title: Comparison of criteria for assigning germ cell tumor patients to "good risk" and "poor risk" studies.
abstract: To evaluate the potential effect of patient selection on chemotherapy trials for patients with advanced germ cell tumors (GCT), four sets of eligibility criteria for poor risk trials were compared in 118 patients. A significant difference was found in the number of patients designated poor risk by the various criteria (P less than .005). Disagreement in the risk assignment by the various selection criteria was seen in 44% of patients. Initial complete response (CR) rates in patients designated poor risk by the various criteria ranged from 38% to 62%. Initial CR rates as high as 94% were seen in patients considered to be poor risk by one set of criteria, but good risk by another. Substantial differences in sensitivity, specificity, overall predictive value, and survival distributions were observed for the various selection criteria. Randomized trials will be necessary to reduce the influence of eligibility criteria on trial outcome and conclusions.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: D
authors.initials: D
authors.lastname: Bajorin
authors.forename: A
authors.initials: A
authors.lastname: Katz
authors.forename: E
authors.initials: E
authors.lastname: Chan
authors.forename: N
authors.initials: N
authors.lastname: Geller
authors.forename: N
authors.initials: N
authors.lastname: Vogelzang
authors.forename: G J
authors.initials: GJ
authors.lastname: Bosl
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D006801:Humans; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000401:mortality; D012307:Risk Factors