Assessment of postoperative therapy de-escalation for early-stage, intermediate-risk cervical cancer.

Objective: The objective of this study was to assess the oncologic outcome of surgically-treated patients with early-stage, intermediate-risk cervical cancer according to postoperative therapy modality.

Methods: This retrospective cohort study queried the Japanese Gynecologic Oncology Group's nationwide surgical data platform. The study population was 1084 patients with stage IB cervical cancer who underwent primary radical hysterectomy and lymphadenectomy from 2004 to 2008. Histology type-incorporated intermediate-risk factor patterns were clustered into three groups based on recurrence risk. Oncologic outcomes were assessed per postoperative therapy: external beam radiotherapy alone, concurrent chemo-radiotherapy, chemotherapy alone, and no treatment.

Results: Histology-incorporated intermediate-risk groups included: no lympho-vascular space invasion in any histology, or squamous cell carcinoma with lympho-vascular space invasion but no deep stromal invasion (n=559, 51.6%, group 1); squamous cell carcinoma with both lympho-vascular space invasion and deep cervical stromal invasion (n=281, 25.9%; group 2); and non-squamous histology with lympho-vascular space invasion (n=244, 22.5%; group 3). The 5-year disease-free survival rates were 93.3%, 89.3%, and 82.5% for group 1,-2, and -3, respectively (p<0.001), with group 3 exhibiting an almost three-fold increased recurrence risk compared with group 1 (adjusted-hazard ratio (aHR) 2.70, 95% confidence interval (CI) 1.70-4.32), followed by group 2 (aHR 1.67, 95% CI 1.01 to 2.75). Disease-free survival was similar across the postoperative therapy groups: 5 year rates for external beam radiotherapy alone, concurrent chemo-radiotherapy, chemotherapy alone, and no postoperative treatment, 94.8%, 87.2%, 93.6%, and 94.2% for group 1 (p=0.294); 85.0%, 93.3%, 87.3%, and 90.5% for group 2 (p=0.578); and 85.4%, 83.1%, 80.5%, and 83.3% for group 3 (p=0.876). The aHR for disease-free survival comparing no postoperative treatment to external beam radiotherapy alone was 1.10 (95% CI 0.37 to 3.28), 0.71 (95% CI 0.29 to 1.79), and 1.21 (95% CI 0.42 to 3.51) for group 1, group 2, and group 3, respectively. The observed exposure-outcome associations were similar for cause-specific survival (all, p>0.05).

Conclusion: In this retrospective investigation in Japan, active surveillance without postoperative therapy following radical hysterectomy and lymphadenectomy was not associated with oncologic outcome in early-stage, intermediate-risk cervical cancer.