JCO：侵润性小叶乳腺癌：曲妥单抗疗效如何？

Dana-Farber癌症研究中心的Otto Metzger-Filho带领的科研小组最近进行了一项名为HERA（赫塞汀佐剂）的临床试验。该研究旨在评估HER-2阳性侵润性小叶癌（ILC）的乳腺癌患者使用佐剂曲妥单抗的受益程度。研究结果表明，曲妥单抗对ILC患者和IDC（侵润性导管癌）患者治疗效果相似。
在HERA试验中，受试患者被随机分为两组，一组接受1年的曲妥单抗治疗，另外一组仅接受1年的观察（没有给予曲妥单抗治疗）（n = 3,401）。该研究集中检测了患者体内的雌激素受体（ER）、孕激素受体（PgR）、HER-2的拷贝数。并且，首个位点特异的复发模式被用来评估ILC和浸润性导管癌（IDC）。应用Cox比例风险模型，研究人员采用无病生存期（DFS）和总生存期（OS）两个指标来评估曲妥单抗治疗的受益程度。
研究人员透露，参加HERA试验的病人平均随访时间为4年。受试患者中，包括了187名ILC的乳腺癌患者和3,213名IDC的乳腺癌患者。
研究结果表明，ILC的患者与IDC的患者Allred得分(6分-8分)均普遍较高；两组相比，患者体内ER升高水平分别为36.9% vs 22.7%，PgR升高水平分别为44.1% vs 28.5%。在ILC的一组中，HER-2的拷贝数有下降趋势。ILC和IDC的亚组也具有类似的首个疾病复发位点模式。研究人员对比了接受1年曲妥单抗治疗的患者和仅接受1年观察（没有给予曲妥单抗治疗）的患者的试验结果，发现ILC与ICD的无病生存期（DFS）的风险比（HRs）分别为：0.63（95% CI, 0.34-1.15）vs 0.77（95% CI, 0.67-0.89；相互作用的P=0.49）；另外，ILC与IDC的总生存期（OS）的风险比分别为：0.60（95% CI, 0.27-1.31）vs 0.86（95% CI, 0.71-1.06；相互作用的P=0.29）。
最终，研究人员给出了结论：在使用佐剂曲妥单抗进行治疗的过程中，ILC队列的患者和IDC队列的患者并没有收获不一样的受益。这提示，曲妥单抗对ILC患者和ICD患者治疗效果相似。
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Magnitude of Trastuzumab Benefit in Patients With HER2-Positive, Invasive Lobular Breast Carcinoma: Results From the HERA Trial.
PURPOSE
To evaluate the benefit of adjuvant trastuzumab in patients diagnosed with human epidermal growth factor receptor 2 (HER2) -positive invasive lobular carcinoma (ILC) enrolled onto the Herceptin Adjuvant (HERA) trial.
PATIENTS AND METHODS
Patients randomly assigned to receive one year of trastuzumab and one year of observation in the HERA trial were included (n = 3,401). Centrally reviewed estrogen receptor (ER), progesterone receptor (PgR), and HER2 copy numbers were used. First site-specific relapse pattern was evaluated for ILC and invasive ductal carcinoma (IDC). The magnitude of trastuzumab benefit was assessed using the Cox proportional hazards model for disease-free survival (DFS) and overall survival (OS).
Results
Median follow-up time was 4 years. A total of 187 ILC and 3,213 IDC patients were included. High Allred scores (6 to 8) were more common in patients with ILC than IDC for both ER (36.9% v 22.7%) and PgR (44.1% v 28.5%). A trend toward decreased HER2 copy number was observed in the ILC group. The ILC and IDC subgroups had similar patterns of first site of disease relapse. DFS hazard ratios (HRs) comparing 1 year of trastuzumab versus observation were 0.63 for ILC (95% CI, 0.34 to 1.15) and 0.77 for IDC (95% CI, 0.67 to 0.89; P for interaction = .49). The OS HRs comparing 1 year of trastuzumab versus observation were 0.60 for ILC (95% CI, 0.27 to 1.31) and 0.86 for IDC (95% CI, 0.71 to 1.06; P for interaction = .29).
CONCLUSION
In this retrospective analysis, there was no suggestion that patients in the ILC cohort experienced a different magnitude of benefit from adjuvant trastuzumab than those in the IDC cohort.