Evidence Level:Sensitive: B - Late Trials
Title:
Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study
Excerpt:CONTRADICTING EVIDENCE: Patients who received T-DM1+P continued adjuvant T-DM1+P, and patients who received TCH+P received adjuvant trastuzumab plus pertuzumab. Risk of an EFS event was higher with TDM-1+P (hazard ratio [HR], 2.61 [95% CI, 1.36 to 4.98]) with more locoregional progression events before surgery (15 [6.7%] v 0). Compared with TCH+P, T-DM1+P resulted in a higher risk of an EFS event owing to locoregional progression events before surgery...
Evidence Level:Sensitive: B - Late Trials
New
Title:
Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial
Excerpt:We did a phase 3 trial to assess a neoadjuvant regimen for HER2-positive breast cancer...A pathological complete response was achieved by 99 (44·4%) of 223 patients in the trastuzumab emtansine plus pertuzumab group...Traditional neoadjuvant systemic chemotherapy plus dual HER2-targeted blockade (docetaxel, carboplatin, and trastuzumab plus pertuzumab) resulted in significantly more patients achieving a pathological complete response...
DOI:10.1016/S1470-2045(17)30716-7
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression
Excerpt:...- HER2-positive disease...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer
Excerpt:...- HER2-positive metastatic or locally advanced breast cancer...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer
Excerpt:...- Histologically documented HER2-positive locally advanced or metastatic breast cancer...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
Excerpt:...- Patients must have HER2-positive Stage II or III histologically confirmed invasive carcinoma of the breast....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine
Excerpt:...- Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab....
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
125MO - Long-term outcomes of neoadjuvant trastuzumab emtansine + pertuzumab (T-DM1+P) and docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP) for HER2-positive primary breast cancer: JBCRG20 study (Neo-peaks)
Excerpt:Patients received TCbHP (6 cycles, group A), TCbHP followed by T-DM1+P (4 cycles each, group B) or T-DM1+P (4 cycles, group C)....We evaluated 5-yr disease-free survival (DFS), distant DFS (DDFS) and overall survival (OS)....The table shows 5-yr DFS, DDFS and OS rates. Of 181 patients who received A-free neoadjuvant therapy, 116 achieved pCR. Of these, 111 did not receive A after surgery and achieved 5-yr DDFS of 97.3% (91.7%–99.1%) with 3 events....Patients with pCR after neoadjuvant therapy had favorable long-term prognosis...
Evidence Level:Sensitive: C3 – Early Trials
Title:
Neoadjuvant Treatment with HER2-Targeted Therapies in HER2-Positive Breast Cancer: A Systematic Review and Network Meta-Analysis
Excerpt:This systematic review aimed to identify neoadjuvant anti-human epidermal growth factor receptor 2 (HER2) therapies with the best balance between efficacy and safety.... The T-DM1PC, T-DM1, and PTC_T-DM1P regimens had the optimal balance between efficacy and safety, while DFS was highest for the PTC regimen.
DOI:10.3390/cancers14030523
Evidence Level:Sensitive: C3 – Early Trials
Title:
Survival outcomes in patients with human epidermal growth factor receptor 2 positive metastatic breast cancer administered a therapy following trastuzumab emtansine treatment
Excerpt:There was a significant difference in the medina PFS with T-DM1 between patients who received Pmab (n = 13) and those who did not (n = 17) [2.8 (95% CI 1.41–4.37) vs 4.8 (95% CI 2.73–7.82), P = .05]….The univariate analysis revealed that the prior use of Pmab (HR 2.70, 95% CI 1.09–6.66, P = .03), brain metastases (HR 5.28, 95% CI 1.69–16.5, P < .004), and the PFS with T-DM1 (HR 2.64, 95% CI 1.08–6.47, P = .03) were significant predictive factors of the PFS of patients with HER2-positive MBC administered the first subsequent therapy (Table 3).
DOI:10.1097/MD.0000000000022331