The PRIMETEST trial: Interim analysis of a phase II trial for primary retroperitoneal lymph node dissection (RPLND) in stage II A/B seminoma patients without adjuvant treatment.

Abstract

507 Background: We thought to evaluate progression-free survival of stage II A/B seminoma patients (pts) undergoing primary retroperitoneal lymph node dissection (RPLND) without adjuvant treatment. Aim is to present interim data of a feasibility study and a phase II trial. Methods: Prior to the phase II study, 9 patients have been treated within a pilot feasibility study. After IRB approval, additional 12 patients from 3/2016 to 9/2018 within the prospective phase II trial were accrued. All patients received primary retroperitoneal lymph node dissection (open or daVinci assisted) for stage IIA/B seminoma without adjuvant treatment. The data was analyzed for peri- and postoperative outcome including recurrence free survival. The trial will have to accrue 30 pts and was designed to exclude a > 30% recurrence to standard treatment. Results: Since 5.2014 twenty-two patients with seminomateous germ cell tumor have been included in both studies, including one patient with an atypical inguinal recurrence and one patient with a 6 cm marker negative recurrence (clinical stage IIC). Primary RPLND was performed in 4 patients with initial CSIIA. 14 and 4 patients experiences a recurrence under surveillance and after carboplatin adjuvant treatment, respectively. Mean tumor size was 2.6 cm with a mean OR time of 134 min and a mean blood loss of 70 cc. One patient after DaVinci RPLND developed a ureteral stricture requiring ileal ureter substitute. The mean follow-up is 24 month (range 1-51 months), 17/22 patients (77%) are free of recurrence. 5/22 (23%) developed a recurrence (4x outside field and 1x inside field) with a mean time to recurrence of 4.5 months. All patients received salvage treatment (4x CTX and 1x radiotherapy) and are currently recurrence free. Conclusions: Primary RPLND in stage IIA/B seminoma patients is an experimental treatment approach in order to reduce long term toxicity and secondary malignancies. Interim results of this strategy justifies continuation of the study. This kind of surgery should only be performed within clinical trials in high volume referral centers. Clinical trial information: NCT 2015053664.

Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST)

“…Considering the alternative advanced relapse definition ($ 3 cm), the increase associated with the three-scan schedule was small (six events, 2.0% increase, ITT) and noninferiority was demonstrated. Thus, the impact of a less frequent imaging schedule on the selection for the use of local treatment at relapse (either radiotherapy or, as recently reported, minimally invasive retroperitoneal surgery 31,32 ) is likely to be small, especially as our data suggest some centers use the same approach (either highdose carboplatin 23 or BEP) regardless of relapse stage/size. Hence, numbers of advanced relapses would not affect care.…”

Indications, feasibility and outcome of robotic retroperitoneal lymph node dissection for metastatic testicular germ cell tumours

“…Of the pR-RPLND mTGCT patients, three were seminomas in CS 2A disease. All of these patients denied radiation or chemotherapy, and with the aim of offering an approach that reduces toxicities and overtreatment and, in response to the setting of the SEMS and PRIMETEST trials, pR-RPLND was performed 34 – 37 . All of these patients were discharged after three to four days.…”

Nerve-sparing Robot-assisted Retroperitoneal Lymph Node Dissection: The Monoblock Technique

“…This change in paradigm is reflected in our series describing a new RPLND technique incorporating the most recent technical modifications, including robotic surgery [14] , nerve-sparing and template resection [6] , [7] , [8] , and en-bloc resection of all lymphatic tissue to ensure complete resection around the large vessels [16] . Those modifications reduce the morbidity of the procedure and could pave the way to reconsideration of RPLND in different settings, including stage 1 nonseminoma [4] , [17] , [18] , stage 2 seminoma with [19] or without adjuvant chemotherapy [20] , and stage 2 nonseminoma at presentation [21] or recurrence after initial surveillance [22] .…”