PDF(Pubmed)
Abstract：
BACKGROUND: The addition of pertuzumab (P) to trastuzumab (H) and standard chemotherapy (CT) as neoadjuvant treatment (NaT) for patients with HER2 + breast cancer (BC), has shown to increase the pathological complete response (pCR) rate, without main safety concerns. The aim of NeoPowER trial is to evaluate safety and efficacy of P + H + CT in a real-world population.
METHODS: We retrospectively reviewed the medical records of stage II-III, HER2 + BC patients treated with NaT: who received P + H + CT (neopower group) in 5 Emilia Romagna institutions were compared with an historical group who received H + CT (control group). The primary endpoint was the safety, secondary endpoints were pCR rate, DRFS and OS and their correlation to NaT and other potential variables.
RESULTS: 260 patients were included, 48% received P + H + CT, of whom 44% was given anthraciclynes as part of CT, compared to 83% in the control group. The toxicity profile was similar, excluding diarrhea more frequent in the neopower group (20% vs. 9%). Three patients experienced significant reductions in left ventricular ejection fraction (LVEF), all receiving anthracyclines. The pCR rate was 46% (P + H + CT) and 40% (H + CT) (p = 0.39). The addition of P had statistically correlation with pCR only in the patients receiving anthra-free regimens (OR = 3.05,p = 0.047). Preoperative use of anthracyclines (OR = 1.81,p = 0.03) and duration of NaT (OR = 1.18,p = 0.02) were statistically related to pCR. 12/21 distant-relapse events and 14/17 deaths occurred in the control group. Patients who achieve pCR had a significant increase in DRFS (HR = 0.23,p = 0.009).
CONCLUSIONS: Adding neoadjuvant P to H and CT is safe. With the exception of diarrhea, rate of adverse events of grade > 2 did not differ between the two groups. P did not increase the cardiotoxicity when added to H + CT, nevertheless in our population all cardiac events occurred in patients who received anthracycline-containing regimens. Not statistically significant, higher pCR rate is achievable in patients receiving neoadjuvant P + H + CT. The study did not show a statistically significant correlation between the addition of P and long-term outcomes.
METHODS: We retrospectively reviewed the medical records of stage II-III, HER2 + BC patients treated with NaT: who received P + H + CT (neopower group) in 5 Emilia Romagna institutions were compared with an historical group who received H + CT (control group). The primary endpoint was the safety, secondary endpoints were pCR rate, DRFS and OS and their correlation to NaT and other potential variables.
RESULTS: 260 patients were included, 48% received P + H + CT, of whom 44% was given anthraciclynes as part of CT, compared to 83% in the control group. The toxicity profile was similar, excluding diarrhea more frequent in the neopower group (20% vs. 9%). Three patients experienced significant reductions in left ventricular ejection fraction (LVEF), all receiving anthracyclines. The pCR rate was 46% (P + H + CT) and 40% (H + CT) (p = 0.39). The addition of P had statistically correlation with pCR only in the patients receiving anthra-free regimens (OR = 3.05,p = 0.047). Preoperative use of anthracyclines (OR = 1.81,p = 0.03) and duration of NaT (OR = 1.18,p = 0.02) were statistically related to pCR. 12/21 distant-relapse events and 14/17 deaths occurred in the control group. Patients who achieve pCR had a significant increase in DRFS (HR = 0.23,p = 0.009).
CONCLUSIONS: Adding neoadjuvant P to H and CT is safe. With the exception of diarrhea, rate of adverse events of grade > 2 did not differ between the two groups. P did not increase the cardiotoxicity when added to H + CT, nevertheless in our population all cardiac events occurred in patients who received anthracycline-containing regimens. Not statistically significant, higher pCR rate is achievable in patients receiving neoadjuvant P + H + CT. The study did not show a statistically significant correlation between the addition of P and long-term outcomes.
摘要：
背景：在曲妥珠单抗（H）和标准化疗（CT）基础上增加帕妥珠单抗（P）作为HER2+乳腺癌（BC）患者的新辅助治疗（NaT），已显示增加病理完全缓解（pCR）率，没有主要的安全问题。NeoPowER试验的目的是评估真实世界人群中P+H+CT的安全性和有效性。
方法：我们回顾性回顾了II-III期的医疗记录，接受NaT治疗的HER2BC患者：在5个EmiliaRomagna机构中接受PHCT（新功率组）的患者与接受HCT的历史组（对照组）进行了比较。主要终点是安全性，次要终点是pCR率，DRFS和OS及其与NaT和其他潜在变量的相关性。
结果：纳入260例患者，48%接受P+H+CT,其中44%的人作为CT的一部分接受了蒽醌治疗，与对照组的83%相比。毒性特征相似,排除新电源组更频繁的腹泻(20%vs.9%)。三例患者左心室射血分数（LVEF）显着降低，都接受蒽环类药物治疗.pCR率为46%(P+H+CT)和40%(H+CT)(p=0.39)。P的添加仅在接受无去甲方案的患者中与pCR具有统计学相关性（OR=3.05，p=0.047）。术前蒽环类药物的使用（OR=1.81，p=0.03）和NaT的持续时间（OR=1.18，p=0.02）与pCR有统计学关系。对照组发生12/21的远处复发事件和14/17的死亡。达到pCR的患者DRFS显着增加（HR=0.23，p=0.009）。
结论：在H和CT中添加新辅助P是安全的。除了腹泻,2级>2级的不良事件发生率两组间无差异.当添加到H+CT时，P没有增加心脏毒性，尽管如此,在我们人群中,所有心脏事件均发生在接受蒽环类药物治疗的患者中.没有统计学意义，在接受新辅助P+H+CT的患者中,可以实现更高的pCR率.该研究未显示P的增加与长期结果之间的统计学显着相关性。
方法：我们回顾性回顾了II-III期的医疗记录，接受NaT治疗的HER2BC患者：在5个EmiliaRomagna机构中接受PHCT（新功率组）的患者与接受HCT的历史组（对照组）进行了比较。主要终点是安全性，次要终点是pCR率，DRFS和OS及其与NaT和其他潜在变量的相关性。
结果：纳入260例患者，48%接受P+H+CT,其中44%的人作为CT的一部分接受了蒽醌治疗，与对照组的83%相比。毒性特征相似,排除新电源组更频繁的腹泻(20%vs.9%)。三例患者左心室射血分数（LVEF）显着降低，都接受蒽环类药物治疗.pCR率为46%(P+H+CT)和40%(H+CT)(p=0.39)。P的添加仅在接受无去甲方案的患者中与pCR具有统计学相关性（OR=3.05，p=0.047）。术前蒽环类药物的使用（OR=1.81，p=0.03）和NaT的持续时间（OR=1.18，p=0.02）与pCR有统计学关系。对照组发生12/21的远处复发事件和14/17的死亡。达到pCR的患者DRFS显着增加（HR=0.23，p=0.009）。
结论：在H和CT中添加新辅助P是安全的。除了腹泻,2级>2级的不良事件发生率两组间无差异.当添加到H+CT时，P没有增加心脏毒性，尽管如此,在我们人群中,所有心脏事件均发生在接受蒽环类药物治疗的患者中.没有统计学意义，在接受新辅助P+H+CT的患者中,可以实现更高的pCR率.该研究未显示P的增加与长期结果之间的统计学显着相关性。
