Etoposide plus carboplatin or cisplatin in good-risk patients with germ cell tumors: a randomized comparison.

Two hundred sixty-five evaluable patients were randomized to receive either carboplatin/etoposide (131 patients) or cisplatin/etoposide (134 patients). Among the carboplatin-treated patients, 115 (88%) achieved a complete remission, compared with 121 (90%) of patients receiving cisplatin. In the carboplatin group, however, 16 patients (12%) relapsed following complete remission, in contrast to four (3%) of those receiving cisplatin. Thus, the total number of unfavorable events (incomplete response + relapse) was 32 (24%) in the carboplatin arm, compared with 17 (13%) in the cisplatin arm (P = .02). In addition, patients receiving carboplatin had a greater likelihood of being hospitalized for neutropenia and fever (P = .016) and had lower platelet nadirs (P < .001). It was concluded that carboplatin administered at the dose and schedule used in this clinical trial resulted in an inferior event-free survival rate and worse toxicity than cisplatin, and is not recommended for use in general practice.