Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Via Nazionale 8/A, Santa Maria Imbaro, Chieti, Italy.
J Cancer Res Clin Oncol. 2012 Feb;138(2):221-9. doi: 10.1007/s00432-011-1091-0. Epub 2011 Nov 18.
Whether combination chemotherapy offers an advantage over sequential therapy in metastatic breast cancer (MBC) is still an unsettled issue. Polychemotherapy regimens containing taxanes has been shown to increase overall survival (OS), time to tumor progression (TTP), and overall response rate (ORR) when compared with regimens that did not contain a taxanes, while taxane-based doublets have a statistically significant benefit over single-agent taxane only for progression-free survival. However, the term "taxanes" generally includes both paclitaxel and docetaxel, drugs with different clinical activity. Aim of this work is to compare OS, TTP, and ORR in patients with MBC receiving docetaxel alone or in combination with chemotherapy using a formal meta-analysis.
We performed a systematic review of all published trials comparing docetaxel alone or in combination with other chemotherapeutic agents in MBC.
Three randomized clinical trials including 1,313 patients were retrieved. A significant reduction of risk ratio was found in TTP (P ≤ 0.0001) but not in OS (P = 0.48) or ORR (P = 0.10) for patients treated with a chemotherapy agent plus docetaxel compared with docetaxel alone. Treatment with docetaxel alone is associated with a lower incidence of grade 3 diarrhea and stomatitis (diarrhea, P = 0.011; stomatitis, P = 0.0004).
Combination chemotherapy regimens with docetaxel show a statistically significant advantage for TTP, but not for OS and ORR in MBC. This review confirms that it is unlikely that any single agent or combination chemotherapy regimen will emerge as superior in MBC, due to its heterogeneous nature.
在转移性乳腺癌（MBC）中，联合化疗是否优于序贯治疗仍然是一个悬而未决的问题。与不含紫杉烷的方案相比，含紫杉烷的多化疗方案已显示出可提高总生存期（OS）、肿瘤进展时间（TTP）和总缓解率（ORR），而紫杉烷类双联方案在无进展生存期方面明显优于单药紫杉烷。然而，“紫杉烷类”一词通常包括紫杉醇和多西他赛，这两种药物具有不同的临床活性。本研究旨在通过正式的荟萃分析比较接受多西他赛单药或联合化疗的 MBC 患者的 OS、TTP 和 ORR。
我们对所有比较多西他赛单药或联合其他化疗药物治疗 MBC 的已发表试验进行了系统评价。
共检索到 3 项随机临床试验，共纳入 1313 例患者。与多西他赛单药治疗相比，联合化疗药物治疗患者的 TTP 风险比显著降低（P≤0.0001），但 OS（P=0.48）或 ORR（P=0.10）无显著差异。多西他赛单药治疗与较低的 3 级腹泻和口腔炎发生率相关（腹泻，P=0.011；口腔炎，P=0.0004）。
在 MBC 中，含多西他赛的联合化疗方案在 TTP 方面具有统计学显著优势，但在 OS 和 ORR 方面没有优势。本综述证实，由于 MBC 的异质性，不太可能出现任何单一药物或联合化疗方案具有优势。
