This study investigated the efficacy and safety of neoadjuvant chemotherapy (NAC) for locally advance penile squamous cell carcinoma (PSCC), for which current evidence is lacking.
Included patients had locally advanced PSCC with clinical lymph node metastasis treated with at least one dose of NAC prior to planned consolidative lymphadenectomy. Objective response rates (ORR) were assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The primary and secondary outcomes were overall survival and progression-free survival, estimated by the Kaplan-Meier method. Treatment-related adverse events (trAEs) were graded per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
209 patients received NAC for locally advanced and clinically node-positive PSCC.The study population consisted of 7% of patients with stage II disease, 48% with stage III, and 45% with stage IV. Grade 2 TrAEs occurred in 35 (17%) patients, and no treatment related mortality was observed. 201 (97%) completed planned consolidative lymphadenectomy. During follow up, 106 (52.7%) patients expired, with a median OS of 37.0 months (95% CI 23.8-50.1), and median PFS of 26.0 months (95% CI 11.7-40.2). ORR was 57.2%, with 87 (43.2%) having partial response and 28 (13.9%) having a complete response. Patients with objective response to NAC had a longer median OS (73.0 vs 17.0 months, p < .01) compared to those who did not. The lymph-node pathologic complete response rate (ypN0) was 24.8% in the cohort.
NAC with lymphadenectomy for locally advanced PSCC is well tolerated and active to reduce the disease burden and improve long term survival outcomes.
Journal of the National Cancer Institute. 2024 Feb 16 [Epub ahead of print]
Kyle M Rose, Rachel Pham, Niki M Zacharias, Filip Ionescu, Mahati Paravathaneni, Kathryn A Marchetti, Darren Sanchez, Arfa Mustasam, Reagan Sandstrom, Raghu Vikram, Jasreman Dhillon, Priya Rao, Amy Schneider, Lance Pagliaro, Constantine Alifrangis, Maarten Albersen, Eduard Roussel, Viraj A Master, Bassel Nazha, Cindy Hernandez, Kelvin A Moses, Chris Protzel, Jeffrey Montgomery, Martin Angel, Marcos Tobias-Machado, Philippe E Spiess, Curtis A Pettaway, Jad Chahoud
Ochsner Medical Center, New Orleans, LA, United States., University of Texas Health Science Center Houston, Houston, TX, United States., University of Texas M.D. Anderson Cancer Center, Houston TX, United States., H. Lee Moffitt Cancer Center, Tampa, FL, United States., Mayo Clinic, Rochester, MN, United States., University College London Hospitals, London, United Kingdom., University Hospitals Leuven, Leuven, Belgium., Winship Cancer Institute of Emory University, Atlanta, GA, United States., Vanderbilt University Medical Center, Nashville TN, United States., University Hospital of Rostock, Rostock, Germany., University of Michigan, Ann Arbor, MI, United States., Instituto Alexander Fleming, Buenos Aires, Argentina., Cancer Institute Dr Arnaldo, Sao Paulo, Brazil.