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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

5886 - Taxane & Cyclophosphamide vs Anthracycline & Taxane combination therapy as adjuvant treatment of breast cancer; a meta-analysis of randomized-controlled trials by the Hellenic Academy of Oncology (E.AK.O.)

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Presenters

Panagiotis Ntellas

Citation

Annals of Oncology (2018) 29 (suppl_8): viii58-viii86. 10.1093/annonc/mdy270

Authors

P. Ntellas1, N. Spathas2, D. Zylis3, S. Agelaki4, E. Zintzaras1, E. Saloustros5

Author affiliations

  • 1 Biostatistics And Clinical Bioinformatics, Faculty of Medicine, University of Thessaly, 41500 - Larissa/GR
  • 2 Oncology Unit, Attikon University Hospital, 12462 - Athens/GR
  • 3 1st Department Of Medical Oncology, Agios Savvas Regional Cancer Hospital, 115 22 - Athens/GR
  • 4 Department Of Medical Oncology, School of Medicine, University of Crete, 70013 - Heraklion, CRETE/GR
  • 5 Oncology Unit, Venizeleio General Hospital, 714 09 - Heraklion/GR
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Resources

Abstract 5886

Background

Adjuvant chemotherapy has an indisputable value for early breast cancer. Τaxane + cyclophosphamide combination (TC) has demonstrated superiority against cyclophosphamide + anthracycline (AC) in disease-free (DFS) and overall survival (OS). However, 5 randomized clinical trials (RCTs) failed to show non-inferiority of TC compared to an anthracycline-taxane combination (TaxAC). We conducted a meta-analysis of these RCTs to better estimate the cumulative evidence for non-inferiority of TC against TaxAC, in the adjuvant setting of HER2-negative, breast cancer.

Methods

The ABC trials, the Plan B trial and a trial by the Hellenic Oncology Research Group (HORG) were meta-analyzed. The DFS was the primary endpoint. A DFS-HR of 1.18 for TC versus TaxAC, was chosen to demonstrate inferiority, as it was the most conservative measure among the included studies. Secondary endpoints were OS and toxicity profile.

Results

Overall, 7,341 patients composed the meta-analysis population. We didn’t encounter heterogeneity between the trials (Q-test p = 0.55, I2:0%) and no publication bias was detected. Non-inferiority of TC was not established (DFS-HR=1.11, 95%CI: 0.95-1.30, p = 0.18). The combined DFS rates, according to the time points set by each study, were 89.04% versus 90.35% for TC and TaxAC respectively. Non-inferiority of TC was also not proven for the node-negative population either (HR = 1.05, 95%CI: 0.82-1.34, p = 0.71). Grade 3-4 leucopenia (OR: 1.2, 95%CI:1.068-1.348, p = 0.002) and thrombocytopenia (OR = 6.455; 95%CI:2.902-14.359, p < 0.001) prevailed in the TaxAC group, while cardiotoxicity was also increased (OR = 2.283; 95%CI:1.155-4.514, p = 0.015).

Conclusions

Although the TC combination was not proven to be non-inferior to TaxAC, the present analysis narrows the HR of recurrence risk of recurrence with a difference in the DFS rate of only 1,31%. Taking into account the more favorable safety profile of the TC combination, the question as to which treatment regimen should be preferred under what circumstances needs to be individualized according to patients’ characteristics and desires.

Clinical trial identification

Legal entity responsible for the study

Hellenic Academy of Oncology.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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