Ramez N Eskander1, James Kauderer2, Krishnansu S Tewari3, Robert S Mannel4, Robert E Bristow5, David M O'Malley6, Stephen C Rubin7, Gretchen E Glaser8, Chad A Hamilton9, Keiichi Fujiwara10, Warner K Huh11, Frederick Ueland12, Jean-Marie Stephan13, Robert A Burger14. 1. University of California, San Diego Medical Center, La Jolla, CA, United States. Electronic address: Reskander@ucsd.edu. 2. NRG Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY, United States. Electronic address: kaudererJ@NRGOncology.org. 3. University of California, Irvine Medical Center, Orange, CA, United States. Electronic address: ktewari@uci.edu. 4. University of Oklahoma, Oklahoma City, OK, United States. Electronic address: Robert_Mannel@ouhsc.edu. 5. University of California, Irvine Medical Center, Orange, CA, United States. Electronic address: rbristow@uci.edu. 6. Ohio State University and Wexner Medical Center, Columbus, OH, United States. Electronic address: omalley.46@osu.edu. 7. University of Pennsylvania, Philadelphia, PA, United States; Chief of Gynecologic Oncology at Fox Chase Cancer Center, Philadelphia, PA. Electronic address: Stephen.rubin@fccc.edu. 8. Mayo Clinic, Rochester, MN, United States. Electronic address: Glaser.Gretchen@mayo.edu. 9. Gynecologic Cancer Center of Excellence, John P. Murtha Cancer Center, Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences, Bethesda, MD, United States. Electronic address: chad.a.hamilton2.mil@mail.mil. 10. Saitama Medical University International Medical Center, Saitama, Japan. 11. University of Alabama Medical Center, Birmingham, AL, United States. Electronic address: whuh@uabmc.edu. 12. University of Kentucky Medical Center, Lexington, KY, United States. Electronic address: fuela0@uky.edu. 13. University of Iowa Hospital; Iowa City, IA, United States. Electronic address: jean-marie-stephan@uiowa.edu. 14. University of Pennsylvania, Philadelphia, PA, United States. Electronic address: burgerr@uphs.upenn.edu.
Abstract
PURPOSE: We sought to determine the level of concordance among surgeons' assessment of residual disease (RD) and pre-treatment computed tomography (CT) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer. METHODS: This is a post-trial ad hoc analysis of a phase 3 randomized clinical trial evaluating the impact of bevacizumab in primary and maintenance therapy for patients with advanced stage ovarian cancer following surgical cytoreduction. All subjects underwent imaging of the chest/abdomen/pelvis to establish a post-surgical baseline prior to the initiation of chemotherapy. Information collected on trial was utilized to compare surgeon's operative assessment of RD, to pre-treatment imaging. RESULTS: Of 1873 enrolled patients, surgical outcome was described as optimal (RD≤1cm) in 639 subjects. Twelve patients were excluded as they did not have a baseline, pretreatment imaging, leaving 627 participants for analysis. The average interval from surgery to baseline scan was 26days (range: 1-109). In 251 cases (40%), the post-operative scan was discordant with surgeon assessment, demonstrating RD>1cm in size. RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%). Patients with RD>1cm on pre-treatment CT (discordant) exhibited a significantly greater risk of disease progression (HR 1.30; 95% CI 1.08-1.56; p=0.0059). CONCLUSIONS: Among patients reported to have undergone optimal cytoreduction, 40% were found to have lesions >1cm on postoperative, pretreatment imaging. Although inflammatory changes and/or rapid tumor regrowth could account for the discordance, the impact on PFS and distribution of RD may suggest underestimation by the operating surgeon.
RCT Entities:
PURPOSE: We sought to determine the level of concordance among surgeons' assessment of residual disease (RD) and pre-treatment computed tomography (CT) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer. METHODS: This is a post-trial ad hoc analysis of a phase 3 randomized clinical trial evaluating the impact of bevacizumab in primary and maintenance therapy for patients with advanced stage ovarian cancer following surgical cytoreduction. All subjects underwent imaging of the chest/abdomen/pelvis to establish a post-surgical baseline prior to the initiation of chemotherapy. Information collected on trial was utilized to compare surgeon's operative assessment of RD, to pre-treatment imaging. RESULTS: Of 1873 enrolled patients, surgical outcome was described as optimal (RD≤1cm) in 639 subjects. Twelve patients were excluded as they did not have a baseline, pretreatment imaging, leaving 627 participants for analysis. The average interval from surgery to baseline scan was 26days (range: 1-109). In 251 cases (40%), the post-operative scan was discordant with surgeon assessment, demonstrating RD>1cm in size. RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%). Patients with RD>1cm on pre-treatment CT (discordant) exhibited a significantly greater risk of disease progression (HR 1.30; 95% CI 1.08-1.56; p=0.0059). CONCLUSIONS: Among patients reported to have undergone optimal cytoreduction, 40% were found to have lesions >1cm on postoperative, pretreatment imaging. Although inflammatory changes and/or rapid tumor regrowth could account for the discordance, the impact on PFS and distribution of RD may suggest underestimation by the operating surgeon.
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