Re the above this is a thought provoking item.
RB.
http://professional.cancerconsultant....aspx?id=29165
ABSTRACT
Hormonal Therapy Equivalent or Superior to Standard Chemotherapy for Adjuvant Treatment of Premenopausal Localized Breast Cancer
Chemotherapy is the current standard adjuvant therapy for localized breast cancer in pre-menopausal women. For patients who have hormone responsive disease, Nolvadex® is often added following completion of adjuvant chemotherapy. There is evidence that some of the effects of adjuvant chemotherapy are not due entirely to cytotoxic anti-tumor effects but to the production of ovarian failure. Pre-menopausal women who stop menstruating after chemotherapy have been shown to have a better outcome than those who continue menstruating. Luteinizing hormone-releasing hormone (LHRH) analogs, such as goserelin, offer an alternative form of ovarian estrogen suppression for pre-menopausal women and are being extensively studied in clinical trials. Two randomized clinical trials have addressed the issue of whether ovarian ablation is comparable to adjuvant chemotherapy for the prevention of recurrences in women with localized stage I-II breast cancer. Both clinical trials, published in the December 17, 2002 issue of the Journal of Clinical Oncology, concluded that combined adjuvant therapy with goserelin and Nolvadex® was superior or at least equivalent to standard adjuvant combination chemotherapy.
In one trial, performed by Austrian researchers, over 1,000 women with hormone-responsive disease were randomly allocated to receive 3 years of goserelin plus 5 years of Nolvadex® or 6 cycles of CMF (cyclophosphamide, methotrexate and 5-FU). In patients receiving hormonal therapy, the relapse rate was 17.2%, compared to 20.8% for those receiving CMF. The local recurrence rate was 4.7% for the hormonal group and 8.0% for the CMF group. However, the number of distant recurrences without local recurrence was the same. Furthermore, there was only a trend for improvement in survival (P = 0.195). These researchers concluded that “Overall, our data suggest that the goserelin-tamoxifen (Nolvadex®) combination is significantly more effective than CMF in the adjuvant treatment of pre-menopausal patients with stage I and II breast cancer”.
The second trial was an international multi-institution study which enrolled 1,640 women with node-positive breast cancer irrespective of hormone status. Patients were randomly allocated to receive goserelin for 2 years or CMF. The researchers found that the disease-free survival was approximately 60% at 5 years for women with hormone responsive disease in both arms of the study. For women with hormone receptor negative breast cancer, the 5-year survival following CMF was approximately 65%, compared to 40% for the goserelin arm. Further analysis showed that women receiving CMF who developed amenorrhea had a survival of 70%, compared to 40% for those who did not have amenorrhea. These authors concluded that “Goserelin offers an effective, well-tolerated alternative to CMF in pre-menopausal patients with ER-positive and node-positive early breast cancer”.
Comments: These are very important clinical trials which were thoroughly discussed in an accompanying editorial. The findings are relatively clear cut in that goserelin appears to be as effective as CMF in pre-menopausal women with localized breast cancer. However, this raises the question of whether or not hormonal therapy is as good as newer regimens including taxanes and dose-dense treatment regimens. Comparisons such as the ones reported here suggest that more comparisons will need to be made with more recently developed chemotherapy regimens.