A Prospective Study of Concurrent Cyclophosphamide/Methotrexate/5-Fluorouracil and Reduced-Dose Radiotherapy in Patients with Early-Stage Breast Carcinoma

Jennifer R. Bellon, Lawrence N. Shulman, Steven E. Come, Xiaochun Li, Rebecca S. Gelman, Barbara J. Silver, Jay R. Harris, Abram Recht

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

BACKGROUND. Concurrent administration of chemotherapy and radiotherapy has the potential advantage of delaying neither treatment and providing radiation sensitization. However, the optimal approach to concurrent treatment in women with early-stage breast carcinoma remains undefined. We present updated results of a prospective protocol of concurrent cyclophosphamide/methotrexate/5-fluorouracil (CMF) and reduced-dose radiotherapy, focusing on tumor control and patient tolerance. METHODS. One hundred twelve women with AJCC Stage I or Stage II breast carcinoma with 0-3 positive axillary lymph nodes were enrolled in a prospective single-arm study of concurrent CMF and reduced-dose radiotherapy (39.6 gray [Gy] to the whole breast, 16-Gy boost). A high proportion of women had risk factors associated with an increased risk of local disease recurrence, including age <40 (32%), close or positive margins (37%), or lymphatic/vascular invasion (51%). The median follow-up period was 94 months. RESULTS. The 5-year overall survival rate was 94%. By 60 months, 5 patients (4%) experienced local disease recurrence and 19 patients (17%) experienced distant metastasis. There were no isolated regional lymph node recurrences. Local disease recurrence occurred in 1 of 25 patients (4%), 1 of 16 patients (6%), and 3 of 70 patients (4%) with positive, close (<1 mm), and negative margins, respectively. One patient developed acute myelogenous leukemia. An additional patient developed Grade 2 pneumonitis. Cosmetic results were not recorded uniformly for all patients and therefore could not be reliably analyzed. CONCLUSIONS. Concurrent CMF and reduced-dose radiotherapy resulted in a low level of late toxicity and excellent local tumor control, despite the large proportion of patients with substantial risk factors for local disease recurrence. Future studies of concurrent regimens, particularly in patients at high risk of local disease recurrence, are warranted.

Original languageEnglish (US)
Pages (from-to)1358-1364
Number of pages7
JournalCancer
Volume100
Issue number7
DOIs
StatePublished - Apr 1 2004
Externally publishedYes

Fingerprint

Methotrexate
Fluorouracil
Cyclophosphamide
Radiotherapy
Prospective Studies
Breast Neoplasms
Recurrence
Cohort Studies
Lymph Nodes
Acute Myeloid Leukemia
Cosmetics
Blood Vessels
Neoplasms
Pneumonia
Breast
Survival Rate
Radiation
Neoplasm Metastasis
Drug Therapy

Keywords

  • Breast
  • Concurrent
  • Cyclophosphamide/methotrexate/5-fluorouracil
  • Radiotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A Prospective Study of Concurrent Cyclophosphamide/Methotrexate/5-Fluorouracil and Reduced-Dose Radiotherapy in Patients with Early-Stage Breast Carcinoma. / Bellon, Jennifer R.; Shulman, Lawrence N.; Come, Steven E.; Li, Xiaochun; Gelman, Rebecca S.; Silver, Barbara J.; Harris, Jay R.; Recht, Abram.

In: Cancer, Vol. 100, No. 7, 01.04.2004, p. 1358-1364.

Research output: Contribution to journalArticle

Bellon, Jennifer R. ; Shulman, Lawrence N. ; Come, Steven E. ; Li, Xiaochun ; Gelman, Rebecca S. ; Silver, Barbara J. ; Harris, Jay R. ; Recht, Abram. / A Prospective Study of Concurrent Cyclophosphamide/Methotrexate/5-Fluorouracil and Reduced-Dose Radiotherapy in Patients with Early-Stage Breast Carcinoma. In: Cancer. 2004 ; Vol. 100, No. 7. pp. 1358-1364.
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abstract = "BACKGROUND. Concurrent administration of chemotherapy and radiotherapy has the potential advantage of delaying neither treatment and providing radiation sensitization. However, the optimal approach to concurrent treatment in women with early-stage breast carcinoma remains undefined. We present updated results of a prospective protocol of concurrent cyclophosphamide/methotrexate/5-fluorouracil (CMF) and reduced-dose radiotherapy, focusing on tumor control and patient tolerance. METHODS. One hundred twelve women with AJCC Stage I or Stage II breast carcinoma with 0-3 positive axillary lymph nodes were enrolled in a prospective single-arm study of concurrent CMF and reduced-dose radiotherapy (39.6 gray [Gy] to the whole breast, 16-Gy boost). A high proportion of women had risk factors associated with an increased risk of local disease recurrence, including age <40 (32{\%}), close or positive margins (37{\%}), or lymphatic/vascular invasion (51{\%}). The median follow-up period was 94 months. RESULTS. The 5-year overall survival rate was 94{\%}. By 60 months, 5 patients (4{\%}) experienced local disease recurrence and 19 patients (17{\%}) experienced distant metastasis. There were no isolated regional lymph node recurrences. Local disease recurrence occurred in 1 of 25 patients (4{\%}), 1 of 16 patients (6{\%}), and 3 of 70 patients (4{\%}) with positive, close (<1 mm), and negative margins, respectively. One patient developed acute myelogenous leukemia. An additional patient developed Grade 2 pneumonitis. Cosmetic results were not recorded uniformly for all patients and therefore could not be reliably analyzed. CONCLUSIONS. Concurrent CMF and reduced-dose radiotherapy resulted in a low level of late toxicity and excellent local tumor control, despite the large proportion of patients with substantial risk factors for local disease recurrence. Future studies of concurrent regimens, particularly in patients at high risk of local disease recurrence, are warranted.",
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T1 - A Prospective Study of Concurrent Cyclophosphamide/Methotrexate/5-Fluorouracil and Reduced-Dose Radiotherapy in Patients with Early-Stage Breast Carcinoma

AU - Bellon, Jennifer R.

AU - Shulman, Lawrence N.

AU - Come, Steven E.

AU - Li, Xiaochun

AU - Gelman, Rebecca S.

AU - Silver, Barbara J.

AU - Harris, Jay R.

AU - Recht, Abram

PY - 2004/4/1

Y1 - 2004/4/1

N2 - BACKGROUND. Concurrent administration of chemotherapy and radiotherapy has the potential advantage of delaying neither treatment and providing radiation sensitization. However, the optimal approach to concurrent treatment in women with early-stage breast carcinoma remains undefined. We present updated results of a prospective protocol of concurrent cyclophosphamide/methotrexate/5-fluorouracil (CMF) and reduced-dose radiotherapy, focusing on tumor control and patient tolerance. METHODS. One hundred twelve women with AJCC Stage I or Stage II breast carcinoma with 0-3 positive axillary lymph nodes were enrolled in a prospective single-arm study of concurrent CMF and reduced-dose radiotherapy (39.6 gray [Gy] to the whole breast, 16-Gy boost). A high proportion of women had risk factors associated with an increased risk of local disease recurrence, including age <40 (32%), close or positive margins (37%), or lymphatic/vascular invasion (51%). The median follow-up period was 94 months. RESULTS. The 5-year overall survival rate was 94%. By 60 months, 5 patients (4%) experienced local disease recurrence and 19 patients (17%) experienced distant metastasis. There were no isolated regional lymph node recurrences. Local disease recurrence occurred in 1 of 25 patients (4%), 1 of 16 patients (6%), and 3 of 70 patients (4%) with positive, close (<1 mm), and negative margins, respectively. One patient developed acute myelogenous leukemia. An additional patient developed Grade 2 pneumonitis. Cosmetic results were not recorded uniformly for all patients and therefore could not be reliably analyzed. CONCLUSIONS. Concurrent CMF and reduced-dose radiotherapy resulted in a low level of late toxicity and excellent local tumor control, despite the large proportion of patients with substantial risk factors for local disease recurrence. Future studies of concurrent regimens, particularly in patients at high risk of local disease recurrence, are warranted.

AB - BACKGROUND. Concurrent administration of chemotherapy and radiotherapy has the potential advantage of delaying neither treatment and providing radiation sensitization. However, the optimal approach to concurrent treatment in women with early-stage breast carcinoma remains undefined. We present updated results of a prospective protocol of concurrent cyclophosphamide/methotrexate/5-fluorouracil (CMF) and reduced-dose radiotherapy, focusing on tumor control and patient tolerance. METHODS. One hundred twelve women with AJCC Stage I or Stage II breast carcinoma with 0-3 positive axillary lymph nodes were enrolled in a prospective single-arm study of concurrent CMF and reduced-dose radiotherapy (39.6 gray [Gy] to the whole breast, 16-Gy boost). A high proportion of women had risk factors associated with an increased risk of local disease recurrence, including age <40 (32%), close or positive margins (37%), or lymphatic/vascular invasion (51%). The median follow-up period was 94 months. RESULTS. The 5-year overall survival rate was 94%. By 60 months, 5 patients (4%) experienced local disease recurrence and 19 patients (17%) experienced distant metastasis. There were no isolated regional lymph node recurrences. Local disease recurrence occurred in 1 of 25 patients (4%), 1 of 16 patients (6%), and 3 of 70 patients (4%) with positive, close (<1 mm), and negative margins, respectively. One patient developed acute myelogenous leukemia. An additional patient developed Grade 2 pneumonitis. Cosmetic results were not recorded uniformly for all patients and therefore could not be reliably analyzed. CONCLUSIONS. Concurrent CMF and reduced-dose radiotherapy resulted in a low level of late toxicity and excellent local tumor control, despite the large proportion of patients with substantial risk factors for local disease recurrence. Future studies of concurrent regimens, particularly in patients at high risk of local disease recurrence, are warranted.

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