title: Early testicular biopsy in males with acute lymphoblastic leukemia: lack of impact on subsequent event-free survival.
abstract: OBJECTIVE
  Children with acute lymphoblastic leukemia (ALL) who had bulky disease (lymphomatous features) at diagnosis had the highest rate of testicular relapse (20%) of any ALL subgroup on previous Children's Cancer Group (CCG) studies in the late 1980s. To limit curative, but sterilizing, testicular irradiation to those with testicular disease, testicular biopsies were performed to detect occult testicular disease within the first 6 months of treatment. Testicular irradiation then was provided to those with occult disease to increase disease-free survival. Identification of those with occult disease was believed to be a factor that would influence ultimate survival in such patients in that era.
  
  
  METHODS
  One hundred ninety-nine patients had bilateral testicular wedge biopsies performed during the first maintenance therapy phase of the four different chemotherapy regimens. Patients with positive biopsy results were treated with testicular irradiation and continued on therapy.
  
  
  RESULTS
  Eleven of 199 biopsy results (5.5%) were judged positive. Patients with positive biopsy results given testicular radiation had a 45% subsequent adverse event rate, compared with 36% for those with a negative biopsy results (P = 0.4). The survival rates for the two groups were similar. The low rate of positive biopsy specimens resulted in discontinuation of the procedure before closure of the study.
  
  
  CONCLUSIONS
  Positive testicular biopsy results early in remission identified patients at a slightly higher risk of subsequent adverse events but did not influence survival. However, because negative biopsy results (94.5%) did not alter the prescribed treatment, the small number of positive biopsy results did not warrant undertaking the procedure in most male patients with ALL, and this procedure was abandoned.
authors.affiliation: DuPont Hospital for Children, Wilmington, Delaware, USA.
authors.forename: M E
authors.initials: ME
authors.lastname: Trigg
authors.forename: P G
authors.initials: PG
authors.lastname: Steinherz
authors.forename: R
authors.initials: R
authors.lastname: Chappell
authors.forename: H S
authors.initials: HS
authors.lastname: Johnstone
authors.forename: P S
authors.initials: PS
authors.lastname: Gaynon
authors.forename: J H
authors.initials: JH
authors.lastname: Kersey
authors.forename: J M
authors.initials: JM
authors.lastname: Cherlow
authors.forename: N J
authors.initials: NJ
authors.lastname: Grossman
authors.forename: H N
authors.initials: HN
authors.lastname: Sather
authors.forename: G D
authors.initials: GD
authors.lastname: Hammond
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001706:Biopsy; D002648:Child; D002675:Child, Preschool; D016371:Cranial Irradiation; D018572:Disease-Free Survival; D006801:Humans; D007223:Infant; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy / Q000473:pathology*; D013736:Testicular Neoplasms / Q000175:diagnosis / Q000473:pathology* / Q000532:radiotherapy; D013737:Testis / Q000473:pathology*; D013997:Time Factors