Sokbom Kang1, Joo-Hyun Nam2, Duk-Soo Bae3, Jae-Weon Kim4, Moon-Hong Kim5, Xiaojun Chen6, Jae-Hong No7, Jong-Min Lee8, Jae-Hoon Kim9, Hidemich Watari10, Seok Mo Kim11, Sung Hoon Kim12, Seok Ju Seong13, Ki Tae Kim14, Seung Cheol Kim15, Jong-Hyeok Kim2, Myung-Cheol Lim1, Jung-Yun Lee12, Sang-Young Ryu5, Bingyi Yang6, Byoung-Gie Kim3. 1. Gynecologic Oncology Research Branch, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea. 2. Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. 3. Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 4. Department of Obstetrics and Gynecology, College of Medicine, Seoul National University, Seoul, Republic of Korea. 5. Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea. 6. Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. 7. Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. 8. Department of Obstetrics and Gynecology, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Republic of Korea. 9. Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. 10. Department of Gynecology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan. 11. Department of Obstetrics and Gynecology, Chonnam National University Medical School, Gwangju, Republic of Korea. 12. Department of Obstetrics and Gynecology, Institute of Women's Life Science, Yonsei University College of Medicine, Seoul, Republic of Korea. 13. Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea. 14. Department of Obstetrics and Gynecology, Busan Paik Hospital, College of Medicine, Inje University, Busan, Republic of Korea. 15. Department of Obstetrics and Gynecology, Ewha Womans University Mokdong Hospital, Ewha Womans University School of Medicine, Seoul, Korea.
Abstract
BACKGROUND: Previously proposed criteria for preoperatively identifying endometrial cancer patients at low risk for lymph node metastasis remain to be verified. For this purpose, a prospective, multicenter observational study was performed. METHODS: Eligible patients with histologically confirmed endometrial cancer underwent magnetic resonance imaging (MRI) and serum cancer antigen 125 (CA 125) testing before surgery. The following criteria were used to identify low-risk patients: 1) endometrioid-type cancer, 2) no evidence of deep myometrial invasion on MRI, 3) no enlarged lymph nodes on MRI, 4) no suspicious metastasis out of the uterine corpus, and 5) serum CA 125 levels less than 35 U/mL. Systematic pelvic and/or para-aortic lymphadenectomy was performed for all patients. The primary endpoint was estimation of the negative predictive value (NPV). RESULTS: From January 2012 to December 2014, 529 patients from 20 hospitals in 3 Asian countries were consecutively enrolled. According to our criteria, 272 patients (51.4%) were categorized into the low-risk group. Fifty-three of the 529 patients (10.0%) had lymph node metastases; these patients included 8 (2.9%) falsely categorized as low-risk. The sensitivity and specificity of the criteria were 84.9% and 55.5%, respectively. The NPV of 97.1% was higher than the predefined target endpoint of 96%. CONCLUSIONS: The low-risk criteria based on preoperative tests were confirmed to be reliable and accurate for identifying patients at low risk for lymph node metastasis. These criteria may facilitate patient counseling and surgical decision making. Cancer 2017;123:263-272.
BACKGROUND: Previously proposed criteria for preoperatively identifying endometrial cancerpatients at low risk for lymph node metastasis remain to be verified. For this purpose, a prospective, multicenter observational study was performed. METHODS: Eligible patients with histologically confirmed endometrial cancer underwent magnetic resonance imaging (MRI) and serum cancer antigen 125 (CA 125) testing before surgery. The following criteria were used to identify low-risk patients: 1) endometrioid-type cancer, 2) no evidence of deep myometrial invasion on MRI, 3) no enlarged lymph nodes on MRI, 4) no suspicious metastasis out of the uterine corpus, and 5) serum CA 125 levels less than 35 U/mL. Systematic pelvic and/or para-aortic lymphadenectomy was performed for all patients. The primary endpoint was estimation of the negative predictive value (NPV). RESULTS: From January 2012 to December 2014, 529 patients from 20 hospitals in 3 Asian countries were consecutively enrolled. According to our criteria, 272 patients (51.4%) were categorized into the low-risk group. Fifty-three of the 529 patients (10.0%) had lymph node metastases; these patients included 8 (2.9%) falsely categorized as low-risk. The sensitivity and specificity of the criteria were 84.9% and 55.5%, respectively. The NPV of 97.1% was higher than the predefined target endpoint of 96%. CONCLUSIONS: The low-risk criteria based on preoperative tests were confirmed to be reliable and accurate for identifying patients at low risk for lymph node metastasis. These criteria may facilitate patient counseling and surgical decision making. Cancer 2017;123:263-272.