A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: An NCCTG study

C. X. Ma, P. Steen, K. M. Rowland, R. D. Niedringhaus, T. R. Fitch, J. W. Kugler, D. W. Hillman, E. A. Perez, J. N. Ingle, Alex Adjei

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Abstract

Purpose: This phase II study was undertaken to define the efficacy and toxicity of pemetrexed in combination with gemcitabine in patients with metastatic breast cancer. Patients and methods: Patients with measurable metastatic breast cancer who had previously received an anthracycline and a taxane in either the adjuvant or metastatic setting were treated with gemcitabine 1250 mg/ m2 (intravenous; days 1 and 8) and pemetrexed 500 mg/m2 (intravenous; day 8) every 21 days. Results: Fifty-nine patients received a median of five cycles (range one to 22) of treatment and were followed until death or for a median of 28 months (range 19.4-36.6) among living patients. Fourteen partial responses for an overall response rate of 24% [95% confidence interval (CI) 16% to 39%] were documented. Nine (15%; CI 5% to 32%) patients had stable disease for >6 months. The median survival time was 10.3 months (95% CI 8.3-18.9) and the 1 year survival rate was 49% (95% CI 38% to 64%). The median time to progression was estimated to be 3.7 months (95% CI 2.3-5.3). The most common grade 3 or 4 toxicities were neutropenia and thrombocytopenia in 83% and 27% of patients, respectively. Fourteen percent of patients experienced febrile neutropenia. Other common grade 3 or 4 non-hematological toxicities included fatigue (17%), dyspnea (15%), rash (7%) and anorexia (5%). Conclusions: The combination of pemetrexed and gemcitabine is clinically active, with an overall response rate of 24% in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane. Myelosuppression (66% grade 4 neutropenia and 14% febrile neutropenia) was the major treatment-related toxicity observed for this combination.

Original languageEnglish (US)
Pages (from-to)226-231
Number of pages6
JournalAnnals of Oncology
Volume17
Issue number2
DOIs
StatePublished - Feb 2006

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gemcitabine
Pemetrexed
Breast Neoplasms
Confidence Intervals
Febrile Neutropenia
Anthracyclines
Neutropenia
Anorexia
Exanthema
Thrombocytopenia
Dyspnea

Keywords

  • Clinical Trial
  • Gemcitabine
  • Metastatic Breast Cancer
  • Pemetrexed

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer : An NCCTG study. / Ma, C. X.; Steen, P.; Rowland, K. M.; Niedringhaus, R. D.; Fitch, T. R.; Kugler, J. W.; Hillman, D. W.; Perez, E. A.; Ingle, J. N.; Adjei, Alex.

In: Annals of Oncology, Vol. 17, No. 2, 02.2006, p. 226-231.

Research output: Contribution to journalArticle

Ma, CX, Steen, P, Rowland, KM, Niedringhaus, RD, Fitch, TR, Kugler, JW, Hillman, DW, Perez, EA, Ingle, JN & Adjei, A 2006, 'A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: An NCCTG study', Annals of Oncology, vol. 17, no. 2, pp. 226-231. https://doi.org/10.1093/annonc/mdj054
Ma, C. X. ; Steen, P. ; Rowland, K. M. ; Niedringhaus, R. D. ; Fitch, T. R. ; Kugler, J. W. ; Hillman, D. W. ; Perez, E. A. ; Ingle, J. N. ; Adjei, Alex. / A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer : An NCCTG study. In: Annals of Oncology. 2006 ; Vol. 17, No. 2. pp. 226-231.
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abstract = "Purpose: This phase II study was undertaken to define the efficacy and toxicity of pemetrexed in combination with gemcitabine in patients with metastatic breast cancer. Patients and methods: Patients with measurable metastatic breast cancer who had previously received an anthracycline and a taxane in either the adjuvant or metastatic setting were treated with gemcitabine 1250 mg/ m2 (intravenous; days 1 and 8) and pemetrexed 500 mg/m2 (intravenous; day 8) every 21 days. Results: Fifty-nine patients received a median of five cycles (range one to 22) of treatment and were followed until death or for a median of 28 months (range 19.4-36.6) among living patients. Fourteen partial responses for an overall response rate of 24{\%} [95{\%} confidence interval (CI) 16{\%} to 39{\%}] were documented. Nine (15{\%}; CI 5{\%} to 32{\%}) patients had stable disease for >6 months. The median survival time was 10.3 months (95{\%} CI 8.3-18.9) and the 1 year survival rate was 49{\%} (95{\%} CI 38{\%} to 64{\%}). The median time to progression was estimated to be 3.7 months (95{\%} CI 2.3-5.3). The most common grade 3 or 4 toxicities were neutropenia and thrombocytopenia in 83{\%} and 27{\%} of patients, respectively. Fourteen percent of patients experienced febrile neutropenia. Other common grade 3 or 4 non-hematological toxicities included fatigue (17{\%}), dyspnea (15{\%}), rash (7{\%}) and anorexia (5{\%}). Conclusions: The combination of pemetrexed and gemcitabine is clinically active, with an overall response rate of 24{\%} in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane. Myelosuppression (66{\%} grade 4 neutropenia and 14{\%} febrile neutropenia) was the major treatment-related toxicity observed for this combination.",
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T2 - An NCCTG study

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AU - Steen, P.

AU - Rowland, K. M.

AU - Niedringhaus, R. D.

AU - Fitch, T. R.

AU - Kugler, J. W.

AU - Hillman, D. W.

AU - Perez, E. A.

AU - Ingle, J. N.

AU - Adjei, Alex

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N2 - Purpose: This phase II study was undertaken to define the efficacy and toxicity of pemetrexed in combination with gemcitabine in patients with metastatic breast cancer. Patients and methods: Patients with measurable metastatic breast cancer who had previously received an anthracycline and a taxane in either the adjuvant or metastatic setting were treated with gemcitabine 1250 mg/ m2 (intravenous; days 1 and 8) and pemetrexed 500 mg/m2 (intravenous; day 8) every 21 days. Results: Fifty-nine patients received a median of five cycles (range one to 22) of treatment and were followed until death or for a median of 28 months (range 19.4-36.6) among living patients. Fourteen partial responses for an overall response rate of 24% [95% confidence interval (CI) 16% to 39%] were documented. Nine (15%; CI 5% to 32%) patients had stable disease for >6 months. The median survival time was 10.3 months (95% CI 8.3-18.9) and the 1 year survival rate was 49% (95% CI 38% to 64%). The median time to progression was estimated to be 3.7 months (95% CI 2.3-5.3). The most common grade 3 or 4 toxicities were neutropenia and thrombocytopenia in 83% and 27% of patients, respectively. Fourteen percent of patients experienced febrile neutropenia. Other common grade 3 or 4 non-hematological toxicities included fatigue (17%), dyspnea (15%), rash (7%) and anorexia (5%). Conclusions: The combination of pemetrexed and gemcitabine is clinically active, with an overall response rate of 24% in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane. Myelosuppression (66% grade 4 neutropenia and 14% febrile neutropenia) was the major treatment-related toxicity observed for this combination.

AB - Purpose: This phase II study was undertaken to define the efficacy and toxicity of pemetrexed in combination with gemcitabine in patients with metastatic breast cancer. Patients and methods: Patients with measurable metastatic breast cancer who had previously received an anthracycline and a taxane in either the adjuvant or metastatic setting were treated with gemcitabine 1250 mg/ m2 (intravenous; days 1 and 8) and pemetrexed 500 mg/m2 (intravenous; day 8) every 21 days. Results: Fifty-nine patients received a median of five cycles (range one to 22) of treatment and were followed until death or for a median of 28 months (range 19.4-36.6) among living patients. Fourteen partial responses for an overall response rate of 24% [95% confidence interval (CI) 16% to 39%] were documented. Nine (15%; CI 5% to 32%) patients had stable disease for >6 months. The median survival time was 10.3 months (95% CI 8.3-18.9) and the 1 year survival rate was 49% (95% CI 38% to 64%). The median time to progression was estimated to be 3.7 months (95% CI 2.3-5.3). The most common grade 3 or 4 toxicities were neutropenia and thrombocytopenia in 83% and 27% of patients, respectively. Fourteen percent of patients experienced febrile neutropenia. Other common grade 3 or 4 non-hematological toxicities included fatigue (17%), dyspnea (15%), rash (7%) and anorexia (5%). Conclusions: The combination of pemetrexed and gemcitabine is clinically active, with an overall response rate of 24% in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane. Myelosuppression (66% grade 4 neutropenia and 14% febrile neutropenia) was the major treatment-related toxicity observed for this combination.

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