Deborah F Billmire1, Frederick J Rescorla2, Jonathan H Ross3, Marc G Schlatter4, Bryan J Dicken5, Mark D Krailo6, Carlos Rodriguez-Galindo7, Thomas A Olson8, John W Cullen9, A Lindsay Frazier7. 1. Department of Surgery, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, IN, United States. Electronic address: dbillmir@iupui.edu. 2. Department of Surgery, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, IN, United States. 3. Division of Urology, Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, OH, United States. 4. Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, MI, United States. 5. Department of Surgery, University of Alberta, Stollery Childrens Hospital, Edmunton, Alberta, United States. 6. Keck School of Medicine, University of Southern California, Los Angeles, CA, United States. 7. Dana-Farber Cancer Institute, Boston Childrens Hospital, Boston, MA, United States. 8. Aflac Cancer and Blood Disorders Center, Childrens Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, United States. 9. Rocky Mountain Hospital for Children, Presbyterian St Luke's Medical, Denver, CO, United States.
Abstract
BACKGROUND: Verification of surgical staging has received little attention in clinical oncology trials. Central surgical review was undertaken during a study of malignant pediatric germ cell tumors. METHODS: Children's Oncology Group study AGCT0132 included central surgical review during the study. Completeness of submitted data and confirmation of assigned stage were assessed. Review responses were: assigned status confirmed, assignment withheld pending review of additional information requested, or institutional assignment of stage disputed with explanation given. Changes in stage assignment were at the discretion of the enrolling institution. RESULTS: A total of 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% with 17/21 discordant patients reassigned to stage recommended by central review. Four ovarian tumor patients not meeting review criteria for Stage I remained in that stratum by institutional decision. Two-year event free survival in Stage I ovarian patients was 25% for discordant patients compared to 57% for those meeting Stage I criteria by central review. CONCLUSIONS: Central review of stage assignment improved complete data collection 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.
BACKGROUND: Verification of surgical staging has received little attention in clinical oncology trials. Central surgical review was undertaken during a study of malignant pediatric germ cell tumors. METHODS:Children's Oncology Group study AGCT0132 included central surgical review during the study. Completeness of submitted data and confirmation of assigned stage were assessed. Review responses were: assigned status confirmed, assignment withheld pending review of additional information requested, or institutional assignment of stage disputed with explanation given. Changes in stage assignment were at the discretion of the enrolling institution. RESULTS: A total of 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% with 17/21 discordant patients reassigned to stage recommended by central review. Four ovarian tumorpatients not meeting review criteria for Stage I remained in that stratum by institutional decision. Two-year event free survival in Stage I ovarian patients was 25% for discordant patients compared to 57% for those meeting Stage I criteria by central review. CONCLUSIONS: Central review of stage assignment improved complete data collection 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.
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Authors: R C Shamberger; K A Guthrie; M L Ritchey; G M Haase; J Takashima; J B Beckwith; G J D'Angio; D M Green; N E Breslow Journal: Ann Surg Date: 1999-02 Impact factor: 12.969
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Authors: Marc Schlatter; Fred Rescorla; Roger Giller; Barbara Cushing; Charles Vinocur; Paul Colombani; John Cullen; Wendy London; Mary Davis; Stephen Lauer; Thomas Olson Journal: J Pediatr Surg Date: 2003-03 Impact factor: 2.545