Adjuvant treatment with one cycle of modified bleomycin, etoposide and cisplatin chemotherapy appeared safe and effective for patients with clinical stage I nonseminomatous germ cell tumors at high risk for relapse, according to long-term results of a single-arm, phase 2 study.
A.D. Vidal, MD, of the department of urology at the University of Bern in Switzerland, and colleagues assigned 40 patients with clinical stage I nonseminomatous germ cell tumors at high risk for relapse to adjuvant treatment with one cycle of BEP chemotherapy, which consisted of 20 mg/m2 modified bleomycin as continuous infusion for 24 hours, 120 mg/m2 etoposide and 40 mg/m2 cisplatin each on days 1, 2 and 3.
Relapse rate served as the primary outcome. Median follow-up was 186 months.
One patient (2.5%) developed a pulmonary relapse 13 months after one treatment cycle and died after three additional cycles. Three patients (7.5%) developed contralateral metachronous testicular tumors and three others developed secondary malignancies. Three patients reported intermittent tinnitus, and one patient (2.5%) developed grade 2 peripheral neuropathy.
“In these patients, [the one-cycle regimen] appears to be an alternative to two cycles of bleomycin, etoposide and cisplatin, and to have a lower relapse rate than retroperitoneal lymph node dissection,” Vidal and colleagues wrote. “If confirmed by other centers, one cycle of adjuvant bleomycin, etoposide and cisplatin chemotherapy should become a first-line treatment option for this group of patients.”