title: Intermediate analysis of a phase II trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma.
abstract: OBJECTIVE
  To perform a phase II study evaluating a combination of gemcitabine and cisplatin in a population of patients with squamous cell carcinoma (SCC) of the penis and unresected locoregional lymph nodes and/or distant metastases, who had a poor prognosis with no standard of chemotherapy.
  
  
  METHODS
  Eligible patients had histologically confirmed SCC of the penis with unresected locoregional lymph nodes and/or distant metastases, at initial diagnosis or at relapse, and measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Patients were treated with a combination of gemcitabine 1250 mg/m(2) on day 1 over 30 min and cisplatin 50 mg/m(2) on day 1 over 1 h, every 2 weeks. The primary endpoint was the objective response rate; secondary endpoints were time to progression (TTP) and overall survival (OS).
  
  
  RESULTS
  In all, 25 patients were included in the first phase of the study between February 2004 and January 2010 and received a median of five cycles. For the intent-to-treat population, two patients (95% confidence interval [CI] 0.98-26.0) presented an objective response and 13 patients (52%) had stable disease (95% CI 35.5-76.8). The median TTP was at 5.48 months (95% CI 2.40-11.73). After a median follow-up of 26.97 months (95% CI 17.77, not reached), nine patients were still alive. The median OS and 2-year OS rate were respectively estimated at 14.98 months (95% CI 9.76-32.9) and 39.32% (95% CI 19.15-59.03). Eleven patients had a serious adverse event (44%), 24% being relied to chemotherapy.
  
  
  CONCLUSIONS
  Every 2 weeks' administration of the combination of gemcitabine and cisplatin showed non-significant responses in patients with unresected locoregional or metastatic penile SCC. Despite manageable side-effects, this combination cannot be recommended as a standard of care, due to disappointing response rates seen in this negative study. Further regimens should be explored to improve the OS of these patients with poor prognosis.
authors.affiliation: Department of Medical Oncology, Nîmes University Hospital, Nîmes, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: Houédé
authors.affiliation: Department of Medical Oncology, Daniel Hollard Institute, Grenoble, France.
authors.forename: Laura
authors.initials: L
authors.lastname: Dupuy
authors.affiliation: Department of Medical Oncology, Léon Bérard Cancer Centre, Lyon, France.
authors.forename: Aude
authors.initials: A
authors.lastname: Fléchon
authors.affiliation: Department of Medical Oncology, Curie Institute, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Beuzeboc
authors.affiliation: Department of Medical Oncology, Paoli-Calmettes Institute, Marseille, France.
authors.forename: Gwenaëlle
authors.initials: G
authors.lastname: Gravis
authors.affiliation: Department of Medical Oncology, Eugène Marquis Cancer Center, Rennes, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Laguerre
authors.affiliation: Department of Medical Oncology, Foch University Hospital, Paris, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Théodore
authors.affiliation: Department of Medical Oncology, Saint-Louis University Hospital, Paris, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Culine
authors.affiliation: Clinical Research and Biostatistic Unit, Claudius Régaud Cancer Institute, Toulouse, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Filleron
authors.affiliation: Department of Medical Oncology, Claudius Régaud Cancer Institute, Toulouse, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Chevreau
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D053208:Kaplan-Meier Estimate; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010412:Penile Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine
keywords: gemcitabine and cisplatin combination; penile cancer; squamous cell carcinoma