Impact of central surgical review in a study of malignant germ cell tumors

• Authors: Deborah F. Billmire, Indiana University; Frederick J. Rescorla, Indiana University; Jonathan H. Ross, Case Western Reserve University; Marc G. Schlatter, Spectrum Health; Bryan J. Dicken, University of Alberta; Mark D. Krailo, University of Southern California; Carlos Rodriguez-Galindo, Dana-Farber Cancer Institute; Thomas Olson, Emory University; John W. Cullen, Rocky Mountain Hospital for Children; A. Lindsay Frazier, Dana-Farber Cancer Institute
• Journal Title: Journal of Pediatric Surgery
• Volume: Volume 50, Number 9
• Publisher: Elsevier | 2015-09-01, Pages 1502-1505
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1016/j.jpedsurg.2014.12.008
• Subjects: Health Sciences, Medicine and Surgery; Health Sciences, Oncology
• Keywords: Science & Technology; Life Sciences & Biomedicine; Pediatrics; Surgery; Malignant germ cell tumors; Surgical quality; Surgical clinical trials; NATIONAL WILMS-TUMOR; PEDIATRIC-ONCOLOGY-GROUP; CELL TUMORS; OVARY

Abstract

BACKGROUND: Verification of surgical staging has received little attention in clinical oncology trials for both children and adults. Central surgical review in a study of malignant pediatric germ cell tumors provided an opportunity to assess the impact of this process. METHODS: Children’s Oncology Group study AGCT0132 data submission at study entry required operative note, surgical checklist, pathology and imaging reports. Central surgical review during the study included assessment for completeness of submitted data and confirmation of assigned stage. Review resulted in one of three conclusions: assigned status confirmed, assignment withheld pending review of additional information requested, or institutional assignment of stage disputed with reasons for recommended stage assignment explained. Changes in stage assignment based on central surgical review were left at the discretion of the enrolling institution. RESULTS: 206 patients underwent central review. Failure to submit required data elements or need for clarification was noted in 40%. Disagreement with stage assignment occurred in 10%; the highest rate of discordance was in ovarian tumors submitted as stage I (34%). 17 of 21 discordant patients were reassigned to the stage recommended by central review. 4 patients with ovarian tumors not meeting central review criteria for Stage I remained in that stratum by institutional decision. Two-year event free survival (EFS) in Stage I ovarian tumor patients was 25% (1/4) for discordant patients compared to 57% (9/21) in patients who met Stage I criteria by central review. CONCLUSIONS: Central review of stage assignment by a dedicated study surgeon improved collection of complete data and assignment of correct tumor stage at study entry, and allowed for prompt initiation of chemotherapy in patients determined not to have Stage I disease.