• Radiation Therapy
• Reproductive Cancers
• Reproductive Cancers
• Radiology Clinical Trials

Data from a randomized phase 3 trial indicate that vaginal brachytherapy (VBT) may be a better option than pelvic radiotherapy for treating high-intermediate risk (age>60 and stage 1C grade 1–2 or stage 1B grade 3; any age and stage 2A grade 1–2 or grade 3 with <50% invasion) endometrial cancers because of a lower rate of side effects, leading to enhanced quality of life.

Remi A. Nout, MD, Leiden University Medical Center, Leiden, The Netherlands, reported the results of the PORTEC-2 trial (NCT00376844), in which patients were randomly assigned to either external beam radiation therapy (EBRT) (214 patients) or VBT (213 patients) as treatment for high-intermediate risk endometrial cancers following total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO). EBRT consisted of 46 Gy that was delivered in 23 fractions; VBT was delivered at a high-dose rate of 21 Gy in 3 fractions or at a low-dose rate of 30 Gy in a single fraction. Vaginal relapse rate was chosen as the primary endpoint, because data from PORTEC-1 indicated that the vagina was the major site of relapse in patients with endometrial cancer who had no further treatment after TAH-BSO (Creutzberg et al. Lancet 2000).

Dr. Nout reported that at a median follow-up of 36 months, the vaginal relapse rates were not significantly different between the 2 arms (0.9% for VBT vs 1.9% for EBRT; p=0.97). The rate of pelvic recurrence was higher for patients in the VBT arm (3.5% vs 0.6%; p=0.03), but Dr. Nout pointed out that the majority of those pelvic recurrences was associated with distant recurrence. Both overall survival and relapse-free survival rates were similar for both arms of the study. The 3-year disease-free survival rate was 89.7% for VBT compared with 88.6% for EBRT (p=0.68). The overall survival at 3 years was 90.8% for VBT and 90.3% for EBRT (p=0.96).

While the efficacy of the 2 treatments was similar, VBT offered an advantage in terms of quality of life, said Dr. Nout. He noted that patients who received VBT after surgery reported significantly less diarrhea (moderate to severe: 6% vs 22%; p<0.001), which resulted in significantly fewer limitations in daily activities (p<0.001) and significantly better social functioning (p<0.002).

In addition to improved quality of life, VBT offers the benefit of a lower time commitment for treatment. Patients who receive 23 fractions of EBRT usually receive treatment 5 times per week for approximately 5 weeks. In contrast, treatment with VBT is usually given with high-dose rate brachytherapy, which requires three outpatient visits in a two week period.

“Vaginal brachytherapy is safe and effective for patients with high-intermediate risk features,” said Dr. Nout, in conclusion. “[It] should be the treatment of choice for patients with high-intermediate risk endometrial carcinoma.”

• © 2008 MD Conference Express