美国临床肿瘤杂志：发现医生对早期乳腺癌患者越来越多地选择TCH方案而非ACTH方案的原因

美国《临床肿瘤杂志》2017年7月20日在线先发

http://ascopubs.org/doi/full/10.1200/JCO.2016.71.4345

目的

化疗与曲妥珠单抗联合是HER2（人表皮生长因子受体2）阳性乳腺癌辅助治疗的标准治疗方案，在美国，广泛采用两种治疗方案：阿霉素、环磷酰胺、紫杉醇和曲妥珠单抗（ACTH）方案，多西他赛、卡铂和曲妥珠单抗（TCH）方案。但没有一个临床试验对这些方案进行了头对头的比较，并且现有临床试验数据对老年患者局限性很强。

方法

我们采用2005-2013年的SEER-Medicare数据库，在年龄大于65岁的患者中对ACTH方案和TCH方案的效果进行了比较。使用倾向评分匹配来平衡治疗组间的队列特征。结果包括毒性相关性住院、生存率、使用曲妥珠单抗完成情况。对1077名接受了ACTH方案或TCH方案的患者数据进行分析，纳入了416名倾向评分匹配的亚组患者。

结果

随着时间的推移，有明显采用TCH方案的倾向，2005年有88%的患者接受了ACTH方案，而2011年有15%的患者接受了ACTH方案。在倾向评分匹配的患者中，我们发现，两种治疗方案在总的医疗措施和化疗引起的不良事件（ACTH方案34%对比TCH方案36.5%，P=0.46）方面没有差异。接受TCH方案的患者明显更有可能完成曲妥珠单抗治疗（89%对比77%，P=0.001）。乳腺癌特异性5年生存率（ACTH方案92%对比TCH96%，风险比2.08；95%CI，0.90-4.82）及总生存率两种方案没有差异。

结论

在样本匹配的老年患者中，ACTH方案与TCH方案相比，严重不良事件率或住院率并没有增加，但ACTH方案组完成曲妥珠单抗治疗少。我们没有检验出ACTH方案比较TCH方案的5年生存率方面的差异。限于老年患者证据的局限性，可能基于毒性或疗效差异方面的考量在这两种方案间进行选择并不适合。

《壹篇》南南和北北

Purpose

The combination of chemotherapy and trastuzumab is the standard of care for adjuvant treatment of human epidermal growth factor receptor 2–positive breast cancer. Two regimens have been widely adopted in the United States: doxorubicin, cyclophosphamide, paclitaxel, and trastuzumab (ACTH) and docetaxel, carboplatin, and trastuzumab (TCH). No head-to-head comparison of these regimens has been conducted in a clinical trial, and existing trial data have limited generalizability to older patients.

Methods

We used SEER-Medicare data from 2005 to 2013 to compare outcomes of ACTH versus TCH among patients age older than 65 years. Propensity score matching was used to balance cohort characteristics between treatment arms. Outcomes included toxicity-related hospitalization, survival, and trastuzumab completion. Data from 1,077 patients receiving ACTH or TCH were analyzed, and the propensity-matched subsample included 416 women.

Results

There was a significant shift toward TCH over time, with 88% of patients receiving ACTH in 2005 compared with 15% by 2011. Among propensity score–matched patients, we found no difference between regimens in health care use overall or for chemotherapy-related adverse events (ACTH, 34% v TCH, 36.5%; P = .46). Patients receiving TCH were significantly more likely to complete trastuzumab (89% v 77%; P = .001). There was no difference in 5-year breast cancer–specific survival (ACTH, 92% v TCH, 96%; hazard ratio, 2.08; 95% CI, 0.90 to 4.82) or overall survival.

Conclusion

Among a matched sample of older patients, ACTH compared with TCH was not associated with a higher rate of serious adverse events or hospitalizations, but it was associated with less completion of adjuvant trastuzumab. We did not detect a difference in 5-year survival outcomes for ACTH compared with TCH. In the context of limited evidence in older patients, selection between these two regimens on the basis of concerns about differential toxicity or efficacy may not be appropriate.

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