RPLND or primary chemotherapy in clinical stage IIA/B nonseminomatous germcell tumors? Results of a prospective multicenter trial including quality of life assessment

Background: In order to reduce therapy-related morbidity in patients with n onseminomatous testicular germ cell tumors in clinical stage IIA/B, we perf ormed a prospective multicenter trial comparing the standard retroperitonea l lymph node dissection (RPLND) +2 cycles of chemotherapy (arm A) with 3-4 cycles of primary chemotherapy (arm B). Methods: From February 1991 to July 1995, 57 participating centers from Ger many and Austria recruited 187 evaluable patients. 109 received primary RPL ND and 78 primary chemotherapy. Two different chemotherapies were applied ( PEB and CEB as adjuvant or inductive treatment). The quality of life (QoL), therapy-related morbidity, suspected predictive factors (histology and siz e of metastases), and outcome were assessed. Results: In arm A, 12% had pathological stage (PS) I, 70% PS II A/B, and 18 % PS II C/III. In arm B, 67% achieved complete remission with chemotherapy alone, 33% required a secondary RPLND. After a median follow-up of 36 month s, 7% of the patients in arm A and 11% in arm B had relapsed. Two patients died due to complications of chemotherapy. Surgical complications amounted to 12% in arm A and 27% of 26 postchemotherapy RPLNDs (9% in arm B). Loss o f ejaculation occurred in 32% in arm A, and 16% in arm B, Acute toxicity of chemotherapy was higher in the group receiving primary chemotherapy. Conclusion: We recommend primary RPLND because adjuvant chemotherapy can be spared in PS I, two cycles of chemotherapy are less toxic than 3 or 4 cycl es, the primary operation is associated with less complications than that f ollowing chemotherapy and, with modern surgical procedures, ejaculation can be preserved in most of the patients, provided that the operation is carri ed out by an experienced surgeon. No statistically significant differences in the QoL outcome occurred between the treatment groups, suggesting that c hemotherapy alone is not superior to primary or secondary RPLND in this res pect. Copyright (C) 2000 S. Karger AG. Basel.