Combination versus sequential doxorubicin and docetaxel as primary chemotherapy for breast cancer

A randomized pilot trial of the Hoosier Oncology Group

Kathy Miller, Worta McCaskill-Stevens, Judy Sisk, David M. Loesch, Frank Monaco, Roopa Seshadri, George W. Sledge

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Abstract

Purpose: To evaluate the efficacy and toxicity of combination and sequential dose-dense chemotherapy with doxorubicin and docetaxel (Taxotere; Rhone-Poulenc Rorer, Collegeville, PA) as primary chemotherapy of breast cancer. Patients and Methods: Patients with newly diagnosed stage II or noninflammatory stage III breast cancer were randomly assigned to receive the same total doses of doxorubicin and docetaxel over a 12-week period before definitive surgery. Patients in arm A received sequential therapy with doxorubicin 75 mg/m2 every 2 weeks for three cycles followed by docetaxel 100 mg/m2 every 2 weeks for three cycles. Patients in arm B received combination therapy with doxorubicin 56 mg/m2 plus docetaxel 75 mg/m2 every 3 weeks for four cycles. Granulocyte colony-stimulating factor was administered on days 2 to 12 of each cycle in both groups. Results: Forty patients were entered onto the trial. Pretreatment tumor size averaged 5.7 cm with clinically positive axillary lymph nodes in 23 patients (57%). As expected, myelosuppression was severe in both groups; however, ≥ 80% of planned dose-intensity was delivered. Hand-foot syndrome was more common after sequential therapy. Clinical responses were similar in both groups, with an overall response rate of 87%, including 20% clinical complete remissions. Pathologic complete remission or residual in situ disease only was confirmed in five patients (12.8%). Patients who received sequential therapy had fewer positive lymph nodes (mean, 2.17 v 4.81; P < .037) at definitive surgery. Conclusion: Primary chemotherapy with doxorubicin and docetaxel is well tolerated and highly active. A sequential treatment schedule increases toxicity but may result in more substantial lymph node clearance than combination therapy.

Original languageEnglish
Pages (from-to)3033-3037
Number of pages5
JournalJournal of Clinical Oncology
Volume17
Issue number10
StatePublished - Oct 1999

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docetaxel
Doxorubicin
Breast Neoplasms
Drug Therapy
Lymph Nodes
Therapeutics
Hand-Foot Syndrome
Granulocyte Colony-Stimulating Factor

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Combination versus sequential doxorubicin and docetaxel as primary chemotherapy for breast cancer : A randomized pilot trial of the Hoosier Oncology Group. / Miller, Kathy; McCaskill-Stevens, Worta; Sisk, Judy; Loesch, David M.; Monaco, Frank; Seshadri, Roopa; Sledge, George W.

In: Journal of Clinical Oncology, Vol. 17, No. 10, 10.1999, p. 3033-3037.

Research output: Contribution to journalArticle

Miller, Kathy ; McCaskill-Stevens, Worta ; Sisk, Judy ; Loesch, David M. ; Monaco, Frank ; Seshadri, Roopa ; Sledge, George W. / Combination versus sequential doxorubicin and docetaxel as primary chemotherapy for breast cancer : A randomized pilot trial of the Hoosier Oncology Group. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 10. pp. 3033-3037.
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abstract = "Purpose: To evaluate the efficacy and toxicity of combination and sequential dose-dense chemotherapy with doxorubicin and docetaxel (Taxotere; Rhone-Poulenc Rorer, Collegeville, PA) as primary chemotherapy of breast cancer. Patients and Methods: Patients with newly diagnosed stage II or noninflammatory stage III breast cancer were randomly assigned to receive the same total doses of doxorubicin and docetaxel over a 12-week period before definitive surgery. Patients in arm A received sequential therapy with doxorubicin 75 mg/m2 every 2 weeks for three cycles followed by docetaxel 100 mg/m2 every 2 weeks for three cycles. Patients in arm B received combination therapy with doxorubicin 56 mg/m2 plus docetaxel 75 mg/m2 every 3 weeks for four cycles. Granulocyte colony-stimulating factor was administered on days 2 to 12 of each cycle in both groups. Results: Forty patients were entered onto the trial. Pretreatment tumor size averaged 5.7 cm with clinically positive axillary lymph nodes in 23 patients (57{\%}). As expected, myelosuppression was severe in both groups; however, ≥ 80{\%} of planned dose-intensity was delivered. Hand-foot syndrome was more common after sequential therapy. Clinical responses were similar in both groups, with an overall response rate of 87{\%}, including 20{\%} clinical complete remissions. Pathologic complete remission or residual in situ disease only was confirmed in five patients (12.8{\%}). Patients who received sequential therapy had fewer positive lymph nodes (mean, 2.17 v 4.81; P < .037) at definitive surgery. Conclusion: Primary chemotherapy with doxorubicin and docetaxel is well tolerated and highly active. A sequential treatment schedule increases toxicity but may result in more substantial lymph node clearance than combination therapy.",
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