Randomized clinical trial of CFP versus CMFP in women with metastatic breast cancer

R. F. Marschke, J. N. Ingle, Daniel J Schaid, J. E. Krook, J. A. Mailliard, S. A. Cullinan, D. M. Pfeifle, H. J. Votava, L. P. Ebbert, H. E. Windschitl

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Abstract

A randomized trial was performed to determine relative efficacy and toxicity of two first-line combination chemotherapy regimens in women with metastatic breast cancer: CFP (cyclophosphamide, 5-fluorouracil, prednisone) and CMFP (cyclophosphamide, 5-fluorouracil, methotrexate, prednisone). Both regimens have reported efficacy in this setting but differ in dosages and scheduling of the agents they have in common. Three hundred thirty-six women with no prior chemotherapy for metastatic disease were eligible and evaluable, and 309 had either measurable or evaluable disease and were assessable for objective response. Responses were seen in 65 of 153 (42%) on CFP and 83 of 156 (53%) on CMFP (two-sided P = 0.06). Median durations of response were 7.1 months for CFP and 8.5 months for CMFP (log-rank, two-sided P = 0.67). Considering all 336 patients, the median times to disease progression were 4.7 months for CFP and 6.2 months for CMFP (log-rank P = 0.31) and median survivals were 15.2 and 14.9 months, respectively (log-rank P = 0.88). Covariate analysis did not alter these findings. Median leukocyte nadirs were 1800 for CFP and 1500 for CMFP, with 22% and 21%, respectively, having nadirs < 1000/μl. Emesis was more frequent on CFP (49%) than on CMFP (26%) but was severe in only 7% and 5%, respectively. It is concluded that despite a higher response rate on CMFP and some differences in toxicities including a higher reported incidence of emesis on CFP, there was no substantial difference in efficacy or tolerability between the two regimens.

Original languageEnglish (US)
Pages (from-to)1931-1937
Number of pages7
JournalCancer
Volume63
Issue number10
StatePublished - 1989

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Prednisone
Methotrexate
Fluorouracil
Cyclophosphamide
Randomized Controlled Trials
Breast Neoplasms
Vomiting
Combination Drug Therapy
Disease Progression
Leukocytes

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Marschke, R. F., Ingle, J. N., Schaid, D. J., Krook, J. E., Mailliard, J. A., Cullinan, S. A., ... Windschitl, H. E. (1989). Randomized clinical trial of CFP versus CMFP in women with metastatic breast cancer. Cancer, 63(10), 1931-1937.

Randomized clinical trial of CFP versus CMFP in women with metastatic breast cancer. / Marschke, R. F.; Ingle, J. N.; Schaid, Daniel J; Krook, J. E.; Mailliard, J. A.; Cullinan, S. A.; Pfeifle, D. M.; Votava, H. J.; Ebbert, L. P.; Windschitl, H. E.

In: Cancer, Vol. 63, No. 10, 1989, p. 1931-1937.

Research output: Contribution to journalArticle

Marschke, RF, Ingle, JN, Schaid, DJ, Krook, JE, Mailliard, JA, Cullinan, SA, Pfeifle, DM, Votava, HJ, Ebbert, LP & Windschitl, HE 1989, 'Randomized clinical trial of CFP versus CMFP in women with metastatic breast cancer', Cancer, vol. 63, no. 10, pp. 1931-1937.
Marschke RF, Ingle JN, Schaid DJ, Krook JE, Mailliard JA, Cullinan SA et al. Randomized clinical trial of CFP versus CMFP in women with metastatic breast cancer. Cancer. 1989;63(10):1931-1937.
Marschke, R. F. ; Ingle, J. N. ; Schaid, Daniel J ; Krook, J. E. ; Mailliard, J. A. ; Cullinan, S. A. ; Pfeifle, D. M. ; Votava, H. J. ; Ebbert, L. P. ; Windschitl, H. E. / Randomized clinical trial of CFP versus CMFP in women with metastatic breast cancer. In: Cancer. 1989 ; Vol. 63, No. 10. pp. 1931-1937.
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abstract = "A randomized trial was performed to determine relative efficacy and toxicity of two first-line combination chemotherapy regimens in women with metastatic breast cancer: CFP (cyclophosphamide, 5-fluorouracil, prednisone) and CMFP (cyclophosphamide, 5-fluorouracil, methotrexate, prednisone). Both regimens have reported efficacy in this setting but differ in dosages and scheduling of the agents they have in common. Three hundred thirty-six women with no prior chemotherapy for metastatic disease were eligible and evaluable, and 309 had either measurable or evaluable disease and were assessable for objective response. Responses were seen in 65 of 153 (42{\%}) on CFP and 83 of 156 (53{\%}) on CMFP (two-sided P = 0.06). Median durations of response were 7.1 months for CFP and 8.5 months for CMFP (log-rank, two-sided P = 0.67). Considering all 336 patients, the median times to disease progression were 4.7 months for CFP and 6.2 months for CMFP (log-rank P = 0.31) and median survivals were 15.2 and 14.9 months, respectively (log-rank P = 0.88). Covariate analysis did not alter these findings. Median leukocyte nadirs were 1800 for CFP and 1500 for CMFP, with 22{\%} and 21{\%}, respectively, having nadirs < 1000/μl. Emesis was more frequent on CFP (49{\%}) than on CMFP (26{\%}) but was severe in only 7{\%} and 5{\%}, respectively. It is concluded that despite a higher response rate on CMFP and some differences in toxicities including a higher reported incidence of emesis on CFP, there was no substantial difference in efficacy or tolerability between the two regimens.",
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AU - Ingle, J. N.

AU - Schaid, Daniel J

AU - Krook, J. E.

AU - Mailliard, J. A.

AU - Cullinan, S. A.

AU - Pfeifle, D. M.

AU - Votava, H. J.

AU - Ebbert, L. P.

AU - Windschitl, H. E.

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N2 - A randomized trial was performed to determine relative efficacy and toxicity of two first-line combination chemotherapy regimens in women with metastatic breast cancer: CFP (cyclophosphamide, 5-fluorouracil, prednisone) and CMFP (cyclophosphamide, 5-fluorouracil, methotrexate, prednisone). Both regimens have reported efficacy in this setting but differ in dosages and scheduling of the agents they have in common. Three hundred thirty-six women with no prior chemotherapy for metastatic disease were eligible and evaluable, and 309 had either measurable or evaluable disease and were assessable for objective response. Responses were seen in 65 of 153 (42%) on CFP and 83 of 156 (53%) on CMFP (two-sided P = 0.06). Median durations of response were 7.1 months for CFP and 8.5 months for CMFP (log-rank, two-sided P = 0.67). Considering all 336 patients, the median times to disease progression were 4.7 months for CFP and 6.2 months for CMFP (log-rank P = 0.31) and median survivals were 15.2 and 14.9 months, respectively (log-rank P = 0.88). Covariate analysis did not alter these findings. Median leukocyte nadirs were 1800 for CFP and 1500 for CMFP, with 22% and 21%, respectively, having nadirs < 1000/μl. Emesis was more frequent on CFP (49%) than on CMFP (26%) but was severe in only 7% and 5%, respectively. It is concluded that despite a higher response rate on CMFP and some differences in toxicities including a higher reported incidence of emesis on CFP, there was no substantial difference in efficacy or tolerability between the two regimens.

AB - A randomized trial was performed to determine relative efficacy and toxicity of two first-line combination chemotherapy regimens in women with metastatic breast cancer: CFP (cyclophosphamide, 5-fluorouracil, prednisone) and CMFP (cyclophosphamide, 5-fluorouracil, methotrexate, prednisone). Both regimens have reported efficacy in this setting but differ in dosages and scheduling of the agents they have in common. Three hundred thirty-six women with no prior chemotherapy for metastatic disease were eligible and evaluable, and 309 had either measurable or evaluable disease and were assessable for objective response. Responses were seen in 65 of 153 (42%) on CFP and 83 of 156 (53%) on CMFP (two-sided P = 0.06). Median durations of response were 7.1 months for CFP and 8.5 months for CMFP (log-rank, two-sided P = 0.67). Considering all 336 patients, the median times to disease progression were 4.7 months for CFP and 6.2 months for CMFP (log-rank P = 0.31) and median survivals were 15.2 and 14.9 months, respectively (log-rank P = 0.88). Covariate analysis did not alter these findings. Median leukocyte nadirs were 1800 for CFP and 1500 for CMFP, with 22% and 21%, respectively, having nadirs < 1000/μl. Emesis was more frequent on CFP (49%) than on CMFP (26%) but was severe in only 7% and 5%, respectively. It is concluded that despite a higher response rate on CMFP and some differences in toxicities including a higher reported incidence of emesis on CFP, there was no substantial difference in efficacy or tolerability between the two regimens.

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