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Phase III trial comparing doxorubicin docetaxel (AT) with doxorubicin cyclophosphamide (AC) in the adjuvant treatment of high-risk node negative (pN0) and limited node positive (pN+≤3) breast cancer (BC) patients (pts): First analysis of toxicity.

617 Background Although recent results have shown the effectiveness of taxanes in the adjuvant treatment of BC, its influence is still under evaluation in most countries. . Methods The primary aim of this randomised trial was to determine whether 4 cycles of adjuvant AT (adriamycin 50 mg/m2 docetaxel 75 mg/m2) will prolong disease-free survival when compared to 4 cycles of AC (adriamycin 60 mg/m2 cyclophosphamide 600 mg/m2) in women age 18-70 with resected high-risk pN0 (Saint Gallen Consensus) or limited pN+ (≤ 3) invasive BC. Chemotherapy was delivered q3w without prophylactic filgrastim, followed by tamoxifen 20 mg/day for 5 years in pts with ER±PgR-positive tumours and radiation therapy according to standard guidelines. The trial planned to recruit 700 pts over 36 months. Results Between 6/1999 and 1/2003, 627 pts were randomised. Pt and tumour characteristics were well balanced between treatment groups: median age 52.2 years; premenopausal 47.9%; clinical tumour size ≤ 2.0/2.1-5 cm 53.5/42.8%; breast conserving surgery 71.8%; pN0/pN+ 43/57%; ER±PgR-positive 81.4%; SBR grade I/II/III 16.7/46.0/37.3%. The trial was closed in 1/2003 after the occurrence of a 2nd toxic death in the AT arm. With an 18-months median follow-up, we report safety data (table). In the AT arm, 1 pt developed perforative peritonitis requiring extensive surgery, and lethal toxicity occurred in 2 pts (1 mesenteric infarction and 1 colic perforation), all 3 with concomitant febrile neutropenia and septic shock. No grade 3-4 oedema or neurotoxicity. Conclusions With a high risk of life-threatening complications, AT combination is not easily manageable as such, without preventive strategies (e.g. filgrastim), especially in adjuvant setting and for an intermediate risk population. [Figure: see text] No significant financial relationships to disclose.