Abstract P1-12-06: UCBG intergroup: 3-years efficacy results of the Unicancer-PACS08 trial including poor prognosis patients treated with docetaxel or ixabepilone in adjuvant setting
| Autor: | L. Roca, PH Cottu, H. Orfeuvre, Bernard Asselain, Frank Mayer, Christine Levy, J-L Canon, Thomas Bachelot, M. Spielmann, J-P. Machiels, Lionel Uwer, Jérôme Lemonnier, H. Roche, D. Verhoeven, T Facchini, J-C Eymard, T Wiston, D Jaubert, Magali Lacroix-Triki, P. Kerbrat, H. Wildiers, M. Campone |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Oncology Cancer Research medicine.medical_specialty medicine.medical_treatment Estrogen receptor 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Breast cancer Internal medicine Progesterone receptor medicine Gynecology business.industry Ixabepilone Cancer medicine.disease Regimen 030104 developmental biology chemistry Docetaxel 030220 oncology & carcinogenesis business Adjuvant medicine.drug |
| Zdroj: | Cancer Research. 76:P1-12 |
| ISSN: | 1538-7445 0008-5472 |
| DOI: | 10.1158/1538-7445.sabcs15-p1-12-06 |
| Popis: | Background: Ixabepilone, an epothilone B analog, has demonstrated single-agent activity in metastatic and neoadjuvant settings. The PACS08 trial aimed to compare adjuvant FEC100-Docetaxel regimen to FEC100-Ixabepilone in poor prognosis early breast cancer (BC) composed of patients presenting with triple-negative (TN) [i.e. estrogen receptor (ER)-/progesterone receptor (PR)-/HER2-] or ER+/PR-/HER2- tumor, which are subgroups significantly associated with worse prognosis. Patients and methods: Between 2007 and 2010, 762 patients with unilateral TNBC (n=592, 78%) or node-positive ER+/PR-/HER2- BC (n=170, 22%) were enrolled. Recruitment was interrupted due to BMS decision to stop ixabepilone development in adjuvant setting. Main inclusion criteria were: age Results: Main pts characteristics were well balanced between the 2 arms. As of September 2014, the median follow-up was 36 months. The safety profile indicates that Docetaxel is more often associated to significant haematological toxicities whereas both neurotoxicities and haematological toxicities are reported in Ixabepilone arm. Log-Rank tests indicate no difference between two arms in terms of both DFS and OS (HR=1.2, 95%CI (0.864-1.728), p=0.256 and HR=1.8, 95%CI (0.751-1.855), p=0.473, respectively). Pathological analysis of the PACS08 collection showed that TNBC displayed significantly higher proliferative activity as shown by mitotic count and Ki67 index (p Conclusions: Our results indicate that Ixabepilone doesn't show higher efficiency compared to Docetaxel in adjuvant setting in poor prognosis early breast cancer. We have an unusual biological collection associated to our clinical data which will allow us to correlate efficacy data to breast cancer subgroups. Other several translational researches are still ongoing. Citation Format: Campone M, Lacroix-Triki M, Roca L, Spielmann M, Wildiers H, Cottu P, Kerbrat P, Levy C, Mayer F, Bachelot T, Wiston T, Eymard J-C, Uwer L, Machiels J-P, Verhoeven D, Jaubert D, Facchini T, Orfeuvre H, Canon J-L, Asselain B, Lemonnier J, Roché H. UCBG intergroup: 3-years efficacy results of the Unicancer-PACS08 trial including poor prognosis patients treated with docetaxel or ixabepilone in adjuvant setting. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-12-06. |
| Databáze: | OpenAIRE |
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