Early testicular biopsy in males with acute lymphoblastic leukemia: Lack of impact on subsequent event-free survival

Purpose: Children with acute lymphoblastic leukemia (ALL) who had bulky dis ease (lymphomatous features) at diagnosis had the highest rate of testicula r relapse (20%) of any ALL subgroup on previous Children's Cancer Group (CC G) studies in the late 1980s. To limit curative, but sterilizing, testicula r irradiation to those with testicular disease, testicular biopsies were pe rformed to detect occult testicular disease within the first 6 months of tr eatment. Testicular irradiation then was provided to those with occult dise ase 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. Patients and Methods: One hundred ninety-nine patients had bilateral testic ular wedge biopsies performed during the first maintenance therapy phase of the four different chemotherapy regimens. Patients with positive biopsy re sults 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% subseque nt adverse event rate, compared with 36% for those with a negative biopsy r esults (P = 0.4). The survival rates for the two groups were similar. The l ow rate of positive biopsy specimens resulted in discontinuation of the pro cedure before closure of the study. Conclusion: Positive testicular biopsy results early in remission identifie d patients at a slightly higher risk of subsequent adverse events but did n ot influence survival. However, because negative biopsy results (94.5%) did not alter the prescribed treatment, the small number of positive biopsy re sults did not warrant undertaking the procedure in most male patients with ALL, and this procedure was abandoned.