{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T21:54:53Z","timestamp":1786658093997,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2010,2,16]],"date-time":"2010-02-16T00:00:00Z","timestamp":1266278400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2010,4,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>BACKGROUND:<\/jats:title><jats:p>The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette\u2010Gu\u00e9rin (BCG) after BCG failure in high\u2010risk, non\u2010muscle\u2010invasive bladder cancer (BC).<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS:<\/jats:title><jats:p>In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high\u2010risk non\u2010muscle\u2010invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg\/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg\/50 mL) over a 6\u2010week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment\u2010related complications were also evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS:<\/jats:title><jats:p>Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (<jats:italic>P<\/jats:italic> = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; <jats:italic>P<\/jats:italic> = .09). Kaplan\u2010Meier analysis of 2\u2010year recurrence\u2010free survival showed significant differences between Group A and B (19% and 3%, respectively, <jats:italic>P<\/jats:italic> &lt; .008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (<jats:italic>P<\/jats:italic> = .12). Both intravesical administrations were generally well tolerated.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS:<\/jats:title><jats:p>Gemcitabine might represent a second\u2010line treatment option after BCG failure in high\u2010risk non\u2010muscle\u2010invasive BC patients. Cancer 2010. \u00a9 2010 American Cancer Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.24914","type":"journal-article","created":{"date-parts":[[2010,2,16]],"date-time":"2010-02-16T13:20:07Z","timestamp":1266326407000},"page":"1893-1900","source":"Crossref","is-referenced-by-count":151,"title":["Gemcitabine versus bacille Calmette\u2010Gu\u00e9rin after initial bacille Calmette\u2010Gu\u00e9rin failure in non\u2010muscle\u2010invasive bladder cancer"],"prefix":"10.1002","volume":"116","author":[{"given":"Giuseppe","family":"Di 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