title: Paclitaxel in pretreated metastatic penile cancer: final results of a phase 2 study.
abstract: BACKGROUND
  Previously published preliminary findings showed promising activity of paclitaxel in chemotherapy-pretreated metastatic penile cancer.
  
  
  OBJECTIVE
  To evaluate the activity and safety of paclitaxel in pretreated metastatic penile cancer.
  
  
  METHODS
  Twenty-five patients were enrolled in a single-arm phase 2 multicentre study and treated with 175 mg/m² paclitaxel at 3-wk intervals until disease progression or irreversible toxicity.
  
  
  METHODS
  The objective response rate was the primary end point. Safety, progression-free survival (PFS), and overall survival (OS) were secondary end points.
  
  
  CONCLUSIONS
  Partial responses were observed in 20% (5 of 25 patients). Grade 1-2 neutropenia, nausea, and oral mucositis were the most common side effects, noted in 13, 9, and 8 patients, respectively. Grade 3-4 neutropenia was reported in seven patients (28%). Median PFS was 11 wk (95% confidence interval [CI], 7-30); median OS was 23 wk (95% CI, 13-48). Median survival in responders was 32 wk (95% CI, 20-48). One limitation of our study was the limited accrual, which did not reach the target of 27 patients, due to the typical slow enrolment of a rare disease.
  
  
  CONCLUSIONS
  Final results of this study demonstrate that paclitaxel is moderately active and well tolerated. Further trials, which may also explore the combination of paclitaxel with other agents, are required to confirm our findings.
authors.affiliation: Genitourinary Oncology and Rare Cancer Center, Federico II University, Naples, Italy. giuseppedilorenzoncol@hotmail.com
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lorenzo
authors.forename: Piera
authors.initials: P
authors.lastname: Federico
authors.forename: Carlo
authors.initials: C
authors.lastname: Buonerba
authors.forename: Nicola
authors.initials: N
authors.lastname: Longo
authors.forename: Giacomo
authors.initials: G
authors.lastname: Cartenì
authors.forename: Riccardo
authors.initials: R
authors.lastname: Autorino
authors.forename: Sisto
authors.initials: S
authors.lastname: Perdonà
authors.forename: Matteo
authors.initials: M
authors.lastname: Ferro
authors.forename: Pasquale
authors.initials: P
authors.lastname: Rescigno
authors.forename: Carmine
authors.initials: C
authors.lastname: D'Aniello
authors.forename: Elide
authors.initials: E
authors.lastname: Matano
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Altieri
authors.forename: Giovannella
authors.initials: G
authors.lastname: Palmieri
authors.forename: Ciro
authors.initials: C
authors.lastname: Imbimbo
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Mirone
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D018572:Disease-Free Survival; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D010412:Penile Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel