medwireNews: Women with triple-negative breast cancer (TNBC) have significantly better outcomes with capecitabine-containing adjuvant chemotherapy than a standard regimen, suggests a phase 3 Chinese trial.
The CBCSG010 researchers therefore believe that capecitabine used concomitantly with docetaxel and epirubicin plus cyclophosphamide could be “an alternative adjuvant regimen” for this patient population.
As reported in the Journal of Clinical Oncology, the primary endpoint of disease-free survival (DFS) at 5 years was achieved by 86.3% of the 297 participants who were randomly assigned to receive three cycles of capecitabine 1000 mg/m2 given twice daily on days 1–14 of each 3-week cycle alongside docetaxel 75 mg/m2 on day 1, followed by a further three cycles of capecitabine on the same schedule plus epirubicin 75 mg/m2 and cyclophosphamide 500 mg/m2 administered on day 1.
This DFS rate was significantly higher than the 80.4% rate for the 288 participants who instead received three cycles of docetaxel followed by three cycles of fluorouracil 500 mg/m2 given on day 1 alongside the same doses of epirubicin and cyclophosphamide, and equated to a hazard ratio (HR) for a disease event or death of 0.66 in favor of the capecitabine combination.
Recurrence-free survival and distant DFS were likewise significantly improved with the capecitabine-containing versus standard regimen, with 5-year rates of 89.5% versus 83.1% and 89.8% versus 84.2%, respectively, and corresponding HRs of 0.59 and 0.63.
Zhimin Shao (Fudan University Shanghai Cancer Center, China) and co-investigators note that overall survival was numerically higher among capecitabine-treated patients than those given the standard regimen, at 93.3% versus 90.7%, but the difference did not reach statistical significance.
They continue: “Safety data were similar to the known capecitabine safety profile and generally comparable between arms.
The most common nonhematologic adverse event (AE) of grade 3 or 4 in both the capecitabine and control groups was alopecia, occurring in 69.4% and 71.2% of patients, respectively, while neutropenia was the most frequent hematologic AE at these grades, with corresponding rates of 45.8% and 41.0%.
There were more cases of grade 3 or 4 hand–foot syndrome and stomatitis in the capecitabine than control study arms, at 8.4% versus 0.0% and 5.1% versus 1.0%, respectively. But there were no treatment-related deaths during the course of the trial.
Discussing the study limitations, Shao and colleagues point out that the control regimen, “a preferred regimen when the trial was designed, is no longer a primary recommendation,” with strategies such as dose-dense sequential anthracycline and taxane therapy now used preferentially.
They therefore caution: “The control regimen, every-3-week dosing, and lower doses of docetaxel and epirubicin used in this trial may have amplified the benefit from capecitabine.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group