Phase II trial of biweekly paclitaxel and cisplatin in advanced breast carcinoma

An Eastern Cooperative Oncology Group Study

Joseph A. Sparano, D. Neuberg, J. H. Glick, N. J. Robert, L. J. Goldstein, G. W. Sledge, W. Wood

Research output: Contribution to journalArticle

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Abstract

Purpose: To determine the efficacy of a biweekly paclitaxel and cisplatin regimen in patients with advanced breast carcinoma, which has previously been reported to produce an 85% response rate in such patients. Patients and Methods: Sixteen patients with metastatic breast carcinoma who had relapsed after prior doxorubicin-containing adjuvant chemotherapy were treated with paclitaxel (90 mg/m2) by intravenous (IV) infusion over 3 hours followed by cisplatin (60 mg/m2) given by IV infusion over 1 hour on an outpatient basis. Treatment was repeated every 2 weeks if the absolute neutrophil count was ≤ 750/μL and platelet count 75,000/μL. After a maximum of eight cycles of paclitaxel/cisplatin, patients received biweekly paclitaxel alone (90 mg/m2 with dose escalation). Thirteen patients were assessable for response and all for toxicity. Nine of 13 patients assessable for response (69%) had at least three sites of metastases and 10 patients (77%) had visceral-dominant disease. Results: Partial response occurred in three of 13 assessable patients (23%; 90% confidence interval, 7% to 49%). All responders had two or fewer sites of metastases. The median time to progression was 4.3 months and the median survival duration was 11.4 months. Patients received a median of seven cycles of therapy (range, two to 21). Severe and/or life-threatening toxicity occurred in 50% and 38%, respectively, and consisted primarily of granulocytopenia, anemia, and neuropathy. The trial was terminated after the first interim analysis as per its two-stage design, since it was unlikely that the response rate would exceed 70%. Conclusion: Biweekly paclitaxel/cisplatin is not likely to produce response rate greater than 70% in patients with metastatic breast cancer who have relapsed after prior doxorubicin-containing adjuvant chemotherapy and who have multiple sites of metastases and/or visceral- dominant disease.

Original languageEnglish (US)
Pages (from-to)1880-1884
Number of pages5
JournalJournal of Clinical Oncology
Volume15
Issue number5
StatePublished - May 1997

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Breast Neoplasms
Adjuvant Chemotherapy
Neoplasm Metastasis
Paclitaxel
Intravenous Infusions
Doxorubicin
TP protocol
Agranulocytosis
Platelet Count
Cisplatin
Anemia
Neutrophils
Outpatients
Confidence Intervals
Survival
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Sparano, J. A., Neuberg, D., Glick, J. H., Robert, N. J., Goldstein, L. J., Sledge, G. W., & Wood, W. (1997). Phase II trial of biweekly paclitaxel and cisplatin in advanced breast carcinoma: An Eastern Cooperative Oncology Group Study. Journal of Clinical Oncology, 15(5), 1880-1884.

Phase II trial of biweekly paclitaxel and cisplatin in advanced breast carcinoma : An Eastern Cooperative Oncology Group Study. / Sparano, Joseph A.; Neuberg, D.; Glick, J. H.; Robert, N. J.; Goldstein, L. J.; Sledge, G. W.; Wood, W.

In: Journal of Clinical Oncology, Vol. 15, No. 5, 05.1997, p. 1880-1884.

Research output: Contribution to journalArticle

Sparano, JA, Neuberg, D, Glick, JH, Robert, NJ, Goldstein, LJ, Sledge, GW & Wood, W 1997, 'Phase II trial of biweekly paclitaxel and cisplatin in advanced breast carcinoma: An Eastern Cooperative Oncology Group Study', Journal of Clinical Oncology, vol. 15, no. 5, pp. 1880-1884.
Sparano, Joseph A. ; Neuberg, D. ; Glick, J. H. ; Robert, N. J. ; Goldstein, L. J. ; Sledge, G. W. ; Wood, W. / Phase II trial of biweekly paclitaxel and cisplatin in advanced breast carcinoma : An Eastern Cooperative Oncology Group Study. In: Journal of Clinical Oncology. 1997 ; Vol. 15, No. 5. pp. 1880-1884.
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abstract = "Purpose: To determine the efficacy of a biweekly paclitaxel and cisplatin regimen in patients with advanced breast carcinoma, which has previously been reported to produce an 85{\%} response rate in such patients. Patients and Methods: Sixteen patients with metastatic breast carcinoma who had relapsed after prior doxorubicin-containing adjuvant chemotherapy were treated with paclitaxel (90 mg/m2) by intravenous (IV) infusion over 3 hours followed by cisplatin (60 mg/m2) given by IV infusion over 1 hour on an outpatient basis. Treatment was repeated every 2 weeks if the absolute neutrophil count was ≤ 750/μL and platelet count 75,000/μL. After a maximum of eight cycles of paclitaxel/cisplatin, patients received biweekly paclitaxel alone (90 mg/m2 with dose escalation). Thirteen patients were assessable for response and all for toxicity. Nine of 13 patients assessable for response (69{\%}) had at least three sites of metastases and 10 patients (77{\%}) had visceral-dominant disease. Results: Partial response occurred in three of 13 assessable patients (23{\%}; 90{\%} confidence interval, 7{\%} to 49{\%}). All responders had two or fewer sites of metastases. The median time to progression was 4.3 months and the median survival duration was 11.4 months. Patients received a median of seven cycles of therapy (range, two to 21). Severe and/or life-threatening toxicity occurred in 50{\%} and 38{\%}, respectively, and consisted primarily of granulocytopenia, anemia, and neuropathy. The trial was terminated after the first interim analysis as per its two-stage design, since it was unlikely that the response rate would exceed 70{\%}. Conclusion: Biweekly paclitaxel/cisplatin is not likely to produce response rate greater than 70{\%} in patients with metastatic breast cancer who have relapsed after prior doxorubicin-containing adjuvant chemotherapy and who have multiple sites of metastases and/or visceral- dominant disease.",
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AU - Wood, W.

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N2 - Purpose: To determine the efficacy of a biweekly paclitaxel and cisplatin regimen in patients with advanced breast carcinoma, which has previously been reported to produce an 85% response rate in such patients. Patients and Methods: Sixteen patients with metastatic breast carcinoma who had relapsed after prior doxorubicin-containing adjuvant chemotherapy were treated with paclitaxel (90 mg/m2) by intravenous (IV) infusion over 3 hours followed by cisplatin (60 mg/m2) given by IV infusion over 1 hour on an outpatient basis. Treatment was repeated every 2 weeks if the absolute neutrophil count was ≤ 750/μL and platelet count 75,000/μL. After a maximum of eight cycles of paclitaxel/cisplatin, patients received biweekly paclitaxel alone (90 mg/m2 with dose escalation). Thirteen patients were assessable for response and all for toxicity. Nine of 13 patients assessable for response (69%) had at least three sites of metastases and 10 patients (77%) had visceral-dominant disease. Results: Partial response occurred in three of 13 assessable patients (23%; 90% confidence interval, 7% to 49%). All responders had two or fewer sites of metastases. The median time to progression was 4.3 months and the median survival duration was 11.4 months. Patients received a median of seven cycles of therapy (range, two to 21). Severe and/or life-threatening toxicity occurred in 50% and 38%, respectively, and consisted primarily of granulocytopenia, anemia, and neuropathy. The trial was terminated after the first interim analysis as per its two-stage design, since it was unlikely that the response rate would exceed 70%. Conclusion: Biweekly paclitaxel/cisplatin is not likely to produce response rate greater than 70% in patients with metastatic breast cancer who have relapsed after prior doxorubicin-containing adjuvant chemotherapy and who have multiple sites of metastases and/or visceral- dominant disease.

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