Taxane & cyclophosphamide vs anthracycline & taxane-based chemotherapy as adjuvant treatment for breast cancer: a pooled analysis of randomized controlled trials by the Hellenic Academy of Oncology
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Panagiotis Ntellas1,2, Nikolaos Spathas3, Sofia Agelaki4, Elias Zintzaras2 and Emmanouil Saloustros5
1Department of Medical Oncology, University Hospital of Ioannina, Ioannina, Greece
2Department of Biostatistics and Clinical Bioinformatics, Faculty of Medicine, University of Thessaly, Larissa, Greece
32nd Department of Medical Oncology, University Hospital Attikon, Athens, Greece
4Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece
5Department of Oncology, University General Hospital of Larissa, Larissa, Greece
Emmanouil Saloustros, email: [email protected]
Keywords: early breast cancer; adjuvant; anthracycline; taxane; non-Inferiority
Received: November 12, 2018 Accepted: December 16, 2018 Published: February 05, 2019
Background: Adjuvant chemotherapy has an indisputable value for early breast cancer patients. Anthracycline and taxane-based regimens (TaxAC) have not been proven superior to taxane & cyclophosphamide (TC), a less toxic combination. Our objective was to estimate the cumulative evidence for non-inferiority of TC against TaxAC, in the adjuvant setting of patients with HER2-negative, breast cancer.
Results: Overall, 7,341 patients were included in this analysis. Superiority of TaxAC or non-inferiority of TC was not established either for the overall population (DFS HR, 1.11; 95% CI, 0.95–1.30; p = 0.18), or for the node-negative patients (HR, 1.05; 95% CI, 0.82–1.34; p = 0.71). A difference in DFS of 1.28% (TC DFS, 89.04%; 95% CI, 88%–90% & TaxAC DFS, 90.32%; 95% CI, 89%–91%) was found in favor of TaxAC. Lower risk of death was not established for either treatment regimen (OS-HR, 1.02; 95% CI, 0.82–1.25; p = 0.88). Overall, the toxicity profile favored TC.
Conclusion: Although non-inferiority of TC was not proven, superiority of TaxAC is still questioned. The present analysis narrows the risk of recurrence between the treatment groups. Considering TC has a more favorable safety profile, the question as to which treatment regimen should be preferred under what circumstances, needs to be individualized according to patients’ characteristics and desires.
Methods: Treatment efficacy data from The ABC trials, the Plan B trial and a trial by the Hellenic Oncology Research group (HORG) were pooled. Disease free survival (DFS) and overall survival (OS) were scrutinized. A HR of 1.18 for TC versus TaxAC was chosen to demonstrate inferiority.
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