A phase II trial of capecitabine and docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) as preoperative treatment in women with stage II/III breast cancer

H. Jinno, M. Sakata, Tetsu Hayashida, Maiko Takahashi, M. Mukai, T. Ikeda, Yuukou Kitagawa

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11 Citations (Scopus)

Abstract

Background: Capecitabine (X) and docetaxel (T) have demonstrated a synergistic effect in preclinical models and a survival benefit in metastatic breast cancer. This study's purpose was to determine the efficacy of X and T followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) in the preoperative setting. Patients and methods: Patients with stage II/III breast cancer received four cycles of XT (capecitabine 1650 mg/m<sup>2</sup> on days 1-14 and docetaxel 60 mg/m<sup>2</sup> on day 8 every 3 weeks), followed by four cycles of FEC (5-fluorouracil 500 mg/m<sup>2</sup>, epirubicin 90 mg/m<sup>2</sup>, and cyclophosphamide 500 mg/m<sup>2</sup> on day 1 every 3 weeks). Primary end points were the pathological complete response (pCR) rate and adverse drug reactions. Results: Seventy-four patients were enrolled and 71 patients were assessable for clinical and pathological responses. The overall response rate was 91.5%. The pCR rate was 14.1% (10 of 71). Grade 3/4 neutropenia was observed in 32.4% of patients. The most common grade 3/4 non-hematologic adverse event was hand-foot syndrome, observed in 11.3% of patients. With 29 months median follow-up, 2-year disease-free survival was estimated 85% for all patients. Conclusion: These data indicate that the sequential combination of XT followed by FEC is a well-tolerated, effective neoadjuvant treatment of stage II/III breast cancer.

Original languageEnglish
Pages (from-to)1262-1266
Number of pages5
JournalAnnals of Oncology
Volume21
Issue number6
DOIs
Publication statusPublished - 2009 Oct 23

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docetaxel
Epirubicin
Fluorouracil
Cyclophosphamide
Breast Neoplasms
Therapeutics
Hand-Foot Syndrome
Neoadjuvant Therapy
Capecitabine
Neutropenia
Drug-Related Side Effects and Adverse Reactions
Disease-Free Survival

Keywords

  • Breast cancer
  • Capecitabine
  • Docetaxel
  • Preoperative chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Hematology
  • Medicine(all)

Cite this

@article{54eca6d1e1674487835aa9954413b069,
title = "A phase II trial of capecitabine and docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) as preoperative treatment in women with stage II/III breast cancer",
abstract = "Background: Capecitabine (X) and docetaxel (T) have demonstrated a synergistic effect in preclinical models and a survival benefit in metastatic breast cancer. This study's purpose was to determine the efficacy of X and T followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) in the preoperative setting. Patients and methods: Patients with stage II/III breast cancer received four cycles of XT (capecitabine 1650 mg/m2 on days 1-14 and docetaxel 60 mg/m2 on day 8 every 3 weeks), followed by four cycles of FEC (5-fluorouracil 500 mg/m2, epirubicin 90 mg/m2, and cyclophosphamide 500 mg/m2 on day 1 every 3 weeks). Primary end points were the pathological complete response (pCR) rate and adverse drug reactions. Results: Seventy-four patients were enrolled and 71 patients were assessable for clinical and pathological responses. The overall response rate was 91.5{\%}. The pCR rate was 14.1{\%} (10 of 71). Grade 3/4 neutropenia was observed in 32.4{\%} of patients. The most common grade 3/4 non-hematologic adverse event was hand-foot syndrome, observed in 11.3{\%} of patients. With 29 months median follow-up, 2-year disease-free survival was estimated 85{\%} for all patients. Conclusion: These data indicate that the sequential combination of XT followed by FEC is a well-tolerated, effective neoadjuvant treatment of stage II/III breast cancer.",
keywords = "Breast cancer, Capecitabine, Docetaxel, Preoperative chemotherapy",
author = "H. Jinno and M. Sakata and Tetsu Hayashida and Maiko Takahashi and M. Mukai and T. Ikeda and Yuukou Kitagawa",
year = "2009",
month = "10",
day = "23",
doi = "10.1093/annonc/mdp428",
language = "English",
volume = "21",
pages = "1262--1266",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "6",

}

TY - JOUR

T1 - A phase II trial of capecitabine and docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) as preoperative treatment in women with stage II/III breast cancer

AU - Jinno, H.

AU - Sakata, M.

AU - Hayashida, Tetsu

AU - Takahashi, Maiko

AU - Mukai, M.

AU - Ikeda, T.

AU - Kitagawa, Yuukou

PY - 2009/10/23

Y1 - 2009/10/23

N2 - Background: Capecitabine (X) and docetaxel (T) have demonstrated a synergistic effect in preclinical models and a survival benefit in metastatic breast cancer. This study's purpose was to determine the efficacy of X and T followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) in the preoperative setting. Patients and methods: Patients with stage II/III breast cancer received four cycles of XT (capecitabine 1650 mg/m2 on days 1-14 and docetaxel 60 mg/m2 on day 8 every 3 weeks), followed by four cycles of FEC (5-fluorouracil 500 mg/m2, epirubicin 90 mg/m2, and cyclophosphamide 500 mg/m2 on day 1 every 3 weeks). Primary end points were the pathological complete response (pCR) rate and adverse drug reactions. Results: Seventy-four patients were enrolled and 71 patients were assessable for clinical and pathological responses. The overall response rate was 91.5%. The pCR rate was 14.1% (10 of 71). Grade 3/4 neutropenia was observed in 32.4% of patients. The most common grade 3/4 non-hematologic adverse event was hand-foot syndrome, observed in 11.3% of patients. With 29 months median follow-up, 2-year disease-free survival was estimated 85% for all patients. Conclusion: These data indicate that the sequential combination of XT followed by FEC is a well-tolerated, effective neoadjuvant treatment of stage II/III breast cancer.

AB - Background: Capecitabine (X) and docetaxel (T) have demonstrated a synergistic effect in preclinical models and a survival benefit in metastatic breast cancer. This study's purpose was to determine the efficacy of X and T followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) in the preoperative setting. Patients and methods: Patients with stage II/III breast cancer received four cycles of XT (capecitabine 1650 mg/m2 on days 1-14 and docetaxel 60 mg/m2 on day 8 every 3 weeks), followed by four cycles of FEC (5-fluorouracil 500 mg/m2, epirubicin 90 mg/m2, and cyclophosphamide 500 mg/m2 on day 1 every 3 weeks). Primary end points were the pathological complete response (pCR) rate and adverse drug reactions. Results: Seventy-four patients were enrolled and 71 patients were assessable for clinical and pathological responses. The overall response rate was 91.5%. The pCR rate was 14.1% (10 of 71). Grade 3/4 neutropenia was observed in 32.4% of patients. The most common grade 3/4 non-hematologic adverse event was hand-foot syndrome, observed in 11.3% of patients. With 29 months median follow-up, 2-year disease-free survival was estimated 85% for all patients. Conclusion: These data indicate that the sequential combination of XT followed by FEC is a well-tolerated, effective neoadjuvant treatment of stage II/III breast cancer.

KW - Breast cancer

KW - Capecitabine

KW - Docetaxel

KW - Preoperative chemotherapy

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U2 - 10.1093/annonc/mdp428

DO - 10.1093/annonc/mdp428

M3 - Article

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SP - 1262

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JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

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