title: The effect of cisplatin dose and surgical resection in children with malignant germ cell tumors at the sacrococcygeal region: a pediatric intergroup trial (POG 9049/CCG 8882).
abstract: OBJECTIVE
  This study was designed to evaluate (1) the efficacy of standard or high-dose cisplatin with etoposide and bleomycin and (2) the role of surgical resection in infants and children with malignant germ cell tumors of the sacrococcygeal region (SCT).
  
  
  METHODS
  Seventy-four of 317 children presenting to Pediatric Oncology Group (POG)/Children's Cancer Group (CCG) institutions from 1990 through 1996 with malignant germ cell tumors had malignant SCT. There were 62 girls and 12 boys with a median age of 21 months (range, 3 days to 37 months) and median serum alpha-fetoprotein of 35,500 ng/mL. Twelve had undergone resection of a benign SCT as a newborn. Forty-four (59%) had evidence of metastatic disease at time of diagnosis. Presentation by type (Altman classification) was I, 0; II, 2; III, 30; and IV, 42. The initial procedure was biopsy in 45 and resection in 29. Patients were assigned randomly to receive 4 cycles of chemotherapy with etoposide (E) and bleomycin (B) and either high-dose cisplatin (200 mg/m(2) per cycle; HDP) or standard dose cisplatin (100 mg/m(2) per cycle; P). After completion of chemotherapy, 42 of 45 initially treated with biopsy underwent resection.
  
  
  RESULTS
  Overall 4-year survival rate is 90% (SE = 4%) and 4-year event-free survival (EFS) is 84% (SE = 6%). Event-free survival data for subgroups of interest are as follows: 4-yr EFS% (SE) P Values Mets (44) 88 (6).48 No Mets (30) 80 (8) HDP EB (37) 89 (6).21 P EB (37) 78 (7) Initial Resection (29) 90 (7).50 Delayed Resection (42) 83 (7) Complete Resection (49) 90 (5).19 CR/PR Partial Resection (22) 77 (10) Biopsy Only (3) 33 (27).005 (3 way)
  
  
  CONCLUSIONS
  (1) The current survival rate of malignant sacrococcygeal tumors is excellent even with metastases. (2) Delayed surgical resection is not associated with an adverse outcome. (3) In this subset the treatment comparison was inconclusive however, followed the trend in the overall study of more than 300 children in which the high-dose cisplatin group had superior EFS (P<.05).
authors.affiliation: Riley Hospital for Children, Indianapolis, IN 46202, USA.
authors.forename: F
authors.initials: F
authors.lastname: Rescorla
authors.forename: D
authors.initials: D
authors.lastname: Billmire
authors.forename: C
authors.initials: C
authors.lastname: Stolar
authors.forename: C
authors.initials: C
authors.lastname: Vinocur
authors.forename: P
authors.initials: P
authors.lastname: Colombani
authors.forename: J
authors.initials: J
authors.lastname: Cullen
authors.forename: R
authors.initials: R
authors.lastname: Giller
authors.forename: B
authors.initials: B
authors.lastname: Cushing
authors.forename: S
authors.initials: S
authors.lastname: Lauer
authors.forename: M
authors.initials: M
authors.lastname: Davis
authors.forename: E
authors.initials: E
authors.lastname: Hawkins
authors.forename: J
authors.initials: J
authors.lastname: Shuster
authors.forename: M
authors.initials: M
authors.lastname: Krailo
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D002675:Child, Preschool; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009367:Neoplasm Staging; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000601:surgery*; D012445:Sacrococcygeal Region; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D001761:Bleomycin; D005047:Etoposide; D002945:Cisplatin