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Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: first report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial
dc.creator | Fountzilas, G. | en |
dc.creator | Dafni, U. | en |
dc.creator | Papadimitriou, C. | en |
dc.creator | Timotheadou, E. | en |
dc.creator | Gogas, H. | en |
dc.creator | Eleftheraki, A. G. | en |
dc.creator | Xanthakis, I. | en |
dc.creator | Christodoulou, C. | en |
dc.creator | Koutras, A. | en |
dc.creator | Papandreou, C. N. | en |
dc.creator | Papakostas, P. | en |
dc.creator | Miliaras, S. | en |
dc.creator | Markopoulos, C. | en |
dc.creator | Dimitrakakis, C. | en |
dc.creator | Korantzopoulos, P. | en |
dc.creator | Karanikiotis, C. | en |
dc.creator | Bafaloukos, D. | en |
dc.creator | Kosmidis, P. | en |
dc.creator | Samantas, E. | en |
dc.creator | Varthalitis, I. | en |
dc.creator | Pavlidis, N. | en |
dc.creator | Pectasides, D. | en |
dc.creator | Dimopoulos, M. A. | en |
dc.date.accessioned | 2015-11-23T10:26:44Z | |
dc.date.available | 2015-11-23T10:26:44Z | |
dc.date.issued | 2014 | |
dc.identifier | 10.1186/1471-2407-14-515 | |
dc.identifier.issn | 1471-2407 | |
dc.identifier.uri | http://hdl.handle.net/11615/27552 | |
dc.description.abstract | Background: Dose-dense sequential chemotherapy including anthracyclines and taxanes has been established in the adjuvant setting of high-risk operable breast cancer. However, the preferable taxane and optimal schedule of administration in a dose-dense regimen have not been defined yet. Methods: From July 2005 to November 2008, 1001 patients (990 eligible) were randomized to receive, every 2 weeks, 3 cycles of epirubicin 110 mg/m(2) followed by 3 cycles of paclitaxel 200 mg/m(2) followed by 3 cycles of intensified CMF (Arm A; 333 patients), or 3 cycles of epirubicin followed by 3 cycles of CMF, as in Arm A, followed 3 weeks later by 9 weekly cycles of docetaxel 35 mg/m(2) (Arm B; 331), or 9 weekly cycles of paclitaxel 80 mg/m(2) (Arm C; 326). Trastuzumab was administered for one year to HER2-positive patients post-radiation. Results: At a median follow-up of 60.5 months, the 3-year disease-free survival (DFS) rate was 86%, 90% and 88%, for Arms A, B and C, respectively, while the 3-year overall survival (OS) rate was 96% in all arms. No differences were found in DFS or OS between the combined B and C Arms versus Arm A (DFS: HR = 0.81, 95% CI: 0.59-1.11, P = 0.20; OS: HR = 0.84, 95% CI: 0.55-1.30, P = 0.43). Among the 255 patients who received trastuzumab, 189 patients (74%) completed 1 year of treatment uneventfully. In all arms, the most frequently reported severe adverse events were neutropenia (30% vs. 27% vs. 26%) and leucopenia (12% vs. 13% vs. 12%), while febrile neutropenia occurred in fifty-one patients (6% vs. 4% vs. 5%). Patients in Arm A experienced more often severe pain (P = 0.002), neurological complications (P = 0.004) and allergic reactions (P = 0.004), while patients in Arm B suffered more often from severe skin reactions (P = 0.020). Conclusions: No significant differences in survival between the regimens were found in the present phase III trial. Taxane scheduling influenced the type of severe toxicities. HER2-positive patients demonstrated comparable 3-year DFS and OS rates with those reported in other similar studies. | en |
dc.source.uri | <Go to ISI>://WOS:000339639700001 | |
dc.subject | Breast cancer | en |
dc.subject | Dose-dense sequential chemotherapy | en |
dc.subject | Anthracyclines | en |
dc.subject | Taxanes | en |
dc.subject | Trastuzumab | en |
dc.subject | WEEKLY PACLITAXEL | en |
dc.subject | WEEKLY DOCETAXEL | en |
dc.subject | EPIRUBICIN | en |
dc.subject | CMF | en |
dc.subject | THERAPY | en |
dc.subject | CYCLOPHOSPHAMIDE | en |
dc.subject | METAANALYSIS | en |
dc.subject | REGIMENS | en |
dc.subject | WOMEN | en |
dc.subject | Oncology | en |
dc.title | Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: first report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial | en |
dc.type | journalArticle | en |
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