title: Neoadjuvant taxane-based combination chemotherapy in patients with advanced penile cancer.
abstract: 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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Despite a fairly good response percentage, TPF chemotherapy was poorly tolerated with disappointing survival rates. Therefore, other treatment options should be considered.
authors.affiliation: Department of Urology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Rosa S
authors.initials: RS
authors.lastname: Djajadiningrat
authors.affiliation: Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Andries M
authors.initials: AM
authors.lastname: Bergman
authors.affiliation: Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Erik
authors.initials: E
authors.lastname: van Werkhoven
authors.affiliation: Department of Nuclear Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Erik
authors.initials: E
authors.lastname: Vegt
authors.affiliation: Department of Urology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: s.horenblas@nki.nl.
authors.forename: Simon
authors.initials: S
authors.lastname: Horenblas
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D010412:Penile Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D049268:Positron-Emission Tomography; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: Carcinoma of the penis; Locally advanced; Neoadjuvant treatment; Prognosis; Squamous cell carcinoma