caa a22 4500 605490465 CHVBK 20210128100505.0 cr unu---uuuuu 210128e20150201xx s 000 0 eng 10.1007/s10147-014-0688-0 doi (NATIONALLICENCE)springer-10.1007/s10147-014-0688-0 Performance of p16INK4a/Ki-67 immunocytochemistry for identifying CIN2+ in atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion specimens: a Japanese Gynecologic Oncology Group study [Elektronische Daten] [Takuma Fujii, Miyuki Saito, Toshihiko Hasegawa, Takashi Iwata, Hiroyuki Kuramoto, Kaneyuki Kubushiro, Mineo Ohmura, Kazunori Ochiai, Hiroharu Arai, Masaru Sakamoto, Teiichi Motoyama, Daisuke Aoki] Background: p16INK4a immunohistochemistry has revealed a high rate of positivity in cervical intraepithelial neoplasia grade 2 (CIN2) and more severe conditions (CIN2+). The Lower Anogenital Squamous Terminology Standardization project proposed p16INK4a immunohistochemistry as an ancillary test for CIN. Immunocytochemistry involving dual staining for p16INK4a and Ki-67 in the triage of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (LSIL) is reported to be useful in the identification of CIN2+. However, it is unclear whether p16INK4a/Ki-67 immunocytochemistry is of practical relevance for the triage of ASCUS and LSIL in the Japanese screening system. Methods: From 427 women fulfilling the eligibility criteria, 188 ASCUS and 239 LSIL specimens were analyzed. The accuracy of p16INK4a/Ki-67 immunocytochemistry and genotyping of high-risk human papillomaviruses (HPVs) in detecting CIN2+ were compared. Results: p16INK4a/Ki-67 immunocytochemistry was positive in 33.5% (63/188) of ASCUS, and 36.8% (88/239) of LSIL specimens. The sensitivity and specificity of p16INK4a/Ki-67 immunocytochemistry was 87.3% (95% confidence interval 78.0-93.8%) and 76.4% (71.6-80.8%), respectively. The positive and negative predictive values were 45.7% (37.6-54.0%) and 96.4% (93.4-98.3%), respectively; positive and negative likelihood ratios were 3.71 and 0.17, respectively. Using the McNemar test, p16INK4a/Ki-67 immunocytochemistry showed equivalent sensitivity but higher specificity than the HPV genotyping test Conclusions: Compared with high-risk HPV genotyping, p16INK4a/Ki-67 immunocytochemistry was a more accurate triage test for identifying CIN2+ in ASCUS and LSIL specimens. Japan Society of Clinical Oncology, 2014 Human papillomavirus nationallicence p16 immunocytochemistry nationallicence Liquid-based cytology nationallicence Cervical cancer screening nationallicence Biomarker nationallicence Fujii Takuma Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan aut Saito Miyuki Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan aut Hasegawa Toshihiko Department of Gynecology, Tokyo Health Service Association, 1-2, Sadoharacho, Ichigaya, Shinjuku-ku, 162-8402, Tokyo, Japan aut Iwata Takashi Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan aut Kuramoto Hiroyuki Department of Gynecology, Kanagawa Health Service Association, 58, Nihon Ohdori, Naka-ku, 231-0021, Yokohama, Kanagawa, Japan aut Kubushiro Kaneyuki Department of Obstetrics and Gynecology, Ohashi Medical Center, Toho University School of Medicine, 2-17-6, Ohashi, Megro-ku, 153-8515, Tokyo, Japan aut Ohmura Mineo Department of Gynecology, Kokoro to Karada no Genki Plaza, 3-6-5, Iidabashi, Chiyoda-ku, 102-8508, Tokyo, Japan aut Ochiai Kazunori Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 3-19-18, Nishi-shinbashi, Minato-ku, 105-8471, Tokyo, Japan aut Arai Hiroharu Department of Gynecology, National Tokyo Medical Center, 2-5-1, Higashigaoka, Meguro-ku, 152-8902, Tokyo, Japan aut Sakamoto Masaru Department of Gynecology, Sasaki Foundation Kyoundo Hospital, 1-8, Surugadai, Kanda, Chiyoda-ku, 101-0062, Tokyo, Japan aut Motoyama Teiichi Department of Pathology, Yamagata University School of Medicine, 2-2-2, Iidanishi, 990-9585, Yamagata-city, Yamagata, Japan aut Aoki Daisuke Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan aut International Journal of Clinical Oncology Springer Japan 20/1(2015-02-01), 134-142 1341-9625 20:1<134 2015 20 10147 https://doi.org/10.1007/s10147-014-0688-0 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-014-0688-0 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Fujii Takuma Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan aut NATIONALLICENCE 700 1- Saito Miyuki Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan aut NATIONALLICENCE 700 1- Hasegawa Toshihiko Department of Gynecology, Tokyo Health Service Association, 1-2, Sadoharacho, Ichigaya, Shinjuku-ku, 162-8402, Tokyo, Japan aut NATIONALLICENCE 700 1- Iwata Takashi Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan aut NATIONALLICENCE 700 1- Kuramoto Hiroyuki Department of Gynecology, Kanagawa Health Service Association, 58, Nihon Ohdori, Naka-ku, 231-0021, Yokohama, Kanagawa, Japan aut NATIONALLICENCE 700 1- Kubushiro Kaneyuki Department of Obstetrics and Gynecology, Ohashi Medical Center, Toho University School of Medicine, 2-17-6, Ohashi, Megro-ku, 153-8515, Tokyo, Japan aut NATIONALLICENCE 700 1- Ohmura Mineo Department of Gynecology, Kokoro to Karada no Genki Plaza, 3-6-5, Iidabashi, Chiyoda-ku, 102-8508, Tokyo, Japan aut NATIONALLICENCE 700 1- Ochiai Kazunori Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 3-19-18, Nishi-shinbashi, Minato-ku, 105-8471, Tokyo, Japan aut NATIONALLICENCE 700 1- Arai Hiroharu Department of Gynecology, National Tokyo Medical Center, 2-5-1, Higashigaoka, Meguro-ku, 152-8902, Tokyo, Japan aut NATIONALLICENCE 700 1- Sakamoto Masaru Department of Gynecology, Sasaki Foundation Kyoundo Hospital, 1-8, Surugadai, Kanda, Chiyoda-ku, 101-0062, Tokyo, Japan aut NATIONALLICENCE 700 1- Motoyama Teiichi Department of Pathology, Yamagata University School of Medicine, 2-2-2, Iidanishi, 990-9585, Yamagata-city, Yamagata, Japan aut NATIONALLICENCE 700 1- Aoki Daisuke Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/1(2015-02-01), 134-142 1341-9625 20:1<134 2015 20 10147