Follow-up of women on a randomised clinical trial of adjuvant docetaxel and doxorubicin for node positive breast cancer.

该项目正在测试一种药物多西他赛在乳腺癌和累及淋巴结（N+）的妇女术后（辅助）治疗中的应用。直到最近，阿霉素一直是治疗乳腺癌最有效的化疗药物，但最近发现了一种名为紫杉烷的新型化疗药物。一种叫做多西他赛的紫杉烷可能比阿霉素更有效。使用现有的治疗方法，包括以阿霉素为基础的化疗，大约一半的N+乳腺癌妇女经历了癌症复发。因此，检验多西紫杉醇辅助治疗是否能减少复发是很重要的。如果包括多西他赛，同样重要的是要测试是否最好同时与阿霉素联合使用（出于安全考虑，需要减少每种药物的剂量），而不是在全剂量下顺序给药。目前，多西他赛在澳大利亚未被批准或资助用于早期乳腺癌。有几个国际试验测试了紫杉烷在乳腺癌辅助治疗中的应用。然而，这个试验很突出，因为所有参加试验的妇女都接受了至少6个月的化疗。在其他一些试验中，为了测试添加紫杉烷可能带来的好处，对照组的女性（随机分配不接受紫杉烷）只接受了3个月的治疗，这使得很难区分更长时间的治疗还是添加紫杉烷药物。这项试验已经完成了2890名妇女的国际招募，她们将被仔细跟踪10年。澳大利亚和新西兰的中心在试验中招募了20%的女性。在对这些妇女进行了5年的随访后，将对该试验的结果进行分析、报告和发表，并为将多西他赛加入辅助化疗的潜在益处提供可靠的证据。

This project is testing the use of a drug docetaxel in the post-operative (adjuvant) treatment of women with breast cancer and involved lymph nodes (N+). Until recently the drug doxorubicin was the most active chemotherapy drug for breast cancer, but more recently a new group of chemotherapy drugs called taxanes were identified. One taxane called docetaxel may be even more effective than doxoubicin. Using available treatments that include doxorubicin based chemotherapy, approximately half the women with N+ breast cancer experience recurrence of their cancer. It is therefore important to test whether the inclusion of docetaxel in adjuvant therapy can reduce relapses. If docetaxel is to be included, it is also important to test whether it is best to combine it with doxorubicin at the same time (which for safety reasons requires the doses of each drug to be reduced), versus giving them sequentially at full dose. Currently, docetaxel is not approved nor funded for use in early breast cancer in Australia. There are several international trials testing the inclusion of taxanes in the adjuvant therapy of breast cancer. However this trial stands out, because all the women in the trial receive chemotherapy of at least 6 months. In some other trials, testing the possible benefit of adding a taxane, women in the control treatment group (who were randomised not to receive the taxane) received only 3 months of treatment, which makes it difficult to distinguish between longer treatment or addition of the taxane drug. This trial has completed international recruitment of 2890 women who will be carefully followed for 10 years. Australian and New Zealand centers recruited 20% of the women in the trial. After the women have been followed-up for 5 years the results of this trial will be analysed, presented and published and should provide reliable evidence about the potential benefit of adding docetaxel into adjuvant chemotherapy.