Dose-dense paclitaxel versus docetaxel following FEC as adjuvant chemotherapy in axillary node-positive early breast cancer: a multicenter randomized study of the Hellenic Oncology Research Group (HORG)

Abstract

Adding a taxane to anthracycline-based adjuvant chemotherapy prolongs survival in node-positive early breast cancer. However, which is the preferable taxane in a dose-dense regimen remains unknown. We conducted a randomized study to compare the efficacy of dose-dense paclitaxel versus docetaxel following 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) as adjuvant chemotherapy in women with node-positive early breast cancer. Following surgery women with HER2-negative breast cancer and at least one infiltrated axillary lymph node were randomized to receive four cycles of FEC (700/75/700 mg/m(2)) followed by four cycles of either paclitaxel (175 mg/m(2)) or docetaxel (75 mg/m(2)). All cycles were administered every 14 days with G-CSF support. The primary endpoint was disease-free survival (DFS) at 3 years. Between 2004 and 2007, 481 women were randomized to paclitaxel (n = 241) and docetaxel (n = 240). After a median follow-up of 6 years, 51 (21%) and 48 (20%) women experienced disease relapse (p = 0.753) and there was no significant difference in DFS between the paclitaxel- and docetaxel-treated groups (3-year DFS 87.4 vs. 88.3%, respectively; median DFS not reached; p = 0.633). Toxicities were manageable, with grade 2-4 neutropenia in 21 versus 31% (p = 0.01), thrombocytopenia 0.8 versus 3.4% (p = 0.06), any grade neurotoxicity 17 versus 7.5% (p = 0.35) and onycholysis 4.9 versus 12.1% (p = 0.03) for patients receiving paclitaxel and docetaxel, respectively. There were no toxic deaths. Dose-dense paclitaxel versus docetaxel after FEC as adjuvant chemotherapy results in a similar 3-year DFS rate in women with axillary node-positive early breast cancer. Due to its more favorable toxicity profile, paclitaxel is the taxane of choice in this setting.

Retrospective comparison of two consecutive cohorts of adjuvant chemotherapy regimens of cyclophosphamide with either docetaxel or paclitaxel in older patients with early breast cancer

“…TC has been widely adopted as an adjuvant chemotherapy option in elderly patients. However this regimen has significant toxicities …”

“…In a previous retrospective analysis of the TC regimen in unselected elderly patients with high‐risk early BC, important adverse events were encountered . On the other hand, three trials, one in metastatic disease and two in the adjuvant setting with weekly paclitaxel demonstrated significant superiority over three‐weekly docetaxel, both for efficacy and safety end points. Therefore we introduced adjuvant three‐weekly cyclophosphamide in combination with weekly paclitaxel (PC) for four cycles in high‐risk patients above 65 years.…”

Sequential vs concurrent epirubicin and docetaxel as adjuvant chemotherapy for high-risk, node-negative, early breast cancer: an interim analysis of a randomised phase III study from the Hellenic Oncology Research Group

“…Anthracyclines and taxanes are recommended for the adjuvant treatment of women with operable breast cancer. Several regimens are being used by clinicians, including standard dose sequential, concurrent and dose-dense sequential ( Saloustros et al , 2014 ). However, due to the relative paucity of data from head-to-head comparisons between these regimens, there is no consensus for the optimal chemotherapy regimen.…”

Etika Profesi Auditor dalam Nilai Budaya Tri Hita Karana

“…Sumber : Rosyida, 2017 Secara etimologi, kata Etika berasal dari bahasa Yunani "ethos" (dalam bentuk tunggal) yang memiliki arti adat, kebiasaan, watak, perasaan, cara berpikir sementara "ta etha" (dalam bentuk jamak) yag memiliki arti adat kebiasaan. Filsuf asal Yunani bernama Aristoteles (384-322 SM) telah menggunakan istilah ethos yang kemudian digunakan untuk menjelaskan filsafat moral.…”