1. A single-cycle of adjuvant bleomycin, etoposide, and cisplatin (BEP) after orchiectomy reduces the relapse rate of stage I non-seminomatous germ cell tumors.
2. The single-cycle regimen may have lower relapse rate than retroperitoneal lymph node dissection and less toxicity than the standard 2-cycle regimen.
Evidence Rating Level: 2 (Good)
Study Rundown: Despite excellent overall cure rates for stage I non-seminomatous germ cell tumors (NSGCT), tumors with pathological findings of vascular invasion (VI) demonstrate a high probability of relapse. In cases of relapse, salvage therapy consisting of 3-4 cycles of bleomycin, etoposide, and cisplatin (BEP) is required but poorly tolerated. The use of adjuvant therapies, such as retroperitoneal lymph node dissection (RPLND) or 2 cycles of modified adjuvant BEP remains controversial in stage I NSGCT cancers with high risk of relapse. RPLND is disadvantaged by its 29% relapse rate, perioperative morbidity, and long-term ejaculatory dysfunction. Two cycles of adjuvant BEP has been shown to be more effective in controlling relapse, but is limited by systemic toxicities and risks of infertility and secondary malignancies. In this phase II study, the efficacy and safety of single-cycle adjuvant BEP was examined. Forty patients with stage I NSGCT were given a single cycle of modified BEP post-orchiectomy and followed for 15 years. At the conclusion of the trial, 1 patient experienced a metastatic relapse, 3 developed contralateral testicular cancers, and 3 developed secondary malignancies. Three patients reported mild tinnitus and 1 suffered peripheral polyneuropathy. These relapse rates are comparable to those achieved with 2 cycles of BEP, with less toxicity. The results support the use of single-cycle adjuvant BEP in stage I NSGCT. However, as a single-arm study, these results do not directly compare the 2 treatment modalities head-to-head. Furthermore, the size of the study may be too small to capture relatively rare, but important, events that occur over a long period of follow-up.
In-Depth [prospective cohort]: In this single arm, phase II clinical trial, 40 patients with high risk, stage I NSGCT with VI and/or >50% embryonal cell carcinoma components were given a single-cycle of modified BEP within 4 weeks after orchiectomy. Patients were 18-44 years old, with a median age of 33 at the time of surgery. Median follow-up was 186 months and the primary endpoint was relapse, with secondary endpoints of metachronous testicular cancer, secondary malignancy, and late chemotherapy-related toxicity. One patient (2.5%) had a pulmonary relapse after 13 months of follow-up and died despite salvage therapy. Three patients (7.5%) developed metachronous tumors of the contralateral testis; all were successfully treated. Three patients (7.5%) developed colorectal cancer or leukemia. With respect to adverse effects, 3 patients experienced tinnitus after adjuvant therapy and 1 patient treated with salvage BEP for contralateral NSGCT developed peripheral neuropathy.
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