[Assessment of goserelin treatment in adjuvant therapy for premenopausal patients with breast cancer in Japan-zoladex breast cancer study group trial-B].

OBJECTIVE: Goserelin (GOS) therapy in an adjuvant setting for estrogen receptor(ER)-positive premenopausal patients with breast cancer was assessed in a randomised comparative study. METHODS: ER positive premenopausal patients with n + or n 0 and T > or = 3 cm received tamoxifen (TAM) 20 mg/day, GOS 3.6 mg/4 weeks or GOS + TAM for 2 years, and the clinical efficacy and safety of these regimens were assessed. RESULTS: In the data analysis of total 207 patients, hazard ratios of disease free survival (DFS) and overall survival (OS) in the GOS group compared to the TAM group were 0.87 and 2.10,respectively. The incidence of adverse drug reactions was similar (42-55%) in all three groups. Since the number of patients in this study did not reach the target number, the efficacy could not be assessed from a statistical aspect. Therefore,meta-analysis with similar foreign studies(ZIPP) was implemented. The results of meta-analysis showed that the hazard ratios of DFS and OS in the GOS group compared to the non-GOS group were 0.83 and 0.85, respectively. CONCLUSION: Although the analysis of 207 patients did not show any statistically significant difference between each of the treatment groups, the results of meta-analysis showed a significant prolongation of DFS in the GOS group. Also high tolerability of GOS was suggested. From these results, GOS was considered highly useful in adjuvant therapy for ER-positive premenopausal patients with breast cancer.

[Incidence of emesis in outpatients on chemotherapy for breast cancer and the clinical efficacy of ondansetron hydrochloride tablets].

The incidence of nausea and vomiting was investigated for a maximum of 7 days in 32 breast cancer patients receiving CAF (cyclophosphamide, adriamycin, 5-fluorouracil) and CMF (cyclophosphamide, methotrexate, 5-fluorouracil) therapies. For those patients who experienced nausea and vomiting, 4 mg/day of ondansetron hydrochloride (OND) in tablet form was given in the next course of the chemotherapy, and the anti-emetic effect of the drug was examined. During the observation period, nausea was seen in 17.2-50.0% of the patients and vomiting in 3.1-15.6%. The number of patients who had nausea and vomiting was 22. The anti-emetic effect was examined in 18 out of 22 cases with nausea and vomiting. An anti-emetic effect based on the judgement criterion (efficacy rate) was seen in 94.4% or more of patients for all the days of observation. A marked effect was seen in higher proportion of patients. In conclusion, nausea and vomiting occurred in 17.2-50.0% of the breast cancer patients on chemotherapy (CAF and CMF therapies). To improve the QOL of those patients, anti-emetic treatment using OND tablets as necessary is considered to be effective.

Breast-conserving therapy versus modified radical mastectomy in the treatment of early breast cancer in Japan.

BACKGROUND: Breast-conserving therapy has been widely utilized as a treatment option for women with early breast cancer. However, no randomized study comparing modified radical mastectomy and breast-conserving therapy has been conducted in Japan. METHODS: Two hundred and twenty-eight Japanese women with early breast cancer enrolled in the Gunma Breast Conserving Therapy Study between 1991 and 1994 were examined to determine whether there is any difference in disease-free survival or overall survival between radical mastectomy and breast-conserving therapy. After informed consent was obtained, a total of 119 patients underwent breast-conserving therapy and 109 underwent mastectomy. RESULTS: Mastectomy was a more frequently utilized treatment than breast-conserving therapy in patients with clinical stage II lesions, older age, larger tumor size or shorter distance between tumor and nipple. The mean follow-up period for all patients was 81 months (median 86 months). There was no significant difference in overall survival or disease-free survival between breast-conserving therapy and mastectomy even after adjusting for the clinical stage of the disease. A multivariate analysis of tumor size, lymph node status, estrogen receptor status and operation method using the Cox proportion hazard model confirmed that only lymph node status was an independent prognostic factor. CONCLUSION: Breast-conserving therapy is comparable to modified radical mastectomy in overall survival and disease-free survival.