Intensive follow-up does not improve survival in endometrial cancer
Intensive follow-up for 5 years did not improve overall survival (OS) or relapse-free survival (RFS) in patients who have undergone surgical treatment for endometrial cancer, according to results of the TOTEM study presented at IGCS 2021.
The study was conducted in 39 centres in Italy and three in France between 2008 and 2018. The final population comprised 1,847 women aged >18 years (median age ~64 years) with no residual macroscopic tumour after undergoing surgical treatment for endometrial cancer. They were categorized according to their risk of recurrence, ie, low risk (IA, G1–G2; 60.1 percent) or high risk (IA, G3 or ≥IB; 39.9 percent), with each group randomized to intensive or minimalist follow-up for 5 years.
In patients with low recurrence risk, intensive follow-up comprised clinical examination every 4 months for 2 years, followed by every 6 months until year 5, CT scan of the chest, abdomen, and pelvis annually for the first 2 years, and annual Pap smear, while minimalist follow-up involved clinical examination every 6 months for 5 years. In patients with high recurrence risk, intensive follow-up included clinical examination and CA125 assessment every 4 months for 3 years, then 6-monthly until year 5, annual Pap smear and chest, abdomen, and pelvic CT scan, and abdominal ultrasound every 4–8 months, while minimalist follow-up involved clinical examination every 4 months for 2 years, followed by every 6 months until year 5, and annual CT scan for the first 2 years.
About 50 percent of patients were treated by laparoscopy and 83.9 percent underwent total hysterectomy with bilateral salpingo-oophorectomy. About 66 percent were treated with surgery only, while 20 percent were treated with surgery and radiation therapy. Compliance to follow-up was 75.3 percent overall and was comparable between the intensive and minimalist groups (74.7 percent vs 75.9 percent).
OS was 91.3 percent after a median follow-up of 66 months. Five-year OS was similar between patients who received intensive or minimal follow-up (90.6 percent vs 91.9 percent; hazard ratio [HR], 1.12, 95 percent confidence interval [CI], 0.85–1.48; p=0.424). [IGCS 2021, abstract O004]
OS did not differ between the intensive and minimal follow-up arms regardless of whether patients had low (94.1 percent vs 96.8 percent; HR, 1.48, 95 percent CI, 0.92–2.37; p=0.104) or high risk (85.3 percent vs 84.7 percent; HR, 0.96, 95 percent CI, 0.68–1.36; p=0.814) of cancer recurrence.
RFS also did not differ between patients who received intensive or minimal follow-up (HR, 1.35, 95 percent CI, 0.92–1.98; p=0.127 [low risk] and HR, 1.06, 95 percent CI, 0.79–1.42; p=0.700 [high risk]). Health-related quality of life was also comparable between patients who received intensive or minimal follow-up.
About 80 percent of recurrences among low-risk patients were detected via clinical examination either alone or along with other strategies. Among high-risk patients, clinical examination together with CT scans diagnosed 53.2 percent of recurrences. Ultrasound, Pap smear, and CA125 tests did not play a role in detecting recurrence.
Endometrial cancer recurs in <20 percent of cases, with 75–90 percent of recurrences occurring within 3 years of initial treatment, presented Dr Paolo Zola from the University of Turin, Turin, Italy.
This study showed that intensive follow-up in patients treated for endometrial cancer does not improve OS, even in those with high risk of recurrence, he said.
“[Additionally,] according to our data, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the minimalist regimens used in the trial,” he concluded.