Controversies in the management of clinical stage i testicular seminoma

International audienceStage I seminoma is the most frequently occurring single stage/histology of testicular cancer, comprising up to 80% of seminomas. Seminomas comprise about 40% of all testicular cancers. Its management is controversial, several treatment options after orchiectomy are considered. These are surveillance, radiation alone or chemotherapy alone. Active surveillance (with treatment upon relapse), adjuvant irradiation, and adjuvant carboplatin, each achieve an overall survival approaching 100%. In this article, we review the existing literature and recent recommendations for the various treatment options, and their advantages and disadvantages

Phase I, double-blind, randomized, placebo-controlled, dose-escalation study of NI-0401 (a fully human anti-CD3 monoclonal antibody) in patients with moderate to severe active Crohn's disease.

Item does not contain fulltextBACKGROUND: NI-0401 is a fully human monoclonal antibody, which binds to the CD3 subunit of the T-cell receptor, causing modulation of T-cell activity. We investigated the safety and the ability to modulate the TCR-CD3 complex of NI-0401 in patients with active Crohn's disease (CD). METHODS: A double-blind, placebo-controlled, randomized, multicenter, dose-escalating trial was conducted in CD patients age 18-70 years, a Crohn's Disease Activity Index (CDAI) of 220-450, and detectable levels of C-reactive protein. The primary outcome was safety and the ability of NI-0401 to modulate the TCR-CD3 complex on T cells. Efficacy parameters included the proportion of patients achieving remission (CDAI /=100), and change from baseline in the CD Endoscopy Index of Severity (CDEIS). RESULTS: Forty patients received placebo (n = 7) or NI-0401 (n = 33) 0.05-10 mg daily for 5 days. NI-0401 doses /=2 mg. The extent and duration of TCR-CD3 modulation increased with dose. No differences between groups were observed in the proportions of patients achieving clinical remission or response. The mean CDEIS at week 6 differed significantly between the 1-mg and placebo group. CONCLUSIONS: NI-0401 was tolerated at doses </=1 mg with manageable side effects. NI-0401 induced a dose-dependent modulation of the TCR-CD3 complex. No significant improvement of CDAI was observed but 1 mg NI-0401 demonstrated an improvement in CDEIS.1 oktober 201