ASCO GU 2017: Phase II trial of TI-CE high dose chemotherapy (HDCT) with drug monitoring for individual carboplatin dosing in patients with relapsed advanced germ cell tumors: A multicenter prospective GETUG trial.

Orlando, Florida USA (UroToday.com) At the genitourinary cancer symposium this year, Christine Chevreau presented the benefit of high dose chemotherapy using the TICE regimen with drug monitoring in patients with advanced germ cell tumors. The TICE regimen for salvage therapy in poor risk germ cell tumors previously demonstrated a 50% complete response. However, concern regarding the very high variability of carboplatin area under the curve needed to be addressed.

Results of the single arm prospective multicenter phase II trial of TICE with therapeutic drug monitoring for individual carboplatin dosing on patients with unfavorable relapsed GCTs was presented. Target dose for the trial was a 3-day AUC of 24 mg/min/mL. Patients were treated according the TICE regimen: two cycles combining paclitaxel and ifosfamide followed by three cycles of carboplatin plus etopiside with stem cell support, with the day 3 carboplatin dose set to reach target dose.

72 of 101 patients (71%) completed the therapy, 29pts (26%) stopped treatment earlier of which only 8 were for toxicity. Three patients died on treatment. The average AUC for carboplatin was 24.5, and the dose of carboplatin varied from -33% to +44% following dose adjustment. The authors felt that Carboplatin dose individualization based on TDM allowed to reach more accurately the target AUC compared to previous reports. Given the nature of this study, it is impossible to create a randomized trial. And despite that the AUC of 24 is a arbitrary target, in the absence of true comparative data, the therapeutic drug monitoring potentially reduced over exposure and had a favourable side effect dose. Therefore, it is recommended to optimize drug delivery. Clinical trial information: NCT00864318

First Author: Christine Chevreau

Written By: Michael J Metcalfe, MD, Fellow of Urologic Oncology Urology, MD Anderson Cancer Center, Houston TX
Ashish M. Kamat, MD, MBBS, FACS, President, International Bladder Cancer Network Chair, Society of Immunotherapy for Cancer (SITC), BCTF, Director of Urologic Oncology Fellowship, Professor of Urology, Attending Surgeon, Division of Surgery, The University of Texas, MD Anderson Cancer Center, Houston TX

at the 2017 Genitourinary Cancers Symposium - February 16 - 18, 2017 – Orlando, Florida USA

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