Risk-adapted treatment for patients with clinical stage I nonseminomatous germ cell tumor of the testis

Objectives. To evaluate whether two courses of chemotherapy after orchiectomy in patients with clinical Stage I nonseminomatous germ cell testicular tumor at high risk of relapse will spare patients additional chemotherapy or surgery. Methods. High-risk patients had one or more of the following: preorchiectomy alpha-fetoprotein level of 80 ng/dL or greater, 80% embryonal cell carcinoma or greater, or vessel invasion in the primary tumor. Low-risk patients had none of these factors or had 50% teratoma or more without vessel invasion. High-risk patients were offered two 21-day courses of outpatient chemotherapy consisting of carboplatin, etoposide, and bleomycin. Low-risk patients and high-risk patients not receiving chemotherapy were observed. Results. Of 99 patients, we classified 76 as high risk and 23 as low risk of relapse. All but eight of the high-risk patients received chemotherapy. No patient who underwent chemotherapy developed relapse, although 1 patient with normal biomarkers and a late-appearing mass underwent retroperitoneal lymphadenectomy for mature teratoma. Two of the 23 low-risk patients had disease relapse; both successfully underwent chemotherapy. The nonhematologic toxicity was mild in patients receiving chemotherapy, and no patient required hospitalization. The median follow-up was 38 months (range 9 to 69). Conclusions. Two courses of postorchiectomy adjuvant chemotherapy were safe and well tolerated and markedly decreased the relapse rate in high-risk patients with clinical Stage I nonseminomatous germ cell testicular tumor without additional surgery or more protracted chemotherapy. This approach may avoid potential problems with compliance and diminish the cost of scrupulous follow-up. Our results support that surveillance for carefully selected patients at a low risk of relapse is appropriate. (C) 2004 Elsevier Inc.