Adjuvant capecitabine for HER2-negative breast cancer
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Adjuvant capecitabine therapy improves disease-free survival and over all survival compared with that for standard therapy in patients with HER...
Adjuvant capecitabine therapy improves disease-free survival and over all survival compared with that for standard therapy in patients with HER2-negative breast cancer, according to new research by Norikazu Masuda (Osaka National Hospital, Osaka, Japan) and colleagues. The phase 3 trial included 910 patients from Japan and South Korea with HER2-negative residual invasive breast cancer, who had pre viously received neoadjuvant chemo therapy containing anthra cyclines, taxanes, or both. Around 32% of patients had triple-negative disease. Patients were randomly assigned (1:1) to either oral capecitabine plus standard therapy (n=455) or standard therapy alone (n=455). Patients in the capecitabine group received 1250 mg/m2 body-surface area capecitabine, twice a day, for 2 out of every 3 weeks, for six or eight
www.thelancet.com/oncology Vol 18 July 2017
cycles. Standard therapy included endocrine therapy for patients with oestrogen receptor-positive disease, and radiotherapy, if indicated. At the final analysis, 5-year diseasefree survival in the capecitabine group was 74·1% versus 67·6% in the control group (hazard ratio [HR] 0·70 [95% CI 0·53–0·92]; p=0·01). Overall survival at 5 years in the capecitabine group was 89·2% versus 83·6% in the control group (HR 0·59 [0·39–0·90]; p=0·01). Patients with triple-negative breast cancer had disease-free survival of 69·8% in the capecitabine group versus 56·1% in the control group (HR 0·58 [0·39–0·87]); overall survival was 78·8% versus 70·3% (HR 0·52 [0·30–0·90]). “The overall trend seems to be clear… and we saw good results in patients with triple-negative disease, which is a very tough cancer to treat”, senior author Masakazu Toi (Kyoto
University Hospital, Kyoto, Japan) told The Lancet Oncology. “We should now look at combining capecitabine with other agents in the adjuvant setting.” The most common grade 3 or worse adverse events were neutropenia (28 [6%] in the capecitabine group vs none in controls), and hand-foot syndrome (49 [11%] vs none); four patients in the capecitabine group had serious treatment-related adverse events. Arnie Purushotham (King’s College London, London, UK) welcomed the results. “It is encouraging to see much improved outcomes for patients who were given additional capecitabinebased chemotherapy”, he said. “As treatments for breast cancer continue to improve, we can focus on finding the most appropriate combination for individual patients.”
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Adjuvant capecitabine for HER2-negative breast cancer
Published Online June 8, 2017 http://dx.doi.org/10.1016/ S1470-2045(17)30451-5 For the study by Masuda and colleagues see N Engl J Med 2017; 376: 2147–59