Of 246 patients over 33 UK centers, 54% had NSGCTT, and 46% with combined GCT. In this cohort, over 39 months four patients had malignant recurrences following one cycle with high dose etopiside BEP. All recurrences were treated with 2ndline chemotherapy and some had surgery. At study end, 3 were alive and free from disease, and 1 died at 9 months with refractory disease. Notably, not counted as a malignant recurrence were 3 recurrences that were considered non-malignant recurrences as pathology for these were differentiated teratoma. All these patients are disease-free post RPLND surgery.
41% patients had grade 3-4 adverse events at end of treatment with 31% having neutropenia and 7% having febrile neutropenia. In this cohort, the 2 year overall survival was excellent at 99.2% (95% CI: 96.7, 99.8%). This is the largest trial for patients on the efficacy and safety of single cycle BEP in patients with high risk, stage 1 NSGCT who have elected to not go ahead with observation.
This presents a novel design to investigate a new treatment approach. Adoption would reduce exposure of toxic chemotherapy to young patients over two cycles of BEP. However, it should be recognized that with GCSF support, febrile neutropenia persisted and a significant portion had ototoxicity, which, for those patients who would not have had any therapy is morbidity from over treatment that would not have occurred had observation been the management plan for these patients.
Clinical trial information: ISRCTN37875250.
First Author: Robert Huddart
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