Zhang Sheng, Zhu Yao, Ye Dingwei
Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Oncotarget. 2015 Oct 13;6(31):32212-9. doi: 10.18632/oncotarget.4802.
Patients with distantly metastatic (M1) penile squamous carcinoma have extremely poor prognosis and few prospective clinical trials evaluating systemic treatment have ever been performed for this population.
Patients (aged ≥ 18 years) with histologically confirmed, distantly metastatic, measurable penile squamous carcinoma were enrolled. They were treated with docetaxel 75 mg/m2 (day1), cisplatin 70 mg/m2 (day1), and fluorouracil 500 mg/m2/d (days 1 to 5) every 3 weeks as first line chemotherapy. The primary endpoint was objective response rate (ORR).
39 patients received chemotherapy with a median of four cycles (range two to six). The median follow-up time was 11 months. 15 patients had a confirmed objective response (38.5%, 95% CI 23.36-55.38), all of which were partial responses. The median progression-free survival (PFS) was 3 months (95% CI 2.92-3.09), and the median overall survival (OS) was 7 months (95% CI 5.99-8.03). Toxicity was manageable and the most frequently recorded adverse events of grade 3 or higher were neutropenia (13 of 39; 33%), nausea/vomiting (7 of 39;18%). There was no treatment-related death.
The palliative regimen of docetaxel, fluorouracil, and cisplatin induced moderate responses and can be used as a choice for the treatment of patients with distantly metastatic penile cancer. However, efforts to improve efficacy and minimize toxicity for this regimen should be made in the future.
远处转移（M1）阴茎鳞状细胞癌患者预后极差，针对该人群评估全身治疗的前瞻性临床试验极少。
纳入年龄≥18岁、经组织学确诊为远处转移且可测量的阴茎鳞状细胞癌患者。他们接受多西他赛75mg/m²（第1天）、顺铂70mg/m²（第1天）和氟尿嘧啶500mg/m²/天（第1至5天），每3周作为一线化疗。主要终点为客观缓解率（ORR）。
39例患者接受化疗，中位周期数为4个周期（范围2至6个周期）。中位随访时间为11个月。15例患者有确认的客观缓解（38.5%，95%CI 23.36 - 55.38），均为部分缓解。中位无进展生存期（PFS）为3个月（95%CI 2.92 - 3.09），中位总生存期（OS）为7个月（95%CI 5.99 - 8.03）。毒性可控，最常记录的3级或更高等级不良事件为中性粒细胞减少（39例中的13例；33%）、恶心/呕吐（39例中的7例；18%）。无治疗相关死亡。
多西他赛、氟尿嘧啶和顺铂的姑息治疗方案诱导了中度缓解，可作为远处转移阴茎癌患者治疗的一种选择。然而，未来应努力提高该方案的疗效并将毒性降至最低。
