Zujewski Jo Anne, Rubinstein Lawrence
Cancer Therapy Evaluation Program, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD USA.
Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD USA.
NPJ Breast Cancer. 2017 Jul 20;3:27. doi: 10.1038/s41523-017-0029-3. eCollection 2017.
Breast cancer patients with residual disease after neoadjuvant chemotherapy and surgery may benefit from additional anti-cancer therapies. Capecitabine, an oral antimetabolite and prodrug of 5-Flurouracil, has been approved for treating metastatic breast cancer. One randomized clinical trial (CREATE-X) of capecitabine versus no additional therapy has been conducted in women with early stage breast cancer who received standard chemotherapy pre-operative therapy and had residual invasive breast cancer at the time of surgery. Results from CREATE-X, showed that capecitabine had a statistically significant survival advantage compared with no additional therapy. This perspective provides a review and analysis of the available data from CREATEx in the context of results from other adjuvant trials of capecitabine in early stage breast cancer that had disease-free survival as a primary endpoint. We conclude that although the previously published studies of capecitabine in the adjuvant setting did not meet their primary endpoint, the data from these studies are consistent with the hypothesis that capecitabine may offer additional survival benefit in patients with chemo-refractory breast cancer at the time of surgery after receiving standard chemotherapy. In these patients, offering a course of adjuvant capecitabine or enrolling the patient in a clinical trial are appropriate therapeutic options. The patient should be informed about both the increased survival observed in the CREATEx trial and the expected toxicities from capecitabine chemotherapy.
新辅助化疗和手术后仍有残留病灶的乳腺癌患者可能从额外的抗癌治疗中获益。卡培他滨是一种口服抗代谢药物，也是5-氟尿嘧啶的前体药物，已被批准用于治疗转移性乳腺癌。一项关于卡培他滨与不进行额外治疗对比的随机临床试验（CREATE-X）已在接受术前标准化化疗且手术时仍有残留浸润性乳腺癌的早期乳腺癌女性患者中开展。CREATE-X的结果显示，与不进行额外治疗相比，卡培他滨具有统计学上显著的生存优势。本观点结合卡培他滨在早期乳腺癌其他辅助试验中以无病生存作为主要终点的结果，对CREATE-X的现有数据进行了综述和分析。我们得出结论，尽管之前发表的卡培他滨辅助治疗研究未达到其主要终点，但这些研究的数据与以下假设一致：在接受标准化化疗后手术时，卡培他滨可能为化疗难治性乳腺癌患者提供额外的生存获益。对于这些患者，给予一个疗程的辅助性卡培他滨治疗或让患者参加一项临床试验都是合适的治疗选择。应告知患者关于CREATE-X试验中观察到的生存改善情况以及卡培他滨化疗预期的毒性。
