Although currently accruing trials have included patients with limited nodal disease, it will be several years Selleck PLX-4720 before mature data are available. Although tumor size has been used in the past to

risk stratify BCT patients, recent data suggest that it may not be associated with IBTR in patients undergoing APBI [82] and [83]. An analysis of more than 1800 patients treated with BCT and WBI found pathologic tumor size to be associated with IBTR and DM; however, a recent pooled analysis of outcomes from the ASBS Registry and WBH did not find tumor size to be associated with IBTR, with nearly 2000 patients evaluated (83). ABS Guideline: Tumor size should be less than or equal to 3 cm (including pure DCIS). To date, limited research has been performed to determine the ideal tumor size criteria for patients undergoing APBI. As noted previously, because of paucity of data available, limited conclusions can be drawn. Furthermore, because of selection bias, published studies are of limited value with a preponderance of subcentimeter tumors. Based on these findings, and consistent with previously published consensus criteria and guidelines along with clinical trial inclusion criteria, the guideline remains 3 cm. In addition, the panel does not believe that APBI

should be PD-0332991 mouse applied off-protocol in the neoadjuvant setting. Previous randomized trials of women undergoing BCT have documented increased rates of IBTR with younger women (8). An analysis of the Christie Hospital randomized trial with partial breast irradiation did not find age to be associated with breast recurrence on multivariate analysis (84). However, the pooled analysis

previously discussed found a trend for increased rates of IBTR for patients under 50 years old (83). ABS Guideline: Patients should be 50 years or older. To date, limited research has been completed to determine the ideal age criteria for patients undergoing APBI. As noted previously, because of paucity of data available, limited conclusions can be drawn but in light of the pooled analysis finding a trend for increased rates of IBTR in patients under age 50 years and similar data seen in patients undergoing WBI, the guideline has been left at 50 years old. The panel did not believe that Olopatadine there were sufficient data to specifically exclude younger patients from being treated with APBI but felt that caution was still warranted. Nonetheless, implicit in this recommendation is the acknowledgment by the panel that further data from Phase III trials will be needed to conclusively establish the efficacy of APBI in younger patients. Although no recent data documenting an increased risk of IBTR in these patients when treated with APBI (beyond that seen when WBI is used) have been conclusively identified, the panel felt that the inclusion of women less than age 50 years was not appropriate at this time. Increasing data have suggested that estrogen receptor negativity is associated with IBTR in women undergoing APBI.