Phase II multicenter trial of albumin-bound paclitaxel and capecitabine in first-line treatment of patients with metastatic breast cancer

Lee Schwartzberg, Francis P. Arena, David M. Mintzer, Amanda L. Epperson, Mark S. Walker

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background: Capecitabine, a tumor-activated oral fluoropyrimidine, and albumin-bound paclitaxel (ab-paclitaxel) have substantial single-agent activity in patients with metastatic breast cancer (MBC). Taxane and antimetabolite doublets have improved efficacy compared with single agents. This phase II open-label trial was designed to test the safety and efficacy of capecitabine and ab-paclitaxel in previously untreated MBC. Patients and Methods: Patients received capecitabine (825 mg/m2 orally twice daily, approximately 12 hours apart, on days 1 to 15) and ab-paclitaxel (125 mg/m2 intravenously on days 1 and 8 of each cycle with no premedication) every 3 weeks. The primary endpoint was overall objective response rate (ORR), with evaluation performed after every 2 cycles. Entry criteria included measurable MBC, human epidermal growth factor receptor 2 (HER2) negativity, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, no previous chemotherapy for metastatic disease, and > 6 months since adjuvant fluoropyrimidine or paclitaxel treatment. Results: Fifty patients received at least 1 dose of study drug, with 46 patients evaluable for efficacy evaluation. Three hundred seventy-four cycles of therapy were delivered. Eighty percent of patients completed 8 cycles. The ORR was 61% (complete response [CR], 4%; partial response [PR], 57%), and 7 patients had sustained (≥ 24 weeks) stable disease for a clinical benefit rate of 76.1%. The median progression-free survival (PFS) was 10.6 months, and the median overall survival was 19.9 months. The most common adverse events (AEs) that were ≥ grade 3 were pain, hand-foot syndrome, and neutropenia. Conclusion: The combination of weekly ab-paclitaxel plus daily capecitabine orally at these doses and scheduling was well tolerated and showed substantial efficacy.

Original languageEnglish (US)
Pages (from-to)87-93
Number of pages7
JournalClinical Breast Cancer
Volume12
Issue number2
DOIs
StatePublished - Jan 1 2012

Fingerprint

Multicenter Studies
Breast Neoplasms
Therapeutics
Hand-Foot Syndrome
Antimetabolites
Premedication
Paclitaxel
Capecitabine
Albumin-Bound Paclitaxel
Neutropenia
Disease-Free Survival
Safety
Drug Therapy
Pain
Survival
Pharmaceutical Preparations
Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Phase II multicenter trial of albumin-bound paclitaxel and capecitabine in first-line treatment of patients with metastatic breast cancer. / Schwartzberg, Lee; Arena, Francis P.; Mintzer, David M.; Epperson, Amanda L.; Walker, Mark S.

In: Clinical Breast Cancer, Vol. 12, No. 2, 01.01.2012, p. 87-93.

Research output: Contribution to journalArticle

Schwartzberg, Lee ; Arena, Francis P. ; Mintzer, David M. ; Epperson, Amanda L. ; Walker, Mark S. / Phase II multicenter trial of albumin-bound paclitaxel and capecitabine in first-line treatment of patients with metastatic breast cancer. In: Clinical Breast Cancer. 2012 ; Vol. 12, No. 2. pp. 87-93.
@article{7344e8a737504250b607d9450a917acb,
title = "Phase II multicenter trial of albumin-bound paclitaxel and capecitabine in first-line treatment of patients with metastatic breast cancer",
abstract = "Background: Capecitabine, a tumor-activated oral fluoropyrimidine, and albumin-bound paclitaxel (ab-paclitaxel) have substantial single-agent activity in patients with metastatic breast cancer (MBC). Taxane and antimetabolite doublets have improved efficacy compared with single agents. This phase II open-label trial was designed to test the safety and efficacy of capecitabine and ab-paclitaxel in previously untreated MBC. Patients and Methods: Patients received capecitabine (825 mg/m2 orally twice daily, approximately 12 hours apart, on days 1 to 15) and ab-paclitaxel (125 mg/m2 intravenously on days 1 and 8 of each cycle with no premedication) every 3 weeks. The primary endpoint was overall objective response rate (ORR), with evaluation performed after every 2 cycles. Entry criteria included measurable MBC, human epidermal growth factor receptor 2 (HER2) negativity, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, no previous chemotherapy for metastatic disease, and > 6 months since adjuvant fluoropyrimidine or paclitaxel treatment. Results: Fifty patients received at least 1 dose of study drug, with 46 patients evaluable for efficacy evaluation. Three hundred seventy-four cycles of therapy were delivered. Eighty percent of patients completed 8 cycles. The ORR was 61{\%} (complete response [CR], 4{\%}; partial response [PR], 57{\%}), and 7 patients had sustained (≥ 24 weeks) stable disease for a clinical benefit rate of 76.1{\%}. The median progression-free survival (PFS) was 10.6 months, and the median overall survival was 19.9 months. The most common adverse events (AEs) that were ≥ grade 3 were pain, hand-foot syndrome, and neutropenia. Conclusion: The combination of weekly ab-paclitaxel plus daily capecitabine orally at these doses and scheduling was well tolerated and showed substantial efficacy.",
author = "Lee Schwartzberg and Arena, {Francis P.} and Mintzer, {David M.} and Epperson, {Amanda L.} and Walker, {Mark S.}",
year = "2012",
month = "1",
day = "1",
doi = "10.1016/j.clbc.2011.10.004",
language = "English (US)",
volume = "12",
pages = "87--93",
journal = "Clinical Breast Cancer",
issn = "1526-8209",
publisher = "Elsevier",
number = "2",

}

TY - JOUR

T1 - Phase II multicenter trial of albumin-bound paclitaxel and capecitabine in first-line treatment of patients with metastatic breast cancer

AU - Schwartzberg, Lee

AU - Arena, Francis P.

AU - Mintzer, David M.

AU - Epperson, Amanda L.

AU - Walker, Mark S.

PY - 2012/1/1

Y1 - 2012/1/1

N2 - Background: Capecitabine, a tumor-activated oral fluoropyrimidine, and albumin-bound paclitaxel (ab-paclitaxel) have substantial single-agent activity in patients with metastatic breast cancer (MBC). Taxane and antimetabolite doublets have improved efficacy compared with single agents. This phase II open-label trial was designed to test the safety and efficacy of capecitabine and ab-paclitaxel in previously untreated MBC. Patients and Methods: Patients received capecitabine (825 mg/m2 orally twice daily, approximately 12 hours apart, on days 1 to 15) and ab-paclitaxel (125 mg/m2 intravenously on days 1 and 8 of each cycle with no premedication) every 3 weeks. The primary endpoint was overall objective response rate (ORR), with evaluation performed after every 2 cycles. Entry criteria included measurable MBC, human epidermal growth factor receptor 2 (HER2) negativity, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, no previous chemotherapy for metastatic disease, and > 6 months since adjuvant fluoropyrimidine or paclitaxel treatment. Results: Fifty patients received at least 1 dose of study drug, with 46 patients evaluable for efficacy evaluation. Three hundred seventy-four cycles of therapy were delivered. Eighty percent of patients completed 8 cycles. The ORR was 61% (complete response [CR], 4%; partial response [PR], 57%), and 7 patients had sustained (≥ 24 weeks) stable disease for a clinical benefit rate of 76.1%. The median progression-free survival (PFS) was 10.6 months, and the median overall survival was 19.9 months. The most common adverse events (AEs) that were ≥ grade 3 were pain, hand-foot syndrome, and neutropenia. Conclusion: The combination of weekly ab-paclitaxel plus daily capecitabine orally at these doses and scheduling was well tolerated and showed substantial efficacy.

AB - Background: Capecitabine, a tumor-activated oral fluoropyrimidine, and albumin-bound paclitaxel (ab-paclitaxel) have substantial single-agent activity in patients with metastatic breast cancer (MBC). Taxane and antimetabolite doublets have improved efficacy compared with single agents. This phase II open-label trial was designed to test the safety and efficacy of capecitabine and ab-paclitaxel in previously untreated MBC. Patients and Methods: Patients received capecitabine (825 mg/m2 orally twice daily, approximately 12 hours apart, on days 1 to 15) and ab-paclitaxel (125 mg/m2 intravenously on days 1 and 8 of each cycle with no premedication) every 3 weeks. The primary endpoint was overall objective response rate (ORR), with evaluation performed after every 2 cycles. Entry criteria included measurable MBC, human epidermal growth factor receptor 2 (HER2) negativity, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, no previous chemotherapy for metastatic disease, and > 6 months since adjuvant fluoropyrimidine or paclitaxel treatment. Results: Fifty patients received at least 1 dose of study drug, with 46 patients evaluable for efficacy evaluation. Three hundred seventy-four cycles of therapy were delivered. Eighty percent of patients completed 8 cycles. The ORR was 61% (complete response [CR], 4%; partial response [PR], 57%), and 7 patients had sustained (≥ 24 weeks) stable disease for a clinical benefit rate of 76.1%. The median progression-free survival (PFS) was 10.6 months, and the median overall survival was 19.9 months. The most common adverse events (AEs) that were ≥ grade 3 were pain, hand-foot syndrome, and neutropenia. Conclusion: The combination of weekly ab-paclitaxel plus daily capecitabine orally at these doses and scheduling was well tolerated and showed substantial efficacy.

UR - http://www.scopus.com/inward/record.url?scp=84858965929&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84858965929&partnerID=8YFLogxK

U2 - 10.1016/j.clbc.2011.10.004

DO - 10.1016/j.clbc.2011.10.004

M3 - Article

VL - 12

SP - 87

EP - 93

JO - Clinical Breast Cancer

JF - Clinical Breast Cancer

SN - 1526-8209

IS - 2

ER -