Introduction 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. Methods 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. Results 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. Conclusion NAC with lymphadenectomy for locally advanced PSCC is well tolerated and active to reduce the disease burden and improve long term survival outcomes.

中文翻译：

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阴茎癌新辅助铂类化疗和淋巴结切除术：一项国际、多机构、真实世界研究


简介 本研究调查了新辅助化疗 (NAC) 对局部晚期阴茎鳞状细胞癌 (PSCC) 的疗效和安全性，目前尚缺乏证据。方法纳入的患者患有局部晚期 PSCC，并伴有临床淋巴结转移，在计划进行巩固性淋巴结切除术之前至少接受一剂 NAC 治疗。使用实体瘤疗效评估标准 (RECIST) v1.1 评估客观缓解率 (ORR)。主要和次要结局是通过 Kaplan-Meier 方法估计的总生存期和无进展生存期。治疗相关不良事件 (trAE) 根据不良事件通用术语标准 (CTCAE) v5.0 进行分级。结果 209 名局部晚期和临床淋巴结阳性 PSCC 患者接受了 NAC。研究人群包括 7% 的 II 期疾病患者、48% 的 III 期患者和 45% 的 IV 期患者。 35 名患者 (17%) 发生 2 级 TrAE，未观察到与治疗相关的死亡。 201 名 (97%) 完成了计划的巩固性淋巴结切除术。随访期间，106 名患者 (52.7%) 死亡，中位 OS 为 37.0 个月 (95% CI 23.8-50.1)，中位 PFS 为 26.0 个月 (95% CI 11.7-40.2)。 ORR 为 57.2%，其中 87 例（43.2%）有部分缓解，28 例（13.9%）有完全缓解。与没有客观缓解的患者相比，对 NAC 做出客观缓解的患者的中位 OS 更长（73.0 个月 vs 17.0 个月，p < .01）。该队列的淋巴结病理完全缓解率 (ypN0) 为 24.8%。结论 NAC 联合淋巴结切除术治疗局部晚期 PSCC 具有良好的耐受性和积极性，可减轻疾病负担并改善长期生存结果。