Combined use of clinical and pathologic staging variables to define outcomes for breast cancer patients treated with neoadjuvant therapy.

PURPOSE Neoadjuvant chemotherapy is being used with increasing frequency for operable breast cancer. We hypothesized that by using clinical and pathologic staging parameters, in conjunction with biologic tumor markers, a novel means of determining prognosis for patients treated with neoadjuvant chemotherapy could be facilitated. PATIENTS AND METHODS A prospective database of patients treated with neoadjuvant chemotherapy from 1997 to 2003 was reviewed, and 932 patients meeting inclusion criteria were identified. Clinical and pathologic tumor characteristics, treatment regimens, and patient outcomes were recorded. Cox proportional hazards models were used to create two prognostic scoring systems. American Joint Committee on Cancer (AJCC) clinical and pathologic staging parameters and biologic tumor markers were investigated to devise the scoring systems. RESULTS Median follow-up time was 5 years (range, 0.4 to 9.4 years). Five-year disease-specific survival rate was 96% for patients who experienced a pathologic complete response (pCR; n = 130) compared with 87% for patients who did not have a pCR (n = 802; P = .001). Two scoring systems, based on summing binary indicators for clinical substages >/= IIB and >/= IIIB, pathologic substages >/= ypIIA and >/= ypIIIC, negative estrogen receptor status, and grade 3 pathology, were devised to predict 5-year patient outcomes. These scoring systems facilitated separation of the study population into more refined subgroups by outcome than the current AJCC staging system. CONCLUSION The scoring systems derived in this work provide a novel means for evaluating prognosis after neoadjuvant therapy. Future work will focus on prospective validation of these scoring systems and refinement of the scoring systems through addition of new biologic markers.