SINGLE-AGENT CARBOPLATINUM FOR ADVANCED SEMINOMA - A PHASE-II STUDY

Background. To reduce the side effects of cisplatin-based combination chemotherapy, the activity of carboplatinum was evaluated in patients with advanced seminoma. Methods. Forty-two evaluable patients with adv anced seminoma (defined as abdominal lymph nodes > 5 cm or supradiaphr agmatic or visceral disease) received single-agent carboplatinum at a dose of 400 mg/m2 intravenously every 4 weeks for a maximum of six cyc les. The median follow-up was 31 months (18-67 months). Results. Thirt y patients (71%) achieved a complete remission (CR; 21 chemotherapy al one, 9 with additional surgery), 8 patients (19%) a partial remission (PR), and 4 patients had disease progression (10%). Patients with meta stases confined to the lymph nodes had a significantly higher remissio n rate than patients with visceral metastases (97% versus 50%; P < 0.0 02). Elevation of lactate dehydrogenase or human chorionic gonadotropi n before radiation therapy had no influence on response rate. Eight pa tients have relapsed (five from CR and three from PR). All 12 patients failing carboplatinum therapy received cisplatin-based combination re gimens. Ten patients achieved a stable favorable response (eight CR, t wo PR), whereas two patients died of their disease. Currently, 30 pati ents (71%) are continuously free from progression (25 CR, 5 PR), and 4 0 patients are alive (survival 93%). Toxicity was mild with no neuroto xicity or nephrotoxicity. Conclusions. The use of up-front carboplatin um therapy appears not to compromise the ultimate curability of patien ts with advanced seminoma. Randomized trials, however, will have to de monstrate the effectiveness of carboplatinum with regard to survival, and help to identify prognostic subgroups of patients who require up-f ront cisplatinum-based combination chemotherapy.