Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal early breast cancer: BIG 1-98

摘要: Purpose To evaluate locally versus centrally assessed estrogen (ER) and progesterone (PgR) receptor status the impact of PgR on letrozole adjuvant therapy compared with tamoxifen in postmenopausal women early breast cancer. Patients Methods Breast International Group (BIG) 1-98 randomly assigned 8,010 patients to four arms comparing sequences each agent. The Central Pathology Office received material for 6,549 (82%), which 79% were assessable (6,291 patients). Prognostic predictive value both local central hormone expression disease-free survival (DFS) evaluated among 3,650 monotherapy arms. treatment effect estimated ER levels using Subpopulation Treatment Effect Pattern Plot. Results review confirmed 97% tumors as receptor‐positive (ER and/or 10%). Of 105 ER-negative, 73 found have more than 10% positive cells, eight had 1% 9%. 6,100 positive, 66 no staining, 54 only Discordance was marked ER. reclassified or receptor‐negative, poor DFS. Centrally showed prognostic value. Among ER-expressing tumors, better DFS tamoxifen, irrespective level. Conclusion changed assessment a substantial proportion patients, should be performed whenever possible similar trials. did not affect relative efficacy over tamoxifen. J Clin Oncol 25:3846-3852. © 2007 by American Society Clinical Oncology