Single-dose Carboplatin (C) AUC7 is an adjuvant treatment option in Seminoma stage I. Many of these patients have very good renal function and hence high absolute doses of C are frequently administered. Some experts and clinical guidelines recommend capping of C dose at Creatinine-Clearance (Crea-Cl) of 125 ml/min because of concerns of excessive toxicity. The rationale for these concerns has not been explored in patients with Seminoma stage I so far.
Analysis of a cohort of patients with stage I Seminoma treated with C AUC 7 in 2 Swiss centres 2005 – 2015. Main inclusion criteria: Normal blood count at treatment, minimum of 2 measurements during first 8 weeks of follow-up. Comparison of incidence and grade (CTCAE v4.0) of hematological adverse events (AEs) in patients with Crea-Cl 125 ml/min without dose capping.
74 patients with 229 documented measurements were identified. Median age 41 years (Range 22 – 71), Crea-Cl (Cockroft-Gault) 126 ml/min (70 - 206), C dose 1013 mg (700 - 1477). 12 patients with Crea-Cl >125 ml/min and capped C dose (resulting in AUC vs. G2
Concerns of excessive toxicity in patients with Seminoma stage I and Crea-Cl >125 ml/min treated with adjuvant C AUC7 are not supported by our data. Most AEs were grade 1 (>80%). There was also no statistically significant excess of AEs > grade 2. Therefore capping of C dose is not justified in this Situation.
Clinical trial identification
BASEC Nr. 2016-00472
Legal entity responsible for the study
Kantonsspital St. Gallen, Switzerland, Dr Martin Fehr
All authors have declared no conflicts of interest.