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* * * * Comment: TTP similar to DFS with same medians and even smaller p-value 0,0007 DR similar in both arms A=?? ; A+H=?? Q: Is there any explanation for the initial part of the KM-plot, which shows a steep and sudden drop at roughly 2.5 months. A: At the current point in time, we cannot explain, why there is a group of patients progressing so quickly. This was not our expectation, when the trial was designed. However, it seems that the perception that a positive hormone receptor status equals a good outcome (positive prediction of response to hormonal treatment) was an overestimate in the subgroup of patients with HER2 / HR co-positive disease. As we have also seen in more recent literature (Lipton 2002, 2003; Marcom 2006) the shape of the KM-plot with the early and steep drop and the separation at 2.5 months has been seen before in this population. As the first tumour assessment for response or progression was scheduled for 9 weeks, we may actually have been missing the precise time points of progression for some of the patients, whose tumours progressed very early, which might have resulted in an earlier separation of the two curves. * * Anti-Aromatase Agents vs Tamoxifen in 1st Line Therapy of Advanced Breast Cancer : Summary Exemestane 25 mg vs TAM Anastrozole 1 mg vs TAM Letrozole 2.5 mg vs TAM No. of patients CR + PR, % 61 vs 59 44 vs 14 325 vs 326 21.1 vs 17 453 vs 454 30 vs 20 * Clin. Benefit, % 55 vs 39* 59.1 vs 45.6* 49 vs 38* Median TTP, mo 8.9 vs 5.2 8.5 vs 7.0 9.4 vs 6.0* OS: not significant, *P0.05 Reported at SABCS 2001 Indirect Comparison: AIs vs Tamoxifen as First-line Treatment of ABC Ref N ORR% P 1 TAM vs LET 907 21 vs 32 0.002 2 TAM vs ANA 1021 27 vs 29 NS 3 TAM vs EXE 382 29 vs 44 NI 1. Mouridsen et al. J Clin Oncology 2003; 21
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