Ovarian cancer is one of the malignant tumors with relatively high incidence among the female reproductive system in China. Due to the deep pelvic location of the ovaries, early lesions are difficult to detect through gynecological examinations. Additionally, patients with early-stage ovarian cancer usually have no specific symptoms, leading most patients to be diagnosed at an advanced clinical stage with a low 5-year survival rate. Therefore, conducting early screening for ovarian cancer (hereinafter referred to as "early screening") is conducive to its early diagnosis, early treatment, and reduction of mortality. This consensus was jointly discussed and formulated by the Gynecologic Oncology Professional Committee of the China Geriatric Health Care Association and the Obstetrics and Gynecology Physicians Branch of the Chinese Medical Doctor Association. It refers to relevant guidelines from the National Comprehensive Cancer Network (NCCN), The American College of Obstetricians and Gynecologists (ACOG), the US Preventive Services Task Force (USPSTF), the European Society for Medical Oncology (ESMO), the British Gynaecological Cancer Society (BGCS), and Cancer Australia (CA). Ultimately, it was developed based on the retrieval of high-level evidence-based medical evidence for clinical reference by clinicians.
Since this consensus cites many studies with negative screening test results (i.e., the screening strategy is not recommended), and the ESMO guidelines have a clear grading system for evidence level and recommendation strength for trials with negative results, the ESMO guidelines' grading system for evidence level and recommendation strength is adopted, as shown in Table 1.
The lifetime risk of developing ovarian cancer in the general population is approximately 1%-1.5%. About 20%-30% of ovarian cancer patients in China have genetic susceptibility, such as BRCA1, BRCA2 gene mutations, and Lynch syndrome. The general-risk population refers to those without a family history of breast or ovarian cancer and no genetic susceptibility. The high-risk population refers to those with a family history of breast or ovarian cancer or genetic susceptibility. Therefore, early screening for ovarian cancer should first collect family history to identify potential high-risk or general-risk individuals. Ovarian cancer has a low incidence rate; if the false-positive rate of screening is too high, many women will experience anxiety and undergo unnecessary surgeries. Thus, the screening strategy must have a high positive predictive value to achieve a good cost-effectiveness ratio. Most epidemiologists use a positive predictive value >10% as the threshold for evaluating the effectiveness of ovarian cancer screening. Reducing ovarian cancer-related mortality is a key indicator of screening benefits. A significant increase in the proportion of early-stage ovarian cancer through screening is a prerequisite for reducing ovarian cancer-related mortality.
No existing clinical trials have proven that early screening can reduce ovarian cancer-related mortality in this population.
Recommendation 1: Early screening for ovarian cancer is not recommended for asymptomatic general-risk populations (Evidence level: Ⅰ, Recommendation strength: E).
Recommendation 2: Gynecological examinations are not recommended for early screening of ovarian cancer in asymptomatic general-risk populations (Evidence level: Ⅳ, Recommendation strength: D).
Recommendation 3: The ovarian cancer symptom index is not recommended for early screening of ovarian cancer in asymptomatic general-risk populations (Evidence level: Ⅳ, Recommendation strength: D).
Recommendation 4: Concurrent screening with CA125 combined with transvaginal ultrasound is not recommended for early screening of ovarian cancer in asymptomatic general-risk populations (Evidence level: Ⅰ, Recommendation strength: E).
Recommendation 5: Sequential screening with CA125-based Risk of Ovarian Cancer Algorithm (ROCA) index combined with transvaginal ultrasound is not recommended for early screening of ovarian cancer in asymptomatic general-risk populations (Evidence level: Ⅰ, Recommendation strength: E).
Recommendation 6: Other tumor markers such as HE4 and their combinations are not recommended for early screening of ovarian cancer in asymptomatic general-risk populations (Evidence level: Ⅳ, Recommendation strength: D).
Recommendation: For high-risk populations with ovarian cancer who postpone or refuse risk-reducing bilateral salpingo-oophorectomy (rrBSO), sequential screening with ROCA index combined with transvaginal ultrasound every 4 months may be considered as appropriate (Evidence level: Ⅲ, Recommendation strength: C).
Recommendation 1: For women with a high-risk family history of ovarian cancer or breast cancer, next-generation multi-gene panel testing covering high-risk and intermediate-risk genes is recommended. If high-risk or intermediate-risk gene testing is positive, tumor risk screening and management should be performed as described below (see Sections 6.1-6.9 in the text). If a gene mutation increases the lifetime risk of ovarian cancer to ≥5%, risk-reducing rrBSO is recommended. If a gene mutation increases the lifetime risk of ovarian cancer to <5% but higher than that of the general population, the potential advantages and disadvantages of rrBSO should be comprehensively considered in combination with family history, and the potential pros and cons of rrBSO should be fully informed to the subject. If the subject has a family history of ovarian cancer but no hereditary pathogenic mutations, the risk of ovarian cancer may be slightly higher than that of the general population. Risk management should consider the overall family history, and concurrent screening with CA125 combined with transvaginal ultrasound is generally not recommended (Evidence level: Ⅳ, Recommendation strength: A).
Recommendation 2: For ovarian cancer screening, individuals with germline BRCA1 mutations should undergo transvaginal ultrasound and CA125 screening every 6 months until rrBSO is completed, and rrBSO should be performed at 35-40 years old after completing childbirth. Individuals with germline BRCA2 mutations should undergo transvaginal ultrasound and CA125 screening every 6 months until rrBSO is completed, and rrBSO should be performed at 40-45 years old after completing childbirth. Women with a family history of early-onset ovarian cancer may have rrBSO performed at an earlier age. There is still controversy regarding whether to screen for pancreatic cancer (Evidence level: Ⅳ, Recommendation strength: B).
Recommendation 3: For endometrial cancer screening in Lynch syndrome, it should start at 30-35 years old, or 5-10 years earlier than the age of the earliest diagnosis of Lynch syndrome-related cancer in the family, with endometrial biopsy performed every 1-2 years. For Lynch syndrome patients who have completed childbirth, prophylactic total hysterectomy (TH) combined with rrBSO is recommended. TH-rrBSO is usually recommended at 40-45 years old, and personalized recommendations can also be made based on whether childbirth is completed, menopause status, comorbidities, family history, and Lynch syndrome gene mutation type. rrBSO is not recommended for patients with MSH6 and PMS2 mutations. The risk of ovarian cancer in Lynch syndrome patients varies significantly according to the type of gene mutation. There is still controversy regarding ovarian cancer screening, and existing clinical data do not support the use of transvaginal ultrasound and CA125 for ovarian cancer screening (Evidence level: Ⅳ, Recommendation strength: C).
Recommendation 4: Li-Fraumeni syndrome slightly increases the risk of ovarian cancer (<5%), and rrBSO is usually not recommended. However, for carriers with a family history of ovarian cancer, the potential advantages and disadvantages of rrBSO should be discussed (Evidence level: Ⅳ, Recommendation strength: C).
Recommendation 5: For PTEN hamartoma tumor syndrome (PHTS), annual random endometrial biopsy and transvaginal ultrasound should start at 35 years old, or 5 years earlier than the earliest age of endometrial cancer diagnosis in the family. PTEN gene mutation slightly increases the risk of ovarian cancer (<5%), and rrBSO is usually not recommended. However, for carriers with a family history of ovarian cancer, the potential advantages and disadvantages of rrBSO should be discussed (Evidence level: Ⅳ, Recommendation strength: C).
Recommendation 6: For Peutz-Jeghers syndrome (PJS), annual physical examinations should start at 8 years old to observe for precocious puberty. For cervical cancer screening, gynecological examinations and thinprep cytologic test (TCT) should be performed annually starting at 18-20 years old. There is still controversy regarding the screening of endometrial cancer and ovarian cancer. Based on research data in the Chinese population, screening may be considered. For endometrial cancer screening, annual gynecological examinations should start at 18-20 years old, and endometrial biopsy may be performed if abnormal uterine bleeding occurs. For ovarian cancer screening, annual gynecological examinations and pelvic ultrasound should start at 18-20 years old. TH-rrBSO may be considered at 35 years old or after completing childbirth (Evidence level: Ⅳ, Recommendation strength: C).
Recommendation 7: rrBSO is recommended at 45-50 years old. If there is a family history of early-onset ovarian cancer, rrBSO can be performed earlier (Evidence level: Ⅳ, Recommendation strength: B).
Recommendation 8: rrBSO is recommended at 45-50 years old (Evidence level: Ⅳ, Recommendation strength: B).
Recommendation 9: rrBSO is recommended at 45-50 years old, and it can be advanced for those with a family history of early-onset ovarian cancer (Evidence level: Ⅳ, Recommendation strength: B).
Recommendation 10: ATM gene mutation slightly increases the risk of ovarian cancer (<5%), and rrBSO is usually not recommended. However, for carriers with a family history of ovarian cancer, the potential advantages and disadvantages of rrBSO should be discussed (Evidence level: Ⅳ, Recommendation strength: C).
Ovarian cancer screening should first collect family history to identify potential high-risk and general-risk individuals. For general-risk individuals, annual sequential screening with ROCA combined with transvaginal ultrasound has a high positive predictive value. Although it can reduce the proportion of advanced ovarian cancer, randomized controlled trials have not proven a benefit in reducing ovarian cancer-related mortality. Therefore, ovarian cancer screening is not recommended for the general-risk population. For high-risk populations, sequential screening with ROCA combined with transvaginal ultrasound every 4 months can increase the proportion of early-stage ovarian cancer, but there is a lack of data on survival benefits. These populations should receive genetic counseling and consider genetic testing, and may benefit from rrBSO. In addition, the application of new technologies such as liquid biopsy and artificial intelligence provides new ideas for ovarian cancer screening, but large-scale population clinical validation is still needed.
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