A prospective study of chemoradiotherapy as primary treatment in patients with locoregionally advanced penile carcinoma
Mené sur 33 patients atteints d'un carcinome pénien localement avancé (durée médiane de suivi : 41 mois), cet essai évalue l'efficacité, du point de vue de la survie sans progression à 1 an, et la toxicité d'une chimioradiothérapie en traitement de première ligne
Purpose: 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. Methods and materials: 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. Results: 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. Conclusions: 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 2022