835P - Carboplatin dose based on actual renal function vs. dose capping: no excess of hematotoxicity in treatment of seminoma stage I

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Germ Cell Tumours
Presenter Martin Fehr
Citation Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373
Authors M. Fehr1, H. Reichegger1, A. Fischer Maranta2, S. Gillessen1, R. Cathomas2
  • 1Medical Oncology/haematology, Kantonsspital St. Gallen, 9007 - St. Gallen/CH
  • 2Medical Oncology, Kantonsspital Graubünden, 7000 - Chur/CH

Abstract

Background

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.

Methods

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.

Results

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 11% (4) 29% (6) .31 Decreased White Cell Count 37% (13) 48% (13) .44 Decreased Neutrophil Count 46% (16) 44% (12) .92 Decreased Neutrophil Count >G2 20% (7) 19% (5) .88 AEs with clinical interventions 2.8% (1 hospitalisation with febrile neutropenia G3) 3.7% (1 platelet transfusion in thrombocytopenia G4) .85

Conclusions

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

Funding

N/A

Disclosure

All authors have declared no conflicts of interest.