Adjuvant chemotherapy for high-risk clinical stage I nonseminomatous testicular germ cell cancer: Long-term results of a prospective trial

Purpose: To assess the impact of short-term adjuvant chemotherapy on relapse rates, treatment-related morbidity, and long-term toxicity in patients with clinical stage I nonseminomatous testicular germ cell tumor (NSGCT I) who carry a high risk of relapse, ie, who show blood-vessel invasion (VI) by the primary tumor. Patients and Methods: From January 1985 to January 1995, 42 NSGCT I patients with VI were treated with two courses of cisplatin, etoposide, and bleomycin (FEB) after orchidectomy. Of these, 29 patients with a followup time of more than 2 years are the subject of this report. NSGCT I patients without VI were assigned to a surveillance program and served as controls for the assessment of long-term toxicity. Results: During a median follow-up time of 79 months (range, 27 to 119), two patients relapsed. One developed fully differentiated mature teratoma; the other was a true chemotherapy failure and again developed embryonal carcinoma. Twenty-seven patients (93%) are alive without evidence of disease; one patient (3%) died of progressive testicular cancer and another of lung cancer. The two courses of FEB did not cause any severe acute adverse reactions. The assessment of late sequels of adjuvant chemotherapy based on clinical and laboratory evidence of cardiovascular and pulmonary disease, fertility, and secondary neoplasms, as well as on a psychosocial questionnaire, did not show any significant disadvantages versus the control group. Conclusion: Adjuvant chemotherapy with two courses of PEB is an effective and reasonable treatment option for patients with clinical stage I NSGCT who carry a high risk of relapse. No adverse late sequelae were detected within a median follow-up time of more than 6 years. (C) 1996 by American Society of Clinical Oncology.