{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T06:32:58Z","timestamp":1778049178302,"version":"3.51.4"},"reference-count":33,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2015,4,27]],"date-time":"2015-04-27T00:00:00Z","timestamp":1430092800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2016,3]]},"abstract":"\n Objective<\/jats:title>\n \n To perform a phase\n II<\/jats:styled-content>\n study evaluating a combination of gemcitabine and cisplatin in a population of patients with squamous cell carcinoma (\n SCC<\/jats:styled-content>\n ) of the penis and unresected locoregional lymph nodes and\/or distant metastases, who had a poor prognosis with no standard of chemotherapy.\n <\/jats:p>\n <\/jats:sec>\n \n Patients and Methods<\/jats:title>\n \n Eligible patients had histologically confirmed\n SCC<\/jats:styled-content>\n of the penis with unresected locoregional lymph nodes and\/or distant metastases, at initial diagnosis or at relapse, and measurable disease as defined by\n R<\/jats:styled-content>\n esponse\n E<\/jats:styled-content>\n valuation\n C<\/jats:styled-content>\n riteria in\n S<\/jats:styled-content>\n olid\n T<\/jats:styled-content>\n umors (\n RECIST<\/jats:styled-content>\n ) criteria. Patients were treated with a combination of gemcitabine 1250\u00a0mg\/m\n 2<\/jats:sup>\n on day 1 over 30\u00a0min and cisplatin 50\u00a0mg\/m\n 2<\/jats:sup>\n on day 1 over 1\u00a0h, every 2\u00a0weeks. The primary endpoint was the objective response rate; secondary endpoints were time to progression (\n TTP<\/jats:styled-content>\n ) and overall survival (\n OS<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n 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\u2010to\u2010treat population, two patients (95% confidence interval [\n CI<\/jats:styled-content>\n ] 0.98\u201326.0) presented an objective response and 13 patients (52%) had stable disease (95%\n CI<\/jats:styled-content>\n 35.5\u201376.8). The median\n TTP<\/jats:styled-content>\n was at 5.48\u00a0months (95%\n CI<\/jats:styled-content>\n 2.40\u201311.73). After a median follow\u2010up of 26.97\u00a0months (95%\n CI<\/jats:styled-content>\n 17.77, not reached), nine patients were still alive. The median\n OS<\/jats:styled-content>\n and 2\u2010year\n OS<\/jats:styled-content>\n rate were respectively estimated at 14.98\u00a0months (95%\n CI<\/jats:styled-content>\n 9.76\u201332.9) and 39.32% (95%\n CI<\/jats:styled-content>\n 19.15\u201359.03). Eleven patients had a serious adverse event (44%), 24% being relied to chemotherapy.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Every 2\u00a0weeks' administration of the combination of gemcitabine and cisplatin showed non\u2010significant responses in patients with unresected locoregional or metastatic penile\n SCC<\/jats:styled-content>\n . Despite manageable side\u2010effects, 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\n OS<\/jats:styled-content>\n of these patients with poor prognosis.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/bju.13054","type":"journal-article","created":{"date-parts":[[2015,1,20]],"date-time":"2015-01-20T02:38:41Z","timestamp":1421721521000},"page":"444-449","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Intermediate analysis of a phase\n II<\/scp>\n trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma"],"prefix":"10.1111","volume":"117","author":[{"given":"Nadine","family":"Hou\u00e9d\u00e9","sequence":"first","affiliation":[{"name":"Department of Medical Oncology N\u00eemes University Hospital N\u00eemes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Dupuy","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Daniel Hollard Institute Grenoble France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aude","family":"Fl\u00e9chon","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology L\u00e9on B\u00e9rard Cancer Centre Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Beuzeboc","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Curie Institute Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gwena\u00eblle","family":"Gravis","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Paoli\u2010Calmettes Institute Marseille France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brigitte","family":"Laguerre","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Eug\u00e8ne Marquis Cancer Center Rennes 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