medwireNews: Patients with residual invasive disease after standard neoadjuvant chemotherapy for HER2-negative breast cancer benefit from adjuvant treatment with capecitabine, CREATE-X trial data show.
The researchers explain that, currently, there is no established adjuvant chemotherapy regimen for these patients, who are typically at high risk for relapse.
To address this, they conducted the CREATE-X (Capecitabine for Residual Cancer as Adjuvant Therapy) trial in which 887 Japanese and South Korean patients with HER2-negative breast cancer and residual invasive disease after neoadjuvant chemotherapy containing an anthracycline, taxane, or both, were randomly assigned to receive standard postsurgical treatment with (n=443) or without (n=444) capecitabine.
The team found that patients in the capecitabine group had a significant 30% reduced risk for recurrence, second cancer, or death compared with those in the control group, with 5-year disease-free survival (DFS) rates of 74.1% and 67.6%, respectively.
Overall survival (OS) was also significantly better in the capecitabine group than in the control group, with 89.2% versus 83.6% of patients alive at 5 years, and a hazard ratio (HR) for death of 0.59.
Writing in The New England Journal of Medicine, Masakazu Toi (Kyoto University Hospital, Japan) and co-investigators point out that the improvement with capecitabine versus control was “particularly notable” among the 286 patients with triple-negative disease, where the hazard ratios for DFS and OS were a significant 0.58 and 0.52, respectively.
And although patients with hormone-receptor positive disease also benefited from capecitabine treatment, the improvements in DFS and OS were not significant compared with control, at HRs of 0.81 and 0.73, respectively.
In terms of safety, hand–foot syndrome was the most common adverse event, occurring in 73.4% of capecitabine-treated patients. Leukopenia, thrombocytopenia, neutropenia, and anemia all occurred in more than 40% of patients in the capecitabine group, while fatigue, nausea, diarrhea, stomatitis, and increases in alanine and aspartate aminotransferase, bilirubin, lactate dehydrogenase, and alkaline phosphatase all occurred in more than 20%. The majority of adverse events were grade 1 or 2 in severity.
Discussing their findings, Toi et al note that “the pharmacokinetic profile of capecitabine may differ slightly between Asians and non-Asians; therefore, racial differences in the safety profile of capecitabine after standard anthracycline or taxane chemotherapy need to be carefully considered in patients with breast cancer.”
But “[w]ith a suitable modification of dose or schedule to manage the toxic effects of capecitabine, the results of our trial are expected to be applicable to patients in Western countries,” they conclude.
By Laura Cowen
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