Malignant testicular germ cell tumors in children and adolescents: The AIEOP (Associazione Italiana Ematologia Oncologia Pediatrica) protocol

Objectives:We report the results of an Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) study on the treatment of testic-ular germ cell tumors (TGCT) with a pediatric PEB (pPEB) regimen (cisplatin 25 mg/m2daily on days 1-4; etoposide 100 mg/m2daily ondays 1-4; bleomycin 15 mg/m2on day 2, once per cycle).Methods and materials:Male patients under 18 years old with malignant TGCT were enrolled for a second national prospective proto-col. All patients underwent orchiectomy at diagnosis. Those with Stage I received no chemotherapy; those with Stage IIIII diseasereceived three cycles of pPEB; and those with Stage IV received four cycles. After chemotherapy, resection of radiologically-evident resid-ual disease was recommended. The main study end-points were overall survival and relapse-free survival.Results:Ninety-nine boys from 0.5 to 17.8 years old (median 15.4 years) were evaluable, and staged as follows: 58 Stage I (59%), 7Stage II (7%), 14 Stage III (14%), and 20 Stage IV (20%). With a median follow-up of 59 months (range 4-165 months), 5-year relapse-freesurvival (95% CI) was 73% (65%-83%) for the whole sample, 65% (53%-79%) for Stage I patients, and 86% (75%-98%) for Stage II-IVpatients. Five-year overall survival (95% CI) was 99% (97%-100%).Conclusions:We confirmed a good prognosis for malignant TGCT in children and adolescents. Reducing the number of chemotherapycycles for Stage II-III disease does not seem to negatively affect survival outcomes.