Weekly docetaxel and gemcitabine as first-line treatment for metastatic breast cancer

Results of a multicenter phase II study

S. Palmeri, M. Vaglica, S. Spada, G. Filippelli, A. Farris, L. Palmeri, B. Massidda, A. Misino, F. Ferraù, G. Comella, V. Leonardi, G. Condemi, A. Mangiameli, G. De Cataldis, M. C. Macaluso, M. Cajozzo, E. Iannitto, M. Danova

Research output: Contribution to journalArticle

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Abstract

Objectives: We conducted a multicenter phase II study to evaluate the clinical efficacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabine as first-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel 35 mg/m2 and gemcitabine 800 mg/m2 i.v. on days 1, 8, 15 every 28 days. Results: All patients were assessable for toxicity and 56 for efficacy. Overall response rate was 64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53-28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71-16.49). The most common hematological toxicity was neutropenia (no febrile neutropenia), which occurred in 28 patients (48.3%) but grade 3-4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experienced grade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule, in agreement with other published studies, need to be further confirmed within a phase III study.

Original languageEnglish
Pages (from-to)438-445
Number of pages8
JournalOncology
Volume68
Issue number4-6
DOIs
Publication statusPublished - Aug 2005

Fingerprint

docetaxel
gemcitabine
Breast Neoplasms
Appointments and Schedules
Alopecia
Therapeutics
Febrile Neutropenia
Anthracyclines
Neutropenia

Keywords

  • Docetaxel
  • Gemcitabine
  • Metastatic breast cancer
  • Phase II study

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Palmeri, S., Vaglica, M., Spada, S., Filippelli, G., Farris, A., Palmeri, L., ... Danova, M. (2005). Weekly docetaxel and gemcitabine as first-line treatment for metastatic breast cancer: Results of a multicenter phase II study. Oncology, 68(4-6), 438-445. https://doi.org/10.1159/000086986

Weekly docetaxel and gemcitabine as first-line treatment for metastatic breast cancer : Results of a multicenter phase II study. / Palmeri, S.; Vaglica, M.; Spada, S.; Filippelli, G.; Farris, A.; Palmeri, L.; Massidda, B.; Misino, A.; Ferraù, F.; Comella, G.; Leonardi, V.; Condemi, G.; Mangiameli, A.; De Cataldis, G.; Macaluso, M. C.; Cajozzo, M.; Iannitto, E.; Danova, M.

In: Oncology, Vol. 68, No. 4-6, 08.2005, p. 438-445.

Research output: Contribution to journalArticle

Palmeri, S, Vaglica, M, Spada, S, Filippelli, G, Farris, A, Palmeri, L, Massidda, B, Misino, A, Ferraù, F, Comella, G, Leonardi, V, Condemi, G, Mangiameli, A, De Cataldis, G, Macaluso, MC, Cajozzo, M, Iannitto, E & Danova, M 2005, 'Weekly docetaxel and gemcitabine as first-line treatment for metastatic breast cancer: Results of a multicenter phase II study', Oncology, vol. 68, no. 4-6, pp. 438-445. https://doi.org/10.1159/000086986
Palmeri, S. ; Vaglica, M. ; Spada, S. ; Filippelli, G. ; Farris, A. ; Palmeri, L. ; Massidda, B. ; Misino, A. ; Ferraù, F. ; Comella, G. ; Leonardi, V. ; Condemi, G. ; Mangiameli, A. ; De Cataldis, G. ; Macaluso, M. C. ; Cajozzo, M. ; Iannitto, E. ; Danova, M. / Weekly docetaxel and gemcitabine as first-line treatment for metastatic breast cancer : Results of a multicenter phase II study. In: Oncology. 2005 ; Vol. 68, No. 4-6. pp. 438-445.
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abstract = "Objectives: We conducted a multicenter phase II study to evaluate the clinical efficacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabine as first-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52{\%} of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel 35 mg/m2 and gemcitabine 800 mg/m2 i.v. on days 1, 8, 15 every 28 days. Results: All patients were assessable for toxicity and 56 for efficacy. Overall response rate was 64.3{\%} with 16.1{\%} of complete responses and 48.2{\%} of partial responses. Median survival was 22.10 months (95{\%} CI: 15.53-28.67) and median time to tumor progression was 13.6 months (95{\%} CI: 10.71-16.49). The most common hematological toxicity was neutropenia (no febrile neutropenia), which occurred in 28 patients (48.3{\%}) but grade 3-4 in only 8 patients (14{\%}). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5{\%}) patients, but only 5 patients (8.6{\%}) experienced grade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule, in agreement with other published studies, need to be further confirmed within a phase III study.",
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T1 - Weekly docetaxel and gemcitabine as first-line treatment for metastatic breast cancer

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AU - Vaglica, M.

AU - Spada, S.

AU - Filippelli, G.

AU - Farris, A.

AU - Palmeri, L.

AU - Massidda, B.

AU - Misino, A.

AU - Ferraù, F.

AU - Comella, G.

AU - Leonardi, V.

AU - Condemi, G.

AU - Mangiameli, A.

AU - De Cataldis, G.

AU - Macaluso, M. C.

AU - Cajozzo, M.

AU - Iannitto, E.

AU - Danova, M.

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N2 - Objectives: We conducted a multicenter phase II study to evaluate the clinical efficacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabine as first-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel 35 mg/m2 and gemcitabine 800 mg/m2 i.v. on days 1, 8, 15 every 28 days. Results: All patients were assessable for toxicity and 56 for efficacy. Overall response rate was 64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53-28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71-16.49). The most common hematological toxicity was neutropenia (no febrile neutropenia), which occurred in 28 patients (48.3%) but grade 3-4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experienced grade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule, in agreement with other published studies, need to be further confirmed within a phase III study.

AB - Objectives: We conducted a multicenter phase II study to evaluate the clinical efficacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabine as first-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel 35 mg/m2 and gemcitabine 800 mg/m2 i.v. on days 1, 8, 15 every 28 days. Results: All patients were assessable for toxicity and 56 for efficacy. Overall response rate was 64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53-28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71-16.49). The most common hematological toxicity was neutropenia (no febrile neutropenia), which occurred in 28 patients (48.3%) but grade 3-4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experienced grade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule, in agreement with other published studies, need to be further confirmed within a phase III study.

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