S3-1: Update of International Breast Cancer Study Group Trial 23-01 To Compare Axillary Dissection Versus No Axillary Dissection in Patients with Clinically Node Negative Breast Cancer and Micrometastases in the Sentinel Node.

2011 ◽  
Author(s):  
V Galimberti ◽  
BF Cole ◽  
S Zurrida ◽  
G Viale ◽  
A Luini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sentinel Node ◽  
Axillary Dissection ◽  
Study Group ◽  
Node Negative ◽  
Cancer Study ◽  
Cancer Study Group ◽  
Node Negative Breast Cancer ◽  
Breast Cancer Study ◽  
Group Trial

Chemoendocrine Compared With Endocrine Adjuvant Therapies for Node-Negative Breast Cancer: Predictive Value of Centrally Reviewed Expression of Estrogen and Progesterone Receptors—International Breast Cancer Study Group

2008 ◽  
Vol 26 (9) ◽  
pp. 1404-1410 ◽  
Author(s):  
Giuseppe Viale ◽  
Meredith M. Regan ◽  
Eugenio Maiorano ◽  
Mauro G. Mastropasqua ◽  
Rastko Golouh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Predictive Value ◽  
Study Group ◽  
Node Negative ◽  
Cancer Study ◽  
Cancer Study Group ◽  
Node Negative Breast Cancer ◽  
Breast Cancer Study ◽  
Low Levels

Purpose To centrally assess estrogen receptor (ER) and progesterone receptor (PgR) levels by immunohistochemistry and investigate their predictive value for benefit of chemo-endocrine compared with endocrine adjuvant therapy alone in two randomized clinical trials for node-negative breast cancer. Patients and Methods International Breast Cancer Study Group Trial VIII compared cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy for 6 cycles followed by endocrine therapy with goserelin with either modality alone in pre- and perimenopausal patients. Trial IX compared three cycles of CMF followed by tamoxifen for 5 years versus tamoxifen alone in postmenopausal patients. Central Pathology Office reviewed 883 (83%) of 1,063 patients on Trial VIII and 1,365 (82%) of 1,669 on Trial IX and determined ER and PgR by immunohistochemistry. Disease-free survival (DFS) was compared across the spectrum of expression of each receptor using the Subpopulation Treatment Effect Pattern Plot methodology. Results Both receptors displayed a bimodal distribution, with substantial proportions showing no staining (receptor absent) and most of the remainder showing a high percentage of stained cells. Chemo-endocrine therapy yielded DFS superior to endocrine therapy alone for patients with receptor-absent tumors, and in some cases also for those with low levels of receptor expression. Among patients with ER-expressing tumors, additional prediction of benefit was suggested in absent or low PgR in Trial VIII but not in Trial IX. Conclusion Low levels of ER and PgR are predictive of the benefit of adding chemotherapy to endocrine therapy. Low PgR may add further prediction among pre- and perimenopausal but not postmenopausal patients whose tumors express ER.

261 POSTER Sentinel node micrometastases - evidence from the Rome Breast Cancer Study Group

2006 ◽  
Vol 32 ◽  
pp. S79
Author(s):  
S. Drago ◽  
L. Fortunato ◽  
G. Gucciardo ◽  
A. Cabassi ◽  
M. Santoni ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sentinel Node ◽  
Study Group ◽  
Cancer Study ◽  
Cancer Study Group ◽  
Breast Cancer Study

Tamoxifen After Adjuvant Chemotherapy for Premenopausal Women With Lymph Node-Positive Breast Cancer: International Breast Cancer Study Group Trial 13-93

2006 ◽  
Vol 24 (9) ◽  
pp. 1332-1341 ◽  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Premenopausal Women ◽  
Study Group ◽  
Negative Group ◽  
Cancer Study ◽  
Cancer Study Group ◽  
Breast Cancer Study ◽  
Er Positive ◽  
Group Trial

Purpose The value of adjuvant tamoxifen after chemotherapy for premenopausal women with breast cancer has not been adequately assessed. Patients and Methods Between 1993 and 1999, International Breast Cancer Study Group Trial 13-93 enrolled 1,246 assessable premenopausal women with axillary node-positive, operable breast cancer. All patients received chemotherapy (cyclophosphamide plus either doxorubicin or epirubicin for four courses followed by immediate or delayed classical cyclophosphamide, methotrexate, and fluorouracil for three courses), which was followed by either tamoxifen (20 mg daily) for 5 years or no further treatment. The primary end point was disease-free survival (DFS). Tumors were classified as estrogen receptor (ER) -positive (n = 735, 59%) if immunohistochemical (IHC) or ligand-binding assays (LBA) were clearly positive. The ER-negative group included all other tumors (n = 511, 41%). A subset of the ER-negative group was defined as ER absent (n = 108, 9%) if IHC staining was none or if the LBA result was 0 fmol/mg cytosol protein. The median follow-up time was 7 years. Results Tamoxifen improved DFS in the ER-positive cohort (hazard ratio [HR] for tamoxifen v no tamoxifen = 0.59; 95% CI, 0.46 to 0.75; P < .0001) but not in the ER-negative cohort (HR = 1.02; 95% CI, 0.77 to 1.35; P = .89). Tamoxifen had a detrimental effect on patients with ER-absent tumors compared with no tamoxifen in an unplanned exploratory analysis (HR = 2.10; 95% CI, 1.03 to 4.29; P = .04). Patients with ER-positive tumors who achieved chemotherapy-induced amenorrhea had a significantly improved outcome (HR for amenorrhea v no amenorrhea = 0.61; 95% CI, 0.44 to 0.86; P = .004), whether or not they received tamoxifen. Conclusion Tamoxifen after adjuvant chemotherapy significantly improved treatment outcome in premenopausal patients with endocrine-responsive disease, but its use as adjuvant therapy for patients with ER-negative tumors is not recommended.

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