| Added by | mollevi |
|---|---|
| Last modified by | celine.gongora |
| Group name | EquipeCG |
| Item Type | Journal Article |
| Title | Intermediate analysis of a phase II trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma |
| Creator | Houede et al. |
| Author | N. Houede |
| Author | L. Dupuy |
| Author | P. Beuzeboc |
| Author | G. Gravis |
| Author | B. Laguerre |
| Author | C. Theodore |
| Author | S. Culine |
| Author | T. Filleron |
| Author | C. Chevreau |
| 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. PATIENTS AND 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/m2 on day 1 over 30 min and cisplatin 50 mg/m2 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. CONCLUSION: 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. |
| Publication | BJU Int |
| Date | Jan 20 2015 |
| Journal Abbr | BJU international |
| DOI | 10.1111/bju.13054 |
| ISSN | 1464-410X (Electronic) 1464-4096 (Linking) |
| Tags | clinic, last |
| Date Added | 2018/07/20 - 10:05:58 |
| Date Modified | 2019/10/24 - 16:14:27 |
| Notes and Attachments | (Note) (Note) 25601543 (Attachment) |
Institut de Recherche en Cancérologie de
