Efficacy of capecitabine-based combination therapy and singleagent capecitabine maintenance therapy in patients with metastatic breast cancer

Objective： The purpose of this study was to observe the efficacy and toxicities of capecitabine-based chemotherapy and capecitabine monotherapy as maintenance therapy in the treatment of metastatic breast cancer（MBC）.Patients and methods： A total of 98 MBC patients were treated with capecitabine combined with vinorelbine（NX）. Results： The median number of treatment was 6 cycles（1-7 cycles）. There were two cases of complete remission（CR）, 58 partial remission, 27 stable disease（SD）, 11 progression disease. The overall response rate（ORR）（CR ＋ PR） was 61.2%. The clinical benefit rate（CBR） was 75.5%. Fifty of effective patients received with capecitabine monotherapy as maintenance therapy. The ORR（CR ＋ PR） was 4%. The CBR was 48%. The median progression-free survival（PFS） was 12 months. In maintenance therapy or not, the median post metastasis survival rate（MSR） was 63 and 28 months, respectively. In the combination therapy group, the major grade 3/4 toxicities included hand-foot syndrome（3.1%）, skin pigmentation（2.0%）, diarrhoea and abdominal distension（5.1%）, stomatitis（1.0%）, and leukopenia（20.4%）.Conclusions： Capecitabine-based combination therapy and single-agent capecitabine maintenance therapy were well tolerated and effective to MBC.

Capecitabine maintenance therapy for XT chemotherapy-sensitive patients with metastatic triple-negative breast cancer

Objective： To investigate the efficacy and safety of capecitabine maintenance therapy（MT） after initial capecitabine plus docetaxel（XT） chemotherapy in patients with metastatic triple-negative breast cancer（m TNBC）.Methods： Fifty-five m TNBC patients treated with XT chemotherapy between May 2007 and June 2013 were retrospectively analyzed. When initial disease control was achieved by the combination chemotherapy, capecitabine was continued for 32 patients（MT）, while 23 patients remained without any treatment（nonMT）. We compared progression-free survival（PFS） and safety of both groups.Results： The median PFS of 55 patients was 8.1 months, overall median PFS time of 32 patients in the capecitabine MT group and 23 in the non-MT group was 10.1 vs. 6.7 months（P=0.032）, respectively. When compared PFS time of maintenance treatment, single-agent capecitabine prolonged PFS by 7.1 months, for non-MT patients, the PFS without any treatment was 3.1 months, and this between-group difference was statistically significant（P=0.003）. Adverse events, including of hematologic toxicity, gastrointestinal toxicities, hand-foot syndrome and abnormal liver function were not significantly different between two groups.Conclusions： After initial disease control was achieved with the XT combination chemotherapy, capecitabine MT can significantly prolong PFS time with a favorable safety profile in m TNBC patients.

Sequential versus simultaneous use of vinorelbine and capecitabine at the same dosage as first-line chemotherapy for patients with metastatic breast cancer

Objective:It remains unclear whether simultaneous use of two chemotherapeutic drugs is better than sequential use.This trial was designed to explore efficacy and safety of sequential vs simultaneous use of vinorelbine and capecitabine at the same dosage as first-line therapy in metastatic breast cancer (MBC).Methods:This was a un-icenter, randomized phase II trial.Patients randomized into the simultaneous group (group A) were simultaneously administered with vinorelbine and capecitabine while those in the sequential group (group B) received vinorelbine followed by capecitabine at the same dosage.Results:Sixty-six patients were screened and 30 patients were randomized into either group.There're significant differences in the clinical benefit rate (CBR) with 80.0% for group A vs 53.3% for group B (P=0.028).With a median follow up time of 13.5 months, there were no significant differences between the two groups in PFS (median PFS:7.70 months for group A vs 7.23 months for group B, P=0.436).Grade III or IV neutropenia (83.3% vs 50.0%, P=0.006), all grades of fatigue (56.7% vs 30.0%, P=0.037) and anorexia (53.3% vs 23.3%, P=0.017) were significantly more frequent in simultaneous group.Conclusion:Simultaneous administration of vinorelbine and capecitabine can bring about improvements in CBR, but cannot translate into long-term benefits, such as progression-free survival (PFS) or overall survival (OS).These findings, combined with a relatively better tolerability in sequential group, showed that both simultaneous and sequential administrations are reasonable options for MBC patients.

参芪扶正注射液联合希罗达在晚期乳腺癌维持治疗中的疗效观察

目的 探讨参芪扶正注射液联合希罗达治疗复发转移乳腺癌的近期疗效和不良反应.方法 40例复发转移性乳腺癌患者,并已进行6～8周期一线治疗,根据治疗方法不同分为实验组与对照组.实验组20例,给予参芪扶正注射液250ml,静脉滴注,1次/天,连用14天＋希罗达800～1000mg/（m2·d）分2次口服,对照组20例,单药希罗达800～1000mg/（m2· d）分2次口服.结果 总有效率两组比较有显著差异性（P＜0.05）.两组治疗前后白细胞变化、胃肠道反应率、卡氏评分改善率比较有显著性差异（P＜0.01）治疗组生活质量较对照组明显改善.结论 参芪扶正注射液联合希罗达治疗复发转移性乳腺癌可减轻化疗引起的毒副作用,使患者化疗依从性更好,从而提高机体免疫功能.

口服小剂量环磷酰胺联合卡培他滨维持治疗晚期三阴性乳腺癌的疗效

目的:观察小剂量环磷酰胺(CTX)联合卡培他滨(CAP)维持治疗晚期三阴性乳腺癌的疗效及安全性。方法:回顾性分析我院收治的经含卡培他滨方案两药联合化疗后达临床稳定的晚期三阴性乳腺癌患者68例,实验组34例给予口服环磷酰胺50 mg/d,d_(8～21),每3周重复,联合卡培他滨1 000 mg/m^2,bid,d_(1～14),休息7天。对照组34例患者仅给予口服卡培他滨单药维持治疗。观察2组患者的ORR、DCR、TTP、安全性及对生活质量的影响。结果:经维持治疗后实验组ORR为29.4%,DCR为85.3%;对照组ORR为14.7%,DCR为64.7%。实验组中位TTP为12个月,明显高于对照组中位TTP 6.9个月(P<0.05)。两组的主要不良反应为手足综合征,实验组的胃肠道反应及血液学毒性稍高于对照组,均为Ⅰ-Ⅱ度。两组患者的生活质量评分均较治疗前明显提高,治疗后组间差异无统计学意义(P>0.05)。结论:口服小剂量环磷酰胺联合卡培他滨维持治疗晚期三阴性乳腺癌有较好的疗效,不良反应可以耐受,可作为复发转移较快的晚期三阴性乳腺癌患者维持治疗的一种选择,具有一定的临床推广应用价值。