In an Italian/French trial (TOTEM) reported in the Journal of Clinical Oncology, Zola et al found no difference in 5-year overall survival with intensive vs minimalist follow-up regimens in patients in complete clinical remission after surgery for endometrial cancer.
Study Details
In the multicenter trial, 1,847 evaluable patients with International Federation of Gynecology and Obstetrics stage I to IV disease (60% and 20% stage IA and IB, respectively) were randomly assigned (after surgery with or without adjuvant therapy) between November 2008 and July 2018 to 5-year intensive (n = 932) vs minimalist (n = 915) follow-up regimens. A total of 562 vs 549 patients had low-risk disease (60% in both groups) and 370 vs 366 had high-risk disease.
Among low-risk patients, the minimalist regimen consisted of 11 scheduled visits for general and gynecological examinations, without serologic, vaginal cytologic, or imaging tests; the intensive regimen consisted of 13 visits, annual vaginal cytology and, in the first 2 years, annual chest, abdomen, and pelvis computed tomography (CT) scans.
An intensive follow-up in endometrial cancer–treated patients does not improve overall survival, even in high-risk patients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the minimalist regimens used in this trial.— Zola et al
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Among high-risk patients, the minimalist regimen consisted of 13 visits and annual CT scans in the first 2 years; the intensive regimen consisted of 14 visits with cancer antigen 125 measurement at every visit, abdomen and pelvis ultrasound examinations twice a year for 3 years, and then annual vaginal cytology and CT scans.
The primary outcome measure was overall survival; the study was powered to demonstrate an absolute improvement of 5% in 5-year overall survival in the intensive regimens group.
Key Findings
Median follow-up was 69 months. Overall survival at 5 years was 90.6% (95% confidence interval [CI] = 88.4%–92.4%) in the intensive group vs 91.9% (95% CI = 89.9%–93.6%) in the minimalist group (hazard ratio [HR] = 1.13, 95% CI = 0.86–1.50, P = .380). Hazard ratios were 1.00 (95% CI = 0.68–1.48) among 311 vs 306 patients who did not receive adjuvant therapy and 1.31 (95% CI = 0.86–1.98) among 621 vs 609 who did receive adjuvant therapy (P = .358 for interaction).
Among patients with low-risk disease, 5-year overall survival was 94.1% (95% CI = 91.5%–95.9%) in the intensive group vs 96.8% (95% CI = 94.7%–98.1%) in the minimalist group (HR = 1.45, 95% CI = 0.91–2.33, P = .121). Among high-risk patients, 5-year overall survival was 85.3% (95% CI = 81.0%–88.7%) in the intensive group vs 84.7% (95% CI = 80.4%–88.1%) in the minimalist group (HR = 0.99, 95% CI = 0.69–1.40, P = .936).
Relapse-free survival at 5 years was 90.7% vs 93.7% (HR = 1.17, 95% CI = 0.92–1.48, P = .194). Hazard ratios were 1.35 (95% CI = 0.91–1.99) among low-risk patients and 1.07 (95% CI = 0.80–1.44) among high-risk patients. A total of 91 (53.2%) of 171 relapses occurring during the first 5 years of follow-up were asymptomatic; asymptomatic relapse was numerically but not significantly more likely to be detected in the intensive group, among both low-risk patients (59.3% vs 40.0%, odds ratio [OR] = 2.18, P = .195) and high-risk patients (56.3% vs 51.7%, OR = 1.17, P = .701).
The investigators concluded, “An intensive follow-up in endometrial cancer–treated patients does not improve overall survival, even in high-risk patients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the minimalist regimens used in this trial.”
Elisa Piovano, MD, PhD, of AOU Città della Salute e della Scienza di Torino, Ospedale Sant’Anna, Torino, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Regional Oncology Network of Piemonte e Valle d’Aosta. For full disclosures of the study authors, visit ascopubs.org.
