Gain study: A phase III trial to compare ETC versus EC-TX and ibandronate versus observation in patients with node-positive primary breast cancer.
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...
| Published in: | Journal of Clinical Oncology Vol. 27; pp. 568 - 569 |
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| Main Authors: | , , , , , , , , , |
| Format: | Journal Article |
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American Society of Clinical Oncology
5/21/2009 Supplement Part 1 of 2
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=120349268&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 120349268 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 0732183X 20D jtl: Journal of Clinical Oncology issn: 0732183X maglogo: N pubinfo: dt: 5/21/2009 Supplement Part 1 of 2 vid: 27 pid: 26892 pub: American Society of Clinical Oncology place: Alexandria, Virginia artinfo: ui: 120349268 NLM27960729 NLM27960729 120349268 ppf: 568 ppct: 1 formats: tig: atl: Gain study: A phase III trial to compare ETC versus EC-TX and ibandronate versus observation in patients with node-positive primary breast cancer. aug: au: Möbus, V Conrad, B Schneeweis, A Kreienberg, R Solomayer, E F Clemens, M R Tesch, H Loibl, S Nekljudova, V von Minckwitz, G affil: Städtische Kliniken Höchst, Frankfurt, Germany; Brustzentrum, Kassel, Germany; Unifrauenklinik, Heidelberg, Germany; Unifrauenklinik, Ulm, Germany; Unifrauenklinik, Tübingen, Germany; Mutterhaus der Borromäerinnen, Trier, Germany; CHOP GmbH, Frankfurt, Germany; GBG Forschungs GmbH, Neu-Isenburg, Germany sug: ab: 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/m2, T: 225 mg/m2, C: 2,000 mg/m2, i.v. day 1, q15 for 3 cycles each: A1; or EC→TX (E: 112.5 mg/m2 + C: 600 mg/m2, i.v. day 1 q 15 for 4 cycles → T: 67.5 mg/m2 i.v. day 1, q 8 for 10 weeks + X: 2000 mg/m2 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]. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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