107 The study, conducted as part of GOG protocol #37, involved 114 women diagnosed with primary invasive squamous cell carcinoma of the vulva. All of the participants had a radical vulvectomy and lymphadenectomy on both sides of the inguinal canal. Those who had metastases in the groyne (one or both sides) were randomly assigned to either more pelvic node removal or radiotherapy to the pelvis and groyne. The primary aim of the research was to determine whether the addition of radiotherapy could enhance survival rates by at least 20% compared to surgery alone. The findings were published in the journal Oncology Reviews. Despite the study’s early termination due to observed benefits in the radiotherapy group, the findings provide valuable insights into the efficacy of this treatment approach. The researchers reported a notable improvement in overall survival (OS) and recurrence-free survival (RFS) among patients who received radiotherapy. One of the study’s significant findings was the difference in six-year overall survival rates between the two groups. Patients who underwent radiotherapy had an OS of 51%, compared to 41% in those who had only pelvic node resection. Although this difference was not statistically significant, the results indicate a trend favouring radiotherapy, particularly when considering the long-term outcomes. The study also revealed that the cumulative incidence of cancer-related deaths was lower in the radiotherapy group, with 29% compared to 51% in the surgery-only group. Recurrence-free survival also showed promising results, with 59% of patients in the radiotherapy group remaining disease-free at six years, compared to 48% in the control group. The study highlighted that radiotherapy was particularly beneficial for patients with more extensive disease, specifically those with over 20% positive groin nodes. In these cases, the six-year OS was significantly higher at 36% for the radiotherapy group, compared to just 13% for those who had pelvic node resection alone. While the study emphasised the potential benefits of radiotherapy, it also addressed the associated risks, particularly in terms of toxicity. Acute toxicities, such as wound infections and urinary tract infections, were comparable between the two groups, with no significant differences observed. But late cutaneous toxicity was slightly higher in the radiotherapy group, affecting 19% of patients compared to 15% in the pelvic node resection group. Chronic lymphedema, a common concern in cancer treatments involving lymph node removal or irradiation, was found to be less prevalent in the radiotherapy group, with 16% of patients affected, compared to 22% in the control group. Despite these findings, the study noted that the quality of life for patients was not assessed, leaving a gap in understanding the long-term impact of these side effects. The study’s findings suggest that adjuvant radiotherapy could offer significant benefits for women with node-positive vulvar cancer, particularly in reducing the risk of recurrence and improving survival rates. However, the researchers caution that the evidence remains of low certainty due to the early termination of the trial and the resulting limitations in statistical power.