Survival assessment of sentinel lymph node biopsy alone without lymphadenectomy for early cervical cancer in real-world data.
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OBJECTIVE: The PHENIX-I clinical trial in China demonstrated that sentinel lymph node (SLN) biopsy alone without additional lymphadenectomy for early cervical cancer had oncologic outcomes non-inferior to SLN biopsy and additional lymphadenectomy. This study examined overall survival associated with SLN biopsy alone without additional lymphadenectomy for early cervical cancer using real-world data in the United States. METHODS: This retrospective cohort study queried the Commission-on-Cancer's National Cancer Database. The study population included 465 patients aged 18-65 years-old with cervical cancer (preoperative stage IA1 with lympho-vascular space invasion, IA2, IB1, and IIA1 with tumor size of ≤3 cm) who underwent primary radical hysterectomy and SLN biopsy from 2012 to 2022. Exposure was additional lymphadenectomy at SLN biopsy (SLN biopsy alone n = 231, SLN biopsy and additional lymphadenectomy n = 234). Outcome measure was overall survival, assessed with Cox proportional hazard regression model adjusting for preoperative factor-derived propensity score and postoperative confounders (pathological lymph node metastasis, radiotherapy, and chemotherapy). RESULTS: The 5-year overall survival rates were 98.6% (95% confidence interval 94.3 to 99.7) for the SLN biopsy alone group and 96.8% (95% confidence interval 93.0 to 98.6) for the SLN biopsy and additional lymphadenectomy group (P = .69). Adjusted-hazard ratio for SLN biopsy alone compared to SLN biopsy and additional lymphadenectomy was 0.94 (95% confidence interval 0.24 to 3.67). Exploratory analysis showed similar results for squamous histology, preoperative stage IB1 with tumor size of ≤3 cm, and robotic-assisted surgery (all, P > .05). CONCLUSION: The results of this real-world data in the United States suggested that SLN biopsy alone without additional lymphadenectomy for early cervical cancer meeting the PHENIX-I trial criteria may not have negative effects on short-term overall survival, warranting further validation.