In this phase II study, 26 patients were treated of which 77% had advanced disease with visceral or pelvic lymph node metastasis. Considering the high-risk group, a response was obtained in 30% over a follow up of 17 months. However, progression free survival and overall survival rates were 24% at 51%, respectively, at 1 year.
Tissue samples from 23 patients were analyzed post Daconatinib. Interestingly TERT mutations (60%) were found in responders only. Mutations were found in 47% of non-responders compared to 25% of responders. HRAS and BRAF mutations were common in the non-responders suggesting association with eGFR resistance.
The authors were able to conclude that Dacomitinib was active in HPV-negative, advanced penile squamous cell carcinoma. Among multiple altered pathways, we were able to delineate the possible molecular profile of responders. We look forward to the an expansion cohort to confirm the translational findings is planned. Clinical trial information: NCT01728233
First Author: Andrea Necchi
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