The rationality of negative margin criteria for conization in early cervical cancer - a cohort study.

The 2023 (1st Edition) NCCN guideline changed the negative margin criteria for cervical conization from ≥ 3 mm to ≥ 1 mm. To explore the clinical safety of this up-dation in the real world, we performed a retrospective study to validate the rationality of the negative margin criteria for conization in patients with early-stage cervical cancer. We retrospectively collected the clinical and pathological data of 986 patients with early-stage cervical cancer from June 2011 to June 2023. All of the patients underwent conization and secondary (radical) hysterectomy at Tianjin Central Hospital of Gynecology Obstetrics. Patients were divided into four groups based on the status of the conization margins: margin < 1 mm (n = 132), margin < 3 mm (n = 147), margin involved (n = 443), and margin not involved (n = 264). The safety of the negative margin criteria for conization (< 1 mm) was evaluated by comparing the residual disease rates in different groups after secondary (radical) hysterectomy. Additionally, univariate and logistic multivariate analyses were conducted to identify the risk factors for residual disease after hysterectomy. A total of 986 patients with cervical cancer at stages IA1-IB1 were included. Among these patients, 382 had residual diseases (HSIL or higher) after hysterectomy, resulting in a residual disease rate of approximately 38.7%. Patients were categorized based on margin status (< 1 mm, <3 mm, margin involved, and, margin not involved). There were statistically significant differences in residual disease rates among the four groups (P < 0.05). There is no significant difference in residual disease rates between patients with the margin < 1 mm and margin < 3 mm, nor between these two groups and the margin not involved group. However, the residual disease rates in cases with margins < 1 mm and margins < 3 mm were significantly lower compared to those with margin involvement. Univariate analysis indicated that multiple factors, including age, were associated with residual disease. However, multivariate analysis revealed that age (P = 0.002, OR = 1.041, 95% CI 1.014–1.069), involvement of the margin by the lesion (P < 0.001, OR = 7.655, 95% CI 4.745–12.349), and cervical biopsy pathology showing cancer (P = 0.020, OR = 1.571, 95% CI 1.074–2.298) were independent risk factors for residual disease after hysterectomy in early-stage cervical cancer patients. Our findings suggest that a ≥ 1 mm negative margin criterion appears to be a safe threshold for early-stage cervical cancer, yet prospective validation is still required.