Capecitabine therapy

The SYSUCC-001 trial (NCT01112826) included 443 women (434 analyzed) with TNBC from 13 Chinese institutions. The women had received adjuvant chemotherapy and were randomly assigned to receive either no further therapy or capecitabine at a dose of 650 mg/m2 twice daily for 1 year. The primary study end point was DFS.[109]

The SYSUCC-001 trial (NCT01112826) included 443 women (434 analyzed) with TNBC from 13 Chinese institutions. The women had received adjuvant chemotherapy and were randomly assigned to receive either no further therapy or capecitabine at a dose of 650 mg/m2 twice daily for 1 year. The primary study end point was DFS.[109]

After a median follow-up of 61 months, the 5-year DFS rate was 82.5% for patients who received capecitabine maintenance therapy compared with 73.0% for patients who received no further therapy (HR, 0.64; 95% CI, 0.42–0.95; P = .03).[109][Level of evidence B1]

The SYSUCC-001 trial (NCT01112826) included 443 women (434 analyzed) with TNBC from 13 Chinese institutions. The women had received adjuvant chemotherapy and were randomly assigned to receive either no further therapy or capecitabine at a dose of 650 mg/m2 twice daily for 1 year. The primary study end point was DFS.[109]

Forty-five percent of patients who received capecitabine developed hand-foot syndrome, which was grade 3 in 7.7% of patients.

The SYSUCC-001 trial (NCT01112826) included 443 women (434 analyzed) with TNBC from 13 Chinese institutions. The women had received adjuvant chemotherapy and were randomly assigned to receive either no further therapy or capecitabine at a dose of 650 mg/m2 twice daily for 1 year. The primary study end point was DFS.[109]

The rate of patients who completed 1 year of therapy was 82.8%.

In a study conducted in Japan and Korea, 910 women with HER2-negative breast cancers were randomly assigned in a nonblinded fashion to receive six to eight 3-week cycles of capecitabine or no further chemotherapy. Patients had residual disease after preoperative chemotherapy with anthracyclines, taxanes, or both, and 30% of the patients also had hormone receptor–negative disease. The primary end point was DFS.[110] The study was terminated because of the results of a planned interim analysis, and a final analysis was done.

In a study conducted in Japan and Korea, 910 women with HER2-negative breast cancers were randomly assigned in a nonblinded fashion to receive six to eight 3-week cycles of capecitabine or no further chemotherapy. Patients had residual disease after preoperative chemotherapy with anthracyclines, taxanes, or both, and 30% of the patients also had hormone receptor–negative disease. The primary end point was DFS.[110] The study was terminated because of the results of a planned interim analysis, and a final analysis was done.

In the final analysis, which included 887 eligible patients the 5-year DFS rate was 74.1% in the capecitabine group and 67.6% in the no-further-chemotherapy group (HR, 0.70; 95% CI, 0.53–0.92; P = .01).[Level of evidence B1]

In a study conducted in Japan and Korea, 910 women with HER2-negative breast cancers were randomly assigned in a nonblinded fashion to receive six to eight 3-week cycles of capecitabine or no further chemotherapy. Patients had residual disease after preoperative chemotherapy with anthracyclines, taxanes, or both, and 30% of the patients also had hormone receptor–negative disease. The primary end point was DFS.[110] The study was terminated because of the results of a planned interim analysis, and a final analysis was done.

OS was a secondary end point. The 5-year OS rate was 89.2% in the capecitabine group and 83.6% in the no-further-chemotherapy group (HR, 0.59; 95% CI, 0.39–0.90; P = .01).

In a study conducted in Japan and Korea, 910 women with HER2-negative breast cancers were randomly assigned in a nonblinded fashion to receive six to eight 3-week cycles of capecitabine or no further chemotherapy. Patients had residual disease after preoperative chemotherapy with anthracyclines, taxanes, or both, and 30% of the patients also had hormone receptor–negative disease. The primary end point was DFS.[110] The study was terminated because of the results of a planned interim analysis, and a final analysis was done.

In a subset analysis, OS was significantly prolonged only in the patients with hormone receptor–negative disease. Among those patients, the 5-year OS rate was 78.8% in the capecitabine group and 70.3% in the no-further-chemotherapy group (HR, 0.52; 95% CI, 0.30–0.90).

In a study conducted in Japan and Korea, 910 women with HER2-negative breast cancers were randomly assigned in a nonblinded fashion to receive six to eight 3-week cycles of capecitabine or no further chemotherapy. Patients had residual disease after preoperative chemotherapy with anthracyclines, taxanes, or both, and 30% of the patients also had hormone receptor–negative disease. The primary end point was DFS.[110] The study was terminated because of the results of a planned interim analysis, and a final analysis was done.

In the capecitabine group, 73.4% of the patients experienced hand-foot syndrome of varying degrees of severity.