Changes to This Summary (04/08/2015)
The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.
Added text to state that the results of these two trials plus two others were included in a meta-analysis that demonstrated reductions in all ipsilateral breast events, ipsilateral invasive recurrence, and ipsilateral DCIS recurrence (cited Goodwin et al. as reference 9 and level of evidence 1iiD).
This section was renamed from Stage I, II, IIIA, and Operable IIIC Breast Cancer; reformatted; and extensively revised.
Added text to state that results were similar after a median follow-up of 17.2 years (cited Bartelink et al. as reference 45 and level of evidence 1iiDii).
Added text to state that in an updated meta-analysis of 1,314 women with axillary dissection and one to three positive nodes, radiation therapy reduced locoregional recurrence, overall recurrence, and breast cancer mortality (cited McGale et al. as reference 53 and level of evidence 1iiA).
Added Tevaarwerk et al. as reference 131.
Added text to state that there was also no significant difference in the impact of the two therapies on bone mineral density or fracture rates (cited Goss et al. as reference 139 and level of evidence 1iiD).
Added text to state that at a final analysis with a median follow-up of 84 months, the results were unchanged for disease-free survival (DFS), overall survival, and distant DFS (cited Coleman et al. as reference 159 and level of evidence 1iiA).
Added text to state that the three studies have been included in three meta-analyses addressing the question of whether the use of zoledronic acid in the adjuvant setting prolongs survival, but the results of these meta-analyses are conflicting because one study found no significant impact on survival (cited Yan et al. as reference 160); a second study found a significant effect on survival (cited Valachis et al. as reference 161); and a third study found a borderline significant effect on survival (cited He et al. as reference 162 and level of evidence 1iiA).
Added text to state that evidence of the mammalian target of rapamycin inhibitor activity in human epidermal growth factor receptor 2 (HER2)-positive breast cancer was shown in the phase III BOLERO-3 (NCT01007942) trial (cited André et al. as reference 51 and level of evidence 1iDiii), described the trial of 569 patients with HER2-positive, trastuzumab-resistant breast cancer who were randomly assigned to receive either everolimus plus trastuzumab plus vinorelbine or placebo plus trastuzumab plus vinorelbine, and provided statistical evidence about survival and adverse events; final outcomes about survival are not yet known.
Added Swain et al. as reference 60 and level of evidence 1iA and added statistical evidence about survival outcomes with the use of pertuzumab in the Cleopatra (NCT00567190) trial at the median follow-up of 50 months.
Added text to state that evidence of the activity of ado-trastuzumab emtansine (T-DM1) in heavily pretreated patients with metastatic, HER2-overexpressed breast cancer who had received previous trastuzumab and lapatinib was shown in the randomized, phase III, (TH3RESA) (NCT01419197) study of T-DM1 versus treatment of physician’s choice (cited Krop et al. as reference 63 and level of evidence 1iiA), which allowed crossover to T-DM1; statistical evidence about survival was provided, with a trend favoring T-DM1.
This summary is written and maintained by the PDQ Adult Treatment Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ NCI's Comprehensive Cancer Database pages.