A. Goldhirsch et al., THE BEST AVAILABLE ADJUVANT TREATMENTS ARE WITHIN THE FRAMEWORK OF CLINICAL-TRIALS - THE INTERNATIONAL BREAST-CANCER STUDY-GROUP, Israel journal of medical sciences, 31(2-3), 1995, pp. 144-154
The International Breast Cancer Study Group (IBCSG, formerly the Ludwi
g Group) is currently conducting several trials to improve available a
djuvant therapies for operable breast cancer. Within the framework of
clinical trials, treatment is available for several subpopulations of
patients with operable disease. Two trials for patients with node-nega
tive breast cancer question the efficacy of the combination of chemoth
erapy and endocrine manipulation. Four trials for patients with node-p
ositive disease investigate questions of chemoendocrine therapy and of
delayed reintroduction of chemotherapy after an initial cytotoxic tre
atment. One trial for elderly patients investigates the role of axilla
ry lymph node dissection in terms of treatment outcome and quality of
life. The ongoing trials are based on the results of past investigatio
ns by the Group: seven clinical trials, conducted since 1978, tested h
ypotheses of timing, duration, and the combined use of chemo- and endo
crine therapies. Several ancillary studies were conducted using the da
tabase amassed from these trials, including pathological findings in n
ode-negative disease, significance of micrometastases detected by seri
al sectioning of axillary nodes, importance of c-erbB-2 oncogene expre
ssion for prediction of treatment responsiveness, patterns of relapse,
and assessing the impact of adjuvant treatment for breast cancer on t
he patients' quality of life. This report presents updated results of
the seven IBCSG trials conducted from 1978 to 1993 and describes the t
rials currently open to patient accrual.