Prospective COTRIMS (Cologne trial of retroperitoneal lymphadectomy in metastatic seminoma) trial: Final results.

Abstract

618 Background: Radiation or chemotherapy represent the standard treatment in clinical stage IIA/B seminoma. Despite high cure rates both modalities are associated with significant long-term toxicities. The COTRIMS trial evaluated the oncological and functional efficacy of primary retroperitoneal lymphadenectomy (RPLND) without adjuvant chemotherapy in CS IIA/B seminomas. Methods: 34 patients with CS IIA/B pure semimomas were prospectively recruited. Exclusion criteria were adjuvant chemotherapy following orchiectomy, CS IIC, previous retroperitoneal surgery or radiation, positive tumor markers. All patients underwent nerve sparing RPLND with a unilateral template; no adjuvant chemotherapy was delivered. Follow-up was done according to EAU guidelines. In 22 patients miR371 was evaluated preoperatively and correlated with pathohistology of lymph nodes. The primary endpoint of the study was a relapse-free rate of < 20% at 3 years. Results: Median age is 34.2 (21-54) years, mean and median follow-up is 41.5 (4-73) and 33.4 (13-56) months. 22 and 12 pts had CS IIA and CS IIB, resp. Mean OR-time, blood loss and hospitalisation were 131 (105-195) min, < 150ml and 4 (3-9) days. 4 (11.7%) pts experienced Clavien Dindo 3a complication. Antegrade ejaculation was preserved in 88%. A mean of 19 (7-57) lymph nodes were dissected. Mean number of positive lymph nodes was 1.4 (1-2), mean diameter was 2.3 (0.8-4.1) cm. Seminoma was present in 85%, non-malignancy and nonseminoma were found in 8.9% and 5.9%. miR371 was positive in 17/18 pts with metastases und negative in 3/3 with benign lesions. 4 (11.7%) pts relapsed after 4, 6, 9 and 12 months and all were salvaged by chemotherapy. Conclusions: RPLND results in high cure rates associated with low frequency of surgery – related complication even after a follow-up of about 3 years. Nearly 90% of patients can be managed without systemic chemotherapy. RPLNSD should be included in the treatment options for CS IIA/B seminomas. miR371 appears to be a valid biomarker to predict presence of lymph node metastases. Clinical trial information: DRKS00025384 .