Randomized adjuvant breast cancer trials in Sweden.

Abstract

A total of 8 major adjuvant trials are today open for entry in Sweden excluding trials conducted by international research groups with Swedish collaboration. The yearly accrual rate is about 1,600 patients. The randomized comparisons are: (1) tamoxifen 2 years versus 5 years in postmenopausal stage I-II patients, (2) sequential tamoxifen/megestrol in alternating 3 months cycles for 2 years versus tamoxifen alone for 2 years in estrogen receptor (ER)-positive, postmenopausal stage I-II patients, (3) tamoxifen for 2 years versus tamoxifen+LHRH-analogue for 2 years versus LHRH-analogue alone versus control in premenopausal stage I-II patients, (4) CMF chemotherapy versus radiological castration in ER-positive, premenopausal stage II patients, (5) high-dose chemotherapy+autologous bone marrow transplantation versus conventional chemotherapy in high-risk (pN6+) stage II patients aged under 60 years, (6) postoperative radiotherapy to the breast versus control after breast-conserving surgery for invasive stage I-II breast cancer, (7) postoperative radiotherapy to the breast versus control after breast-conserving surgery for ductal carcinoma in situ (DCIS), and (8) CMF- or FEC-chemotherapy plus APD (pamidronate) versus the same chemotherapy without APD. Current plans for future trials include in vivo monitoring of treatment response, that is, the change in the proportion of proliferating tumor cells, during neo-adjuvant chemotherapy.