Disease-free survival advantage of adjuvant cyclophosphamide, methotrexate, and fluorouracil in patients with node-negative, rapidly proliferating breast cancer: A randomized multicenter study

Dino Amadori, Oriana Nanni, Maurizio Marangolo, Paolo Pacini, Alberto Ravaioli, Dino Amadori D., Oriana Nanni O., Maurizio Marangolo M., Palol Pacini P., Alberto Ravaioli A., Andrea Rossi A., Angelo Gambi A., Giuseppina Catalano G., Davide Perroni D., Emanuela Scarpi E., Donata Casadei Giunchi D.C., Amelia Tienghi A., Aldo Becciolini A., Annalisa Volpi A.

Research output: Contribution to journalArticle

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Abstract

Purpose: According to one of the most recent key scientific questions concerning the use of biomarkers in clinical trials, we investigated whether node-negative breast cancer patients, defined as high-risk cases on the basis of tumor cell proliferation, could benefit from cyclophosphamide, methotrexate, and fluorouracil (CMF) adjuvant therapy. Patients and Methods: Two hundred eighty-one patients with negative nodes and rapidly proliferating tumors, defined according to thymidine labeling index (TLI), were randomized to receive six cycles of CMF or no further treatment after surgery ± radiotherapy. Results: The 5-year disease-free survival (DFS) was 83% for patients treated with CMF compared with 72% in the control group (P = .028). Adjuvant treatment reduced both lecoregional and distant metastases. When clinical outcome was analyzed in cell kinetic subgroups characterized according to tertile criteria, compared with patients in the control arm, 5-year DFS was significantly higher after adjuvant CMF in patients with TLI values in the second (78% v 88%, respectively; P = .037) and third tertiles (58% v 78%, respectively; P = .024). Conclusion: The results from this randomized clinical study indicate that patients with node-negative, rapidly proliferating tumors significantly benefit from adjuvant CMF. (C) 2000 by American Society of Clinical Oncology.

Original languageEnglish
Pages (from-to)3125-3134
Number of pages10
JournalJournal of Clinical Oncology
Volume18
Issue number17
Publication statusPublished - 2000

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Methotrexate
Fluorouracil
Cyclophosphamide
Multicenter Studies
Disease-Free Survival
Breast Neoplasms
Thymidine
Neoplasms
Radiotherapy
Therapeutics
Biomarkers
Cell Proliferation
Clinical Trials
Neoplasm Metastasis
Control Groups

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Disease-free survival advantage of adjuvant cyclophosphamide, methotrexate, and fluorouracil in patients with node-negative, rapidly proliferating breast cancer : A randomized multicenter study. / Amadori, Dino; Nanni, Oriana; Marangolo, Maurizio; Pacini, Paolo; Ravaioli, Alberto; Amadori D., Dino; Nanni O., Oriana; Marangolo M., Maurizio; Pacini P., Palol; Ravaioli A., Alberto; Rossi A., Andrea; Gambi A., Angelo; Catalano G., Giuseppina; Perroni D., Davide; Scarpi E., Emanuela; Giunchi D.C., Donata Casadei; Tienghi A., Amelia; Becciolini A., Aldo; Volpi A., Annalisa.

In: Journal of Clinical Oncology, Vol. 18, No. 17, 2000, p. 3125-3134.

Research output: Contribution to journalArticle

Amadori, D, Nanni, O, Marangolo, M, Pacini, P, Ravaioli, A, Amadori D., D, Nanni O., O, Marangolo M., M, Pacini P., P, Ravaioli A., A, Rossi A., A, Gambi A., A, Catalano G., G, Perroni D., D, Scarpi E., E, Giunchi D.C., DC, Tienghi A., A, Becciolini A., A & Volpi A., A 2000, 'Disease-free survival advantage of adjuvant cyclophosphamide, methotrexate, and fluorouracil in patients with node-negative, rapidly proliferating breast cancer: A randomized multicenter study', Journal of Clinical Oncology, vol. 18, no. 17, pp. 3125-3134.
Amadori, Dino ; Nanni, Oriana ; Marangolo, Maurizio ; Pacini, Paolo ; Ravaioli, Alberto ; Amadori D., Dino ; Nanni O., Oriana ; Marangolo M., Maurizio ; Pacini P., Palol ; Ravaioli A., Alberto ; Rossi A., Andrea ; Gambi A., Angelo ; Catalano G., Giuseppina ; Perroni D., Davide ; Scarpi E., Emanuela ; Giunchi D.C., Donata Casadei ; Tienghi A., Amelia ; Becciolini A., Aldo ; Volpi A., Annalisa. / Disease-free survival advantage of adjuvant cyclophosphamide, methotrexate, and fluorouracil in patients with node-negative, rapidly proliferating breast cancer : A randomized multicenter study. In: Journal of Clinical Oncology. 2000 ; Vol. 18, No. 17. pp. 3125-3134.
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abstract = "Purpose: According to one of the most recent key scientific questions concerning the use of biomarkers in clinical trials, we investigated whether node-negative breast cancer patients, defined as high-risk cases on the basis of tumor cell proliferation, could benefit from cyclophosphamide, methotrexate, and fluorouracil (CMF) adjuvant therapy. Patients and Methods: Two hundred eighty-one patients with negative nodes and rapidly proliferating tumors, defined according to thymidine labeling index (TLI), were randomized to receive six cycles of CMF or no further treatment after surgery ± radiotherapy. Results: The 5-year disease-free survival (DFS) was 83{\%} for patients treated with CMF compared with 72{\%} in the control group (P = .028). Adjuvant treatment reduced both lecoregional and distant metastases. When clinical outcome was analyzed in cell kinetic subgroups characterized according to tertile criteria, compared with patients in the control arm, 5-year DFS was significantly higher after adjuvant CMF in patients with TLI values in the second (78{\%} v 88{\%}, respectively; P = .037) and third tertiles (58{\%} v 78{\%}, respectively; P = .024). Conclusion: The results from this randomized clinical study indicate that patients with node-negative, rapidly proliferating tumors significantly benefit from adjuvant CMF. (C) 2000 by American Society of Clinical Oncology.",
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T1 - Disease-free survival advantage of adjuvant cyclophosphamide, methotrexate, and fluorouracil in patients with node-negative, rapidly proliferating breast cancer

T2 - A randomized multicenter study

AU - Amadori, Dino

AU - Nanni, Oriana

AU - Marangolo, Maurizio

AU - Pacini, Paolo

AU - Ravaioli, Alberto

AU - Amadori D., Dino

AU - Nanni O., Oriana

AU - Marangolo M., Maurizio

AU - Pacini P., Palol

AU - Ravaioli A., Alberto

AU - Rossi A., Andrea

AU - Gambi A., Angelo

AU - Catalano G., Giuseppina

AU - Perroni D., Davide

AU - Scarpi E., Emanuela

AU - Giunchi D.C., Donata Casadei

AU - Tienghi A., Amelia

AU - Becciolini A., Aldo

AU - Volpi A., Annalisa

PY - 2000

Y1 - 2000

N2 - Purpose: According to one of the most recent key scientific questions concerning the use of biomarkers in clinical trials, we investigated whether node-negative breast cancer patients, defined as high-risk cases on the basis of tumor cell proliferation, could benefit from cyclophosphamide, methotrexate, and fluorouracil (CMF) adjuvant therapy. Patients and Methods: Two hundred eighty-one patients with negative nodes and rapidly proliferating tumors, defined according to thymidine labeling index (TLI), were randomized to receive six cycles of CMF or no further treatment after surgery ± radiotherapy. Results: The 5-year disease-free survival (DFS) was 83% for patients treated with CMF compared with 72% in the control group (P = .028). Adjuvant treatment reduced both lecoregional and distant metastases. When clinical outcome was analyzed in cell kinetic subgroups characterized according to tertile criteria, compared with patients in the control arm, 5-year DFS was significantly higher after adjuvant CMF in patients with TLI values in the second (78% v 88%, respectively; P = .037) and third tertiles (58% v 78%, respectively; P = .024). Conclusion: The results from this randomized clinical study indicate that patients with node-negative, rapidly proliferating tumors significantly benefit from adjuvant CMF. (C) 2000 by American Society of Clinical Oncology.

AB - Purpose: According to one of the most recent key scientific questions concerning the use of biomarkers in clinical trials, we investigated whether node-negative breast cancer patients, defined as high-risk cases on the basis of tumor cell proliferation, could benefit from cyclophosphamide, methotrexate, and fluorouracil (CMF) adjuvant therapy. Patients and Methods: Two hundred eighty-one patients with negative nodes and rapidly proliferating tumors, defined according to thymidine labeling index (TLI), were randomized to receive six cycles of CMF or no further treatment after surgery ± radiotherapy. Results: The 5-year disease-free survival (DFS) was 83% for patients treated with CMF compared with 72% in the control group (P = .028). Adjuvant treatment reduced both lecoregional and distant metastases. When clinical outcome was analyzed in cell kinetic subgroups characterized according to tertile criteria, compared with patients in the control arm, 5-year DFS was significantly higher after adjuvant CMF in patients with TLI values in the second (78% v 88%, respectively; P = .037) and third tertiles (58% v 78%, respectively; P = .024). Conclusion: The results from this randomized clinical study indicate that patients with node-negative, rapidly proliferating tumors significantly benefit from adjuvant CMF. (C) 2000 by American Society of Clinical Oncology.

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