Final survival results from the PENELOPE-B trial investigating palbociclib versus placebo for patients with high-risk HR+/HER2- breast cancer and residual disease after neoadjuvant chemotherapy.

patients_and_methods

The PENELOPE-B trial investigated whether adding 1 year of palbociclib to ET in hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer (BC) patients with residual disease and high relapse risk (clinical and pathological stage + estrogen receptor status and histological grade score ≥3 or 2 and ypN+) after taxane-based neoadjuvant chemotherapy would improve patient survival. Patients (n = 1250) were randomly assigned to receive either palbociclib 125 mg or placebo d1-21 q4w for 13 cycles in addition to ET.

PENELOPE-B试验研究了在激素受体阳性（HR阳性）、人类表皮生长因子受体2阴性（HER2阴性）乳腺癌（BC）患者中，对于接受基于紫杉醇的新辅助化疗后仍有残留疾病和高复发风险（临床和病理分期+雌激素受体状态和组织学分级评分≥3或2和ypN+）的患者，添加1年帕博西利至内分泌治疗（ET）是否能改善患者的生存率。患者（n = 1250）被随机分配接受帕博西利125 mg或安慰剂d1-21 q4w，共13个周期，另外接受ET治疗。

Results

After a median follow-up of 77.8 months, we recorded 225 deaths (108 palbociclib; 117 placebo) with a 6-year overall survival(OS) rate of 82.4% in the palbociclib arm versus 80.3% in the placebo arm (hazard ratio0.87, 95% confidence interval(CI) 0.67-1.14, P = 0.31).

经过中位随访77.8个月，我们记录了225例死亡（108例帕博西利；117例安慰剂），帕博西利组的6年总生存（OS）率为82.4%，而安慰剂组为80.3%（风险比0.87，95%置信区间（CI）0.67-1.14，P = 0.31）。

No significant improvement was noted for palbociclib versus placebo for iDFS, distant disease-free survival or locoregional relapse rate, even with longer follow-up.

即使随访时间更长，帕博西利与安慰剂相比，无进展生存期（iDFS）、远处无病生存期或局部区域复发率也未见显著改善。

Upon stratified analysis, we found no benefits across major subgroups.

在分层分析中，我们发现主要亚组中没有明显益处。

However, exploratory post hoc analyses of the lobular BC (LBC) subgroup indicated a trend toward better survival outcomes in favor of palbociclib (hazard ratio0.45, 95% CI 0.19-1.07, P = 0.062 for OS and hazard ratio0.52, 95% CI 0.28-0.97, P = 0.035 for iDFS).

然而，对浸润性小叶癌（LBC）亚组进行的探索性事后分析显示，与帕博西利相比，生存结果有向好的趋势（总生存的危险比为0.45，95%置信区间为0.19-1.07，P = 0.062；无病生存期的危险比为0.52，95%置信区间为0.28-0.97，P = 0.035）。

Conclusions

The study concluded that palbociclib did not significantly improve survival outcomes in the overall population.

研究得出结论，帕博西利并未显著改善整体人群的生存结果。

Exploratory post hoc analyses suggested a trend toward better iDFS outcome in patients with LBC receiving palbociclib.

探索性的事后分析表明，在接受帕博西利治疗的局部晚期乳腺癌患者中，无侵袭性疾病生存（iDFS）结果有向好的趋势。