title: Cisplatin and 5-fluorouracil in inoperable, stage IV squamous cell carcinoma of the penis.
abstract: What's known on the subject? and What does the study add? Metastatic or locally advanced squamous cell carcinoma of the penis (SCCP) is generally incurable, but it can be palliated with systemic chemotherapy. Two retrospective studies, involving <10 patients each, showed that cisplatin plus continuous infusion of 5-fluorouracil (5-FU) may be effective and well tolerated. Cisplatin, methotrexate and bleomycin, cisplatin and irinotecan and taxanes can also play an important role for patients with locally advanced/metastatic SCCP. Finally, anti-EGFR therapy may also be effective in advanced SCCP. Although cisplatin plus continuous infusion of 5-FU is widely used in clinical practice for palliation of SCCP, toxicity and efficacy data regarding this schedule include a total of 14 patients with SCCP, treated more than two decades ago. In our retrospective study, cisplatin plus continuous infusion of 5-FU was used for palliative purposes in a homogenous sample of 25 patients with SCCP. Partial responses and stable disease were observed in 8 (32%) and 10 (40%) patients, respectively, with a median progression-free survival of 20 weeks. Neutropenia was the most important grade 3-4 side effect observed, occurring in 20% of patients. These data provide confirmation that such a combination regimen is moderately effective and well tolerated in patients with SCCP.
  
  
  OBJECTIVE
  • To investigate the activity and toxicity of 5-fluorouracil (5-FU) as a first-line treatment in metastatic squamous cell carcinoma of the penis (SCCP).
  
  
  METHODS
  • The medical records of 78 patients with SCCP treated between January 2000 and June 2011 at the four participating centres were reviewed. • Data regarding patients treated with first-line 5-FU were extracted. • Patients were included in the study if radiological reports were available for determination of response and progression-free survival (PFS) according to response evaluation criteria in solid tumours (RECIST) 1.1.
  
  
  RESULTS
  • Between January 2000 and June 2011, 25 patients were treated with i.v. cisplatin on day 1 followed by 5-FU as a continuous 24-h infusion for 4 days every 3 weeks until disease progression or unacceptable toxicity. Partial responses and stable disease were observed in eight (32%) and 10 (40%) patients, respectively, with a disease control rate of 72%. • Severe neutropenia was the most important grade 3-4 side effect observed, occurring in 20% of patients. • The median (interquartile range [IQR]) PFS was 20 (11-20) weeks and the median (IQR) overall survival (OS) was 8 (7-12) months.
  
  
  CONCLUSIONS
  • 5-FU is associated with a moderate response rate and is well tolerated in patients with metastatic SCCP.
authors.affiliation: Genitourinary Cancer Section and Rare-Cancer Center, University Federico II, Naples, Italy. giuseppedilorenzoncol@hotmail.com
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lorenzo
authors.forename: Carlo
authors.initials: C
authors.lastname: Buonerba
authors.forename: Piera
authors.initials: P
authors.lastname: Federico
authors.forename: Sisto
authors.initials: S
authors.lastname: Perdonà
authors.forename: Michele
authors.initials: M
authors.lastname: Aieta
authors.forename: Pasquale
authors.initials: P
authors.lastname: Rescigno
authors.forename: Carmine
authors.initials: C
authors.lastname: D'Aniello
authors.forename: Livio
authors.initials: L
authors.lastname: Puglia
authors.forename: Antonella
authors.initials: A
authors.lastname: Petremolo
authors.forename: Matteo
authors.initials: M
authors.lastname: Ferro
authors.forename: Alfredo
authors.initials: A
authors.lastname: Marinelli
authors.forename: Giovannella
authors.initials: G
authors.lastname: Palmieri
authors.forename: Guru
authors.initials: G
authors.lastname: Sonpavde
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Mirone
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010412:Penile Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D002945:Cisplatin; D005472:Fluorouracil