Weekly docetaxel and gemcitabine following docetaxel plus epirubicin or vinorelbine as first-line treatment of metastatic breast cancer: Results of a multicenter phase II study

Alberto Riccardi, Silvia Brugnatelli, Marco Danova, Monica Giordano, Palma Pugliese, Giovanna Luchena, Donatella Grasso, Giovanni Trotti, Raffaella Bertè, Giovanni Pansini, Carmine Tinelli

Research output: Contribution to journalArticle

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Abstract

Aims and background: Sequential docetaxel and gemcitabine following initial docetaxel plus epirubicin or vinorelbine association could be worthwhile as first-line treatment of metastatic breast cancer. Methods: Fifty-eight patients entered a phase II study that included two sequential phases. In the first phase, 36 and 22 patients previously unexposed or exposed to adjuvant anthracyclines received the association of docetaxel (75 mg/m2, day 1) with epirubicin (75 mg/m2, day 1) or vinorelbine (20 mg/m2, days 1 and 5), respectively, every 21 days for 4 courses. In the second phase, patients who had a response (R) or stable disease (SD) received docetaxel (35 mg/m2) and gemcitabine (800 mg/m2) on days 1, 8 and 15 every 28 days for 4 courses. Results: In the first phase, grade ≥ III neutropenia occurred in 51% and 37% of patients during docetaxel-epirubicin and docetaxel-vinorelbine, respectively. In the second phase, it occurred in the 27% and 15% of patients initially treated with docetaxel-epirubicin and docetaxel-vinorelbine, respectively. On an intention to treat basis, the complete (CR) + partial response (PR) rate to the first phase was 71%, and 22% of patients had SD, without a significant difference between the docetaxel-epirubicin and docetaxel-vinorelbine arms. After the second phase, the CR + PR rate was 65%, and 14% of patients had SD. Median time to progression and survival were 12.1 and 22.0 months, respectively, without a significant difference between patients initially treated with docetaxel-epirubicin and docetaxel-vinorelbine. Conclusions: Following an initial docetaxel-based treatment, weekly docetaxel and gemcitabile maintains high percentages of R and SD, with improved toxicity. Survival was similar in patients previously untreated and treated with adjuvant anthracyclines.

Original languageEnglish
Pages (from-to)6-12
Number of pages7
JournalTumori
Volume92
Issue number1
Publication statusPublished - Jan 2006

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docetaxel
gemcitabine
Epirubicin
Breast Neoplasms
Therapeutics
Anthracyclines
vinorelbine

Keywords

  • Advanced breast cancer
  • Sequential chemotherapy
  • Weekly docetaxel and gemcitabine

ASJC Scopus subject areas

  • Cancer Research

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Weekly docetaxel and gemcitabine following docetaxel plus epirubicin or vinorelbine as first-line treatment of metastatic breast cancer : Results of a multicenter phase II study. / Riccardi, Alberto; Brugnatelli, Silvia; Danova, Marco; Giordano, Monica; Pugliese, Palma; Luchena, Giovanna; Grasso, Donatella; Trotti, Giovanni; Bertè, Raffaella; Pansini, Giovanni; Tinelli, Carmine.

In: Tumori, Vol. 92, No. 1, 01.2006, p. 6-12.

Research output: Contribution to journalArticle

Riccardi, Alberto ; Brugnatelli, Silvia ; Danova, Marco ; Giordano, Monica ; Pugliese, Palma ; Luchena, Giovanna ; Grasso, Donatella ; Trotti, Giovanni ; Bertè, Raffaella ; Pansini, Giovanni ; Tinelli, Carmine. / Weekly docetaxel and gemcitabine following docetaxel plus epirubicin or vinorelbine as first-line treatment of metastatic breast cancer : Results of a multicenter phase II study. In: Tumori. 2006 ; Vol. 92, No. 1. pp. 6-12.
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abstract = "Aims and background: Sequential docetaxel and gemcitabine following initial docetaxel plus epirubicin or vinorelbine association could be worthwhile as first-line treatment of metastatic breast cancer. Methods: Fifty-eight patients entered a phase II study that included two sequential phases. In the first phase, 36 and 22 patients previously unexposed or exposed to adjuvant anthracyclines received the association of docetaxel (75 mg/m2, day 1) with epirubicin (75 mg/m2, day 1) or vinorelbine (20 mg/m2, days 1 and 5), respectively, every 21 days for 4 courses. In the second phase, patients who had a response (R) or stable disease (SD) received docetaxel (35 mg/m2) and gemcitabine (800 mg/m2) on days 1, 8 and 15 every 28 days for 4 courses. Results: In the first phase, grade ≥ III neutropenia occurred in 51{\%} and 37{\%} of patients during docetaxel-epirubicin and docetaxel-vinorelbine, respectively. In the second phase, it occurred in the 27{\%} and 15{\%} of patients initially treated with docetaxel-epirubicin and docetaxel-vinorelbine, respectively. On an intention to treat basis, the complete (CR) + partial response (PR) rate to the first phase was 71{\%}, and 22{\%} of patients had SD, without a significant difference between the docetaxel-epirubicin and docetaxel-vinorelbine arms. After the second phase, the CR + PR rate was 65{\%}, and 14{\%} of patients had SD. Median time to progression and survival were 12.1 and 22.0 months, respectively, without a significant difference between patients initially treated with docetaxel-epirubicin and docetaxel-vinorelbine. Conclusions: Following an initial docetaxel-based treatment, weekly docetaxel and gemcitabile maintains high percentages of R and SD, with improved toxicity. Survival was similar in patients previously untreated and treated with adjuvant anthracyclines.",
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T1 - Weekly docetaxel and gemcitabine following docetaxel plus epirubicin or vinorelbine as first-line treatment of metastatic breast cancer

T2 - Results of a multicenter phase II study

AU - Riccardi, Alberto

AU - Brugnatelli, Silvia

AU - Danova, Marco

AU - Giordano, Monica

AU - Pugliese, Palma

AU - Luchena, Giovanna

AU - Grasso, Donatella

AU - Trotti, Giovanni

AU - Bertè, Raffaella

AU - Pansini, Giovanni

AU - Tinelli, Carmine

PY - 2006/1

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N2 - Aims and background: Sequential docetaxel and gemcitabine following initial docetaxel plus epirubicin or vinorelbine association could be worthwhile as first-line treatment of metastatic breast cancer. Methods: Fifty-eight patients entered a phase II study that included two sequential phases. In the first phase, 36 and 22 patients previously unexposed or exposed to adjuvant anthracyclines received the association of docetaxel (75 mg/m2, day 1) with epirubicin (75 mg/m2, day 1) or vinorelbine (20 mg/m2, days 1 and 5), respectively, every 21 days for 4 courses. In the second phase, patients who had a response (R) or stable disease (SD) received docetaxel (35 mg/m2) and gemcitabine (800 mg/m2) on days 1, 8 and 15 every 28 days for 4 courses. Results: In the first phase, grade ≥ III neutropenia occurred in 51% and 37% of patients during docetaxel-epirubicin and docetaxel-vinorelbine, respectively. In the second phase, it occurred in the 27% and 15% of patients initially treated with docetaxel-epirubicin and docetaxel-vinorelbine, respectively. On an intention to treat basis, the complete (CR) + partial response (PR) rate to the first phase was 71%, and 22% of patients had SD, without a significant difference between the docetaxel-epirubicin and docetaxel-vinorelbine arms. After the second phase, the CR + PR rate was 65%, and 14% of patients had SD. Median time to progression and survival were 12.1 and 22.0 months, respectively, without a significant difference between patients initially treated with docetaxel-epirubicin and docetaxel-vinorelbine. Conclusions: Following an initial docetaxel-based treatment, weekly docetaxel and gemcitabile maintains high percentages of R and SD, with improved toxicity. Survival was similar in patients previously untreated and treated with adjuvant anthracyclines.

AB - Aims and background: Sequential docetaxel and gemcitabine following initial docetaxel plus epirubicin or vinorelbine association could be worthwhile as first-line treatment of metastatic breast cancer. Methods: Fifty-eight patients entered a phase II study that included two sequential phases. In the first phase, 36 and 22 patients previously unexposed or exposed to adjuvant anthracyclines received the association of docetaxel (75 mg/m2, day 1) with epirubicin (75 mg/m2, day 1) or vinorelbine (20 mg/m2, days 1 and 5), respectively, every 21 days for 4 courses. In the second phase, patients who had a response (R) or stable disease (SD) received docetaxel (35 mg/m2) and gemcitabine (800 mg/m2) on days 1, 8 and 15 every 28 days for 4 courses. Results: In the first phase, grade ≥ III neutropenia occurred in 51% and 37% of patients during docetaxel-epirubicin and docetaxel-vinorelbine, respectively. In the second phase, it occurred in the 27% and 15% of patients initially treated with docetaxel-epirubicin and docetaxel-vinorelbine, respectively. On an intention to treat basis, the complete (CR) + partial response (PR) rate to the first phase was 71%, and 22% of patients had SD, without a significant difference between the docetaxel-epirubicin and docetaxel-vinorelbine arms. After the second phase, the CR + PR rate was 65%, and 14% of patients had SD. Median time to progression and survival were 12.1 and 22.0 months, respectively, without a significant difference between patients initially treated with docetaxel-epirubicin and docetaxel-vinorelbine. Conclusions: Following an initial docetaxel-based treatment, weekly docetaxel and gemcitabile maintains high percentages of R and SD, with improved toxicity. Survival was similar in patients previously untreated and treated with adjuvant anthracyclines.

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