title: Non-seminomatous testicular germ cell tumours. Preliminary analysis of ongoing trials in the DATECA Study.
abstract: This report deals with the preliminary results of trials in the DATECA project with stage I, II and III patients with non-seminomatous germ cell tumours. Stage I patients were randomized between infradiaphragmatic irradiation and observation. No significant difference in recurrence rates has been observed as yet. Eighteen of 95 patients had recurrence with a median time to relapse of 3 months. Fifteen patients achieved complete remission after treatment by combination chemotherapy while 3 patients are still undergoing treatment. Stage II patients received 6 series of cis-platinum, bleomycin, and vinblastine. The patients were initially randomized to receive chemotherapy alone versus chemotherapy plus irradiation. Irradiation led to increased toxicity and decreased doses of the antineoplastic drugs. Fifty-one patients were studied. The overall complete remission rate was 89 per cent including 7 patients who achieved complete remission after secondary surgery. Three patients died from testicular tumours and two toxic deaths occurred in this group. Stage III patients were treated with 6 series of cis-platinum, bleomycin, and vinblastine. Fifty patients were studied. The complete remission rate was 72 per cent including 2 patients who achieved complete remission after secondary surgery. Sixteen patients relapsed after achieving complete remission with a median time to relapse of 4 months. Eight of these died, 4 achieved a new complete remission, while 4 patients are still under treatment. Sixty per cent of the patients are at present alive without evidence of disease, while 12 patients died from testicular tumours and 2 from toxic side effects.
mesh_terms: D000206:Actuarial Analysis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001761:Bleomycin / Q000008:administration & dosage; D006063:Chorionic Gonadotropin / Q000097:blood; D002945:Cisplatin / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D011379:Prognosis; D011897:Random Allocation; D013736:Testicular Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D014751:Vindesine; D000509:alpha-Fetoproteins / Q000032:analysis
chemical_list: D006063:Chorionic Gonadotropin; D000509:alpha-Fetoproteins; D001761:Bleomycin; D014747:Vinblastine; D002945:Cisplatin; D014751:Vindesine