Changes to This Summary (07/11/2014)
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.
The Post-breast conservation surgery subsection was extensively revised.
Added text to state that a French trial failed to demonstrate that 6 months of adjuvant trastuzumab was noninferior to 12 months of treatment; the authors concluded that 12 months should remain the standard duration of trastuzumab adjuvant therapy (cited Pivot et al. as reference 213 and level of evidence [LOE] 1iiA).
Added text to state that a number of studies have evaluated the use of subcutaneous trastuzumab in the neoadjuvant and adjuvant settings.
Added text to state that a number of studies have evaluated newer anti-HER2 therapies and combinations of anti-HER2 therapy in the early breast cancer and metastatic settings. The studies incorporated close monitoring of left ventricular ejection fraction (LVEF); a pooled analysis of cardiac safety in patients with cancer treated with pertuzumab was performed (cited Lenihan et al. as reference 218 and LOE 3iiiD).
Added text to state that a meta-analysis of six studies reported no increased risk of cardiac toxic effects with dual blockade of the HER2 pathway (cited Valachis et al. as reference 219 and LOE 1iiA).
Added text to state that a phase III trial (Z1041 [NCT00513292]) randomly assigned patients with operable HER2-positive breast cancer to receive trastuzumab sequential to or concurrent with the anthracycline component of the neoadjuvant chemotherapy regimen; all patients received trastuzumab concurrent with paclitaxel. Also added that there was no significant difference in pathological complete response (pCR) in the breast between the arms; additionally, asymptomatic declines in LVEF during neoadjuvant chemotherapy were identified in similar proportions of patients in each arm. The conclusion was that concurrent administration of trastuzumab with anthracyclines is not warranted based on these findings (cited Buzdar et al. as reference 232 and LOE 1iiDiv).
Added text to state that an international, open-label, phase III (HannaH [NCT00950300]) trial also demonstrated that the pharmacokinetics and efficacy of neoadjuvant subcutaneous (SQ) trastuzumab is noninferior to the intravenous (IV) formulation. Added that women with operable, locally advanced, or inflammatory HER2-positive breast cancer were assigned to neoadjuvant chemotherapy concurrent with either SQ-administered or IV-administered trastuzumab every 3 weeks before surgery. Data regarding the disease-free survival and overall survival differences between the arms are not yet available (cited Ismael et al. as reference 233 and LOE 1iiD).
Added text to state that PrefHer was a randomized, cross-over design trial in which all patients were randomly assigned to receive four cycles of 600 mg, fixed-dose, SQ-administered, adjuvant trastuzumab followed by four cycles of standard IV-administered trastuzumab, or the reverse sequence; almost all of the patients preferred the SQ formulation. Added that the primary endpoint was the proportion of patients indicating an overall preference for SQ-administered or IV-administered trastuzumab, which was assessed by patient interview (cited LOE 1iiC). Also added that the SafeHer trial is evaluating the safety of self-administered versus clinician-administered SQ trastuzumab, which is approved for use in Europe in early and late stage breast cancer.
Added text to state that there was a numerical but not a statistically significant difference in pCR rate in patients observed in a phase III (NSABP B-41 [NCT00486668]) trial in which women with operable HER2-positive breast cancer were randomly assigned to doxorubicin and cyclophosphamide, followed by paclitaxel concurrent with trastuzumab, lapatinib, or the combination of trastuzumab and lapatinib (cited Robindoux et al. as reference 238 and LOE 1iiDiv).
Added Hickey et al. as reference 244 and LOE 1iiA.
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