Recommendations From an International Expert Panel on the Use of Neoadjuvant (Primary) Systemic Treatment of Operable Breast Cancer: An Update

Abstract

Neoadjuvant (primary systemic) treatment is the standard treatment for locally advanced breast cancer and a standard option for primary operable disease. Because of new treatments and new understandings of breast cancer, however, recommendations published in 2003 regarding neoadjuvant treatment for operable disease required updating. Therefore, a second international panel of representatives of a number of breast cancer clinical research groups was convened in September 2004 to update these recommendations. As part of this effort, data published to date were reviewed critically and indications for neoadjuvant treatment were newly defined.

Impact of treatment characteristics on response of different breast cancer phenotypes: pooled analysis of the German neo-adjuvant chemotherapy trials

“…The final, but most important limitation of this analysis is the use of pCR (the primary endpoint of all 7 trials) as a surrogate outcome. Even though pCR was found to be associated with prognosis [5,6,7], the associations with pCR observed in this analysis may not necessarily translate into associations of treatment characteristics with recurrence-free or overall survival.…”

“…Neoadjuvant regimens are considered equivalent to adjuvant regimens with identical dosing schemes [5,6,7].…”

“…Pathologically confirmed complete response (pCR) after chemotherapy highly correlates with favorable long-term outcome and was therefore suggested as a surrogate marker for survival [5,8]. Between 1998 and 2006, the German Breast Group (GBG) and the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) "Breast", conducted a series of neoadjuvant trials.…”

Comparison of different approaches for assessment of HER2 expression on protein and mRNA level: prediction of chemotherapy response in the neoadjuvant GeparTrio trial (NCT00544765)

“…has been shown to be predictive of longer recurrence-free and overall survival [20,21]. However, only 15 to 20% of the patients achieve a pathological complete response.…”

High efficacy of pre-operative trastuzumab combined with paclitaxel following doxorubicin & cyclophosphamide in operable breast cancer

“…Neo-adjuvant systemic therapy is an accepted standard approach for women with early breast cancer and has been shown to reduce tumor size and allow for breast conserving surgery [1]. While pre-operative therapy does not prolong disease free or overall survival compared to post-operative therapy, it can provide predictive and prognostic information and may also provide in vivo assessment of tumor sensitivity to therapy [2,3].…”