| Purpose Trastuzumab-refractory patients will derive clinical benefit from further anti-HER2 therapy.It is unclear whether we should adopt empiric continuation of trastuzumab beyond progression.We evaluate the efficacy and safety of lapatinib plus capecitabine(LC or LX)versus trastuzumab plus chemotherapy in patients with HER-positive metastatic breast cancer who were resistant to trastuzumab.Patients and methods We retrospectively analyzed breast cancer patients linked to detailed demographic,treatment,outcome data who began the regimen of lapatinib plus capecitabine(LC or LX)or trastuzumab beyond progression(TBP)at eight hospitals between May 2010 and October 2017.Amomg those,299 patients had received TBP and 255 were treated with LX.The clinicopathologic parameters explored included age,hormone receptor status,metastatic sites,primary or acquired trastuzumab resistance,previous treatment.Primary endpoint was evaluation of progression-free survival(PFS),key secondary endpoints were overall response rate(ORR),clinical benefit rate(CBR).Results Among 554 patients who had developed resistance to trastuzumab,255 in the LX group and 299 in the TBP group.The median PFS was 6.77 months in the LX group compared with 5.6 months in the TBP group(hazard ratio 0.7955;95% CI,0.6632 to 0.9542;log-rank P =0.014).In the primary resistant patients,the median was significantly increased from 4.3 months for TBP to 6.8 months for LX(HR=0.4986;95%CI,0.3632 to 0.6844;P<0.001).In the secondary resistant patients,no significant difference was observed(median PFS: 6.6 months for LX vs 6.3 months for TBP,P =0.883).The central nervous system progression rate during treatment was 5.9% in LX group and 12.5% in TBP group,respectively(P=0.018).Conclusion The combination of lapatinib and capecitabine has shown a prolonged PFS compared with TBP in patients who had progressed on trastuzumab. |
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