Combined external beam radiotherapy and vaginal brachytherapy versus vaginal brachytherapy in stage I, intermediate- and high-risk cases of endometrium carcinoma

Abstract

PurposeRandomized trials on the effect of external beam radiotherapy (EBRT) with or without vaginal brachytherapy (VBT) for endometrial carcinoma are very few. In view of this, the current study was conducted with the hypothesizes: whether the escalated dose of 26 Gy (VBT alone) in comparison with various major international trials (PORTEC-2) has any difference in rates of disease-free and overall survival with fewer adverse effects in low resource setting like India.Material and methodsAn open-labeled, non-inferiority, randomized control trial was undertaken at a regional cancer center among patients with stage IA or IB high-intermediate risk endometrial carcinoma. A total of 50 patients were divided equally among two arms of combined EBRT with VBT (arm I) and VBT alone (arm II). A dose of 50-50.4 Gy in 25-28 fractions of EBRT with 2 fractions of VBT 6.5 Gy each were delivered to patients in arm I and 4 fractions of VBT 6.5 Gy each to patients in arm II, and were followed up for 60 months.ResultsDuring the median follow-up of 36.5 months, two patients developed loco-regional recurrence in arm II, three (arm II), and one (arm I) developed distant metastasis. The 5-year survival rates for arms I and II were 96.0% vs. 92.0% overall, and 88.0% vs. 84.0% disease-free, respectively, and were not found to be statistically significantly different. Dermatological, gastro-intestinal toxicities, and cystitis were lower in the VBT group compared to combined group.ConclusionsVBT alone is as effective as EBRT+VBT in ensuring loco-regional control and achieving comparable survival rates, with fewer toxic effects for patients with stage I intermediate- and high-risk endometrial carcinoma. The dose escalation did not make a difference in the survival rates and was like in the other major trials (PORTEC-2).

The Effect of Prognostic Factors and Adjuvant Radiotherapy on Survival in Patients with High-Grade Early-Stage Endometrial Cancer: A Retrospective Clinical Study

“…Nout et al proposed VBT as the first-line adjuvant treatment for patients at intermediate or high risk of developing vaginal recurrence of endometrial and reported fewer gastrointestinal side effects when compared with external beam radiotherapy (EBRT) [18]. The results from a recently reported randomized study showed that VBT treatment alone was as effective as adjuvant EBRT combined with VBT in achieving loco-regional tumor control and resulted in similar survival rates, with fewer episodes of radiation toxicity in patients diagnosed with stage I intermediate-risk and high-risk endometrial carcinoma [19].…”

Vaginal toxicity after high-dose-rate endovaginal brachytherapy: 20 years of results

“…Different data in literature showed one correlation between total dose prescribed, doses for fractions, length of vagina treated, and vaginal late toxicity [8,48,49,50,51,52,53,54,55,56,60,61,62,63,64,65]. Sorbe et al .…”

ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma

“…Adjuvant brachytherapy provides excellent vaginal control and high survival rates, similar to those after adjuvant EBRT in this intermediate-risk population, as shown in large randomized trials, particularly the PORTEC-2 trial and Swedish trial. [306][307][308][309][310][311][312][313][314] It was also shown that only the small minority of patients with higher risk based on substantial LVSI, p53abn, or L1CAM overexpression had a slightly higher risk of pelvic recurrence with vaginal brachytherapy than those who had EBRT. Therefore, the intermediate-risk category only includes those with none or only focal LVSI and no p53abn.…”