中国癌症杂志 ›› 2022, Vol. 32 ›› Issue (1): 80-89.doi: 10.19401/j.cnki.1007-3639.2022.01.011
收稿日期:
2021-12-18
出版日期:
2022-01-30
发布日期:
2022-01-25
通信作者:
《中国乳腺癌新辅助治疗专家共识(2022年版)》专家组
E-mail:zhimingshao@yahoo.com
Expert group of expert consensus on neoadjuvant treatment of breast cancer in China (2021 edition) ()
Received:
2021-12-18
Published:
2022-01-30
Online:
2022-01-25
Contact:
Expert group of expert consensus on neoadjuvant treatment of breast cancer in China (2021 edition)
E-mail:zhimingshao@yahoo.com
摘要:
新辅助治疗已经成为乳腺癌综合治疗中非常重要的组成部分,2019年中国乳腺癌新辅助治疗专家组就新辅助治疗的目的、适应证、评估规范、手术治疗原则及新辅助系统治疗的策略进行了详细探讨和阐述,结合近两年新的循证医学证据和学术理念,对新辅助治疗临床实施规范和治疗原则予以更新和说明。
中图分类号:
《中国乳腺癌新辅助治疗专家共识(年版)》专家组. 中国乳腺癌新辅助治疗专家共识(2022年版)[J]. 中国癌症杂志, 2022, 32(1): 80-89.
Expert group of expert consensus on neoadjuvant treatment of breast cancer in China ( edition) . Expert consensus on neoadjuvant treatment of breast cancer in China (2021 edition)[J]. China Oncology, 2022, 32(1): 80-89.
表 1
专家组投票结果"
题目 | 投票结果 | ||
---|---|---|---|
同意 | 不同意 | 弃权或无法确定 | |
临床实践中,初诊不可手术患者,病灶穿刺明确病理学检查结果(浸润性癌)后,何时常规推荐等待IHC结果以制订后续治疗策略: | |||
A.只要化疗方案选择合适(如先蒽环类药物序贯紫杉类药物),不需等待IHC结果,后续调整即可; | 7% | 92% | 0% |
B.所有患者均需等待IHC结果后方制订方案。 | 84% | 15% | 0% |
临床实践中,初诊可手术患者,拟行新辅助治疗,病灶穿刺明确病理学检查结果(浸润性癌)后, 具有以下特征时,推荐等待IHC结果: | |||
A.只要化疗方案选择合适(如蒽环类药物序贯紫杉类药物),所有患者均不需等待IHC结果; | 12% | 87% | 0% |
B.肿块超过2 cm但cN0期; | 59% | 40% | 0% |
C.肿块超过5 cm但cN3期; | 79% | 20% | 0% |
D.腋窝淋巴结阳性cN1期; | 96% | 4% | 0% |
E.所有患者均需等待IHC结果后方制订方案。 | 92% | 7% | 0% |
对于腋窝临床体检阴性的患者,新辅助治疗前仍建议进行超声评估腋窝状态 | 100% | 0% | 0% |
如腋窝临床体检阴性但超声提示可疑腋窝淋巴结,建议超声引导下行穿刺明确 | 92% | 7% | 0% |
新辅助治疗前,所有患者均需行基线的下述哪项检查,以完整评估原发灶范围: | |||
A.超声; | 100% | 0% | 0% |
B.乳腺X线; | 89% | 7% | 3% |
C.乳腺磁共振。 | 86% | 10% | 3% |
新辅助治疗前,哪些患者需行骨扫描: | |||
A.全部患者; | 23% | 69% | 7% |
B.仅T3期和(或)N2期及以上患者; | 67% | 25% | 7% |
C.无需。 | 0% | 96% | 3% |
新辅助治疗前,哪些患者需行PET/CT: | |||
A.全部患者; | 0% | 100% | 0% |
B.仅T3期和(或)N2期及以上患者; | 75% | 17% | 6% |
C.无需。 | 11% | 85% | 3% |
仅新辅助治疗前cN1期及以下患者,新辅助治疗降期后才能进行前哨淋巴结活检(即cN2-3期患者新辅助治疗降期后也不适合SLNB)。 | 72% | 24% | 3% |
新辅助治疗降期后,行前哨淋巴结活检时建议常规采用双示踪(蓝染+核素),其他的替代方法有: | |||
A.采用荧光染料示踪替代核素示踪; | 33% | 48% | 18% |
B.对于有经验的操作者,可用蓝染单示踪。 | 56% | 26% | 17% |
已确认新辅助治疗前,乳腺原发灶需进行标识(内标记marker & 外标记体表投影纹身),若进行内 标记,推荐marker放置的部位为: | |||
A.病灶中央放置marker; | 75% | 17% | 6% |
B.病灶中央及边缘放置marker。 | 67% | 21% | 10% |
已确认新辅助治疗前,乳腺原发灶需进行标识(内标记marker & 外标记体表投影纹身),若无内标记,应该通过表面病灶投影如纹身或图示等方法外标记。 | 92% | 7% | 0% |
ER+HER2+患者,哪些可采用靶向(双靶或单靶抗体药物)联合内分泌治疗: | |||
A.所有患者,基于药敏尝试; | 13% | 81% | 4% |
B.高选择的不能耐受化疗患者; | 100% | 0% | 0% |
C.ER高表达、淋巴结阴性的绝经后患。 | 37% | 50% | 12% |
ER-HER2+患者,是否可采用仅用双靶治疗: | |||
A.所有患者,基于药敏尝试; | 3% | 96% | 0% |
B.高选择的不能耐受化疗患者; | 82% | 13% | 3% |
C.淋巴结阴性的患者。 | 11% | 88% | 0% |
TNBC患者,患者充分告知并且药物可及时,可推荐新辅助PD-1/PD-L1免疫治疗: | |||
A.所有患者; | 7% | 88% | 3% |
B.仅PD-1/PD-L1阳性患者; | 37% | 51% | 11% |
C.不常规推荐。 | 80% | 11% | 7% |
具有较重肿瘤负荷(cN+期)的TNBC患者,新辅助治疗首选方案: | |||
A.蒽环类药物联合/序贯紫杉类药物; | 96% | 3% | 0% |
B.蒽环类药物序贯紫杉类药物和铂类药物; | 53% | 38% | 7% |
C.紫杉类药物、铂类药物联合方案(后续序贯或不序贯蒽环类药物); | 66% | 33% | 0% |
D.蒽环类药物、紫杉类药物方案+PARP抑制剂; | 3% | 88% | 7% |
E.蒽环类药物、紫杉类药物、铂类药物联合方案+PARP抑制剂。 | 0% | 100% | 0% |
gBRCAmut患者,新辅助首选方案: | |||
A.蒽环类药物联合/序贯紫杉类药物; | 73% | 26% | 0% |
B.蒽环类药物序贯紫杉类药物和铂类药物; | 84% | 11% | 3% |
C.紫杉类药物、铂类药物联合方案(后续序贯或不序贯蒽环类药物); | 76% | 19% | 3% |
D.化疗联合PARP抑制剂; | 17% | 72% | 10% |
E.仅PARP抑制剂。 | 3% | 96% | 0% |
Luminal型患者新辅助内分泌治疗适用于: | |||
A.所有患者,基于药敏平台; | 7% | 92% | 0% |
B.不能耐受化疗的患者; | 88% | 7% | 3% |
C.ER高表达、cT1-2N0期患者; | 37% | 59% | 3% |
D.除临床试验外,不常规推荐。 | 59% | 37% | 3% |
Luminal型患者如果使用新辅助内分泌治疗,推荐采用: | |||
A.AI(绝经前+OFS); | 81% | 18% | 0% |
B.氟维司群(绝经前+OFS); | 28% | 60% | 12% |
C.CDK4/6抑制剂+AI(绝经前+OFS)。 | 42% | 53% | 3% |
2个疗程评估退缩不佳的患者,需考虑治疗策略的改换(局部和或全身治疗) | 57% | 32% | 10% |
4个疗程评估退缩不佳的患者,需考虑治疗策略的改换(局部和或全身治疗) | 96% | 0% | 3% |
可手术乳腺癌,4个疗程临床评估SD时,HER2阳性,初始化疗+HP双靶治疗: | |||
A.更改化疗方案+HP; | 7% | 80% | 11% |
B.更改化疗方案+TKI; | 46% | 53% | 0% |
C.更改化疗方案+TKI+曲妥珠单抗; | 48% | 51% | 0% |
D.手术; | 75% | 21% | 3% |
E.继续原方案。 | 0% | 0% | 0% |
可手术乳腺癌,4个疗程临床评估SD时,TNBC,初始EC新辅助治疗: | |||
A.继续序贯紫杉类药物方案; | 61% | 30% | 7% |
B.序贯紫杉类药物+铂类药物; | 75% | 20% | 4% |
C.手术。 | 69% | 26% | 3% |
可手术乳腺癌,4个疗程临床评估SD时,TNBC,初始TEC新辅助治疗: | |||
A.更改为含铂类药物方案; | 50% | 42% | 7% |
B.更改为NX方案; | 30% | 57% | 11% |
C.手术; | 86% | 13% | 0% |
D.继续TEC 2个疗程。 | 0% | 96% | 3% |
可手术乳腺癌,4个疗程临床评估SD时,TNBC,初始PCb新辅助治疗: | |||
A.更改为EC; | 32% | 64% | 4% |
B.手术; | 92% | 7% | 0% |
C.继续PCb 2个疗程。 | 0% | 100% | 0% |
在规范的新辅助治疗评估,以及足疗程治疗后,初始cN1期的TNBC或HER2+患者新辅助治疗后cN0期,前哨淋巴结活检仅获得2枚,均阴性,腋窝如何处理: | |||
A.腋窝淋巴结清扫; | 50% | 41% | 8% |
B.腋窝区域放疗; | 63% | 18% | 18% |
C.腋窝不处理。 | 25% | 70% | 4% |
在规范的新辅助治疗评估,以及足疗程治疗后,初始cN1期的TNBC或HER2+患者,新辅助治疗后cN0期,前哨淋巴结活检仅获得1枚,阴性,腋窝如何处理: | |||
A.腋窝淋巴结清扫; | 73% | 23% | 3% |
B.腋窝区域放疗; | 33% | 58% | 8% |
C.腋窝不处理。 | 4% | 84% | 12% |
在规范的新辅助治疗评估,以及足疗程治疗后,初始cN1期患者,新辅助治疗后cN0期,前哨淋巴结活检3枚及以上的石蜡包埋切片病理学检查仅1枚ITC时,后续腋窝如何处理: | |||
A.腋窝淋巴结清扫; | 50% | 50% | 0% |
B.腋窝区域放疗。 | 60% | 34% | 4% |
在规范的新辅助治疗评估,以及足疗程治疗后,初始cN1期患者,新辅助治疗后cN0期,前哨淋巴结活检3枚及以上的石蜡包埋切片病理学检查仅1枚微转移时,后续腋窝如何处理: | |||
A.腋窝淋巴结清扫; | 88% | 12% | 0% |
B.腋窝区域放疗。 | 50% | 41% | 8% |
在规范的新辅助治疗评估,以及足疗程治疗后,初始cN1期患者,新辅助治疗后cN0期,前哨淋巴结活检3枚及以上的石蜡包埋切片病理学检查仅1枚宏转移时,后续腋窝如何处理: | |||
A.腋窝淋巴结清扫; | 96% | 3% | 0% |
B.腋窝区域放疗。 | 13% | 78% | 8% |
初始不可保乳患者,新辅助治疗降期后,临床需慎重保乳的因素: | |||
A.多灶病灶; | 100% | 0% | 0% |
B.TNBC; | 15% | 84% | 0% |
C.gBRCAmut。 | 57% | 38% | 3% |
新辅助治疗后实施保乳手术,石蜡包埋切片病理学检查提示切缘不典型增生,后续除了放疗外的处理: | |||
A.残腔广泛切除; | 48% | 48% | 3% |
B.全切; | 0% | 100% | 0% |
C.不处理。 | 63% | 31% | 0% |
新辅助治疗后实施保乳手术,切缘阴性的定义: | |||
A.No ink on tumor; | 80% | 16% | 4% |
B.1 mm; | 48% | 40% | 11% |
C.2 mm; | 51% | 44% | 3% |
D.5 mm; | 12% | 84% | 4% |
E.10 mm。 | 0% | 96% | 3% |
HER2阳性,HP双靶+化疗,新辅助治疗后pCR,辅助治疗策略为: | |||
A.继续完成满1年双靶; | 100% | 0% | 0% |
B.如新辅助治疗前肿瘤负荷较小(T2N0期),仅使用曲妥珠单抗满1年; | 39% | 60% | 0% |
C.如新辅助治疗前肿瘤负荷较大[T3期和(或)N2期],辅助HP治疗后,继续TKI治疗1年。 | 40% | 54% | 4% |
HER2阳性,HP双靶+化疗,新辅助治疗后non-pCR,T-DM1是当前标准的辅助治疗策略,以下情况: | |||
A.残留肿瘤负荷较小时(MP4或RCB1),可仅HP双靶治疗; | 59% | 36% | 4% |
B.残留肿瘤负荷较小时(MP4或RCB1),可HP双靶治疗后,延长TKI治疗1年; | 28% | 60% | 12% |
C.退缩不明显、残留肿瘤负荷较大时(MP1-2或RCB3)可采用T-DM1后再延长TKI治疗1年。 | 20% | 70% | 8% |
TNBC标准足疗程的新辅助治疗后,pCR,辅助强化治疗: | |||
A.无需进行强化治疗; | 91% | 8% | 0% |
B.如新辅助治疗前肿瘤负荷较大[T3期和(或)N2期]继续卡培他滨节拍用法1年。 | 36% | 52% | 12% |
TNBC标准足疗程的新辅助治疗后,non-pCR,卡培他滨是当前标准的辅助治疗策略。如采用PCb新辅助治疗6个疗程后,辅助强化治疗策略为: | |||
A.EC3~4个疗程+/-卡培他滨; | 40% | 55% | 5% |
B.卡培他滨。 | 95% | 4% | 0% |
Luminal(HER2-)型标准足疗程的新辅助治疗后,non-pCR,辅助治疗策略除了标准内分泌治疗(AI+/-OFS)外: | |||
A.卡培他滨; | 37% | 62% | 0% |
B.CDK4/6抑制剂。 | 77% | 13% | 9% |
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