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Maintenance Strategy with Fluoropyrimidines (Fp) Plus Bevacizumab (Bev), Bev Alone or No Treatment, Following a 24-Week First-Line Induction with Fp, Oxaliplatin (Ox) and Bev for Patients with Metastatic Colorectal Cancer: Mature Data and Subgroup Analysis of the Aio Krk 0207 Phase III Study

2014; Elsevier BV; Volume: 25; Linguagem: Inglês

10.1093/annonc/mdu333.2

1569-8041

S. Hegewisch-Becker, Ullrich Graeven, Christian Lerchenmüller, B. Killing, Reinhard Depenbusch, Claus-Christoph Steffens, Salah‐Eddin Al‐Batran, Thoralf Lange, Georg Dietrich, Jan Stoehlmacher, Andrea Tannapfel, A. Reinacher-Schick, Julia Quidde, Axel Hinke, Dirk Arnold, Hans‐Joachim Schmoll,

Genetic factors in colorectal cancer

ABSTRACT Aim: AIO KRK 0207 investigates which maintenance strategy, no treatment or Bev alone, is non-inferior to FP plus Bev, following a 24-week induction with FP/Ox/Bev. Methods: Following registration pts received induction treatment with FP/Ox/Bev. Pts without progression after 24 weeks were randomized into arms: A) standard maintenance with FP plus Bev; B) Bev alone; or C) observation. At first progression, re-induction of the initial treatment was planned. Primary endpoint was the to failure of strategy (TFS), including maintenance plus re-induction after first progression. Secundary endpoints included time to first progression (PFS1) and overall survival (OS). Results: 837 pts were enrolled, 473 randomized. Primary tumor was resected in 74% of pts, 56% had involvement of >1 site. Median PFS1 in arms A, B, C were 6.2 vs 4.8 vs 3.6 mos., respectively (logrank p value: Conclusions: With respect to the primary endpoint TFS, our findings suggest that maintenance with Bev mono is non-inferior to FP/Bev. Updated results including OS, multivariate analyses and sequential treatment data will be presented. Disclosure: S. Hegewisch-Becker: Advisory role: Merck, Roche, Lilly; C. Steffens: Advisory role: Roche; A. Reinacher-Schick: Advisory role: Amgen,Roche,Sanofi, Merck Honoraria: Amgen, Roche, Sanofi, Merck, Pfizer Research funding: Roche Sanofi; D. Arnold: Advisory role: Merck, Roche; H. Schmoll: Advisory role: Roche. All other authors have declared no conflicts of interest.