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

Journal of Pediatric Surgery
Deborah F BillmireA Lindsay Frazier

Abstract

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. 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. 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. Central review of stage assignment improved complete data collectio...Continue Reading

References

Jul 7, 1999·Journal of Pediatric Surgery·M P ContadorR P Castleberry
Mar 16, 2004·Journal of Pediatric Surgery·D BillmireUNKNOWN Children's Oncology Group (COG)
May 4, 2005·Journal of Pediatric Surgery·Peter F EhrlichRobert C Shamberger
Jul 14, 2010·Journal of Pediatric Surgery·Sarah C OltmannAnne C Fischer
Apr 14, 2012·Journal of Pediatric Surgery·Kathleen KieranAndrew M Davidoff

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Citations

Apr 30, 2016·Journal of Pediatric Surgery·Arin L MadenciChristopher B Weldon

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