Dr Agustí on Patient Eligibility for Evaluating Chemoradiotherapy vs Radiotherapy Alone in Intermediate-Risk Cervical Cancer

Núria Agustí, MD

“[In this study,] we included patients who have undergone radical hysterectomy with negative lymph nodes, and we divided the population based on whether they received radiotherapy alone vs chemoradiation.”

Núria Agustí, MD, a postdoctoral fellow at MD Anderson Cancer Center, discussed the patient population included in a cohort study evaluating adjuvant chemoradiotherapy vs radiotherapy alone in the treatment of intermediate-risk cervical cancer.

The study used data retrieved from the National Cancer Database between 2010 and 2020, Agustí Garcia began. She emphasized that data prior to 2010 were not included because there were no values for lymphovascular space invasion (LVSI), and there also wasn’t information on surgical approaches. These variables could directly affect primary outcomes, which is largely why prior data were excluded, she explained.

The patient population included those with cervical cancer who underwent radical hysterectomy with negative lymph nodes and were stratified based on whether they had received adjuvant chemoradiotherapy or radiotherapy alone, Agustí noted. Patients not included on the study had high-risk disease factors, such as positive margins, parametrial extension, and positive lymph nodes. Furthermore, the Sedlis criteria for the study included the intermediate-risk group of patients with cervical cancer, Agustí said. For missing values, multiple imputation allowed for a more accurate representation of the patient population, she added. After imputation, the propensity score was matched 1:1 to control the cofounders related to clinical, pathologic, and demographic variables to have a well balanced population, she said.

Of note, a total of 1116 patients were identified ,and 43.5% had received concurrent chemoradiotherapy, according to the findings from the study published in JAMA Oncology. Patients with adenocarcinoma or adenosquamous histology more commonly received chemotherapy compared with those with squamous cell carcinoma (risk ratio [RR]; 12.6; 95% CI, 1.10-1.44) and those with tumors larger than 4 cm vs tumors less than 4 cm (RR, 1.31; 95% CI, 1.14-1.51).

In the study, a subgroup analysis was also performed based on 5 variables that could affect the primary outcome of survival, based on prior evidence, Agustí noted. She concluded that these variables included the LVSI, tumor size, histology, surgical approach, and radiotherapy use.

The study also evaluated the potential association of unmeasured confounders using the E-value, a sensitivity analysis that quantified the strength of association an unmeasured confounder must have with the exposure and outcome to explain an observed association. A sensitivity analysis was also performed using a complete case approach and compared the results with those from the fully imputed datasets.

The results of this cohort study suggested that adding chemotherapy to radiotherapy was not associated with improved overall survival (OS) in patients with intermediate-risk cervical cancer. The subgroup analysis did not show any differences in OS according to the use of chemoradiotherapy or radiotherapy alone.