Neoadjuvant Docetaxel in Locally Advanced Breast Cancer
Neoadjuvant Docetaxel in Locally Advanced Breast Cancer
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新辅助多西他赛治疗局部晚期乳腺癌
DOI：
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发表时间：
2004
影响因子：
3.8
通讯作者：
T. Sarkar
中科院分区：
文献类型：
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作者：
A. Hutcheon;S. Heys;T. Sarkar
新辅助化疗可显著提高临床反应率和保乳治疗率。病理学缓解率虽然通常较低，但也是一个重要的结局，因为它可能与微转移性疾病的根除相关，并可能导致结局改善。蒽环类药物一直被认为是早期乳腺癌新辅助治疗最有效的化疗药物。不幸的是，并非所有患者都对基于蒽环类药物的新辅助化疗有反应。为了改善原发性肿瘤缓解，已在新辅助治疗中评价了多西他赛（一种乳腺癌活性药物）。已经报道了几项随机试验，包括NSABP B-27、GEPAR-duo和Aberdeen试验，评价多西他赛与基于多柔比星的新辅助治疗方案的顺序，结果令人鼓舞。我们设计的Aberdeen试验有两个主要目的：（1）评价多西他赛在最初以蒽环类药物为基础的新辅助化疗方案失败的患者中的主要作用，（2）比较以多西他赛为基础的新辅助化疗方案与以标准蒽环类药物为基础的方案在以蒽环类药物为基础的方案的前4个周期有效的患者中的作用。合格患者（n = 162）既往未接受过治疗的大型（≥3 cm）或局部晚期（T3、T4、TxN 2）乳腺癌。所有患者均接受了4个周期的CVAP治疗，之后评估了临床反应。然后将应答患者随机分配至另外4个周期的CVAP或多西他赛100 mg/m2，每3周一次，共4个周期。对CVAP无效的患者接受多西他赛方案治疗。在CVAP的前四个周期后，总体缓解率（ORR）为67%。最终，随机分配至多西他赛组的缓解率高于继续CVAP组（cCR：94% vs. 66%; p = 0.001; pCR 34% vs. 16%; p = 0.04）。与接受8个周期CVAP治疗的患者相比，加入多西他赛改善了4个周期CVAP治疗患者的总生存期和无病生存期。随机分配至多西他赛组的相对剂量强度较高，重度白细胞减少症的发生率较低。这些数据和NSABP B-27和GEPAR-duo试验的数据强烈支持蒽环类药物/多西他赛联合方案用于新辅助治疗。
Neoadjuvant chemotherapy produces substantial increases in clinical response rates and rates of breast conserving therapy. Pathologic response rate, though generally low, is an important outcome as it is presumably associated with eradication of micrometastatic disease and may likely result in improved outcomes. Anthracyclines have long been considered the most efficacious chemotherapy agents for neoadjuvant therapy of early breast cancer. Unfortunately, not all patients respond to neoadjuvant anthracycline-based chemotherapy. In an effort to improve primary tumor response, docetaxel, an active agent in breast cancer, has been evaluated in the neoadjuvant setting. Several randomized trials, including the NSABP B-27, GEPAR-duo, and the Aberdeen trial, evaluating docetaxel in sequence with a doxorubicin-based neoadjuvant regimen have been reported, with encouraging findings. We designed the Aberdeen trial with two primary aims: (1) to evaluate primary docetaxel in patients that initially fail a neoadjuvant anthracycline-based polychemotherapy regimen, and (2) to compare a docetaxel-based neoadjuvant regimen with a standard anthracycline-based regimen in patients who do respond to the first four cycles of the anthracycline-based regimen. Eligible patients (n = 162) had previously untreated large (≥3 cm) or locally advanced (T3, T4, TxN2) breast cancer. All received four cycles of CVAP, after which clinical response was assessed. Responding patients were then randomized to four additional cycles of CVAP or to docetaxel 100 mg/m2 every 3 weeks for four cycles. Patients failing to respond to CVAP received the docetaxel regimen. After the first four cycles of CVAP, the overall response rate (ORR) was 67%. Ultimately, responses were higher in the group randomized to docetaxel compared with those continuing CVAP (cCR: 94% v.s. 66%; p = 0.001; pCR 34% v.s. 16%; p = 0.04). The addition of docetaxel improved overall survival and disease-free survival for patients responding to four cycles of CVAP as compared with those receiving eight cycles of CVAP. Relative dose intensity was higher and the incidence of severe leukopenia was lower in the group randomized to docetaxel. These data and data from the NSABP B-27 and GEPAR-duo trials strongly support a combined anthracycline/docetaxel regimen in the neoadjuvant setting.
影响因子：
45.3
作者：
Fisher, B;Bryant, J;Bear, HD
通讯作者：
Bear, HD