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Usefulness of p16(INK4a) staining for managing histological high-grade squamous intraepithelial cervical lesions.

p16(INK4a)染色在规范宫颈高级别鳞状上皮内瘤变治疗中的作用。

Miralpeix E,Genovés J,Maria Solé-Sedeño J,Mancebo G,Lloveras B,Bellosillo B,Alameda F,Carreras R
阅读:1382 Modern PathologyFeb 2017; 30 (2): 158 - 313:304-310 

Abstract

p16(INK4a) (p16) tumor-suppressor protein is a biomarker of human papillomavirus (HPV) oncogenic activity that has revealed a high rate of positivity in histological high-gade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade 2 (HSIL/CIN2) lesions. However, there is a paucity of data regarding p16 status as a surrogate marker of HSIL/CIN2 evolution. The aim of this study was to evaluate the outcome of HSIL/CIN2 patients followed up without treatment for 12 months according to p16 immunohistochemical staining. Patients diagnosed with HSIL/CIN2 colposcopy-directed biopsy, were recruited prospectively between December 2011 and October 2013. p16 staining was performed in all HSIL/CIN2 diagnostic biopsies. Follow-up was conducted every 4 months by cytology, colposcopy and biopsy if suspicion of progression and once the 12 months of follow-up completed. Complete regression, partial regression, persistence, and progression rates of HSIL/CIN2 were defined as a final outcome. A total of 96 patients were included in the analysis. The rate of spontaneous regression was 64%, while 28% had persistent disease, and 8% progressed at 12 months of follow-up. p16 was positive in 81 (84%) initial HSIL/CIN2 biopsies. Regression was observed in all 15 p16 negative cases and in 46 of 81 (57%) p16 positive cases (P=0.001). In conclusion, patients with p16 negative HSIL/CIN2 biopsy had a high rate of regression during first 12 months of follow-up. Status of p16 staining could be considered for HSIL/CIN2 management.

摘要

p16(INK4a) (p16)肿瘤抑制蛋白是一种与人乳头瘤病毒致瘤活性有关的生物标记,它在宫颈高级别鳞状上皮内瘤变/宫颈上皮内瘤变2级(HSIL/CIN2) 中阳性率较高。然而,现在还没有足够的数据支持p16可以作为显示HSIL/CIN2演变的替代标记物。此次研究的目的就是依据p16免疫组织化学染色情况,来评估12个月未经治疗HSIL/CIN2患者的随访结果。

我们在2011年到2013年,将阴道镜活检确诊为HSIL/CIN2的患者召集起来。所有诊断为HSIL/CIN2的组织切片均进行了p16染色。每4个月对患者的细胞学、阴道镜和活检组织进行复查,且完成了12个月的随访工作。最终得到了 HSIL/CIN2 的完全好转、部分好转、病情持续和病情进展的比率。我们一共分析了96位患者。其中64%的患者病情好转,28%的患者病情持续,而8%的患者在12个月后病情进展了。p16在HSIL/CIN2活检标本中有81例(84%)阳性。15个 P16阴性的病例均表现为病情好转,而且在81个P16阳性的病例中有46个 (84%)病情好转(P=0.001)。结论:在第一个12个月的随访中,P16阴性的HSIL/CIN2患者有较高的好转机率。P16染色可以考虑用来规范HSIL/CIN2的治疗。

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