The excellent results and minimum morbidity of nerve-sparing RPLND together with the increased concerns on late complications of radiotherapy may turn the preference of surgery in low-stage seminoma into the subject of future discussion.
A treatment program that consists of three cycles of EP caused complete disease control in all patients. The applied regimen may be considered as a therapeutic option with reduced toxicity in clinical stage IS nonseminomatous testicular cancer patients. More evidence, however, needs to be accumulated.
Objective: In nonseminomatous testicular cancer patients with normal serum tumor markers and no distant metastasis, postorchiectomy surgery is a valid treatment option if the disease extension into the retroperitoneum is not advanced. We assessed the ability of ultrasound (US) to exclude the presence of bulky retroperitoneal disease. Materials and Methods: One hundred and forty testicular cancer patients underwent US and computed tomography (CT) of the retroperitoneum. US results were analyzed using three cutoffs: 5 cm (conventional staging), 3 cm (based on the minimal sonographical dimension of actual bulky disease) and 0 cm (‘clean retroperitoneum’ or any detectable nodes), and were compared with CT data using the 5-cm cutoff (‘gold standard’). Results: The sensitivity, specificity, overall accuracy, positive and negative predictive values of US in detecting of bulky retroperitoneum for the 5-cm cutoff were 83, 96, 93, 88 and 94%, for the 3-cm cutoff 100, 91, 94, 80 and 100%, and for the 0-cm cutoff 100, 66, 74, 49 and 100%, respectively. Conclusions: In stage I and IIA/B marker-negative nonseminomas if the treatment strategy is surgery, US may facilitate the selection process; the report of a clean retroperitoneum safely excludes the presence of bulky disease and may be an indication for lymphadenectomy, although in case of positive findings a CT should be performed.
5533 Background: NOX66 is a new formulation of the small molecule, idronoxil. The primary mechanism of action of idronoxil stems from its binding to the transmembrane enzyme ENOX2 expressed on cancer cells, resulting in reduced S1P and increased ceramide levels, thereby promoting apoptosis. Additional intracellular effects include the inhibition of DNA repair mechanisms. There is growing evidence that S1P is a promotor of tumour resistance to immune cell infiltration, highlighting NOX66’s potential to modulate the immune response against cancer. Methods: This two-part phase 1b open-label study enrolled patients with late-stage progressive mCRPC. Part 1 was a dose-escalation safety assessment of three doses of NOX66 (400 mg, n = 4; 800 mg, n = 6 and 1200 mg, n = 15) administered daily for 14 days with radiation therapy (20 Gy) delivered in 5 fractionated doses to one or more symptomatic lesion/s. Part 2 was an expansion cohort with NOX66 at 1200 mg in conjunction with radiation therapy. The primary endpoint of safety was assessed by the frequency and grade of treatment-emergent adverse events (TEAEs). At 6 weeks, 3- and 6-month follow up, treatment response was assessed radiographically by RECIST1.1 and by PSA >50% reduction. Results: 25 patients received and completed treatment. TEAEs considered related to NOX66 alone were mild (Grade 1) cases of dry mouth and oral mucositis; mild (Grade 1) fatigue was considered related to both NOX66 and radiation. None of the 21 Grade ≥3 TEAEs were considered related to NOX66. At 6 months, of the 15 evaluable patients by RECIST1.1, 9 had SD and 1 had PR and these same patients had maintained this response from 3 months. Five of the 16 PSA-evaluable patients achieved a PSA response (61-98% PSA reduction) at 6 months, which again was maintained from 3 months. Conclusions: NOX66 in combination with low-dose radiation therapy was found to be safe and well tolerated with promising signals of durable efficacy in patients with late-stage mCRPC. Responses of lesions outside the radiation field are being reviewed. Clinical trial information: NCT03307629 .
Objective: To assess the feasibility of bleomycin omission from second and third cycles of bleomycin, etoposide and cisplatin (BEP) chemotherapy in low-volume stage II nonseminomatous germ cell tumor patients who achieve a normal tumor marker level after the first cycle of treatment. Materials and Methods: Out of 59 nonseminomatous testicular cancer patients with low-volume retroperitoneal disease, serum markers normalized after the first cycle of treatment in 30 cases. 12 patients completed 3BEP (group 1; years 1994–1998) and other 18 patients received etoposide and cisplatin (EP) as second and third cycles of chemotherapy (group 2; years 1998–2004). Results: All patients from each group achieved complete response with chemotherapy alone or by subsequent resection of teratoma or necrosis. There was no relapse with active cancer after the treatment. All patients remained disease-free during the median follow-up period of 97 and 48 months for groups 1 and 2 respectively. Conclusions: One cycle of BEP plus two cycles of EP chemotherapy was as effective as three standard cycles of BEP. The regimen can be suggested as a less toxic therapeutic alternative in these selected patients. More cases, however, in a prospective randomized setting are required to further verify these data.
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