(UroToday.com) The 2023 GU ASCO annual meeting included a session on testicular cancer, featuring a presentation by Dr. Tim Nestler discussing the interim analysis of the prospective COTRIMS trial. Radiation therapy or systemic chemotherapy with 3 cycles PEB represent the guideline recommended treatment options in marker negative clinical stage IIA/B seminoma. Despite a high cure rate of 90% to 94% and 82% to 90% in CS IIA and IIB, respectively, both therapeutic options are associated with significant long-term toxicities, especially in seminomas beyond 15 years. The aim of this trial was to evaluate the feasibility, oncological efficacy and treatment associated morbidity of primary nerve sparing RPLND in stage IIA/B seminoma.
There were 30 patients with marker negative clinical stage IIA and IIB classical seminoma of the testis recruited in the prospective trial. The primary goal was a relapse rate <20% within 2 years follow-up. Exclusion criteria were adjuvant carboplatin therapy for clinical stage I disease, extensive clinical stage IIb or clinical stage IIC disease, previous retroperitoneal surgery or radiation therapy, and positive tumor markers. All patients underwent nerve sparing RPLND with a modified template resection. None of the patients received adjuvant chemotherapy in the presence of positive lymph nodes. All patients underwent close follow-up with imaging studies and tumor markers at 3-month intervals during the first 2 years, at 6-month intervals in year 3 and annually thereafter.
The mean age was 34.2 (range: 21-65) years, and mean follow-up was 29.4 (range: 3-60) months. All patients were treatment-naïve: 19 and 11 patients were diagnosed with stage IIA and IIB disease, respectively, at time of RPLND:
Overall, 27 and three patients underwent open and robot assisted nerve sparing RPLND, respectively. The mean OR time was 131 (105-195) min, mean blood loss was < 150ml and the mean hospitalization time was 4.5 (3-9) days. Four patients (13.3%) had a Clavien-Dindo IIIA-IV complication (lymphocele, chylous ascites, ileus), and the antegrade ejaculation rate was (86.7%). The mean number of dissected lymph nodes was 17.1 (range: 8-56), the mean number of positive lymph nodes was 1.4 (range: 1-2) and the mean diameter of positive nodes was 2.1 (range: 1.0-4.5) cm. Histology of the resected lymph nodes revealed metastatic seminoma in 26 (86.7%) patients, and 1 and 3 patients demonstrated embryonal carcinoma and benign disease, respectively. Eighteen patients underwent serum analysis of miR371 preoperatively with a sensitivity for metastatic disease in 93.3% and specificity of 100%. Overall survival was 100%, and intervention-free survival was 86.7% with two (6.7%) patients developing an outfield relapse at 4.6 and 9 months postoperatively. Both patients were salvaged by systemic chemotherapy with 3 cycles PEB and are currently NED.
Dr. Nestler noted several limitations for this trial:
- Relatively low number of patients
- Mid-term length of follow-up
- Remains a center-based treatment option
- Lack of prospective randomization to nerve-sparing RPLND vs radiotherapy + carboplatin
Dr. Nestler concluded his presentation discussing the interim analysis of the prospective COTRIMS trial with the following concluding messages:
- Nerve sparing RPLND results in a high cure rate at midterm follow-up and it is associated with a low frequency of treatment associated morbidities making this approach a feasible alternative to standard radiation therapy or systemic chemotherapy
- 13.3% had no seminomatous metastases
- MiR371p might be a useful marker to predict presence/absence of metastases in equivocal findings
Clinical Trial Information: DRKS00025384.
Presented by: Tim Nestler, MD, Department of Urology, University Hospital of Cologne, Cologne, Germany
Co-Authors: Axel Heidenreich, Felix Seelemeyer, Pia Paffenholz, David A. Pfister
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2023 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, Thurs, Feb 16 – Sat, Feb 18, 2023.