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ABREAST: a prospective, real-world study on the effect of nab-paclitaxel treatment on clinical outcomes and quality of life of patients with metastatic breast cancer

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Abstract

Purpose

The efficacy of nab-paclitaxel in patients with metastatic breast cancer (MBC) has been demonstrated in randomized clinical trials. However, real-world evidence on effectiveness remains limited.

Patients and methods

The primary objective of this multicenter prospective study was to assess the overall response rate (ORR) of patients with MBC treated with nab-paclitaxel. Secondary objectives included progression-free survival (PFS), overall survival (OS) and quality of life, assessed with the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument.

Results

Eligible patients (N = 150; 36% with de novo MBC presentation) with a median age of 64.5 years were enrolled (86% were ER+, 33.3% (50/150) were ≥ 70 years of age and 53% were treated in the third or later line of treatment). A median of 6 cycles were administered but 26% of patients required dose reduction due to toxicity. The ORR was 26.7% [95% confidence interval (CI) 19.6–33.7], the median PFS was 6.2 months (95% CI 5.2–7.3), and the median OS 21.1 months (95% CI 17.2-not estimable). There was no statistical significant difference in the median PFS of patients < and ≥ 70 years of age. The patients’ baseline FACT-B total score remained unchanged. The serious and non-serious adverse event incidence rates were 13% and 48%, respectively.

Conclusions

This prospective study provides further evidence on quality of life, efficacy, and safety of nab-paclitaxel in patients with MBC and sheds more light in special subpopulations such as the elderly and those treated beyond the second line.

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Acknowledgements

All Authors thankfully acknowledge the grammatical assistance in the preparation of this manuscript and related financial support from Qualitis Ltd and Genesis Pharma SA, respectively. The Authors acknowledge data collection and support from Α. Αnogiannaki, A. Bokas, E. Bournakis, K. Nikolopoulos, M. Sougleri, E. Res, A. Visvikis, E. Zouroudi, E. Galani, G. Klouvas, G. Economopoulos, N. Charalampakis, K. Tsigaridas, E. Tsouchlou, V. Chatzaki, A. Papoulia, and N. Soupos.

Funding

This work was supported by Genesis Pharma SA.

Author information

Authors and Affiliations

  1. Hematology Oncology Unit, Fourth Department of Internal Medicine, ATTIKON University General Hospital, National and Kapodistrian University of Athens, Medical School, Rimini 1, 124 62, Haidari, Athens, Greece

    A. Koumarianou & Κ. Kampoli

  2. Second Chemotherapeutic Clinic, THEAGENIO Anti-Cancer Hospital of Thessaloniki, Thessaloniki, Greece

    P. Makrantonakis

  3. Therapeutic Clinic, ALEXANDRA General Hospital, Faculty of Medicine, National and Kapodistrian University of Athens, Athens, Greece

    F. Zagouri

  4. Oncology Unit, 2nd Dept. of Surgery, ARETAIEIO University Hospital, National and Kapodistrian University of Athens, Athens, Greece

    C. Papadimitriou

  5. Oncology Department, AGIOS ANDREAS General Hospital of Patras, Patras, Greece

    A. Christopoulou

  6. Third Oncology Clinic, AGIOI ANARGIROI Athens General Hospital, Athens, Greece

    E. Samantas

  7. Second Oncology Clinic, METROPOLITAN Athens Private Hospital, Piraeus, Greece

    C. Christodoulou

  8. Division Medical Oncology, ATTIKON University General Hospital of Athens, Haidari, Greece

    A. Psyrri

  9. First Oncology Clinic, METROPOLITAN Athens Private Hospital, Piraeus, Greece

    D. Bafaloukos

  10. Second Oncology Clinic, AGIOI ANARGIROI Athens General Hospital, Athens, Greece

    G. Aravantinos

  11. First Chemotherapeutic Oncology Department, THEAGENION Anti-Cancer Hospital of Thessaloniki, Thessaloniki, Greece

    P. Papakotoulas

  12. Oncology Department, European INTERBALKAN Private Hospital of Thessaloniki, Thessaloniki, Greece

    S. Baka

  13. Third Department of Clinical Oncology and Chemotherapy, THEAGENION Anti-Cancer Hospital of Thessaloniki, Thessaloniki, Greece

    C. Andreadis

  14. Oncology Department, HYGEIA Athens Private Hospital, Maroussi, Athens, Greece

    A. Alexopoulos

  15. Oncology Department, AGIOS GEORGIOS General Hospital of Chania, Chania, Crete, Greece

    I. Bompolaki

  16. First Department of Medical Oncology, AGIOS SAVVAS Athens General Hospital, Athens, Greece

    S. Liori & A. Ardavanis

  17. Medical Department Hematology/Oncology, Genesis Pharma S.A, Halandri, Athens, Greece

    K. Karvounis

Authors
  1. A. Koumarianou
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  2. P. Makrantonakis
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  3. F. Zagouri
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  4. C. Papadimitriou
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  6. E. Samantas
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  12. S. Baka
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  19. A. Ardavanis
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Contributions

AK, KK, and AA involved in conception/design, collection and/or assembly of data, and data analysis and interpretation.. AK, PM, FZ, CP, AC, ES, CC, AP, DB, GA, PP, SB, CA, AA, IB, KK, and AA involved in provision of study material or patients. AK, PM, FZ, ChP, AC, ES, CC, AP, DB, GA, PP, SB, CA, AA, IB, KK, and AA participated in manuscript writing. AK, PM, FZ, CP, AC, ES, CC, AP, DB, GA, PP, SB, CA, AA, IB, ΚK, SL, KK, and AA participated in final approval of the manuscript:.

Corresponding author

Correspondence to A. Koumarianou.

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Conflict of interest

AK: honoraria for consultation or advisory board, study investigator fees from Genesis pharma; PM: study investigator fees from Genesis pharma; FZ: honoraria for lectures, consultation, or advisory board participation from Novartis, Pfizer, Astra Zeneca, Daiichi Sankyo, Roche, Merck, Lilly, study investigator fees from Genesis pharma; CP, AC, AP, DB, GA, and AA: honoraria for advisory board, study investigator fees from Genesis pharma; ; ES and AA: honoraria for consultation or advisory board, study investigator fees from Genesis pharma; CC: honoraria for advisory board from Genesis pharma; PP, SB, CA, SL, and IB: study investigator fees from Genesis pharma; KK: has declared no conflict of interest and Genesis pharma Medical Department employe.

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Koumarianou, A., Makrantonakis, P., Zagouri, F. et al. ABREAST: a prospective, real-world study on the effect of nab-paclitaxel treatment on clinical outcomes and quality of life of patients with metastatic breast cancer. Breast Cancer Res Treat 182, 85–96 (2020). https://doi.org/10.1007/s10549-020-05677-4

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  • DOI: https://doi.org/10.1007/s10549-020-05677-4

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