24 UTERUS-11 STUDY: A randomized clinical trial on surgical staging versus ct-staging prior to primary chemoradiation in patients with FIGO2009 stages IIB-IVA cervical cancer. (18th September 2019) - Marnitz-Schulze, S
Abstract : Objectives: Surgical staging potentially modifies radiation field in locally advanced cervical cancer (LACC), although a survival benefit has never been proved in a randomized clinical trial. Uterus-11 Study (German GOG and Radiation Oncology Group) is a RCT designed to evaluate the impact of surgical staging compared to standard clinical/radiological staging, followed by chemoradiation (CR). Primary endpoint was disease free survival (DFS), secondary was overall survival (OS). Methods: From 2009 to 2013, a total of 255 LACC patients (FIGO2009 IIB-IVA) were randomized to surgical staging and CR (ArmA), or clinical staging followed by CR (ArmB). CR consisted in pelvic external beam radiotherapy with weekly cisplatin (40mg/m2) and brachytherapy. Extended-field radiation was performed in cases of confirmed paraaortic metastases. Results: Among 240 patients (n=121 ArmA;n=119 ArmB), 236(98.3%) received CR. Arms were balanced. Surgical approach was transperitoneal laparoscopy in 93.4%(mean 19pelvic/17paraaortic lymph nodes (LN). CR started 7–21days after surgery. Surgery upstaged 40/121(33%). Median follow-up: 66.5months. ArmA was superior for PFS (HR=1.38 ArmB vs. ArmA, p=0.115) and OS (HR=1.29, p=0.24). Clinically or surgically LN+ negatively impacted PFS (pelvic:HR=2.38, p=0.007; paraaortic:HR=2.84, p=0.001; anyLN+:HR=2.83, p=0.003) and OS (pelvic:HR=2.90, p=0.003; paraaortic:HR=3.03, p=0.001; anyLN+:HR=3.51, p=0.001). Adeno/adenosquamous were comparable to squamous cell carcinomas (PFS:HR=1.26, p=0.44, OS:HR=1.35, p=0.32). Stages III/IV had worse prognosis than IIb (PFS:HR=1.86, p=0.003; OS:HR=2.07, p=0.001). Conclusions: Although statistical significance could not be reached, surgical staging in LACC lead to superior DFS and OS compared to clinical staging with acceptable morbidity and no significant CR delay. The high risk of distant metastases in both arms underlies the need for further treatment intensification.