Phase II trial of doxorubicin and paclitaxel plus granulocyte colony- stimulating factor in metastatic breast cancer: An eastern cooperative oncology group study

Joseph A. Sparano, Ping Hu, Radha M. Rao, Carla I. Falkson, Antonio C. Wolff, William C. Wood

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Abstract

Purpose: Several groups have reported that the combination of doxorubicin plus paclitaxel given as a 3-hour intravenous (IV) infusion for up to eight cycles produces a high response rate (> 80%) and complete response rate (> 20%) in metastatic breast cancer, but is also complicated by a 20% incidence of congestive heart failure (CHF). The purpose of this phase II trial was to evaluate the antineoplastic activity of the regimen in a multi-institutional setting and to reduce the incidence of cardiotoxicity by limiting treatment to a maximum of six cycles. Patients and Methods: Fifty- two patients with advanced breast cancer received doxorubicin (60 mg/m2 by IV injection) followed 15 minutes later by paclitaxel (200 mg/m2 by IV infusion over 3 hours) every 3 weeks for four to six cycles. Results: Objective responses occurred in 25 of 48 assessable patients (52%; 95% confidence interval [Cl], 38% to 66%), including four complete responses (8%; 95% Cl, 0% to 16%). The median cumulative doxorubicin dose given was 240 mg/m2 (range, 132 to 360 mg/m2). Eleven patients (21%) were documented as having a decrease in the LVEF below normal, including three patients (6%; 95% Cl, 0% to 12%) who developed CHF. Conclusion: The doxorubicin/paclitaxel regimen that we used is unlikely to produce an objective response rate of more than 70% and a complete response rate of more than 20% in patients with metastatic breast cancer, and proved to be excessively cardiotoxic for use in the adjuvant setting.

Original languageEnglish (US)
Pages (from-to)3828-3834
Number of pages7
JournalJournal of Clinical Oncology
Volume17
Issue number12
StatePublished - Dec 1999
Externally publishedYes

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Granulocyte Colony-Stimulating Factor
Paclitaxel
Doxorubicin
Breast Neoplasms
Intravenous Infusions
Heart Failure
Incidence
Intravenous Injections
Antineoplastic Agents
Confidence Intervals

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II trial of doxorubicin and paclitaxel plus granulocyte colony- stimulating factor in metastatic breast cancer : An eastern cooperative oncology group study. / Sparano, Joseph A.; Hu, Ping; Rao, Radha M.; Falkson, Carla I.; Wolff, Antonio C.; Wood, William C.

In: Journal of Clinical Oncology, Vol. 17, No. 12, 12.1999, p. 3828-3834.

Research output: Contribution to journalArticle

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abstract = "Purpose: Several groups have reported that the combination of doxorubicin plus paclitaxel given as a 3-hour intravenous (IV) infusion for up to eight cycles produces a high response rate (> 80{\%}) and complete response rate (> 20{\%}) in metastatic breast cancer, but is also complicated by a 20{\%} incidence of congestive heart failure (CHF). The purpose of this phase II trial was to evaluate the antineoplastic activity of the regimen in a multi-institutional setting and to reduce the incidence of cardiotoxicity by limiting treatment to a maximum of six cycles. Patients and Methods: Fifty- two patients with advanced breast cancer received doxorubicin (60 mg/m2 by IV injection) followed 15 minutes later by paclitaxel (200 mg/m2 by IV infusion over 3 hours) every 3 weeks for four to six cycles. Results: Objective responses occurred in 25 of 48 assessable patients (52{\%}; 95{\%} confidence interval [Cl], 38{\%} to 66{\%}), including four complete responses (8{\%}; 95{\%} Cl, 0{\%} to 16{\%}). The median cumulative doxorubicin dose given was 240 mg/m2 (range, 132 to 360 mg/m2). Eleven patients (21{\%}) were documented as having a decrease in the LVEF below normal, including three patients (6{\%}; 95{\%} Cl, 0{\%} to 12{\%}) who developed CHF. Conclusion: The doxorubicin/paclitaxel regimen that we used is unlikely to produce an objective response rate of more than 70{\%} and a complete response rate of more than 20{\%} in patients with metastatic breast cancer, and proved to be excessively cardiotoxic for use in the adjuvant setting.",
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