Intravesical gemcitabine therapy for superficial transitional cell carcinoma: Results of a Phase II prospective multicenter study

Bartoletti, Riccardo; Cai, Tommaso; Gacci, Mauro; Giubilei, Gianluca; Viggiani, F.; Santelli, G; Repetti, Fabio; Nerozzi, Stefano; Ghezzi, P; Sisani, Michele

doi:10.1016/j.urology.2005.04.062

Cited by 92 publications

(35 citation statements)

References 15 publications

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“…In Bartoletti et al's (2005) study, Gem given once a week for 6 weeks was associated with a 74% and 13% recurrence-free survival in patients with intermediate-and high-risk lesions, respectively, at a median follow up of 13.6 months. The usefulness of the antimetabolite was also confirmed by Kohjimoto in a small series of BCG-refractory patients following biweekly administration (Kohjimoto et al, 2005).…”

Section: Toxicitymentioning

confidence: 86%

Activity of endovesical gemcitabine in BCG-refractory bladder cancer patients: a translational study

et al. 2007

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Intravesical gemcitabine (Gem) has shown promising activity against transitional cell carcinomas (TCC) of the bladder, with moderate urinary toxicity and low systemic absorption. The present phase II study evaluated the activity of biweekly intravesical treatment with Gem using a scheme directly derived from in vitro preclinical studies. Patients with Bacille Calmette-Guérin (BCG) -refractory Ta G3, T1 G1-3 TCC underwent transurethral bladder resection and then intravesical instillation with 2000 mg Gem diluted in 50 ml saline solution on days 1 and 3 for 6 consecutive weeks. Thirty-eight (95%) of the 40 patients showed persistent negative post-treatment cystoscopy and cytology 6 months after Gem treatment, while the remaining 2 patients relapsed at 5 and 6 months. At a median follow-up of 28 months, recurrences had occurred in 14 patients. Among these, four had downstaged (T) disease, three had a lower grade (G) lesion and three had a reduction in both T and G. Urinary and systemic toxicity was very low, with no alterations in biochemical profiles. In conclusion, biweekly instillation of Gem proved active in BCG-refractory Ta G3, T1 G1-3 TCC. Our results highlight the importance of preclinical studies using in vitro systems that adequately reproduce the conditions of intravesical clinical treatment to define the best therapeutic schedule.

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Section: Toxicitymentioning

confidence: 86%

Activity of endovesical gemcitabine in BCG-refractory bladder cancer patients: a translational study

et al. 2007

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“…Bartoletti et al 23 administered intravesical gemcitabine as a prophylactic treatment in BCG-refractory patients. Eighteen of 24 intermediate-risk and 7 of 16 high-risk patients remained recurrence-free.…”

Section: Toxicitymentioning

confidence: 99%

Gemcitabine versus bacille Calmette‐Guérin after initial bacille Calmette‐Guérin failure in non‐muscle‐invasive bladder cancer

Lorenzo

Perdonà

Damiano

et al. 2010

Cancer

154

103

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BACKGROUND:The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guérin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC). METHODS: In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive 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-week 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-related complications were also evaluated. RESULTS: Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P ¼ .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P ¼ .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P < .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 (P ¼ .12). Both intravesical administrations were generally well tolerated. CONCLUSIONS: Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients. Cancer 2010;116:1893-900.

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“…[15] In a phase II study, Bartoletti et al used GEM once a week for 6 weeks with an intravesical dosage of 2000 mg in 116 patients with intermediate-high risk BC. [16] In the intermediate risk group, 21 of 81 patients (25.9%) had recurrence (2 cases with disease-progression) whereas, in the high risk group 27 of 35 patients (77.1%) experienced recurrences (5 cases with disease-progression) after 1 year. Tumor recurrence was observed in 35.2% (13/40) and 21% (16/76) of the BCG-relapsing, and BCG naïve patients, respectively.…”

Section: Gemcitabinementioning

confidence: 90%

Alternative therapies in patients with non-muscle invasive bladder cancer

Şanlı

Lotan

2017

Turkish Journal of Urology

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Bladder cancer (BC) is one of the leading causes of cancer-related deaths worldwide. Despite, the majority of the cases were diagnosed as non-muscle invasive bladder cancer (NMIBC) with favorable prognosis, it has tendency to recur or progress to a higher grade or stage. The first line treatment of patients with NMIBC is transurethral resection with adjuvant therapies primarily intravesical Bacillus Calmette-Guérin (BCG) immunotherapy. However, in a portion of patients whose BCG treatment failed, alternative treatments may be required. Furthermore, intravesical BCG may be contraindicated in or untolerated by a group of patients. For these patients, some treatment options are readily available and a variety of them are currently under clinical investigation. In this review, these alternative therapies have been summarized.

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Intravesical gemcitabine therapy for superficial transitional cell carcinoma: Results of a Phase II prospective multicenter study

Cited by 92 publications

References 15 publications

Activity of endovesical gemcitabine in BCG-refractory bladder cancer patients: a translational study

Activity of endovesical gemcitabine in BCG-refractory bladder cancer patients: a translational study

Gemcitabine versus bacille Calmette‐Guérin after initial bacille Calmette‐Guérin failure in non‐muscle‐invasive bladder cancer

Alternative therapies in patients with non-muscle invasive bladder cancer

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