This manuscript summarizes the currently available immunotherapy-based trials that are open for accrual for penile cancer patients with relapsed disease, highlighting that most of those studies are using single-agent immune checkpoint blockade in an all-solid tumors population. Other combination trials that are available in basket trials for patients with relapsed advanced penile cancer are nivolumab with ipilimumab, atezolizumab with bevacizumab, atezolizumab with valproic acid, and nivolumab with cabozantinib. We noted that the current clinical trial landscape lacks immunotherapy combinatory trials in the neoadjuvant treatment setting for penile cancer patients. In the era of immunotherapy, investigation of chemotherapy and immune therapy combination in the neoadjuvant setting is justified and should be the interest of future collaborative groups’ clinical trials.
The manuscript also described the recent data from a Phase II clinical showing that dacomitinib, a second-generation pan-HER tyrosine kinase inhibitor, in 28 chemotherapy-naïve patients with locally advanced or metastatic PSCC had clinical benefit with the ORR was 32.1% with median PFS of 4.1 months and OS of 13.7 months. The treatment was relatively well tolerated with only 10% grade 3-4 skin rash as the major toxicity.
Lastly, we discuss the potential role for assessing the penile tumor HPV status, beyond the potential prognostic information, patient with HPV positive tumors could benefit from enrollment to HPV directed trials. We summarized the HPV directed trials that are open for accrual for penile cancer patients in the US.
Written by: Jad Chahoud, MD, MPH, Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, Florida & Andrea Necchi, MD, Fondazione IRCCS Instituto Nazionale dei Tumori, Milan, Italy
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