乌鸦传媒

After treatment for endometrial cancer, it is recommended that patients return for regular follow-up visits for 5 years.^1-3 However, whether those visits happen in real-world practice, what happens during the visits, and whether they are effective in improving patient survival or quality of life, is less certain.⁴ 

According to Elisa Piovano, MD, PhD, SC Ginecologia e Ostetricia n. 3, AOU Citt脿 della Salute e della Scienza di Torino, Ospedale Sant鈥橝nna in Torino, Italy, 鈥淐urrent international guidelines recommend a minimalist follow-up in patients treated for endometrial cancer. However, the supporting evidence of these recommendations is weak, and the adherence to guidelines has been generally low. As a consequence, intensive follow-up regimens, with multiple scheduled visits and examinations, are widespread, at least in Southern Europe, also on the basis of a theoretical supposed usefulness and for medicolegal reasons.鈥�

To determine if survival and quality of life are improved by the more popular intensive approach to follow-up care for endometrial cancer versus the guideline-preferred minimalist approach, Piovano and colleagues conducted the TOTEM study鈥攁 large, randomized, pragmatic, parallel-group, multicenter trial鈥攊n 42 National Health Service hospitals in Italy and France.⁴ Adult patients in complete remission after surgical treatment for endometrial cancer were randomly assigned after surgery to either intensive or minimalist follow-up in a 1:1 ratio within strata based on center and low or high risk of relapse.⁴ 

Minimalist and intensive follow-up regimens differed by risk of relapse. For low-risk patients, the minimalist follow-up regimen consisted of 11 physical examinations (both general and gynecological), with no serological, vaginal cytological, or imaging tests; the intensive follow-up regimen included 13 visits, annual vaginal cytology, and, in the first 2 years, CT scans of the chest, abdomen, and pelvis every year.⁴ High-risk patients assigned to the minimalist follow-up group came in for 13 visits and an annual CT scan for the first 2 years; the intensive follow-up regimen consisted of 14 visits, with serum cancer antigen 125 dosage at every visit, ultrasounds of the abdomen and pelvis twice a year for 3 years, and then annually, as well as annual vaginal cytology and CT scan.⁴ The primary outcome measure was overall survival.⁴

A total of 1847 patients (932 intensive arm, 915 minimalist arm) were included in the intent-to-treat analysis.⁴ Approximately 60% of patients in each arm were at low risk of relapse, and 40% had a high risk of relapse.⁴ Patients鈥� mean age was 63.7 years, and most (59.3%) had endometrioid, International Federation of Gynecology and Obstetrics (FIGO) Stage IA, grade 1 to 2 endometrial cancer.⁴ The majority of patients (66.6%) were treated by surgery alone, whereas 33.4% of patients had both surgery and adjuvant treatment.⁴

No significant difference in 5-year overall survival rates was present between arms: 90.6% (95% CI, 88.4%鈥�92.4%) in the intensive follow-up arm and 91.9% (95% CI, 89.9%鈥�93.6%) in the minimalist follow-up arm (HR 1.13; 95% CI, 0.86鈥�1.50; P=0.380).⁴ Also, no significant difference in 5-year overall survival existed within each risk group when the 2 follow-up regimens were compared. In the low-risk group, overall survival was 94.1% (95% CI, 91.5%鈥�95.9%) in the intensive follow-up arm and 96.8% (95% CI, 94.7%鈥�98.1%) in the minimalist follow-up arm (HR, 1.45; 95% CI, 0.91鈥�2.33; P=0.121).⁴ In the high-risk group, overall survival was 85.3% (95% CI, 81.0%鈥�88.7%) in the intensive follow-up arm compared with 84.7% (95% CI, 80.4%鈥�88.1%) in the minimalist follow-up arm (HR, 0.99; 95% CI, 0.69鈥�1.40; P=0.936).⁴ Subgroup analyses also found no differences in overall survival when taking into consideration age, adjuvant therapy, risk of relapse, and degree of the center鈥檚 adherence to the scheduled follow-up regimen.⁴

Given the lack of a difference in survival between the intensive and minimalist follow-up regiments, Piovano said, 鈥淭he key message is that there is no reason to systematically add vaginal cytology, laboratory, or imaging investigations to the minimalist follow-up used in this trial, including scheduled clinical visits and chest, abdomen, and pelvis computed tomography in the first 2 years in high-risk patients.鈥� These findings have many different implications for patients and the healthcare systems. 鈥淢ore intensive follow-up regimens are more time-consuming, lead to higher healthcare costs, and can be a further source of stress for these women, without this translating into a survival advantage for them,鈥� said Piovano. 

With the TOTEM study, the medical community now has evidential support behind guideline recommendations for a minimalist follow-up approach to the post-surgical care of patients with endometrial cancer. 鈥淲e hope that these results will help reinforce the recommendations of the guidelines and that clinicians and women will be more reassured in adopting less-intensive regimens of follow-up,鈥� Piovano concluded.

Published: October 06, 2022