RT Journal Article
SR Electronic
T1 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
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP A15
OP A15
DO 10.1136/ijgc-2019-IGCS.24
VO 29
IS Suppl 3
A1 S Marnitz-Schulze
A1 A Tsunoda
A1 P Martus
A1 MV Vieira
A1 R Affonso
A1 JS Nunes
A1 V Budach
A1 A Schneider
A1 H Hertel
A1 A Mustea
A1 J Sehouli
A1 A Plaikner
A1 A Ebert
A1 C Köhler
YR 2019
UL http://ijgc.bmj.com/content/29/Suppl_3/A15.1.abstract
AB 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.