Superficial bladder cancer

Lamm, Donald L.

doi:10.1007/s11864-002-0005-4

Cited by 25 publications

(7 citation statements)

References 20 publications

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“…[21] The main toxicities of intravesical chemotherapy are irritative bladder symptoms. More severe, drug-specific side effects, including myelosuppression, systemic allergic reactions, contact toxicity, and bladder fibrosis leading to contracture, occur in 10%–20% of patients.…”

Section: Discussionmentioning

confidence: 99%

Phase II study of intravesical therapy with AD32 in patients with papillary urothelial carcinoma or carcinoma in situ (CIS) refractory to prior therapy with bacillus Calmette-Guerin (E3897): A trial of the Eastern Cooperative Oncology Group

Ignatoff¹,

Chen²,

Greenberg³

et al. 2009

Urologic Oncology: Seminars and Original Investigations

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SUMMARYObjectives-Assess the safety and effectiveness of AD32, a doxorubicin analogue with little systemic exposure when administered intravesically, in patients with recurrent or refractory superficial urothelial carcinoma (formerly called transitional cell carcinoma [TCC]), or carcinoma in situ (CIS), who have failed prior BCG-based immunotherapy.Methods-Eligible patients received 6 weekly doses (800mg) of intravesical AD32 and were evaluated at 12-week intervals for 24 months or until date of worsening disease. Primary analysis was the proportion of all patients recurrence-free at 12 months. Treatment-related and GU-specific toxicities were also examined. All participating institutions submitted the protocol for Institutional Review Board (IRB) approval.Results-The study was halted due to unavailability of study drug after accrual of 48 of a planned 64 patients; 42 were included in the analysis. Of these, 28 (67%) were still alive after median followup of 61.1 months. Of 21 TCC patients, 18 (85.7%) experienced disease recurrence (median time to recurrence, 5.3 months). Of the 5 CIS patients with complete response (CR), 3 (60%) experienced disease recurrence; (median time to recurrence, 37.3 months). Recurrence-free rates at 12 and 24 months were 20% (90% CI, 7.8%, 36.1%) and 15% (90 CI, 4.9%, 30.2%), respectively, for patients with TCC and 80% (90% CI, 31.4%, 95.8%) at both intervals for CIS patients with CR. Infection was the most common treatment-related toxicity; no grade 4 or higher toxicity was observed. The most common GU-specific toxicity was increased frequency/urgency.Conclusions-AD32 is safe and active for treatment of recurrent or refractory superficial bladder carcinoma. The agent awaits more complete characterization when drug production problems can be solved.

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Section: Discussionmentioning

confidence: 99%

Phase II study of intravesical therapy with AD32 in patients with papillary urothelial carcinoma or carcinoma in situ (CIS) refractory to prior therapy with bacillus Calmette-Guerin (E3897): A trial of the Eastern Cooperative Oncology Group

Ignatoff¹,

Chen²,

Greenberg³

et al. 2009

Urologic Oncology: Seminars and Original Investigations

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“…One possible explanation is that in patients with grade 3 tumours or Cis, the urothelial surface is of inferior quality or partially absent, ‘denuded’, making it more vulnerable to BCG. Additionally, there are no reports about which symptoms will improve after a reduced dose, as suggested by O’Donnell et al [7] and Lamm [13].…”

Section: Discussionmentioning

confidence: 99%

Intravesical bacillus Calmette‐Guèrin therapy: experience with a reduced dwell‐time in patients with pronounced side‐effects

2005

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patients self-reported side-effects after each instillation in a questionnaire. RESULTSAfter reducing the BCG dwell-time, fever, chills, dysuria and the overall time-torecovery were significantly reduced but frequency and haematuria were not influenced. Patients with carcinoma in situ had significantly less dysuria than patients with papillary tumours. There was no difference in the treatment results between patients who had a normal dwell-time and a reduced dwell-time, determined at the first and second follow-up cystoscopy.

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“…Since the initial report in the 1960s [1], intravesical therapy was given at weekly intervals. The previous observation that the increase of the interval between the instillation does not affect the response rates [Bassi, unpubl. data] prompted us to investigate the role of a delayed intravesical regimen.…”

Section: Discussionmentioning

confidence: 99%

“…Several agents such as bacillus Calmette-Guérin (BCG), mitomycin C and epirubicin are currently used [1,2] to this aim. Among them, epirubicin has been shown to be active; interestingly, a direct relationship between dose and activity has been demonstrated in a phase I-II trial in patients with carcinoma in situ [2,3].…”

Section: Introductionmentioning

confidence: 99%

Delayed High-Dose Intravesical Epirubicin Therapy of Superficial Bladder Cancer

Bassi

Longo²,

Saraeb³

et al. 2002

Urol Int

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Introduction: Intravesical epirubicin is a widely used agent for the treatment of superficial bladder cancer. A direct relationship between dose and activity has been reported: unfortunately the dose increase also increased the frequency and the intensity of treatment-related side effects. Materials and Methods: A phase 2 trial was designed to evaluate the toxicity and the activity of a delayed (biweekly) high-dose (80 mg) epirubicin therapy of superficial bladder cancer. Thirty patients with intermediate risk superficial bladder cancer (stage mTa, G2) have been treated with transurethral resection and epirubicin intravesical therapy: the patients were given 80 mg epirubicin in 50 ml sterile saline every 2 weeks for 6 times (delayed regimen). The follow-up ranged from 3 to 26 months. Eleven of 30 (37%) patients experienced a local adverse reaction to intravesical epirubicin requiring specific medication (grade ≧2 according to NCI-CTC v.2.0, 1999). No systemic toxicity related to the treatment was observed. Results: Out of the 29 evaluable patients, 22 (76%) were free of disease after the induction course, 6 (21%) had superficial bladder cancer recurrences and 1 (3%) experienced tumor progression. Conclusion: A delayed (biweekly instillation) high-dose (80 mg) intravesical epirubicin regimen was acceptable in terms of side effects and showed a worthwhile therapeutical impact in patients with intermediate risk superficial bladder cancer.

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Superficial bladder cancer

Cited by 25 publications

References 20 publications

Phase II study of intravesical therapy with AD32 in patients with papillary urothelial carcinoma or carcinoma in situ (CIS) refractory to prior therapy with bacillus Calmette-Guerin (E3897): A trial of the Eastern Cooperative Oncology Group

Phase II study of intravesical therapy with AD32 in patients with papillary urothelial carcinoma or carcinoma in situ (CIS) refractory to prior therapy with bacillus Calmette-Guerin (E3897): A trial of the Eastern Cooperative Oncology Group

Intravesical bacillus Calmette‐Guèrin therapy: experience with a reduced dwell‐time in patients with pronounced side‐effects

Delayed High-Dose Intravesical Epirubicin Therapy of Superficial Bladder Cancer

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