Ten-year Results of Intense Dose-dense chemotherapy show superior survival compared to a conventional schedule in High-risk Primary Breast Cancer: Final results of AGO Phase III iddEPC trial.

Möbus V,Jackisch C, Lueck H J,du Bois A, Thomssen C, Kuhn W, Nitz U,Schneeweiss A,Huober J, Harbeck N,von Minckwitz G, Runnebaum I B,Hinke A,Konecny G E, Untch M, Kurbacher C, Kahlert S, Hauser N, Marmé F, Kiesel L, Wallwiener D, Rautenberg B, Hofmann R, Barinoff J, Stickeler E,Eidtmann H, Müller V, Emons G, Mallmann P, Hackenberg R, Hielscher C, Räber G, Sommer H, Schmidt-Rhode P, Jahns B, von der Assen A, Dietterle S, Kaufmann M, Strunk C,Goebel R, Paepke S, Paulenz A, Junker-Stein A, Rhein U, Bremer K, Bauer W, Hohlweg-Majert P, Kramer D,Meerpohl H-G, Diedrich K, Dall P, Kölbl H, Brückner B, Gros R, Stehle H, Lobodasch K, Dinkelacker T, Klöpper E, Karg C, Stibora M, Weise W, Melchert F, Mohrmann S, Klatt C, Schmidt M, Glados M, Mickan H, Pollmanns A, Beck T, Schröder W, Klingemann H, Köhler G, Freier W, Graßhoff S-T, Söling U, Keil E, Höß C, Kullmer U, Niesel A, Bodenstein H, Bartzke G,Schlotter C M, Wiest W, Ernst W, Brudler O, Heinrich B, Hackmann J, Niedner W, Hoffmann G, Knapp W, Dresemann G, Karl C, Klemm F-J, Schliesser G C, Butterwegge M, Meden H, Kirschbaum M, Schwenzer T, Voigt H-J, Weiß U, Önder G, Langer W, Glaubitz M, Beha M, Coumbos A, Ko Y,Deuker J-U, Prümmer O, Wagner U, Kohlstedt A, Schreiber P, Jovanovic V, Drzewiecki K, Guba H, Seipt H, Stauch M,Maintz C, Morenz B

Annals of Oncology（2018）

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摘要

Background: Primary breast cancer (BC) patients with extensive axillary lymph-node involvement have a limited prognosis. The Arbeitsgemeinschaft fuer Gynaekologische Onkologie (AGO) trial compared intense dose-dense (idd) adjuvant chemotherapy with conventionally scheduled chemotherapy in high-risk BC patients. Here we report the final, 10-year follow-up analysis. Patients and methods: Enrolment took place between December 1998 and April 2003. A total of 1284 patients with 4 or more involved axillary lymph nodes were randomly assigned to receive 3 courses each of idd sequential epirubicin, paclitaxel and cyclophosphamide (iddEPC) q2w or standard epirubicin/cyclophosphamide followed by paclitaxel (EC -> P) q3w. Event-free survival (EFS) was the primary end point. Results: A total of 658 patients were assigned to receive iddEPC and 626 patients were assigned to receive EC! P. The median duration of follow-up was 122 months. EFS was 47% (95% CI 43% to 52%) in the standard group and 56% (95% CI 52% to 60%) in the iddEPC group [hazard ratio (HR) 0.74, 95% CI 0.63-0.87; log-rank P = 0.00014, one-sided]. This benefit was independent of menopausal, hormone receptor or HER2 status. Ten-year overall survival (OS) was 59% (95% CI 55% to 63%) for patients in the standard group and 69% (95% CI 65% to 73%) for patients in the iddEPC group (HR = 0.72, 95% CI 0.60-0.87; log-rank P = 0.0007, two-sided). Nine versus two cases of secondary myeloid leukemia/myelodysplastic syndrome were observed in the iddEPC and the EC! P arm, respectively. Conclusion: The previously reported OS benefit of iddEPC in comparison to conventionally dosed EC -> P has been further increased and achieved an absolute difference of 10% after 10 years of follow-up.

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关键词

high-risk early breast cancer,dose-dense,intense dose-dense

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