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• W1770213088 abstract "568 Background: Möbus et al. showed that dd epirubicin (E), paclitaxel (T), cyclophosphamide (C) results in a superior DFS compared to conventionally dosed EC-T in pts with primary breast cancer (PBC) and ≥3 involved lymph nodes (LN). In this study, the dd, dose intensified strategy has been further investigated as well as the use of ibandronate (I) adjuvant and ESF. Methods: A prospective, multi-center, controlled, non-blinded, randomized phase III trial investigating ETC (E: 150 mg/m 2 , T: 225 mg/m 2 , C: 2,000 mg/m 2 , i.v. day 1, q15 for 3 cycles each: A1; or EC→TX (E: 112.5 mg/m 2 + C: 600 mg/m 2 , i.v. day 1 q 15 for 4 cycles → T: 67.5 mg/m 2 i.v. day 1, q 8 for 10 weeks + X: 2000 mg/m 2 p. o. day 1–14, q 22 for 4 cycles: A2). Pts were further randomized in a 2:1 ratio to receive I: 50 mg/day p.o. for 2 years (B1) or observation (B2). Pts received a primary prophylaxis with either epoetin β or darbepoetin α and during ETC/EC with pegfilgrastim. After recruitment of 1500 pts prophylactic ciprofloxacin was implemented. Eligible: Females ≥18 and <65 years, histologically confirmed LN positive uni- or bilateral PBC; adequate surgery, ≥1 pos. LN out of ≥ 10; no previous/concurrent therapy; ECOG ≤2; written informed consent. Primary objective: compare DFS A1 vs. A2 and B1 vs. B2. Secondary objectives: OS, safety, incidence of secondary primaries, and EFS in subgroups of hormone sensitivity and pos. LN between arms; assessment of compliance and responders to ESF; determine prognostic factors. 3,000 pts with 801 events are needed to show an increase of 5-year DFS from 75% to 79% for pts receiving EC→TX and 728 events to show an increase of 5-year DFS from 75% to 79.5% for pts receiving I, assuming a drop-out rate of 5%. A clinically relevant difference between the arms is to be detected at α = 0.05 (two-sided) with 80% power. Results: 3024 patients were recruited between June 2004 and August 2008. The trial was amended several times implementing an oral antibiotic prophylaxis, reducing the dose of C; reducing the dose of dexamethasone in the group receiving weekly T, and using an Hb adapted dosing of ESF. Conclusions: The therapy in the two regimen seems feasible if precautions are taken. Final safety data will be presented at the Meeting. [Table: see text]" @default.
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• W1770213088 date "2009-05-20" @default.
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• W1770213088 title "Gain study: A phase III trial to compare ETC versus EC-TX and ibandronate versus observation in patients with node-positive primary breast cancer" @default.
• W1770213088 doi "https://doi.org/10.1200/jco.2009.27.15_suppl.568" @default.
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