Nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients

Prospective evaluation of activity, safety, and quality of life

Raffaella Palumbo, Federico Sottotetti, Giuseppe Trifirò, Elena Piazza, Antonella Ferzi, Anna Gambaro, Elena Giulia Spinapolice, Emma Pozzi, Barbara Tagliaferri, Cristina Teragni, Antonio Bernardo

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Background: A prospective, multicenter trial was undertaken to assess the activity, safety, and quality of life of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer (MBC). Patients and methods: Fifty-two women with HER2-negative MBC who were candidates for second-line chemotherapy for the metastatic disease were enrolled and treated at three centers in Northern Italy. All patients had previously received taxane-based chemotherapy in the adjuvant or first-line metastatic setting. Single-agent nab-paclitaxel was given at the dose of 260 mg/m2 as a 30-minute intravenous infusion on day 1 each treatment cycle, which lasted 3 weeks, in the outpatient setting. No steroid or antihistamine premedication was provided. Treatment was stopped for documented disease progression, unacceptable toxicity, or patient refusal. Results: All of the enrolled patients were evaluable for the study endpoints. The objective response rate was 48% (95% CI, 31.5%–61.3%) and included complete responses from 13.5%. >6 months in 15 of them; the overall clinical benefit rate was 77%. The median time to response was 70 days (range 52–86 days). The median progression-free survival time was 8.9 months (95% CI, 8.0–11.6 months, range 5–21+ months). The median overall survival point has not yet been reached. Toxicities were expected and manageable with good patient compliance and preserved quality of life in patients given long-term treatment. Conclusion: Our results showed that single-agent nab-paclitaxel 260 mg/m2 every 3 weeks is an effective and well tolerated regimen as second-line chemotherapy in HER2-negative, taxane-pretreated MBC patients, and that it produced interesting values of objective response rate and progression-free survival without the concern of significant toxicity. Specifically, the present study shows that such a regimen is a valid therapeutic option for that ‘difficult to treat’ patient population represented by women who at the time of disease relapse have already received the most active agents in the adjuvant and/or metastatic setting (ie, conventional taxanes).

Original languageEnglish
Pages (from-to)2189-2199
Number of pages11
JournalDrug Design, Development and Therapy
Volume9
DOIs
Publication statusPublished - Mar 15 2015

Fingerprint

Nanoparticles
Quality of Life
Breast Neoplasms
Safety
Drug Therapy
Disease-Free Survival
Taxoids
Premedication
Histamine Antagonists
Therapeutics
Adjuvant Chemotherapy
Patient Compliance
Albumin-Bound Paclitaxel
taxane
Intravenous Infusions
Italy
Multicenter Studies
Disease Progression
Outpatients
Steroids

Keywords

  • Metastatic breast cancer
  • Nab-paclitaxel
  • Quality of life
  • Taxanes

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology
  • Drug Discovery

Cite this

Nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients : Prospective evaluation of activity, safety, and quality of life. / Palumbo, Raffaella; Sottotetti, Federico; Trifirò, Giuseppe; Piazza, Elena; Ferzi, Antonella; Gambaro, Anna; Spinapolice, Elena Giulia; Pozzi, Emma; Tagliaferri, Barbara; Teragni, Cristina; Bernardo, Antonio.

In: Drug Design, Development and Therapy, Vol. 9, 15.03.2015, p. 2189-2199.

Research output: Contribution to journalArticle

@article{30a2717c6e2f401eb177c42f38b88b5d,
title = "Nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients: Prospective evaluation of activity, safety, and quality of life",
abstract = "Background: A prospective, multicenter trial was undertaken to assess the activity, safety, and quality of life of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer (MBC). Patients and methods: Fifty-two women with HER2-negative MBC who were candidates for second-line chemotherapy for the metastatic disease were enrolled and treated at three centers in Northern Italy. All patients had previously received taxane-based chemotherapy in the adjuvant or first-line metastatic setting. Single-agent nab-paclitaxel was given at the dose of 260 mg/m2 as a 30-minute intravenous infusion on day 1 each treatment cycle, which lasted 3 weeks, in the outpatient setting. No steroid or antihistamine premedication was provided. Treatment was stopped for documented disease progression, unacceptable toxicity, or patient refusal. Results: All of the enrolled patients were evaluable for the study endpoints. The objective response rate was 48{\%} (95{\%} CI, 31.5{\%}–61.3{\%}) and included complete responses from 13.5{\%}. >6 months in 15 of them; the overall clinical benefit rate was 77{\%}. The median time to response was 70 days (range 52–86 days). The median progression-free survival time was 8.9 months (95{\%} CI, 8.0–11.6 months, range 5–21+ months). The median overall survival point has not yet been reached. Toxicities were expected and manageable with good patient compliance and preserved quality of life in patients given long-term treatment. Conclusion: Our results showed that single-agent nab-paclitaxel 260 mg/m2 every 3 weeks is an effective and well tolerated regimen as second-line chemotherapy in HER2-negative, taxane-pretreated MBC patients, and that it produced interesting values of objective response rate and progression-free survival without the concern of significant toxicity. Specifically, the present study shows that such a regimen is a valid therapeutic option for that ‘difficult to treat’ patient population represented by women who at the time of disease relapse have already received the most active agents in the adjuvant and/or metastatic setting (ie, conventional taxanes).",
keywords = "Metastatic breast cancer, Nab-paclitaxel, Quality of life, Taxanes",
author = "Raffaella Palumbo and Federico Sottotetti and Giuseppe Trifir{\`o} and Elena Piazza and Antonella Ferzi and Anna Gambaro and Spinapolice, {Elena Giulia} and Emma Pozzi and Barbara Tagliaferri and Cristina Teragni and Antonio Bernardo",
year = "2015",
month = "3",
day = "15",
doi = "10.2147/DDDT.S79563",
language = "English",
volume = "9",
pages = "2189--2199",
journal = "Drug Design, Development and Therapy",
issn = "1177-8881",
publisher = "Dove Medical Press Ltd.",

}

TY - JOUR

T1 - Nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients

T2 - Prospective evaluation of activity, safety, and quality of life

AU - Palumbo, Raffaella

AU - Sottotetti, Federico

AU - Trifirò, Giuseppe

AU - Piazza, Elena

AU - Ferzi, Antonella

AU - Gambaro, Anna

AU - Spinapolice, Elena Giulia

AU - Pozzi, Emma

AU - Tagliaferri, Barbara

AU - Teragni, Cristina

AU - Bernardo, Antonio

PY - 2015/3/15

Y1 - 2015/3/15

N2 - Background: A prospective, multicenter trial was undertaken to assess the activity, safety, and quality of life of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer (MBC). Patients and methods: Fifty-two women with HER2-negative MBC who were candidates for second-line chemotherapy for the metastatic disease were enrolled and treated at three centers in Northern Italy. All patients had previously received taxane-based chemotherapy in the adjuvant or first-line metastatic setting. Single-agent nab-paclitaxel was given at the dose of 260 mg/m2 as a 30-minute intravenous infusion on day 1 each treatment cycle, which lasted 3 weeks, in the outpatient setting. No steroid or antihistamine premedication was provided. Treatment was stopped for documented disease progression, unacceptable toxicity, or patient refusal. Results: All of the enrolled patients were evaluable for the study endpoints. The objective response rate was 48% (95% CI, 31.5%–61.3%) and included complete responses from 13.5%. >6 months in 15 of them; the overall clinical benefit rate was 77%. The median time to response was 70 days (range 52–86 days). The median progression-free survival time was 8.9 months (95% CI, 8.0–11.6 months, range 5–21+ months). The median overall survival point has not yet been reached. Toxicities were expected and manageable with good patient compliance and preserved quality of life in patients given long-term treatment. Conclusion: Our results showed that single-agent nab-paclitaxel 260 mg/m2 every 3 weeks is an effective and well tolerated regimen as second-line chemotherapy in HER2-negative, taxane-pretreated MBC patients, and that it produced interesting values of objective response rate and progression-free survival without the concern of significant toxicity. Specifically, the present study shows that such a regimen is a valid therapeutic option for that ‘difficult to treat’ patient population represented by women who at the time of disease relapse have already received the most active agents in the adjuvant and/or metastatic setting (ie, conventional taxanes).

AB - Background: A prospective, multicenter trial was undertaken to assess the activity, safety, and quality of life of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer (MBC). Patients and methods: Fifty-two women with HER2-negative MBC who were candidates for second-line chemotherapy for the metastatic disease were enrolled and treated at three centers in Northern Italy. All patients had previously received taxane-based chemotherapy in the adjuvant or first-line metastatic setting. Single-agent nab-paclitaxel was given at the dose of 260 mg/m2 as a 30-minute intravenous infusion on day 1 each treatment cycle, which lasted 3 weeks, in the outpatient setting. No steroid or antihistamine premedication was provided. Treatment was stopped for documented disease progression, unacceptable toxicity, or patient refusal. Results: All of the enrolled patients were evaluable for the study endpoints. The objective response rate was 48% (95% CI, 31.5%–61.3%) and included complete responses from 13.5%. >6 months in 15 of them; the overall clinical benefit rate was 77%. The median time to response was 70 days (range 52–86 days). The median progression-free survival time was 8.9 months (95% CI, 8.0–11.6 months, range 5–21+ months). The median overall survival point has not yet been reached. Toxicities were expected and manageable with good patient compliance and preserved quality of life in patients given long-term treatment. Conclusion: Our results showed that single-agent nab-paclitaxel 260 mg/m2 every 3 weeks is an effective and well tolerated regimen as second-line chemotherapy in HER2-negative, taxane-pretreated MBC patients, and that it produced interesting values of objective response rate and progression-free survival without the concern of significant toxicity. Specifically, the present study shows that such a regimen is a valid therapeutic option for that ‘difficult to treat’ patient population represented by women who at the time of disease relapse have already received the most active agents in the adjuvant and/or metastatic setting (ie, conventional taxanes).

KW - Metastatic breast cancer

KW - Nab-paclitaxel

KW - Quality of life

KW - Taxanes

UR - http://www.scopus.com/inward/record.url?scp=84929163847&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84929163847&partnerID=8YFLogxK

U2 - 10.2147/DDDT.S79563

DO - 10.2147/DDDT.S79563

M3 - Article

VL - 9

SP - 2189

EP - 2199

JO - Drug Design, Development and Therapy

JF - Drug Design, Development and Therapy

SN - 1177-8881

ER -