OBJECTIVE: Patients with squamous cell carcinoma of the penis and unresected loco-regional lymph nodes and/or distant metastases have a poor prognostic with no standard of chemotherapy.
We performed a phase II study evaluating the association of gemcitabine and cisplatin in this population.
PATIENTS AND METHOD: Eligible patients had histological confirmed squamous cell carcinoma of the penis with unresected locoregional lymph nodes and/or distant metastases at initial diagnosis or at relapse, and measurable disease as defined by RECIST criteria. Patients were treated with the association of gemcitabine 1250 mg/m2 on day 1 over 30 minutes and cisplatin 50 mg/m2 on day 1 over 1 hour, every two weeks. Primary endpoint was the objective response rate; secondary endpoints were time to progression (TTP) and overall survival (OS).
RESULTS: Twenty five patients were included in the first step of the study between February 2004 and January 2010 and received a median of 5 cycles. For ITT population, 2 patients (95%CI = [0.98 ;26.0]) presented an objective response. Thirteen patients had stable disease (52% 95%CI = [35.5-76.8]). Median TTP is estimated 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. OS median and 2 years OS rates are 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 SAE (44%) within 24% were relied to chemotherapy.
CONCLUSION: The every two weeks administration of the combination of gemcitabine and cisplatin showed non-significant responses in patients with unresected loco-regional or metastatic penile squamous cell carcinoma. Despite manageable side effects, this combination cannot be recommended as a standard of care due to disappointing response rates observed in this negative study. Further regimens should be explored to improve the overall survival of these patients with poor prognosis.
Written by:
Houédé N, Dupuy L, Fléchon A, Beuzeboc P, Gravis G, Laguerre B, Théodore C, Culine S, Filleron T, Chevreau C. Are you the author?
Department of Medical Oncology, Nîmes University Hospital, Nîmes, France.
Reference: BJU Int. 2015 Jan 20. Epub ahead of print.
doi: 10.1111/bju.13054
PubMed Abstract
PMID: 25601543