Nab-Paclitaxel in Advanced HER2-negative Breast Cancer Patients: Efficacy and Safety Beyond Clinical Trials

Antonio Bernardo, Raffaella Palumbo, Rebecca Pedersini, Elena Rota Caremoli, Anna Rita Gambaro, Antonella Ferzi, Francesca Riva, Donatella Grasso, Marco Danova, Emiliana Tarenzi, Valter Torri, Marina E Cazzaniga

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Few data are available regarding efficacy and safety of nanoparticle albumin-bound (nab)-paclitaxel in advanced breast cancer patients outside a controlled trial, especially for the weekly schedule.

PATIENTS AND METHODS: We prospectively collected data of advanced breast cancer patients who were candidates to be treated with weekly (125 mg/m(2) for 3 consecutive weeks followed by a 1-week rest) or every 3 weeks (260 mg/m(2)) schedules of nab-paclitaxel, according to physician's decision.

RESULTS: The study enrolled 209 patients, of whom 92 (39.3%) received weekly nab-paclitaxel. The median age was 58 (range, 31-84) years; 21.8% of the patients were classified as triple-negative breast cancer (estrogen-recetor/progesteron-receptor-negative). The median number of cycles was 5.5. The overall response rate was 32.1% in the whole population, without any significant difference according to schedule, previous paclitaxel exposure, presence of visceral metastases, or line of treatment. The median time to disease progression was 6 months (95% confidence interval, 1-34), with no differences according to the schedule of treatment. Severe adverse events (Grade 3-4) were observed in 60.6% of the patients. The main toxicities were alopecia (53.4%), neutropenia (3%), and sensory neuropathy (2.1%).

CONCLUSION: Our real-life data indicate that both schedules of nab-paclitaxel are manageable and safe in advanced breast cancer patients, even if previously treated with other taxanes.

Original languageEnglish
Pages (from-to)433-440
Number of pages8
JournalClinical Breast Cancer
Volume17
Issue number6
DOIs
Publication statusPublished - Oct 2017

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Patient Safety
Clinical Trials
Breast Neoplasms
Appointments and Schedules
Nanoparticles
Triple Negative Breast Neoplasms
Taxoids
Alopecia
Progesterone Receptors
Paclitaxel
Neutropenia
Disease Progression
130-nm albumin-bound paclitaxel
Estrogens
Confidence Intervals
Neoplasm Metastasis
Physicians
Safety
Albumin-Bound Paclitaxel
Therapeutics

Keywords

  • Journal Article

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Nab-Paclitaxel in Advanced HER2-negative Breast Cancer Patients : Efficacy and Safety Beyond Clinical Trials. / Bernardo, Antonio; Palumbo, Raffaella; Pedersini, Rebecca; Rota Caremoli, Elena; Gambaro, Anna Rita; Ferzi, Antonella; Riva, Francesca; Grasso, Donatella; Danova, Marco; Tarenzi, Emiliana; Torri, Valter; Cazzaniga, Marina E.

In: Clinical Breast Cancer, Vol. 17, No. 6, 10.2017, p. 433-440.

Research output: Contribution to journalArticle

Bernardo, A, Palumbo, R, Pedersini, R, Rota Caremoli, E, Gambaro, AR, Ferzi, A, Riva, F, Grasso, D, Danova, M, Tarenzi, E, Torri, V & Cazzaniga, ME 2017, 'Nab-Paclitaxel in Advanced HER2-negative Breast Cancer Patients: Efficacy and Safety Beyond Clinical Trials', Clinical Breast Cancer, vol. 17, no. 6, pp. 433-440. https://doi.org/10.1016/j.clbc.2017.03.004
Bernardo, Antonio ; Palumbo, Raffaella ; Pedersini, Rebecca ; Rota Caremoli, Elena ; Gambaro, Anna Rita ; Ferzi, Antonella ; Riva, Francesca ; Grasso, Donatella ; Danova, Marco ; Tarenzi, Emiliana ; Torri, Valter ; Cazzaniga, Marina E. / Nab-Paclitaxel in Advanced HER2-negative Breast Cancer Patients : Efficacy and Safety Beyond Clinical Trials. In: Clinical Breast Cancer. 2017 ; Vol. 17, No. 6. pp. 433-440.
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AU - Bernardo, Antonio

AU - Palumbo, Raffaella

AU - Pedersini, Rebecca

AU - Rota Caremoli, Elena

AU - Gambaro, Anna Rita

AU - Ferzi, Antonella

AU - Riva, Francesca

AU - Grasso, Donatella

AU - Danova, Marco

AU - Tarenzi, Emiliana

AU - Torri, Valter

AU - Cazzaniga, Marina E

N1 - Copyright © 2017 Elsevier Inc. All rights reserved.

PY - 2017/10

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N2 - BACKGROUND: Few data are available regarding efficacy and safety of nanoparticle albumin-bound (nab)-paclitaxel in advanced breast cancer patients outside a controlled trial, especially for the weekly schedule.PATIENTS AND METHODS: We prospectively collected data of advanced breast cancer patients who were candidates to be treated with weekly (125 mg/m(2) for 3 consecutive weeks followed by a 1-week rest) or every 3 weeks (260 mg/m(2)) schedules of nab-paclitaxel, according to physician's decision.RESULTS: The study enrolled 209 patients, of whom 92 (39.3%) received weekly nab-paclitaxel. The median age was 58 (range, 31-84) years; 21.8% of the patients were classified as triple-negative breast cancer (estrogen-recetor/progesteron-receptor-negative). The median number of cycles was 5.5. The overall response rate was 32.1% in the whole population, without any significant difference according to schedule, previous paclitaxel exposure, presence of visceral metastases, or line of treatment. The median time to disease progression was 6 months (95% confidence interval, 1-34), with no differences according to the schedule of treatment. Severe adverse events (Grade 3-4) were observed in 60.6% of the patients. The main toxicities were alopecia (53.4%), neutropenia (3%), and sensory neuropathy (2.1%).CONCLUSION: Our real-life data indicate that both schedules of nab-paclitaxel are manageable and safe in advanced breast cancer patients, even if previously treated with other taxanes.

AB - BACKGROUND: Few data are available regarding efficacy and safety of nanoparticle albumin-bound (nab)-paclitaxel in advanced breast cancer patients outside a controlled trial, especially for the weekly schedule.PATIENTS AND METHODS: We prospectively collected data of advanced breast cancer patients who were candidates to be treated with weekly (125 mg/m(2) for 3 consecutive weeks followed by a 1-week rest) or every 3 weeks (260 mg/m(2)) schedules of nab-paclitaxel, according to physician's decision.RESULTS: The study enrolled 209 patients, of whom 92 (39.3%) received weekly nab-paclitaxel. The median age was 58 (range, 31-84) years; 21.8% of the patients were classified as triple-negative breast cancer (estrogen-recetor/progesteron-receptor-negative). The median number of cycles was 5.5. The overall response rate was 32.1% in the whole population, without any significant difference according to schedule, previous paclitaxel exposure, presence of visceral metastases, or line of treatment. The median time to disease progression was 6 months (95% confidence interval, 1-34), with no differences according to the schedule of treatment. Severe adverse events (Grade 3-4) were observed in 60.6% of the patients. The main toxicities were alopecia (53.4%), neutropenia (3%), and sensory neuropathy (2.1%).CONCLUSION: Our real-life data indicate that both schedules of nab-paclitaxel are manageable and safe in advanced breast cancer patients, even if previously treated with other taxanes.

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JO - Clinical Breast Cancer

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