Capecitabine Approach May Extend Early TNBC Disease-Free Survival

Author: By Lynda Williams, Senior medwireNews Reporter 

medwireNews: Disease-free survival (DFS) in women with a new diagnosis of triple-negative breast cancer (TNBC) may be improved by the inclusion of capecitabine in their adjuvant chemotherapy regimen, suggest phase III study findings. 

The Chinese Breast Cancer Study Group 010 trial investigators report significantly better DFS at 5 years with three cycles of capecitabine plus docetaxel, followed by three cycles of capecitabine, epirubicin and cyclophosphamide than with a conventional regimen of docetaxel, followed by fluorouracil, epirubicin and cyclophosphamide. 

After a median 67 months of follow-up, the 5-year DFS rate was 86.3% for the 297 women assigned to receive the capecitabine regimen following surgery with a clear margin versus 80.4% for the 288 controls, giving a significant hazard ratio (HR) for local relapse, distant metastasis, contralateral disease, a second primary tumour or death of 0.66 in favour of capecitabine use. 

The 5-year rates for the secondary endpoints of recurrence-free survival and distant disease-free survival were also significantly better with the capecitabine-based than the conventional regimen, with HRs of 0.59 and 0.63, respectively, but the trend towards improved 5-year overall survival did not reach significance. 

Zhimin Shao, from Fudan University in Shanghai, China, and co-workers write in the Journal of Clinical Oncology that the side effects were “in line with the known capecitabine safety profile”, with 39.1% of patients requiring a capecitabine dose reduction and 52.5% of patients experiencing hand–foot syndrome, including 8.4% at grade 3 or more severe. 

However, the researchers report “no notable differences in the incidence of alopecia, nausea and vomiting, peripheral neuropathy, or fatigue between the 2 groups.” 

The capecitabine and control arms also experienced “similar” rates of grade 3 and more severe neutropenia (45.8 vs 41.0%) and febrile neutropenia (16.8 vs 16.0%), although capecitabine-treated patients had a higher rate of grade 3 or more severe stomatitis (5.1 vs 1.0%). 

“[T]he results of our study indicate that capecitabine concomitantly used with docetaxel and epirubicin […] is an alternative adjuvant regimen for TNBC, with clinically meaningful improvement in [disease-free survival] and modest toxicity”, Zhimin Shao et al summarise.

Although the current study included only Chinese participants and East Asian patients may have better capecitabine tolerance than other populations, the researchers nevertheless believe that the results “are expected to be applicable to patients in Western countries with dose reductions as indicated.”

They conclude: “These data support the subset analysis of the CREATE-X trial as well as the recent meta-analysis of capecitabine for early-stage TNBC.” 

Reference  

Li J, Yu K, Pang D, et al. Adjuvant capecitabine with docetaxel and cyclophosphamide plus epirubicin for triple-negative breast cancer (CBCSG010): An open-label, randomized, multicenter, phase III trial. J Clin Oncol; Advance online publication 10 April 2020. doi:10.1200/JCO.19.02474