Phase II study of gemcitabine plus cisplatin in patients with metastatic breast cancer: A north central cancer treatment group trial

Patrick A. Burch, James A. Mailliard, David W. Hillman, Edith A. Perez, James E. Krook, Kendrith M. Rowland, Michael H. Veeder, Michael W. Cannon, James N. Ingle

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background: This 2-stage, phase II cooperative group trial examined the efficacy and toxicity of 1000 mg/m2 gemcitabine plus 25 mg/m 2 cisplatin weekly for 3 weeks and repeated every 28 days for patients with previously treated metastatic breast cancer. Methods: Eligible patients had to have measurable metastatic disease. Progression on prior treatment with at least 1 chemotherapy program for metastatic disease and 1 prior anthracycline and/or taxane-containing regimen in either the metastatic or adjuvant setting was required. Patients who had received more than 2 chemotherapy treatments were not eligible for this study. Results: Fifty-eight eligible patients were entered on this 2-stage study. A 38% incidence of grade 4 thrombocytopenia observed in the first stage of accrual required lowering the chemotherapy doses to 800 mg/m2 gemcitabine plus 20 mg/m2 cisplatin weekly for the first 3 weeks of a 4-week cycle during the second stage of the study. The overall response rate was 29% (95% confidence interval [CI], 11-52%) among patients receiving the original study dose and 32% (95% CI, 18-50%) for patients receiving the lower dose. In the original- and lower-dose groups, median time to progression was 30.7 weeks (95% CI, 12.7-43.4 weeks) and 26.0 weeks (95% CI, 19.0-32.1 week), respectively. Median survival of the original- and low-dose groups was 67.9 weeks (95% CI, 42.3-90.6 weeks) and 54.1 weeks (95% CI, 41.6-73.6 weeks), respectively. Hematologic toxicities were more manageable in the lower-dose group, whereas the nonhematologic toxicity profile was similar in the 2 dose groups. Conclusions: The response rate of this combination of gemcitabine and cisplatin is similar to that reported by other investigators but may not differ substantially from reports with single-agent gemcitabine in this patient population. The original dose level we used had unacceptable toxicity, which required lowering the doses of both gemcitabine and cisplatin by 20% to achieve acceptable toxicity and preserve clinical activity.

Original languageEnglish (US)
Pages (from-to)195-200
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume28
Issue number2
DOIs
StatePublished - Apr 2005

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gemcitabine
Cisplatin
Breast Neoplasms
Confidence Intervals
Neoplasms
Drug Therapy
Therapeutics
Anthracyclines
Research Personnel

Keywords

  • Gemcitabine and cisplatin
  • Metastatic breast cancer
  • Phase II Cooperative Group Trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Phase II study of gemcitabine plus cisplatin in patients with metastatic breast cancer : A north central cancer treatment group trial. / Burch, Patrick A.; Mailliard, James A.; Hillman, David W.; Perez, Edith A.; Krook, James E.; Rowland, Kendrith M.; Veeder, Michael H.; Cannon, Michael W.; Ingle, James N.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 28, No. 2, 04.2005, p. 195-200.

Research output: Contribution to journalArticle

Burch, Patrick A. ; Mailliard, James A. ; Hillman, David W. ; Perez, Edith A. ; Krook, James E. ; Rowland, Kendrith M. ; Veeder, Michael H. ; Cannon, Michael W. ; Ingle, James N. / Phase II study of gemcitabine plus cisplatin in patients with metastatic breast cancer : A north central cancer treatment group trial. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2005 ; Vol. 28, No. 2. pp. 195-200.
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T2 - A north central cancer treatment group trial

AU - Burch, Patrick A.

AU - Mailliard, James A.

AU - Hillman, David W.

AU - Perez, Edith A.

AU - Krook, James E.

AU - Rowland, Kendrith M.

AU - Veeder, Michael H.

AU - Cannon, Michael W.

AU - Ingle, James N.

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N2 - Background: This 2-stage, phase II cooperative group trial examined the efficacy and toxicity of 1000 mg/m2 gemcitabine plus 25 mg/m 2 cisplatin weekly for 3 weeks and repeated every 28 days for patients with previously treated metastatic breast cancer. Methods: Eligible patients had to have measurable metastatic disease. Progression on prior treatment with at least 1 chemotherapy program for metastatic disease and 1 prior anthracycline and/or taxane-containing regimen in either the metastatic or adjuvant setting was required. Patients who had received more than 2 chemotherapy treatments were not eligible for this study. Results: Fifty-eight eligible patients were entered on this 2-stage study. A 38% incidence of grade 4 thrombocytopenia observed in the first stage of accrual required lowering the chemotherapy doses to 800 mg/m2 gemcitabine plus 20 mg/m2 cisplatin weekly for the first 3 weeks of a 4-week cycle during the second stage of the study. The overall response rate was 29% (95% confidence interval [CI], 11-52%) among patients receiving the original study dose and 32% (95% CI, 18-50%) for patients receiving the lower dose. In the original- and lower-dose groups, median time to progression was 30.7 weeks (95% CI, 12.7-43.4 weeks) and 26.0 weeks (95% CI, 19.0-32.1 week), respectively. Median survival of the original- and low-dose groups was 67.9 weeks (95% CI, 42.3-90.6 weeks) and 54.1 weeks (95% CI, 41.6-73.6 weeks), respectively. Hematologic toxicities were more manageable in the lower-dose group, whereas the nonhematologic toxicity profile was similar in the 2 dose groups. Conclusions: The response rate of this combination of gemcitabine and cisplatin is similar to that reported by other investigators but may not differ substantially from reports with single-agent gemcitabine in this patient population. The original dose level we used had unacceptable toxicity, which required lowering the doses of both gemcitabine and cisplatin by 20% to achieve acceptable toxicity and preserve clinical activity.

AB - Background: This 2-stage, phase II cooperative group trial examined the efficacy and toxicity of 1000 mg/m2 gemcitabine plus 25 mg/m 2 cisplatin weekly for 3 weeks and repeated every 28 days for patients with previously treated metastatic breast cancer. Methods: Eligible patients had to have measurable metastatic disease. Progression on prior treatment with at least 1 chemotherapy program for metastatic disease and 1 prior anthracycline and/or taxane-containing regimen in either the metastatic or adjuvant setting was required. Patients who had received more than 2 chemotherapy treatments were not eligible for this study. Results: Fifty-eight eligible patients were entered on this 2-stage study. A 38% incidence of grade 4 thrombocytopenia observed in the first stage of accrual required lowering the chemotherapy doses to 800 mg/m2 gemcitabine plus 20 mg/m2 cisplatin weekly for the first 3 weeks of a 4-week cycle during the second stage of the study. The overall response rate was 29% (95% confidence interval [CI], 11-52%) among patients receiving the original study dose and 32% (95% CI, 18-50%) for patients receiving the lower dose. In the original- and lower-dose groups, median time to progression was 30.7 weeks (95% CI, 12.7-43.4 weeks) and 26.0 weeks (95% CI, 19.0-32.1 week), respectively. Median survival of the original- and low-dose groups was 67.9 weeks (95% CI, 42.3-90.6 weeks) and 54.1 weeks (95% CI, 41.6-73.6 weeks), respectively. Hematologic toxicities were more manageable in the lower-dose group, whereas the nonhematologic toxicity profile was similar in the 2 dose groups. Conclusions: The response rate of this combination of gemcitabine and cisplatin is similar to that reported by other investigators but may not differ substantially from reports with single-agent gemcitabine in this patient population. The original dose level we used had unacceptable toxicity, which required lowering the doses of both gemcitabine and cisplatin by 20% to achieve acceptable toxicity and preserve clinical activity.

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