Treatment is established for testicular germ cell tumors, but there are few data on its effectiveness as the first line in the treatment of phase II metastatic seminoma
During the 2021 Genitourinary Cancers Symposium, The SEMS (NCT02537548), a phase II, multi-institutional, single-arm trial of RPLN dissection as a first-line treatment for testicular seminoma with an isolated retroperitoneal disease, was presented.
Twelve sites in the United States and Canada prospectively enrolled patients with testicular seminoma and isolated retroperitoneal lymphadenopathy, 1-3 cm in size. Patients were excluded if they had received previous therapy (except orchiectomy) for testicular cancer. Modified open RPLND was performed by qualified surgeons with a primary outcome of two-year recurrence-free survival. Data short- and long-term complication rates, increase or decrease in pathological staging, recurrence patterns, adjuvant therapies, and treatment-free survival were assessed.
A total of 55 patients were enrolled and submitted to RPLND. 14 had initial phase I disease, which developed isolated retroperitoneal recurrence, while the other 41 were diagnosed with clinical phase IIA-B at presentation.
With an average follow-up of 24 months, there were a total of 10 recurrences. The overall rate was 18%, with an average time of eight months. Among these patients, eight received chemotherapy (six of which were treated with three BEP cycles, one with four cycles of EP and one treated with carboplatin associated with etoposide). Two of them submitted additional surgery.
Two-year recurrence-free survival was 87% and overall survival was 100%. There were seven (13%) patients who had short-term complications within one year of RPLND. Of these, five (9%) were classified as Clavien Dindo I-II and two (3.6%). No patient reported long-term complications.
The trial establishes RPLND as a first-line therapeutic option in the initial metastatic seminoma. Surgery offers cancer control rates similar to those observed in non-seminomatous germ cell tumors.
Daneshmand S, et al. SEMS trial: Result of a prospective, multi-institutional phase II clinical trial of surgery in early metastatic seminoma. Abstract 375. 2021 Genitourinary Cancers Symposium. DOI:10.1200/JCO.2021.39.6_suppl,375