sarcoma (KS), but relapse is common. To identify new interventions for relapsed or progressive KS, a phase II study of low-dose etoposide to assess its toxicity and efficacy was conducted.

PATIENTS AND METHODS: Thirty-six patients with high-risk KS were treated with oral etoposide 50 mg/d for 7 consecutive days of every 2-week cycle. All patients’ disease had relapsed or progressed after prior combination chemotherapy or anthracycline therapy. For patients without a complete or partial response after two cycles of therapy and no toxicity greater than grade 2, the dose of etoposide was escalated to 100 mg/d orally on days 1 to 7 of each 14-day cycle. Treatment-related and disease-specific quality of life was evaluated using patient reports on the General Health Self-Assessment Form and a KS-specific measure.

RESULTS: One patient achieved a complete response, 12 patients had a partial response (overall response rate, 36.1%), and stable disease was observed in 12 patients (33.3%). Tumor responses were seen in all disease sites. Fourteen patients had their dose escalated, of whom five responded. The median time to response was 17.7 weeks; the median duration of response was 25 weeks. The most frequent hematologic abnormality was neutropenia, which was grade 4 in seven patients and grade 3 in six. Opportunistic infections occurred in eight patients during the treatment period. Both response to treatment and toxicity influenced patient-reported quality of life.

CONCLUSION: We conclude that low-dose oral etoposide at a dose of 50 mg/d is safe and effective for the treatment of refractory or progressed AIDS-related KS and has an overall positive effect on the quality of life of responding patients.

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