TY - JOUR
TI - 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
AU - Koumarianou, A.
AU - Makrantonakis, P.
AU - Zagouri, F.
AU - Papadimitriou, C.
AU - Christopoulou, A.
AU - Samantas, E.
AU - Christodoulou, C.
AU - Psyrri, A.
AU - Bafaloukos, D.
AU - Aravantinos, G.
AU - Papakotoulas, P.
AU - Baka, S.
AU - Andreadis, C.
AU - Alexopoulos, A.
AU - Bompolaki, I.
AU - Kampoli, Κ.
AU - Liori, S.
AU - Karvounis, K.
AU - Ardavanis, A.
JO - Breast Cancer Research and Treatment
PY - 2020
VL - 182
TODO - 1
SP - 85-96
PB - Springer-Verlag
SN - 0167-6806, 1573-7217
TODO - 10.1007/s10549-020-05677-4
TODO - aspartate aminotransferase;  paclitaxel;  130-nm albumin-bound paclitaxel;  albuminoid;  epidermal growth factor receptor 2;  ERBB2 protein, human;  estrogen receptor;  paclitaxel;  progesterone receptor, adult;  age distribution;  aged;  Article;  backache;  bone metastasis;  cancer growth;  cancer survival;  clinical effectiveness;  clinical outcome;  dizziness;  drug safety;  dysesthesia;  dyspnea;  fatigue;  febrile neutropenia;  female;  Functional Assessment of Cancer Therapy Breast Instrument;  Greece;  heart infarction;  human;  hypocalcemia;  liver failure;  liver metastasis;  lung metastasis;  major clinical study;  metastatic breast cancer;  multicenter study;  multiple cycle treatment;  myalgia;  nausea;  neuritis;  neutropenia;  overall survival;  pleura effusion;  priority journal;  progression free survival;  prospective study;  quality of life;  quality of life assessment;  side effect;  treatment outcome;  treatment response;  vein insufficiency;  vestibular disorder;  vomiting;  breast tumor;  clinical trial;  follow up;  lobular carcinoma;  metabolism;  middle aged;  mortality;  Paget nipple disease;  pathology;  prognosis;  survival rate, Aged;  Albumins;  Breast Neoplasms;  Carcinoma, Ductal, Breast;  Carcinoma, Lobular;  Female;  Follow-Up Studies;  Humans;  Middle Aged;  Paclitaxel;  Prognosis;  Prospective Studies;  Quality of Life;  Receptor, ErbB-2;  Receptors, Estrogen;  Receptors, Progesterone;  Survival Rate
TODO - 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. © 2020, Springer Science+Business Media, LLC, part of Springer Nature.
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