Randomized Adjuvant Trial of Tamoxifen (Nolvadex) and Goserelin (Zoladex) – significantly more effective than CMF

Recently the Journal of Clinical Oncology published the results of a trial of tamoxifen with goserelin in adjuvant therapy for premenopausal patients with stage one and two breast cancer.

Click on the link above to read the full report.

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.

Assessable trial subjects (N 51,034) presenting with hormone-responsive disease were randomised to receive either 3 years of goserelin plus 5 years of tamoxifen or six cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF). Stratification criteria included tumour stage and grade, number of involved nodes, type of surgery, and steroid hormone receptor content. Relapse-free survival (RFS) was defined as time from randomisation 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 (P5 .037 and P5 .015), with a similar trend observed in OS (P5 .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.