To compare the effect of different regimens (capecitabine plus docetaxel vs capecitabine plus vinorelbine) on the quality of life in anthracycline-resistant advanced breast cancer patients.

This was a prospective, open, single-centered, phase 3 randomized trial, including 206 anthracycline-resistant advanced breast cancer patients in Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. They were treated by different regimens of chemotherapy (capecitabine plus docetaxel vs capecitabine plus vinorelbine) and divided into two groups accordingly: TX group received intravenous infusion of 75 mg/m² docetaxel on day 1 and 1 g/m² capecitabine twice per day on days 1-14, every 3 weeks; NX group received 25 mg/m² vinorelbine on days 1 and 8 and 1 g/m² capecitabine twice per day, on days 1-14, every 3 weeks. After the treatment of 6-8 cycles, the patients with clinical response continued the maintenance treatment of capecitabine. Totally 98 patients were evaluated by quality of life (QOL)scale and functional assessment of cancer therapy-breast cancer (FACT-B), including 48 patients in TX group and 50 patients in NX group. Using t test, QOL and FACT-B scores in two groups were compared before and after treatment. χ² test was used to compare the number of cases. The rank sum test was used to analyze the rank data.

In TX group, QOL score was 55.08±4.64 and 52.58±5.38 before and after chemotherapy, indicating a significant difference (t=4.417, P<0.001). In NX group, QOL score was 53.22±4.95 and 50.94±5.29 before and after treatment, indicating a significant difference (t=4.347, P<0.001). FACT-B scores showed no significant difference before and after treatment in TX group and NX group (95.94±17.54 vs 93.13±16.65, t=1.826, P=0.074, 94.28±14.60 vs 91.40±12.96, t=1.956, P=0.056). The score gap before and after treatment presented no significant difference between TX group and NX group (QOL: 2.50±4.18 vs 2.42±3.83, t=0.099, P=0.921; FACT-B: 2.40±10.45 vs 2.88±10.41, t=-0.230, P=0.819). According to QOL scores, the patients showed significant differences in the loss of appetite, fatigue, decreased mental status and affected sleep between TX and NX groups [58.33%(28/48) vs 36.00%(18/50), χ²=4.904, P=0.027; 54.17%(26/48) vs 34.00%(17/50), χ²=4.045, P=0.044; 33.33%(16/48)vs 16.00%(8/50), χ²=3.979, P=0.046; 31.25%(15/48) vs 14.00%(7/50), χ²=4.186, P=0.041). FACT-B scores showed that the proportion of nausea patients was 52.08%(28/48) in TX group and 22.00%(11/50) in NX group, indicating a significant difference (χ²=9.537, P=0.002); the proportion of patients with pain symptom was 29.17%(14/48) in TX group and 40.00%(20/50) in NX group, indicating no significant difference (χ²=1.269, P=0.260). According to the treatment outcome, 78 patients showed clinical response, the chemotherapy was ineffective in 20 patients and there was no significant difference in life quality between two groups(QOL: 2.32±4.05 vs 3.00±3.74, t=-0.679, P=0.499; FACT-B: 1.90±10.84 vs 5.55±7.90, t=-1.411, P=0.161). In 78 patients with clinical response, there was no significant difference between the patients with hand-foot syndrome and the patients without (QOL: 1.50±4.37 vs 2.53±3.98, t=-0.907, P=0.367; FACT-B: 0.25±7.52 vs 2.32±11.56, t=-0.679, P=0.499). None had hand-foot syndrome in 20 patients with no clinical response.

TX and NX regimens of chemotherapy may have little influence on life quality of advanced breast cancer patients. The chemotherapy efficacy and the occurrence of hand-foot syndrome produce no remarkable effect on life quality of pateints.