POSTOPERATIVE ADJUVANT RANDOMIZED TRIAL COMPARING CHEMOENDOCRINE THERAPY, CHEMOTHERAPY AND IMMUNOTHERAPY FOR PATIENTS WITH STAGE-II BREAST-CANCER - 5-YEAR RESULTS FROM THE NISHINIHON COOPERATIVE STUDY-GROUP OFADJUVANT CHEMOENDOCRINE THERAPY FOR BREAST-CANCER (ACETBC) OF JAPAN

Between 1985 and 1988, the effect of using ftorafur (FT) or PSK (an im munotherapy agent) in combination with the conventional postoperative adjuvant therapy using mitomycin (MMC) plus tamoxifen (TAM) was assess ed in stage II, oestrogen receptor-positive (ER+) breast cancer patien ts. Furthermore, in ER- breast cancer stage II patients, the effects o f postoperative adjuvant therapy using MMC plus FT were compared with the effects of postoperative adjuvant therapy using MMC plus PSK. Pati ents had primary stage II breast cancer and had undergone total mastec tomy plus axillary dissection or more radical surgery. On the day of s urgery, MMC (13 mg/m(2)) was administered intravenously. Then, ER+ pat ients received one of three regimens of drug therapy, starting 2 weeks after surgery: regimen A (daily oral treatment with 20 mg of TAM), re gimen B (daily oral treatment with 20 mg of TAM and 600 mg of FT) or r egimen C (daily oral treatment with 20 mg of TAM and 3 g of PSK). ER- patients received either regimen D (daily oral treatment with 600 mg o f FT) or regimen E (daily oral treatment with 3 g of PSK), starting 2 weeks after surgery. Of the 540 ER+ patients registered, 525 were eval uated. The 5-year overall survival rate for ER+ patients was higher fo r patients who received regimen B (94.2%) than for those who received regimen A (86.9%) or regimen C (89.9%) (P = 0.063). The 5-year relapse -free survival rate was higher for regimen B (88.9%) than for regimen A (78.6%) and regimen C (77.2%) (P = 0.010). Stratified analysis revea led better results with the FT-combined therapy in patients positive f or lymph node metastasis and premenopausal patients. These results ind icate the effectiveness of using FT in combination with TAM. Of the 37 6 ER- patients registered, 364 were evaluated. The 5-year overall and relapse-free survival rate for ER- patients did not differ significant ly between patients who received regimen D and those who received regi men E.