The efficacy of NAPC in locally advanced PSCC was suggested in prior small case series. Although the phase III randomized InPACT trial is expected to report results for this disease space within the next 4 years, we are currently left with scant evidence-based guidance in managing these patients. Thus, we aimed to bridge that gap and provide evidence on real-world outcomes of patients with PSCC who received NAPC prior to surgical resection.
After internal review board approval, patients from eight tertiary care centers who had undergone NAPC prior to surgical resection for PSCC were analyzed. Patients had locally advanced (cTany, cN+) disease. Outcomes analyzed included clinicopathologic data, agents utilized, and surgical modalities. The primary outcome, overall survival (OS), was analyzed using Kaplan-Meier Method and compared using Cox Proportional Hazard Modelling. Secondary outcomes included the best overall response measured with RECIST 1.1 criteria.
One hundred and fifty-six patients treated with NAPC for PSCC were included. The median age of the cohort was 59 years (range, 48-67), and 109 (70%) had an Eastern Cooperative Oncology Group score of 0-1. The clinical stages prior to NAC were cIIA-IIB (12%), cIIIa (16%), cIIIb (22%), and cIV (47%). 123 (79%) of patients received TIP (Paclitaxel - Ifosfamide - Cisplatin) NAC prior to surgical resection. 76% of patients underwent penile-sparing surgical procedures, 24% had a radical penectomy and 84% had inguinal lymphadenectomy. The median (95% CI) OS was 39 months (20.9 – 57.1), while the median progression free survival was 23 months (10.4 – 35.5). On serial imaging after NAPC, 20.7% had progressive disease (PD), 23.3% had stable disease, 48.4% had partial response, and 7.6% had complete response. On Cox Regression, significant predictors (hazard ratio (HR), p<0.05) for OS included PD (HR 2.1, p=0.02) following administration of NAPC.
NAPC is efficacious in PSCC. This study represents the largest conglomeration of multi-institutional PSCC patients treated with systemic chemotherapy, which will guide management strategies while we await prospective clinical trial data.
Clinical trial identification
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Has not received any funding.
J. Chahoud: Financial Interests, Personal, Advisory Role: Pfizer, Aveo, Exelixis. P.E. Spiess: Non-Financial Interests, Leadership Role, Vice-Chair of NCCN Bladder and Penile Cancer Panel: NCCN; Non-Financial Interests, Leadership Role, President of Global Society of Rare GU Tumors: Global Society of Rare GU Tumors; Financial Interests, Leadership Role, Member of the ASCO/EAU Panel on penile cancer: ASCO/EAU. A. Schneider: Financial Interests, Institutional, Invited Speaker, for Prostate Cancer: NCCN. All other authors have declared no conflicts of interest.