Djajadiningrat Rosa S, Bergman Andries M, van Werkhoven Erik, Vegt Erik, Horenblas Simon
Department of Urology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Clin Genitourin Cancer. 2015 Feb;13(1):44-9. doi: 10.1016/j.clgc.2014.06.005. Epub 2014 Jun 8.
INTRODUCTION/BACKGROUND: Neoadjuvant taxane-based combination chemotherapy has shown promising results in unresectable squamous cell carcinoma of the head and neck area, and the penis. Our primary aim was to assess the objective response in penile cancer patients neoadjuvantly treated with taxane-based combination chemotherapy. Secondary outcomes were progression-free survival (PFS), disease-specific survival (DSS), and toxicity.
Twenty-six patients were treated within the framework of a nonrandomized institutional registration study with 4 courses of TPF (docetaxel, cisplatin, and 5-fluorouracil) for advanced penile cancer between 2008 and 2012. Response was measured using computed tomography (CT) and/or fluorodeoxyglucose positron emission tomography/CT according to Response Evaluation Criteria in Solid Tumours 1.1 criteria and European Organisation for Research and Treatment of Cancer recommendations, respectively. Toxicity, PFS, and DSS were analyzed using either the Common Toxicity Criteria of Adverse Events version 4.0 or the Kaplan-Meier methods. To analyze possible association with survival, univariable and multivariable Cox regression analyses were performed for tumor differentiation, N-category, recurrent disease, tumor margins, and administration of radiotherapy.
During a median follow-up of 30 months, an imaging-based response was obtained in 60% (95% confidence interval [CI], 39%-79%) (15/25) of patients. However, pathologic complete response was observed in 1 of 25 evaluable patients (4%; 95% CI, 0%-20%). Toxicity was considerable with registered toxicity in every patient. The 2-year PFS and DSS probability were 12% and 28%, respectively. Patients responsive to chemotherapy had significantly better survival than nonresponsive patients.
Despite a fairly good response percentage, TPF chemotherapy was poorly tolerated with disappointing survival rates. Therefore, other treatment options should be considered.
引言/背景：基于紫杉烷的新辅助联合化疗已在不可切除的头颈部鳞状细胞癌及阴茎癌治疗中显示出有前景的结果。我们的主要目的是评估接受基于紫杉烷的联合化疗新辅助治疗的阴茎癌患者的客观缓解情况。次要结局为无进展生存期（PFS）、疾病特异性生存期（DSS）及毒性。
2008年至2012年间，26例患者在一项非随机的机构注册研究框架内接受了4个疗程的TPF（多西他赛、顺铂和5-氟尿嘧啶）治疗晚期阴茎癌。分别根据实体瘤疗效评价标准1.1版标准及欧洲癌症研究与治疗组织的建议，使用计算机断层扫描（CT）和/或氟脱氧葡萄糖正电子发射断层扫描/CT测量缓解情况。使用不良事件通用毒性标准4.0版或Kaplan-Meier方法分析毒性、PFS和DSS。为分析与生存的可能关联，对肿瘤分化、N分期、复发性疾病、肿瘤切缘及放疗应用进行单变量和多变量Cox回归分析。
在中位随访30个月期间，60%（95%置信区间[CI]，39%-79%）（15/25）的患者获得了基于影像学的缓解。然而，25例可评估患者中有1例观察到病理完全缓解（4%；95%CI，0%-20%）。毒性相当大，每位患者均有记录到毒性。2年PFS和DSS概率分别为12%和28%。对化疗有反应的患者生存明显优于无反应患者。
尽管缓解率相当不错，但TPF化疗耐受性差，生存率令人失望。因此，应考虑其他治疗选择。
