Figure 2.

Percentage change in Ki67 between pretreatment (baseline) and surgery for part 1 (A) and part 2 (B); Kaplan–Meier estimates by treatment group for relapse free survival (C) and overall survival (D). A, Waterfall plots for part 1 and part 2: for each patient, bar height represents percentage change at surgery from baseline. Percentage change was calculated as [(surgery score + 0.1) − (pretreatment score + 0.1)]/[(pretreatment score + 0.1)]*100. The constant of 0.1 was added to accommodate cases with a value of 0%. Negative values represent decrease from baseline, positive values represent increase from baseline. pCR in breast: patients with pCR (no disease in ether breast or nodes) plus two additional patients with 0% breast cellularity but nodal involvement are represented as bars of height −120% at the left of the figures and noted “pCR in breast;” any existing Ki67 values for these patients have been excluded of the main analysis; in a sensitivity analysis, we imputed a value of −100% change for these patients (Appendix 2). Small triangles indicate patients with RCB1. Disease recurrences are also indicated at the top of each figure with circles and crosses. B, RFS is represented in the time interval of up to 6 years after randomization, as no RFS event occurred later. Overall survival is represented in the fully observed range of values. Log-rank test comparing concurrently randomized treatment groups are reported in the figures. In the figure, trastuzumab and control part 1 and part 2 groups are combined to improve readability. C, control; L, lapatinib; T, trastuzumab; T+L, combination; P1, part 1; P2, part 2; all, P1&P2; P, P value.