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

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Abstract

Nab-P is widely used in MBC, but limited data from clinical practice are available. This is an open-label, multicentre prospective cohort study prospectively collecting data of MBC pts treated with weekly, or every 3 week administration of Nab-P. For this survey a convenience sample was used. An attempt was made to get at least a sample of 200 pts, which guarantees a standard error of 3.5% for estimation of survival time at 1 year, overall response rate and grade 3-4 toxicity. 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. Median time to progression was 6 months (95% confidence interval, 1-34), with no differences according to the schedule of treatment. No new data on toxicity were reported. Results from this real life experience suggest that Nab-P can be safely used with both the weekly and the 3-weekly schedule with comparable efficacy, leaving the choice to the physician according to the patient's needs and preference, with a carefully balance between activity and potential toxicity. 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/m2 for 3 consecutive weeks followed by a 1-week rest) or every 3 weeks (260 mg/m2) 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 1 2017

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

Keywords

  • Elderly patient
  • Neuropathy
  • Real-life
  • Taxane exposure
  • Weekly schedule

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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, 01.10.2017, p. 433-440.

Research output: Contribution to journalArticle

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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abstract = "Nab-P is widely used in MBC, but limited data from clinical practice are available. This is an open-label, multicentre prospective cohort study prospectively collecting data of MBC pts treated with weekly, or every 3 week administration of Nab-P. For this survey a convenience sample was used. An attempt was made to get at least a sample of 200 pts, which guarantees a standard error of 3.5{\%} for estimation of survival time at 1 year, overall response rate and grade 3-4 toxicity. 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. Median time to progression was 6 months (95{\%} confidence interval, 1-34), with no differences according to the schedule of treatment. No new data on toxicity were reported. Results from this real life experience suggest that Nab-P can be safely used with both the weekly and the 3-weekly schedule with comparable efficacy, leaving the choice to the physician according to the patient's needs and preference, with a carefully balance between activity and potential toxicity. 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/m2 for 3 consecutive weeks followed by a 1-week rest) or every 3 weeks (260 mg/m2) 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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author = "Antonio Bernardo and Raffaella Palumbo and Rebecca Pedersini and {Rota Caremoli}, Elena and Gambaro, {Anna Rita} and Antonella Ferzi and Francesca Riva and Donatella Grasso and Marco Danova and Emiliana Tarenzi and Valter Torri and Cazzaniga, {Marina E.}",
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T1 - Nab-Paclitaxel in Advanced HER2-negative Breast Cancer Patients

T2 - Efficacy and Safety Beyond Clinical Trials

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.

PY - 2017/10/1

Y1 - 2017/10/1

N2 - Nab-P is widely used in MBC, but limited data from clinical practice are available. This is an open-label, multicentre prospective cohort study prospectively collecting data of MBC pts treated with weekly, or every 3 week administration of Nab-P. For this survey a convenience sample was used. An attempt was made to get at least a sample of 200 pts, which guarantees a standard error of 3.5% for estimation of survival time at 1 year, overall response rate and grade 3-4 toxicity. 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. Median time to progression was 6 months (95% confidence interval, 1-34), with no differences according to the schedule of treatment. No new data on toxicity were reported. Results from this real life experience suggest that Nab-P can be safely used with both the weekly and the 3-weekly schedule with comparable efficacy, leaving the choice to the physician according to the patient's needs and preference, with a carefully balance between activity and potential toxicity. 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/m2 for 3 consecutive weeks followed by a 1-week rest) or every 3 weeks (260 mg/m2) 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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KW - Neuropathy

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