Table Info

Table 1.

Characteristics of included studies

First author (year)	Study design	Location	Inclusion criteria (original study)	Exclusion criteria (original study)	Sample size	Sample type	Main result
Agha-Hosseini, et al. (2009) [13]	Case-control study	Iran	Case: patients who are candidates for surgery Control: healthy women	-	Healthy women: 25 Untreated breast cancer: 24 Treated breast cancer: 23	Serum and unstimulated whole saliva	The mean saliva and serum cancer antigen 125 (CA-125) levels were significantly higher in untreated cancer women compared to healthy and treated groups
Fang et al. (2017) [14]	Case-control study	China	Invasive breast cancer	-	Invasive breast cancer: 151 Control: 180	Serum	High preoperative CA-125 levels may reflect tumor burden and are associated with aggressive molecular subtype
Gioia et al. (2016) [15]	Prospective follow-up study	Germany	End of the adjuvant therapy (chemotherapy and/or radiotherapy) First treatment with a therapeutic approach	Patients with a history of Metastatic disease (lymph node and organ metastases) Patients under palliative treatment	Metastatic group: 47 Control group: 48	Serum	The assessment of CA-125 in combination with carcinoembryonic antigen (CEA) and CA 15-3 can be a useful tool in follow-up
Norum et al. (2001) [16]	Retrospective study	Norway	Patients examined at least three times	-	221	Serum	Increased CA-125 was associated with metastasis in or near the pleura, and in stage IV breast cancer, it was related to poor prognosis
Zhang et al. (2021) [17]	Prospective study	China	Not prohibiting imaging examinations Absence of other malignant tumors Acceptance of neoadjuvant therapy	Incomplete clinical data The presence of inflammation and other diseases affecting the results of the research Failure to cooperate with clinical follow-up	65	Serum	Serum levels of CA-125 are useful for the evaluation of the impact of neoadjuvant chemotherapy on breast cancer patients
Chen et al. (2017) [18]	Retrospective study	China	-	Bone metabolic diseases Kidney failure Eating disorders Another primary malignancy Breast patients with other distant organ metastases such as lung, liver, and brain metastases	2,133	Serum	Axillary lymph node metastases and the concentrations of CA-125, CA-153, alkaline phosphatase (ALP), and hemoglobin were the independent risk factors for bone metastases in patients with breast cancer
Gaughran et al. (2020) [19]	Retrospective study	Australia	-	Patients without three or more tumor markers within 4 weeks of diagnosis Patients without four tumor markers at 3 months after diagnosis Patients without imaging at diagnosis Patients with other concurrent malignancies	193	Serum	Increased CA-125 was significantly associated with pleural/peritoneal metastases
Ju et al. (2016) [20]	Case-control study	China	-	-	Initial diagnostic:47 Recurrent:44 Healthy control: 43	Serum	Serum CA-125 levels in recurrent breast cancer patients were higher than in initial diagnostic patients
Yerushalmi et al. (2012) [21]	Retrospective study	Canada	Visiting the patient in stage M 1 Distant recurrence in later stages	Previous, synchronous, or subsequent invasive or in situ cancer of any site other than nonmelanoma skin	810	-	Elevation of CA-125 was documented in the majority of patients with metastatic breast cancer
Ma et al. (2022) [22]	Retrospective study	China	18-75 years old ECOG score of 0-1 Er, pr positive and human epidermal growth factor receptor 2 (HER-2) negative IV stage	Acute or chronic inflammation Breast cancer in males HER-2 positive and triple-negative breast cancer	130	Serum	The high CA-125 related to worse overall survival than the low CA-125 group
Lian et al. (2019) [23]	Retrospective study	China	No history of cancer Complete medical record Performing serum tumor markers two weeks before surgery No history of radiotherapy/chemotherapy/endocrine therapy before surgery	Unknown TNM stage Breast cancers in male Other cancer Patients with stage IV disease at diagnosis	Breast cancer: 804 Healthy women: 305	Serum	In comparison with the healthy volunteer group, both patients with breast cancer and patients with benign breast diseases had higher CA-125
Zhang et al. (2014) [24]	-	China	Female breast cancer patients with brain metastases Age group 26–79 years Diagnosis of breast cancer by biopsy	IV stage	166	Serum	Breast cancer patients with brain metastases’ CA-125 and CA-153 express levels are correlated to their clinicopathologic feature
Zhang et al. (2013) [25]	Follow-up study	China	-	-	65	Serum	CA-125 in the recurrence group was higher than in the non-recurrence group
Yuan et al. (2009) [26]	Retrospective study	China	Female breast cancer without the use of adjuvant chemotherapy or neoadju and trastuzumab Sufficient sample to investigate biological factors	-	274	Serum	No significant correlation exists between CA-125 and HER2 status in invasive ductal breast cancer patients
Tang et al. (2021) [27]	Retrospective observational study	China	Women with breast cancer Postmenopausal status Primary breast cancer	Primary ocular malignancies or benign tumors without pathology reports	865	Serum	Our investigation suggests that CA-125, remarkably predicts intraocular metastases in postmenopausal breast cancer as risk factors, and the combination of CA-125 and CA 15-3 shows considerable diagnostic value
Wang et al. (2015) [28]	-	China	-	Poor general conditions Failure to tolerate the side effects of the chemotherapeutic agent(s) Malignant disease (other than breast cancer) in the past 5 years Immunological disease	348	Serum	CA-125 has little clinical significance in predicting neoadjuvant treatment response in locally advanced breast cancer
Winden et al. (2012) [29]	Nested case-control study	Netherlands	Breast cancer within three years of entering the cohort Menopausal women	Diabetes Present smokers Using oral contraceptives or menopausal hormone therapy	Breast cancer: 68 Healthy controls: 68	Serum	The panel of selected tumor markers cannot be used for the diagnosis of early breast cancer.
López-Jornet et al. (2021) [30]	Cross-sectional study	Spain	Women with breast cancer Age over 18 years Control group: women were matched with breast cancer patients in terms of age, body weight, and body mass index (BMI) No history of malignancy	Fixed orthodontics Drug treatments associated with gingival overgrowth (nifedipine, cyclosporine, and phenytoin) Psychomotor disorders	Breast cancer patients: 91 Controls: 60	Saliva	The salivary biomarkers CA-125 appear to be promising tools in the diagnosis of breast cancer
Nazmeen et al. (2017) [31]	Cross-sectional study	India	-	-	-	Serum/tissue	CA-125 is a predictive marker in ovarian/breast carcinoma depending on the disease’s nature/stages
Luan et al. (2021) [32]	Retrospective case-control study	China	Female patients Between 18 and 75 years No malignancy within 5 years before entering the study Detection of circulating tumor cells (CTC) and tumor marker tests before initiation of any treatment	Pregnancy or breastfeeding at the time of CTC detection or serum tumor marker tests The time between CTC detection and serum tumor marker tests over 48 hours Extreme values of test results of CTC or serum tumor markers (1,000 times higher than average)	Breast cancer: 141 Control women: 71	Serum	CA-125 was not considered a biomarker for breast cancer
Luo et al. (2023) [33]	Retrospective observational study	China	Breast cancer: other malignant tumors and gynecological diseases or benign breast lesions in patients Breast cancer patients in line with the guidelines and norms for diagnosis and treatment of breast cancer Benign lesions: patients diagnosed with pathologically benign breast lesions (such as breast fibroadenoma)	Breast cancer: other malignant tumors and gynecological diseases Severe diseases, such as those of the liver, kidney, or heart Pregnant or lactating women Benign lesions: patients with malignant tumors or gynecological diseases Patients with severe diseases, such as those of the liver, kidney, or heart Pregnant or lactating women	Breast cancer: 108 Benign lesions: 77	Serum	Combinations of Alpha-fetoprotein (AFP) + CA153 + CA-125 have high accuracy (80.25%) in the screening and diagnosis of female breast cancer
Feng et al. (2020) [34]	-	China	Confirmation of breast cancer using pathology 20–60 years old Examination of the patient within 3 years after the radical operation Smooth operation and dissection of lymph nodes No severe complications	Abnormal PET-CT imaging caused by abscesses and active infection History of thyroid diseases, fractures, osteoarthritis, and osteoporosis; patients with other organ metastases Using drugs affecting bone metabolism Hormone therapy Autoimmune diseases Severe heart, liver, and kidney disease Other malignant tumors Severe infectious diseases	Bone metastasis: 60 Non-bone metastasis: 58	Serum	CA-125 may be involved in the occurrence and progression of bone metastasis of breast cancer
Geng et al. (2022) [35]	Prospective study	China	Confirmation of breast cancer using pathology Not using neoadjuvant chemotherapy Clinically n0 and some regions n1 Taking blood samples within 3 days before surgery	-	705	Serum	CEA, CA-125, CA153, tumor size, vascular invasion, calcification, and tumor grade were independent prognostic factors for positive lymph node metastasis
Kosmas et al. (2005) [36]	-	Greece	Confirmation of breast cancer in terms of histology Treatment with different chemotherapy regimens Tumor markers measurable in cerebrospinal fluid (CSF)	-	5	CSF and serum	CSF tumor marker evaluation may provide a reliable means and surrogate end-points for monitoring the response of carcinomatous meningitis to treatment
Tornos et al. (2005) [37]	-	USA	Confirmation of the diagnosis of metastatic breast carcinoma	-	Ovarian carcinoma: 42 Breast carcinoma: 36 Metastasis: 39	-	The presence of immunoreactivity for wt1 and CA-125 in a carcinoma involving the ovary strongly favors a primary lesion
Moritani et al. (2008) [38]	Case-control study	Japan	-	-	Breast cancer: 37 Genital organ cancer: 23	-	CA-125 is not a sufficient marker to differentiate Invasive micropapillary carcinoma of the breast from serous papillary adenocarcinoma
Dong et al. (2015) [39]	Retrospective study	China	-	-	26	Serum	No significant difference in the CEA and CA-125 serum levels between confirmed positive and confirmed negative PET/CT groups was found
Lin et al. (2018) [40]	Cohort study	China	-	Past radiotherapy or chemotherapy Non-cooperation in follow-up	486	Serum	Higher levels of preoperative serum tumor markers, such as CA-125, could represent tumor burden and have been suggested to be independent risk factors for the prognosis of breast cancer
Li et al. (2019) [41]	Retrospective analysis	China	Invasive breast cancer patients Age ≤ 40 years old treated during that period	Patients without follow-up CEA, CA-125, or other necessary data could not be extracted Neoadjuvant chemotherapy before surgery Metastasis at the time of diagnosis Previous or coexisting cancers Severe disease that influences patients’ survival	576	Serum	Preoperative serum CA-125 levels could be the independent prognostic factors for overall survival
Li et al. (2017) [42]	-	China	-	Infections Diabetes Encyesis Other reasons that might cause a high serum level	168	Serum	Serum CA-125 levels after the operation have certain instructional significance for the prognosis of breast cancer patients
Fan et al. (2022) [43]	Retrospective study	China	Invasive breast cancer Mastectomy or breast surgery and armpit lymph nodes Absence of distant metastasis Standard postoperative systemic treatment and regular follow-up examinations No other malignancy at the first visit	Less than 18 years of age Lack of standard systemic treatment after surgery Bilateral breast cancer Distant metastasis or occurrence of primary malignancy elsewhere Preoperative blood loss Postoperative infections	190	Serum	The tumor marker of CA-125 has potential prognostic value for breast carcinoma
Lou et al. (2020) [44]	Retrospective analysis	China	Triple-negative breast cancer Age 18–75 years Receiving radical mastectomy and regular chemotherapy after the operation	Incomplete clinical data Serious diseases, heart and kidney diseases, and other diseases Absence of mental illness or brain disease Absence of other cancers or non-primary breast cancer	Triple-negative breast cancer: 107 Non-triple-negative breast cancer: 235	Serum	The combination of serum CA-125, CA153, and CEA has a certain value in the diagnosis of triple-negative breast cancer, and high levels of CA-125 and CA153 after the operation in triple-negative breast cancer Patients indicate poor prognosis
Li et al. (2020) [45]	Cohort study	China	Pathologically confirmed breast cancer	Patients with stage IV at diagnosis Preoperative metastasis Receiving neoadjuvant chemotherapy	10,836	Serum	CA-125 is directly associated with aggressive clinicopathological characteristics

Declarations

Author contributions

ZM, AM: Conceptualization, Methodology, Investigation, Writing—original draft. HS, IA, and LA: Conceptualization, Methodology, Formal analysis, Writing—review & editing. ZK: Formal analysis, Writing—review & editing. All authors contributed to the article and approved the submitted version.

Conflicts of interest

All authors declare that they have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

The primary data for this systematic review were sourced online from databases listed in the methods. Referenced articles are accessible on PubMed/MEDLINE, Scopus, and Web of Science databases. Additional supporting data are available from the corresponding author upon request.

Funding

Not applicable.

Copyright

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Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.

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