Accuracy of surveillance serum squamous cell carcinoma antigen for cervical cancer recurrence after definitive chemoradiation.

Recurrence remains a significant clinical problem for patients with cervical cancer, and early detection may improve outcomes. Serum squamous cell carcinoma antigen (SCCA) is a biomarker of prognosis and response to chemoradiotherapy. We hypothesized that elevated serum SCCA during surveillance is sensitive and specific for recurrence. Pre-treatment and follow-up serum SCCA from patients treated with definitive-intent radiotherapy were measured via enzyme-linked immunosorbent assay in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory and analyzed retrospectively. Follow-up SCCA was defined as the value closest to recurrence, or as last available for patients without recurrence. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of follow-up SCCA for recurrence was determined for the whole cohort (Cohort 1), for patients with elevated (Cohort 2), and normal pre-treatment SCCA (Cohort 3). Patterns of failure were also evaluated. Of 227 patients in Cohort 1, 23% experienced recurrence, and 17% died of cervical cancer. Mean follow-up SCCA was 0.9 (±2.5) for patients with no recurrence and 6.0 (±18.7) for patients with recurrence (p=0.02). Sensitivity, specificity, PPV, and NPV of follow-up SCCA for recurrence in Cohort 1 were 38.5%, 97.1%, 80%, and 84.2%, and for patients in Cohort 2 were 54.5%, 95%, 78.3%, and 86.5%, respectively. Four of 86 patients in Cohort 3 had an elevated follow-up SCCA, two of these at the time of recurrence. Elevated pre-treatment SCCA and follow-up SCCA were associated with isolated pelvic recurrence. Surveillance serum SCCA has high specificity and NPV for recurrence, and may be of limited utility in patients with normal pre-treatment SCCA.

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Competing interests: JS has research grant funding on cervical cancer from the National Institutes for Health (NIH), AACR-Bristol-Myers Squibb Female Investigator Grant. LK serves on the Society of Gynecologic Oncology (SGO) Diversity, Inclusion, Health Equity Committee. MP has grants from GSK, has received consulting fees from Merck, AstraZeneca, GSK/Tesaro, Eisai, Clovis Oncology, Immunogen, Seagen, and serves on committees for NRG Oncology/National Cancer Institute (NCI), Foundation for Women’s Cancer. PT has grant funding from Glaxo Smith Kline, Merck, and consulting fees from Immunon. She serves on the Data Safety Monitoring Board or Advisory Boards for Iovance, Astra Zeneca, Immunon, Novocure, Glaxo Smith Kline, Verastem, Clovis Oncology, Caris, R Pharm, Merck, Mersana, Immunogen, Aadi Pharmaceuticals, Seagen, Zentalis, and has stock options in Immunon. SM has cervical cancer grant funding from the NCI, American Cancer Society, American Society of Clinical Oncology (ASCO) and Conquer Cancer Foundation, leadership or fiduciary role in other board, society, committee or advocacy groups, paid or unpaid: National Comprehensive Cancer Network (NCCN) Thyroid Carcinoma Panel, NRG Oncology – Gynecologic Cancers Radiation Therapy Committee, K12 Paul Calabresi Program in Oncology, Alumni Advisory Council (AAC) Wisconsin Surgical Outcomes Research Program (WiSOR), American Society for Radiation Oncology (ASTRO), MDACC Moonshots Advisory Committee; other financial or non-financial interests: Principal Investigator of clinical trial, ClinicalTrials.gov Identifier: NCT03955978 – TSR-042. SG has grants or contracts from NCI, and receives consulting fees from GenesisCare USA, and speaking honoraria from Varian Medical Systems.