European Cooperative Trial in Operable Breast Cancer (ECTO): Improved freedom from progression (FFP) from adding paclitaxel (T) to doxorubicin (A) followed by cyclophosphamide methotrexate and fluorouracil (CMF)

• DOI: 10.1200/jco.2005.23.16_suppl.513
• Publication Date: 2017-02-23T13:55:09Z
• Authors: L. Gianni; J. Baselga; W. Eiermann; V. Guillem Porta; V. Semiglazov; A. Lluch; M. Zambetti; P. Valagussa; G. Bonadonna
• Keywords: Taxane

513 Background: In the mid 1990's data indicated that paclitaxel had marked antitumor activity in metastatic breast cancer, justifying attempt at investigating whether taxane could improve therapeutic benefit of established regimens early cancer Methods: From 1996 to 2002 a total 1355 women with operable (T>2cm) were randomized adjuvant A (75 mg/m2 q21d x 4) followed by i.v. CMF (day 1&8 q28d 4), or (60 mg/m2) and T (200 over 3 hrs (AT→CMF), AT→CMF as primary systemic therapy (PST). Results: Main patient characteristics (T-size, ER/PgR status, grade age) evenly distributed among arms. After median follow-up 43 months, freedom from progression (FFP) was significantly better for receiving than A→CMF (HR 0.65, range 0.48–0.90, P=0.01). multivariate analysis, treatment inclusive stood out associated FFP 0.66, P=0.012), together clinical diameter <4 cm, positive PgR negative nodal status. not statistically different between patients PST 0.83, 0.59–1.16, P=0.27). Total survival randomization arms present analysis. As already reported (ASCO 2002, abstract 132) 23% undergoing obtained eradication invasive (pCR). Women achieving pCR relapse-free months surgery 89% v. 74% who did reach (P=0.005). Incidence local recurrence low (4%) (4.1%). At almost 5 years follow up analysis symptomatic cardiac toxicity (Common Toxicity Criteria 3) 0.7% A→CMF, 0.4% those AT→CMF. Conclusions: The introduction sequence doxorubicin improved efficacy without increasing toxicity. No difference administration observed so far. Longer is needed conclusive considerations on survival. Author Disclosure Employment Leadership Consultant Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb