JCO：紫杉醇/吉西他滨维持化疗可改善转移性乳腺癌患者生存

在2013年4月8日在线出版的《临床肿瘤学杂志》(Journal of Clinical Oncology)上，韩国成均馆大学Young-Hyuck Im博士等人发表了KCSG-BR07-02临床III期试验(NCT00561119)结果，该研究主要面向接受六个周期紫杉醇/吉西他滨(PG)一线治疗后，取得病情控制的转移性乳腺癌(MBC)患者，旨在评价PG维持化疗方案是否在无进展生存时间(PFS)改善方面优于观察治疗。
KCSG-BR07-02研究为一项前瞻性、随机、多中心临床III期试验。转移性乳腺癌(MBC)患者在接受六个周期的紫杉醇/吉西他滨(PG)一线治疗并取得病情控制后，被随机分配接受维持化疗或观察，直至出现病情进展。
在10个中心招募的324例患者中，231例MBC患者的病情通过一线PG方案得到了控制(完全缓解 + 部分缓解 + 病情稳定)，这些患者被随机分配接受维持化疗(n = 116)或观察(n = 115)。患者中位年龄为48岁(范围, 28岁至76 岁)，中位随访时间为33个月，在随机分配后，维持化疗组患者所接受化疗周期的中位值为6个周期。研究人员发现，与观察组相比，维持化疗组中位PFS时间更长(3.8v 7.5 个月; P = .026)。并且，维持治疗组患者的中位生存期也长于观察组患者(32.3 v 23.5 个月; P = .047)。但在维持化疗组患者中，3级或以上中性粒细胞减少症发生率高于观察组(61% v 0.9%; P < .001)。
研究人员最终认为，对于经6个周期的PG化疗后取得病情控制的MBC患者，通过PG维持化疗可在PFS及OS方面取得优于观察治疗的结果
与乳腺癌相关的拓展阅读：

• Medpage：他莫西芬或可预防乳腺癌
• AACR2013：他汀类药物可显著降低乳腺癌死亡率
• Ann Surg：肥胖乳腺癌患者术前抗生素预防可降低手术部位感染发生率
• Radiother Oncol：放疗在乳腺癌和前列腺癌患者中的使用有上升趋势
• Lancet：持续三苯氧胺治疗10年能降低雌激素受体阳性的乳腺癌患者的复发率和死亡率
• Clin Cancer Res. ：在HER2阴性乳腺癌中鉴定出HER2阳性干细胞
更多信息请点击：有关乳腺癌更多资讯

Phase III, Multicenter, Randomized Trial of Maintenance Chemotherapy Versus Observation in Patients With Metastatic Breast Cancer After Achieving Disease Control With Six Cycles of Gemcitabine Plus Paclitaxel As First-Line Chemotherapy: KCSG-BR07-02.
PURPOSE
The primary purpose of our study was to evaluate whether maintenance chemotherapy with paclitaxel/gemcitabine (PG) was superior to observation in improving progression-free survival (PFS) in patients with metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG as their first-line treatment.
PATIENTS AND METHODS
The study was a prospective, randomized, multicenter, phase III trial. Patients MBC with who achieved disease control after six cycles of PG chemotherapy were randomly assigned to maintenance chemotherapy or observation until progression.
Results
Of 324 patients from 10 centers enrolled, 231 patients with MBC exhibited disease control (complete response + partial response + stable disease) with first-line PG and were randomly assigned to maintenance chemotherapy (n = 116) or observation (n = 115). The median age was 48 years (range, 28 to 76 years), median follow-up was 33 months, and median number of chemotherapy cycles in the maintenance group after random assignment was six. The median PFS time after random assignment was longer in the maintenance group than in the observation group (7.5 v 3.8 months, respectively; P = .026). The median overall survival (OS) time was longer in the maintenance group than in the observation group (32.3 v 23.5 months, respectively; P = .047). The rate of grade 3 or higher neutropenia after random assignment was higher in the maintenance group than in the observation group (61% v 0.9%, respectively; P < .001).
CONCLUSION
In patients with MBC who achieved disease control with an initial six cycles of PG chemotherapy, maintenance PG chemotherapy resulted in better PFS and OS compared with observation.