Randomized adjuvant trial of tamoxifen and goserelin versus cyclophosphamide, methotrexate, and fluorouracil: evidence for the superiority of treatment with endocrine blockade in premenopausal patients with hormone-responsive breast cancer--Austrian Breast and Colorectal Cancer Study Group Trial 5.

Abstract

PURPOSE:

Effective adjuvant treatment modalities in premenopausal breast cancer patients today include chemotherapy, ovariectomy, and tamoxifen administration. The purpose of Austrian Breast and Colorectal Cancer Study Group Trial 5 was to compare the efficacy of a combination endocrine treatment with standard chemotherapy.

PATIENTS AND METHODS:

Assessable trial subjects (N = 1,034) presenting with hormone-responsive disease were randomized to receive either 3 years of goserelin plus 5 years of tamoxifen or six cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF). Stratification criteria included tumor stage and grade, number of involved nodes, type of surgery, and steroid hormone receptor content. Relapse-free survival (RFS) was defined as time from randomization to first relapse, local recurrence, or contralateral incidence, and overall survival (OS) as time to date of death.

RESULTS:

With a 60-month median follow-up, 17.2% of patients in the endocrine group and 20.8% undergoing chemotherapy developed relapses. Local recurrences emerged in 4.7% and 8.0%, respectively. RFS and local recurrence-free survival differed significantly in favor of endocrine therapy (P =.037 and P =.015), with a similar trend observed in OS (P =.195).

CONCLUSION:

Overall, our data suggest that the goserelin-tamoxifen combination is significantly more effective than CMF in the adjuvant treatment of premenopausal patients with stage I and II breast cancer.

• Authors: Raimund Jakesz, Hubert Hausmaninger, Ernst Kubista, Michael Gnant, Christian Menzel, Thomas Bauernhofer, Michael Seifert, Karin Haider, Brigitte Mlineritsch, Peter Steindorfer, Werner Kwasny, Michael Fridrik, Guenther Steger, Viktor Wette, Hellmut Samonigg, Austrian Breast and Colorectal Cancer Study Group Trial 5
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 20 Issue 24 Pg. 4621-7 (Dec 15 2002) ISSN: 0732-183X [Print] United States
• PMID: 12488405 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents, Hormonal
• Tamoxifen
• Goserelin
• Cyclophosphamide
• Fluorouracil
• Methotrexate

Topics

• Antineoplastic Agents, Hormonal (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (mortality, therapy)
• Chemotherapy, Adjuvant
• Cyclophosphamide (therapeutic use)
• Female
• Fluorouracil (therapeutic use)
• Goserelin (administration & dosage)
• Humans
• Methotrexate (therapeutic use)
• Neoplasm Recurrence, Local
• Ovariectomy
• Premenopause
• Survival Rate
• Tamoxifen (administration & dosage)