Phase II trial of simple oral therapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer

SWOG S0430

Anne F. Schott, William E. Barlow, Kathy S. Albain, Helen K. Chew, James L.Wade III, Keith S. Lanier, Danika L. Lew, Daniel F. Hayes, Julie R. Gralow, Robert B Livingston, Gabriel N. Hortobagyi

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background. Interest in oral agents for the treatment of metastatic breast cancer (MBC) has increased because many patients prefer oral to i.v. regimens. We evaluated a simple oral combination of capecitabine with cyclophosphamide (CPA) for MBC. Methods. The trial was designed to determine whether or not combination therapy would achieve a 42% response rate (RR) using the Response Evaluation Criteria in Solid Tumors (RECIST) in MBC. Patients with two or fewer prior chemotherapy regimens forMBCwere eligible. Those with estrogen receptor-positive MBC had to have progressed on endocrine therapy. Patients had measurable disease or elevated mucin (MUC)-1 antigen and received CPA, 100 mg daily on days 1-14, and capecitabine, 1,500 mg twice daily on days 8-21, in 21-day cycles. Results. In 96 eligible patients, the median progressionfree survival (PFS) interval was 5.9 months (95% confidence interval [CI], 3.7-8.0 months) and median overall survival (OS) time was 18.8 months (95% CI, 13.1-22.0 months). The RR was 36% (95% CI, 26%-48%) in 80 patients with measurable disease. The MUC-1 antigen RR was 33% (95% CI, 20%-48%), occurring in 15 of 46 patients with elevated MUC-1 antigen. Toxicity was mild, with no treatment-related deaths. Conclusions. PFS, OS, and RR outcomes with capecitabine plus CPA compare favorably with those of capecitabine monotherapy and combination therapy with bevacizumab, sorafenib, or ixabepilone. The addition of these other agents to capecitabine does not improve OS time in MBC patients, and this single-arm study does not suggest that the addition of CPA to capecitabine has this potential in an unselected MBC population. When OS prolongation is the goal, clinicians should choose single-agent capecitabine.

Original languageEnglish (US)
Pages (from-to)179-187
Number of pages9
JournalOncologist
Volume17
Issue number2
DOIs
StatePublished - 2012

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Cyclophosphamide
Breast Neoplasms
Mucin-1
Survival
Confidence Intervals
Antigens
Therapeutics
Capecitabine
Estrogen Receptors
Survival Rate
Drug Therapy
Population

Keywords

  • Metastatic breast cancer capecitabine cyclophosphamide oral therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Schott, A. F., Barlow, W. E., Albain, K. S., Chew, H. K., L.Wade III, J., Lanier, K. S., ... Hortobagyi, G. N. (2012). Phase II trial of simple oral therapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer: SWOG S0430. Oncologist, 17(2), 179-187. https://doi.org/10.1634/theoncologist.2011-0235

Phase II trial of simple oral therapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer : SWOG S0430. / Schott, Anne F.; Barlow, William E.; Albain, Kathy S.; Chew, Helen K.; L.Wade III, James; Lanier, Keith S.; Lew, Danika L.; Hayes, Daniel F.; Gralow, Julie R.; Livingston, Robert B; Hortobagyi, Gabriel N.

In: Oncologist, Vol. 17, No. 2, 2012, p. 179-187.

Research output: Contribution to journalArticle

Schott, AF, Barlow, WE, Albain, KS, Chew, HK, L.Wade III, J, Lanier, KS, Lew, DL, Hayes, DF, Gralow, JR, Livingston, RB & Hortobagyi, GN 2012, 'Phase II trial of simple oral therapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer: SWOG S0430', Oncologist, vol. 17, no. 2, pp. 179-187. https://doi.org/10.1634/theoncologist.2011-0235
Schott, Anne F. ; Barlow, William E. ; Albain, Kathy S. ; Chew, Helen K. ; L.Wade III, James ; Lanier, Keith S. ; Lew, Danika L. ; Hayes, Daniel F. ; Gralow, Julie R. ; Livingston, Robert B ; Hortobagyi, Gabriel N. / Phase II trial of simple oral therapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer : SWOG S0430. In: Oncologist. 2012 ; Vol. 17, No. 2. pp. 179-187.
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abstract = "Background. Interest in oral agents for the treatment of metastatic breast cancer (MBC) has increased because many patients prefer oral to i.v. regimens. We evaluated a simple oral combination of capecitabine with cyclophosphamide (CPA) for MBC. Methods. The trial was designed to determine whether or not combination therapy would achieve a 42{\%} response rate (RR) using the Response Evaluation Criteria in Solid Tumors (RECIST) in MBC. Patients with two or fewer prior chemotherapy regimens forMBCwere eligible. Those with estrogen receptor-positive MBC had to have progressed on endocrine therapy. Patients had measurable disease or elevated mucin (MUC)-1 antigen and received CPA, 100 mg daily on days 1-14, and capecitabine, 1,500 mg twice daily on days 8-21, in 21-day cycles. Results. In 96 eligible patients, the median progressionfree survival (PFS) interval was 5.9 months (95{\%} confidence interval [CI], 3.7-8.0 months) and median overall survival (OS) time was 18.8 months (95{\%} CI, 13.1-22.0 months). The RR was 36{\%} (95{\%} CI, 26{\%}-48{\%}) in 80 patients with measurable disease. The MUC-1 antigen RR was 33{\%} (95{\%} CI, 20{\%}-48{\%}), occurring in 15 of 46 patients with elevated MUC-1 antigen. Toxicity was mild, with no treatment-related deaths. Conclusions. PFS, OS, and RR outcomes with capecitabine plus CPA compare favorably with those of capecitabine monotherapy and combination therapy with bevacizumab, sorafenib, or ixabepilone. The addition of these other agents to capecitabine does not improve OS time in MBC patients, and this single-arm study does not suggest that the addition of CPA to capecitabine has this potential in an unselected MBC population. When OS prolongation is the goal, clinicians should choose single-agent capecitabine.",
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T1 - Phase II trial of simple oral therapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer

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AU - Schott, Anne F.

AU - Barlow, William E.

AU - Albain, Kathy S.

AU - Chew, Helen K.

AU - L.Wade III, James

AU - Lanier, Keith S.

AU - Lew, Danika L.

AU - Hayes, Daniel F.

AU - Gralow, Julie R.

AU - Livingston, Robert B

AU - Hortobagyi, Gabriel N.

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N2 - Background. Interest in oral agents for the treatment of metastatic breast cancer (MBC) has increased because many patients prefer oral to i.v. regimens. We evaluated a simple oral combination of capecitabine with cyclophosphamide (CPA) for MBC. Methods. The trial was designed to determine whether or not combination therapy would achieve a 42% response rate (RR) using the Response Evaluation Criteria in Solid Tumors (RECIST) in MBC. Patients with two or fewer prior chemotherapy regimens forMBCwere eligible. Those with estrogen receptor-positive MBC had to have progressed on endocrine therapy. Patients had measurable disease or elevated mucin (MUC)-1 antigen and received CPA, 100 mg daily on days 1-14, and capecitabine, 1,500 mg twice daily on days 8-21, in 21-day cycles. Results. In 96 eligible patients, the median progressionfree survival (PFS) interval was 5.9 months (95% confidence interval [CI], 3.7-8.0 months) and median overall survival (OS) time was 18.8 months (95% CI, 13.1-22.0 months). The RR was 36% (95% CI, 26%-48%) in 80 patients with measurable disease. The MUC-1 antigen RR was 33% (95% CI, 20%-48%), occurring in 15 of 46 patients with elevated MUC-1 antigen. Toxicity was mild, with no treatment-related deaths. Conclusions. PFS, OS, and RR outcomes with capecitabine plus CPA compare favorably with those of capecitabine monotherapy and combination therapy with bevacizumab, sorafenib, or ixabepilone. The addition of these other agents to capecitabine does not improve OS time in MBC patients, and this single-arm study does not suggest that the addition of CPA to capecitabine has this potential in an unselected MBC population. When OS prolongation is the goal, clinicians should choose single-agent capecitabine.

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