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Abstract：
BACKGROUND: Following the positive iDFS and OS results of the phase III clinical trials monarchE, NATALEE and OlympiA, new oral anticancer agents (the CDK4/6 inhibitors abemaciclib, ribociclib as well as the PARP inhibitor olaparib) have recently been introduced into the treatment of high-risk early breast cancer (eBC). However, only few male patients were included in these trials (0.4%, 0.6% and 0.3%, respectively). The objective of this real-world analysis was to determine the proportion of male patients with eBC fulfilling the clinical high-risk criteria of above-mentioned trials.
METHODS: We conducted a data inquiry and analysis with the Cancer Registry of Baden-Württemberg of men with breast cancer diagnosed between January 1, 2015 and December 31, 2021. Men with eBC were identified and the number of patients at clinical high-risk according to the inclusion criteria of monarchE, NATALEE and OlympiA was assessed.
RESULTS: Of 397 men with eBC, 354 (89.1%) had a HR + /Her2- and 4 (1.0%) a triple-negative subtype. 84 patients (21.2%) met the clinical high-risk criteria according to the monarchE, 189 (47.6%) those according to the NATALEE and 50 (12.6%) those according to the OlympiA trial.
CONCLUSIONS: In a large real-world sample, more men with eBC are at clinical high risk according to the inclusion criteria of monarchE, NATALEE and OlympiA than would be expected in women. This is most likely due to more advanced stages at initial diagnosis in men. To evaluate whether CDK4/6 and PARP inhibitors improve prognosis also in men should be the topic of future real- world analyses.
METHODS: We conducted a data inquiry and analysis with the Cancer Registry of Baden-Württemberg of men with breast cancer diagnosed between January 1, 2015 and December 31, 2021. Men with eBC were identified and the number of patients at clinical high-risk according to the inclusion criteria of monarchE, NATALEE and OlympiA was assessed.
RESULTS: Of 397 men with eBC, 354 (89.1%) had a HR + /Her2- and 4 (1.0%) a triple-negative subtype. 84 patients (21.2%) met the clinical high-risk criteria according to the monarchE, 189 (47.6%) those according to the NATALEE and 50 (12.6%) those according to the OlympiA trial.
CONCLUSIONS: In a large real-world sample, more men with eBC are at clinical high risk according to the inclusion criteria of monarchE, NATALEE and OlympiA than would be expected in women. This is most likely due to more advanced stages at initial diagnosis in men. To evaluate whether CDK4/6 and PARP inhibitors improve prognosis also in men should be the topic of future real- world analyses.
摘要：
背景：在III期临床试验monarchE的iDFS和OS结果阳性之后，娜塔莉和奥林匹亚,新的口服抗癌剂(CDK4/6抑制剂abemaciclib，ribociclib以及PARP抑制剂olaparib）最近已被引入高风险早期乳腺癌（eBC）的治疗中。然而,这些试验中只有少数男性患者(0.4%，0.6%和0.3%，分别)。该真实世界分析的目的是确定符合上述试验的临床高风险标准的eBC男性患者的比例。
方法：我们通过巴登-符腾堡州癌症登记处对2015年1月1日至2021年12月31日诊断为乳腺癌的男性进行了数据查询和分析。根据君主的纳入标准，确定了患有eBC的男性，并确定了临床高危患者的数量，娜塔莉和奥林匹亚进行了评估。
结果：在397名患有eBC的男性中，354(89.1%)具有HR+/Her2-和4(1.0%)具有三阴性亚型。根据君主的说法，84例患者（21.2％）符合临床高风险标准，根据NATALEE的189（47.6％）和根据OlympiA试验的50（12.6％）。
结论：在一个大型现实世界样本中，根据君主的纳入标准，更多的EBC男性处于临床高风险，娜塔莉和奥林匹亚比女性预期的要多。这很可能是由于男性的初始诊断阶段更先进。评估CDK4/6和PARP抑制剂是否也改善男性的预后应该是未来现实世界分析的主题。
方法：我们通过巴登-符腾堡州癌症登记处对2015年1月1日至2021年12月31日诊断为乳腺癌的男性进行了数据查询和分析。根据君主的纳入标准，确定了患有eBC的男性，并确定了临床高危患者的数量，娜塔莉和奥林匹亚进行了评估。
结果：在397名患有eBC的男性中，354(89.1%)具有HR+/Her2-和4(1.0%)具有三阴性亚型。根据君主的说法，84例患者（21.2％）符合临床高风险标准，根据NATALEE的189（47.6％）和根据OlympiA试验的50（12.6％）。
结论：在一个大型现实世界样本中，根据君主的纳入标准，更多的EBC男性处于临床高风险，娜塔莉和奥林匹亚比女性预期的要多。这很可能是由于男性的初始诊断阶段更先进。评估CDK4/6和PARP抑制剂是否也改善男性的预后应该是未来现实世界分析的主题。
