Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: Results of a multicenter phase II trial

M. R. Ranson, J. Carmichael, K. O'Byrne, S. Stewart, D. Smith, A. Howell

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Purpose: A multicenter phase H study to determine the activity and toxicity of Caelyx (Doxil; Sequus Pharmaceuticals Inc, Menlo Park, CA) in patients with metastatic breast cancer. Patients and Methods: Seventy-one patients with stage IV breast cancer were treated with Caelyx at doses of 45 to 60 mg/m2 every 3 to 4 weeks for a maximum of six cycles. Twenty-eight patients had received prior chemotherapy with a nonanthracycline regimen. Fifty-two patients had disease at multiple sites. Hepatic and pulmonary disease were the predominant metastatic site in 50 patients. Response was assessable in 64 cases. Results: Sixteen patients achieved a partial response and four a complete response (overall response rate, 31%; (95% confidence interval, 20% to 43%). Twenty patients (31%) had stable disease on treatment. Neutropenia grade 3 occurred in 10% of cycles (27% of patients) and mucositis ≤ grade 3 in 10% of cycles (32% of patients). Significant alopecia was rare and routine prophylactic antiemetics were not required. At doses of 60 mg/m2 every 3 weeks, seven of 13 patients had ≤ grade 3 skin toxicity; overall, this toxicity complicated 25% of treatment cycles. The incidence of ≤ grade 3 skin toxicity was greatly reduced at doses of 45 mg/m2 every 4 weeks, occurring in five of 32 patients and affecting only 5% of 126 treatment cycles. Conclusion: Caelyx is an active agent in advanced breast cancer with a safety profile that differs markedly from nonlipasomal doxorubicin. A regimen of 45 mg/m2 every 4 weeks was well tolerated in this cohort of women with advanced poor-prognosis breast cancer. The mild myelosuppression seen with this regimen would favor its use in combination chemotherapy.

Original languageEnglish
Pages (from-to)3185-3191
Number of pages7
JournalJournal of Clinical Oncology
Issue number10
Publication statusPublished - 1 Jan 1997


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