Back to Search
Start Over
Long-term efficacy analysis of the randomised, phase II TRYPHAENA cardiac safety study: Evaluating pertuzumab and trastuzumab plus standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer.
- Source :
-
European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2018 Jan; Vol. 89, pp. 27-35. Date of Electronic Publication: 2017 Dec 08. - Publication Year :
- 2018
-
Abstract
- Background: We report long-term efficacy and cardiac safety outcomes in patients with HER2-positive early breast cancer treated with neoadjuvant pertuzumab plus trastuzumab with anthracycline-containing or anthracycline-free chemotherapy.<br />Methods: Descriptive efficacy analyses were conducted in patients randomised to group A (cycles 1-6: trastuzumab [8 mg/kg loading dose and 6 mg/kg maintenance] plus pertuzumab [840 mg loading dose and 420 mg maintenance], plus 5-fluorouracil, epirubicin and cyclophosphamide [FEC] [cycles 1-3; 500 mg/m <superscript>2</superscript> 5-fluorouracil/100 mg/m <superscript>2</superscript> epirubicin/600 mg/m <superscript>2</superscript> cyclophosphamide] then docetaxel [cycles 4-6; 75 mg/m <superscript>2</superscript> , escalated to 100 mg/m <superscript>2</superscript> if well tolerated]), B (cycles 1-3: FEC, cycles 4-6: trastuzumab plus pertuzumab plus docetaxel as mentioned previously) or C (cycles 1-6: trastuzumab plus pertuzumab plus docetaxel [75 mg/m <superscript>2</superscript> , without dose escalation], and carboplatin [AUC 6]), five years after randomisation of the last patient. This study is registered with ClinicalTrials.gov, number NCT00976989.<br />Results: Three-year Kaplan-Meier survival estimates for disease-free survival (DFS) were 87% (95% confidence interval: 79-95), 88% (80-96) and 90% (82-97) in groups A-C, respectively. Progression-free survival (PFS) rates were 89% (81-96), 89% (81-96) and 87% (80-95). DFS hazard ratio for total pathological complete response (tpCR) versus no tpCR was 0.27 (0.11-0.64). During post-treatment follow-up, 2/72 (2.8%), 3/75 (4.0%) and 4/76 (5.4%) patients in groups A-C had any-grade left ventricular systolic dysfunction; eight (11.1%), 12 (16.0%) and nine (11.8%) patients experienced left ventricular ejection fraction declines ≥10% from baseline to <50%.<br />Conclusions: Long-term DFS and PFS were similar between groups. Patients who achieved tpCR had improved DFS. No new safety signals were identified.<br /> (Copyright © 2017 Elsevier Ltd. All rights reserved.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Anthracyclines adverse effects
Antibodies, Monoclonal, Humanized adverse effects
Antineoplastic Combined Chemotherapy Protocols adverse effects
Breast Neoplasms mortality
Female
Humans
Middle Aged
Stroke Volume drug effects
Trastuzumab adverse effects
Ventricular Function, Left drug effects
Anthracyclines administration & dosage
Antibodies, Monoclonal, Humanized administration & dosage
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Breast Neoplasms drug therapy
Heart drug effects
Trastuzumab administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1879-0852
- Volume :
- 89
- Database :
- MEDLINE
- Journal :
- European journal of cancer (Oxford, England : 1990)
- Publication Type :
- Academic Journal
- Accession number :
- 29223479
- Full Text :
- https://doi.org/10.1016/j.ejca.2017.10.021