Single-agent topotecan as first-line chemotherapy in women with metastatic breast cancer

Final results of Eastern Cooperative Oncology Group trial E8193

Antonio C Wolff, Anne O'Neill, M. John Kennedy, James A. Stewart, William J. Gradishar, Raymond S. Lord, Nancy E. Davidson, William C. Wood

Research output: Contribution to journalArticle

Abstract

Purpose: The purpose of this multicenter phase II trial was to evaluate the clinical activity of topotecan as first-line chemotherapy in patients with metastatic breast cancer and previous exposure to adjuvant doxorubicin. Patients and methods: Patients with measurable disease received a 72-hour continuous intravenous infusion of topotecan 1.3 mg/m2 per day repeated every 21 days. The primary objective was to determine whether ≥ 4 responses were observed among 30 evaluable patients after 3 cycles of therapy using a 2-stage design (≥ 2 responses required in the first 20 evaluable patients). Duration of response, time to tumor progression, overall survival, and toxicity were also examined. Thirty-five patients altogether received 78 cycles of therapy (median, 3 cycles; range, 1-8 cycles). Results: Two partial responses (6%; 95% confidence interval, 0.7%-19%) were observed among 30 evaluable patients (median age, 55 years; range, 34-76 years; median Eastern Cooperative Oncology Group performance status, 0; range, 0-2). Median time to progression and overall survival were 2.3 months and 18.7 months, respectively. Myelosuppression was the most common toxicity among 34 evaluable patients (grade 3/4 neutropenia and thrombocytopenia in 62% and 53%, respectively) with only 1 life-threatening event. Conclusion: Although tolerable, this dose and schedule of topotecan has limited activity in unselected patients with breast cancer even as first-line therapy. Identification of potential predictive markers of response and toxicity is encouraged before considering further studies of topotecan and camptothecin analogues in breast cancer.

Original languageEnglish (US)
Pages (from-to)334-339
Number of pages6
JournalClinical Breast Cancer
Volume6
Issue number4
StatePublished - 2005

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Topotecan
Breast Neoplasms
Drug Therapy
Camptothecin
Survival
Neutropenia
Intravenous Infusions
Doxorubicin
Reaction Time
Appointments and Schedules
Therapeutics
Confidence Intervals

Keywords

  • Camptothecin analogues
  • Hematopoietic toxicity
  • Topoisomerase I inhibitor

ASJC Scopus subject areas

  • Cancer Research

Cite this

Single-agent topotecan as first-line chemotherapy in women with metastatic breast cancer : Final results of Eastern Cooperative Oncology Group trial E8193. / Wolff, Antonio C; O'Neill, Anne; Kennedy, M. John; Stewart, James A.; Gradishar, William J.; Lord, Raymond S.; Davidson, Nancy E.; Wood, William C.

In: Clinical Breast Cancer, Vol. 6, No. 4, 2005, p. 334-339.

Research output: Contribution to journalArticle

Wolff, AC, O'Neill, A, Kennedy, MJ, Stewart, JA, Gradishar, WJ, Lord, RS, Davidson, NE & Wood, WC 2005, 'Single-agent topotecan as first-line chemotherapy in women with metastatic breast cancer: Final results of Eastern Cooperative Oncology Group trial E8193', Clinical Breast Cancer, vol. 6, no. 4, pp. 334-339.
Wolff, Antonio C ; O'Neill, Anne ; Kennedy, M. John ; Stewart, James A. ; Gradishar, William J. ; Lord, Raymond S. ; Davidson, Nancy E. ; Wood, William C. / Single-agent topotecan as first-line chemotherapy in women with metastatic breast cancer : Final results of Eastern Cooperative Oncology Group trial E8193. In: Clinical Breast Cancer. 2005 ; Vol. 6, No. 4. pp. 334-339.
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