First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II study
<p>Abstract</p> <p>Background</p> <p>This phase II study evaluated the efficacy and safety of gemcitabine (G) plus paclitaxel (T) as first-line therapy in recurrent or metastatic breast cancer.</p> <p>Methods</p> <p>Patients with locally, recurre...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2005-11-01
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| Series: | BMC Cancer |
| Online Access: | http://www.biomedcentral.com/1471-2407/5/151 |
| _version_ | 1818531235313483776 |
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| author | Piperno-Neumann Sophie Tubiana-Mathieu Nicole Tubiana-Hulin Michele Gawande Sulochana R Allouache Djelila Mefti Fawzia Bozec Laurence Genot Jean-Yves |
| author_facet | Piperno-Neumann Sophie Tubiana-Mathieu Nicole Tubiana-Hulin Michele Gawande Sulochana R Allouache Djelila Mefti Fawzia Bozec Laurence Genot Jean-Yves |
| author_sort | Piperno-Neumann Sophie |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>This phase II study evaluated the efficacy and safety of gemcitabine (G) plus paclitaxel (T) as first-line therapy in recurrent or metastatic breast cancer.</p> <p>Methods</p> <p>Patients with locally, recurrent or metastatic breast cancer and no prior chemotherapy for metastatic disease received G 1200 mg/m<sup>2 </sup>on days 1 and 8, and T 175 mg/m<sup>2 </sup>on day 1 (before G) every 21 days for a maximum of 10 cycles.</p> <p>Results</p> <p>Forty patients, 39 metastatic breast cancer and 1 locally-advanced disease, were enrolled. Their median age was 61.5 years, and 85% had a World Health Organization performance status (PS) of 0 or 1. Poor prognostic factors at baseline included visceral involvement (87.5%) and ≥2 metastatic sites (70%). Also, 27 (67.5%) patients had prior adjuvant chemotherapy, 25 of which had prior anthracyclines. A total of 220 cycles (median 6; range, 1–10) were administered. Of the 40 enrolled patients, 2 had complete response and 12 partial response, for an overall response rate of 35.0% for intent-to-treat population. Among 35 patients evaluable for efficacy the response rate was 40%. Additional 14 patients had stable disease, and 7 had progressive disease. The median duration of response was 12 months; median time to progression, 7.2 months; median survival, 25.7 months. Common grade 3/4 toxicities were neutropenia in 17 (42.5%) patients each, grade 3 leukopenia in 19 (47.5%), and grade 3 alopecia in 30 (75.0%) patients; 1 (2.5%) patient had grade 4 thrombocytopenia.</p> <p>Conclusion</p> <p>GT exhibited encouraging activity and tolerable toxicity as first-line therapy in metastatic breast cancer. Phase III trials for further evaluation are ongoing.</p> |
| first_indexed | 2024-12-11T17:29:49Z |
| format | Article |
| id | doaj.art-728dda3476ca40d894407659bb8912b3 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-11T17:29:49Z |
| publishDate | 2005-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-728dda3476ca40d894407659bb8912b32022-12-22T00:56:52ZengBMCBMC Cancer1471-24072005-11-015115110.1186/1471-2407-5-151First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II studyPiperno-Neumann SophieTubiana-Mathieu NicoleTubiana-Hulin MicheleGawande Sulochana RAllouache DjelilaMefti FawziaBozec LaurenceGenot Jean-Yves<p>Abstract</p> <p>Background</p> <p>This phase II study evaluated the efficacy and safety of gemcitabine (G) plus paclitaxel (T) as first-line therapy in recurrent or metastatic breast cancer.</p> <p>Methods</p> <p>Patients with locally, recurrent or metastatic breast cancer and no prior chemotherapy for metastatic disease received G 1200 mg/m<sup>2 </sup>on days 1 and 8, and T 175 mg/m<sup>2 </sup>on day 1 (before G) every 21 days for a maximum of 10 cycles.</p> <p>Results</p> <p>Forty patients, 39 metastatic breast cancer and 1 locally-advanced disease, were enrolled. Their median age was 61.5 years, and 85% had a World Health Organization performance status (PS) of 0 or 1. Poor prognostic factors at baseline included visceral involvement (87.5%) and ≥2 metastatic sites (70%). Also, 27 (67.5%) patients had prior adjuvant chemotherapy, 25 of which had prior anthracyclines. A total of 220 cycles (median 6; range, 1–10) were administered. Of the 40 enrolled patients, 2 had complete response and 12 partial response, for an overall response rate of 35.0% for intent-to-treat population. Among 35 patients evaluable for efficacy the response rate was 40%. Additional 14 patients had stable disease, and 7 had progressive disease. The median duration of response was 12 months; median time to progression, 7.2 months; median survival, 25.7 months. Common grade 3/4 toxicities were neutropenia in 17 (42.5%) patients each, grade 3 leukopenia in 19 (47.5%), and grade 3 alopecia in 30 (75.0%) patients; 1 (2.5%) patient had grade 4 thrombocytopenia.</p> <p>Conclusion</p> <p>GT exhibited encouraging activity and tolerable toxicity as first-line therapy in metastatic breast cancer. Phase III trials for further evaluation are ongoing.</p>http://www.biomedcentral.com/1471-2407/5/151 |
| spellingShingle | Piperno-Neumann Sophie Tubiana-Mathieu Nicole Tubiana-Hulin Michele Gawande Sulochana R Allouache Djelila Mefti Fawzia Bozec Laurence Genot Jean-Yves First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II study BMC Cancer |
| title | First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II study |
| title_full | First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II study |
| title_fullStr | First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II study |
| title_full_unstemmed | First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II study |
| title_short | First-line therapy with gemcitabine and paclitaxel in locally, recurrent or metastatic breast cancer: A phase II study |
| title_sort | first line therapy with gemcitabine and paclitaxel in locally recurrent or metastatic breast cancer a phase ii study |
| url | http://www.biomedcentral.com/1471-2407/5/151 |
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