Abstract
605 Background: To define the value of biopathological parameters as prognostic and predictive markers in patients (pts) with node positive, operable breast cancer involved in the phase III trial PACS 01. Methods: We retrospectively analyzed the prognostic value of ER, PR, HER2, and Ki-67, in 1190 patients with primary operable node positive breast cancer patients treated with either Arm A: 6 cycles of FEC100 (595 pts) or arm B: docetaxel 100 mg/m replaced FEC100 for the last 3 cycles (595 pts), extracted from the data base of 1999 pts enrolled in PACS01 trial. This subgroup was similar to the whole population of the trial in terms of age, node involvement, and ER positivity. A panel of pathologists centrally and blindly reviewed the cases. All four markers were tested by immunohistochemistry centrally. Results were correlated to clinical out come at a median follow up of 59.7 months (SABCS 2004). Results: Using 5 years of follow-up data, we showed i) for arm B, a better DFS: unadjusted log rank (log) p =0,023 and OS: log p=0.015, ii) an association between HER2 overexpression and/or amplification (DFS: log p =.0002; OS log p<.0001), high Ki-67 (DFS: log p <0.0001; OS: log p <0.0001) and worse outcome. ER+ /PR + and ER-/PR+ pts had a better outcome than pts whose tumors were ER-/PR-or ER+/PR- (p<0.001 for both). Her2 positivity was not a poor prognosis factor for pts in arm B which is suggesting its role as a putative predictive factor of response to sequential treatment. Conclusion: This retrospective investigation demonstrated that HER2, PR, ER, and Ki-67 expressions had significant prognostic value for N+ patients. Furthermore, HER2 could be used to discern groups of individuals who could benefit from the use of sequential chemotherapy with anthracycline and docetaxel. More results will be presented at the meeting. No significant financial relationships to disclose.
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