Maisano R, Zavettieri M, Azzarello D, Raffaele M, Maisano M, Bottari M, Nardi M
Unità Operativa di Oncologia Medica, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.
J Chemother. 2011 Feb;23(1):40-3. doi: 10.1179/joc.2011.23.1.40.
Triple-negative breast cancer (TNBC) is characterized by lack of hormone receptors and HER-2 and shares many features with BRCA1-associated cancer. Preclinical data indicate cisplatin sensitivity, suggesting that these tumors may have defects in the BRCA1 pathway. The carboplatin and gemcitabine (CG) combination is active in unselected anthracycline/taxane pretreated metastatic breast cancer patients, so we carried out a phase II study to evaluate the activity of the CG combination in pretreated metastatic TNBC patients. From 10/2004 to 3/2009 we enrolled 31 patients. Median age was 57 years and 29 patients out of 31 had visceral involvement. The overall response rate (ORR) was 32% (1 complete response /9 partial responses), in addition 5 patients obtained stable disease for >12 weeks. After a median follow-up of 34 months, all patients progressed with a median time to progression of 5.5 months and median overall survival of 11 months. Dose reductions, delays and omissions occurred in 75 (60%), 36 (29%) and 22 (18%) cycles. Grade 3/4 neutropenia occurred in 17 and febrile neutropenia in 4 patients. Ten patients had Grade 3/4 thrombocytopenia. Non hematological toxicities were manageable. The CG combination is a reasonable option for the treatment of metastatic pretreated TNBC patients.
三阴性乳腺癌（TNBC）的特征是缺乏激素受体和HER-2，并且与BRCA1相关癌症有许多共同特征。临床前数据表明其对顺铂敏感，提示这些肿瘤可能在BRCA1通路存在缺陷。卡铂和吉西他滨（CG）联合方案在未经选择的接受过蒽环类/紫杉类治疗的转移性乳腺癌患者中具有活性，因此我们开展了一项II期研究，以评估CG联合方案在接受过治疗的转移性TNBC患者中的活性。从2004年10月至2009年3月，我们纳入了31例患者。中位年龄为57岁，31例患者中有29例有内脏受累。总缓解率（ORR）为32%（1例完全缓解/9例部分缓解），此外有5例患者疾病稳定超过12周。中位随访34个月后，所有患者均进展，中位至进展时间为5.5个月，中位总生存期为11个月。75个周期（60%）出现剂量减少，36个周期（29%）出现延迟，22个周期（18%）出现遗漏。17例患者出现3/4级中性粒细胞减少，4例患者出现发热性中性粒细胞减少。10例患者出现3/4级血小板减少。非血液学毒性易于处理。CG联合方案是治疗接受过治疗的转移性TNBC患者的一个合理选择。
