Neoadjuvant chemotherapy followed by surgery for locoregionally advanced penile carcinoma (LAPSCC) is associated with severe toxicity and a one-year survival probability of ∼50%. We aimed to evaluate the safety and efficacy of chemoradiotherapy (CRT) as the primary treatment for LAPSCC and the association of high-risk Human Papilloma Virus (hrHPV) with the outcome.
This was a prospective single-center single-arm study of CRT in LAPSCC, defined as a large/inoperable primary tumor, large palpable nodes, suspicion of extranodal extension or pelvic nodal involvement, and no distant metastases. CRT consisted of 49.5 Gy (33 × 1.5 Gy) on affected inguinal and pelvic areas, combined with intravenous mitomycin C on day one and capecitabine on radiation days. Primary tumors and PET/CT-positive deposits received a boost of 59.4 Gy (33 × 1.8 Gy). The response was evaluated by FDG-PET/CT. If feasible, patients with residual/recurrent disease underwent salvage surgery. The primary endpoint was one-year progression-free survival (PFS), reached when 1-year PFS is ≥50%. Other endpoints were two-year PFS, overall survival (OS), and toxicity rates. Kaplan-Meier survival curves were compared using the log-rank test.
Thirty-three patients were included; 29 (88%) with stage IV disease (T4 any-N M0 and/or any-T N3 M0) and 8 (24%) with hrHPV-positive disease. Median follow-up was 41 months. Thirty-two completed CRT. Eleven (33%) experienced ≥1 grade 3 treatment-related adverse events. No grade 4 or 5 treatment-related events. Twenty-four patients (73%) responded, including 13 (39%) complete responses. Nine patients (27%) underwent salvage surgery, an additional eight patients underwent later surgery (together 52%). One and two-year PFS were 34% and 31%, respectively. One- and two-year OS were 73% and 46%, respectively. No significant difference between patients with hrHPV-positive and negative tumors was observed.
CRT is a viable treatment option for LAPSCC with acceptable toxicity. CRT can result in an enduring response. If patients have residual tumor, salvage surgery is feasible. HrHPV-status was not associated with outcomes.
International journal of radiation oncology, biology, physics. 2023 Apr 06 [Epub ahead of print]
S R Ottenhof, H M de Vries, B Doodeman, G L Vrijenhoek, V van der Noort, M L Donswijk, J M de Feijter, E Schaake, S Horenblas, O R Brouwer, M S van der Heijden, F J Pos
Department of Urology, Netherlands Cancer Institute, Amsterdam, Netherlands. Electronic address: ., Department of Urology, Netherlands Cancer Institute, Amsterdam, Netherlands. Electronic address: ., Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, Netherlands., Department of Biometrics, Netherlands Cancer Institute, Amsterdam, Netherlands. Electronic address: ., Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam, Netherlands., Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands., Department of Urology, Netherlands Cancer Institute, Amsterdam, Netherlands., Department of Urology, Netherlands Cancer Institute, Amsterdam, Netherlands. Electronic address: .
PubMed http://www.ncbi.nlm.nih.gov/pubmed/37030606