Intra vesical gemcitabine (G) single agent as adjuvant chemotherapy in superficial transitional cell carcinoma (TCC) of the bladder: Final results

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5078-5078
Author(s):  
A. Bounedjar ◽  
R. Ferhat ◽  
F. Smaili ◽  
K. Bouzid
Keyword(s):  
Transitional Cell Carcinoma ◽  
Cell Carcinoma ◽  
Bladder Carcinoma ◽  
Performance Status ◽  
Single Agent ◽  
Transitional Cell ◽  
Hot Flashes ◽  
Haematological Toxicity ◽  
Urinary Cytology ◽  
Bcg Therapy

5078 Background: Systemic intravenous G is usually used in advanced bladder carcinoma. A phase I study of intravesical G has shown safety profile in pts refractory to BCG therapy (Dalbani G et al JCO 2002; 20:3193–98). In this study we evaluate the toxicity and the efficacy of intravesical G in patients (pts) with superficial bladder carcinoma. Methods: The study population criteria were: age = 18 years old, histological diagnosis of transitional cell carcinoma (TCC) of bladder (Cis and pT1) confirmed by transurethral resection (TUR), no prior chemotherapy, a performance status (PS) < 2, good bone marrow reserve, adequate renal and liver function and informed consent. Three weeks after a total TUR, pts receive intravesical instillation of 2,000 mg G every wk for 6 wks, than every month for six months. Evaluation is performed 3–4 wks after the last instillation (CT scan and/or US pelvis, urinary cytology and cystoscopy with biopsy). Results: From February 2003 to June 2004, 60 pts (57M/3F) were enrolled in the study (M/F = 57/3). The median age was 59,5 years old (24–84). Nine pts had a carcinoma in situ (Cis) and 51 had pT1 lesions. They received a total of 720 instillations. All pts were evaluable for toxicity and response Toxicity (CTC/NCI scale) is evaluated over the 720 instillations. Non haematological toxicity was grade 1: irritate bladder reaction (4.7%), asthenia (2.9%), nausea and vomiting (1.8%) and hot flashes (2%). Grade 1 haematological toxicity: anaemia (6.8%), leucopenia (4.5%) and thrombocytopenia (0.4%). After a follow-up time of 30 to 48 months, all pts were evaluable for tumor response: 53 patient had a persistant complete remission after TUR. Five patients (8.3%) had a superficial relapse of TCC (one at six months, 2 at 9 months and 2 others at 12 months). Two patients had progressive disease at 18 months and 27 months. Conclusion: Intravesical G is an active and well tolerated treatment even after repeated instillation in pts with superficial TCC carcinoma of the bladder. No significant financial relationships to disclose.

Results of a phase II study of pralatrexate in patients with advanced/metastatic relapsed transitional cell carcinoma of the urinary bladder.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4574-4574
Author(s):  
Yohann Loriot ◽  
Karim Fizazi ◽  
Joan Carles ◽  
Garry Alan Weems ◽  
Lacey Chance ◽  
...  
Keyword(s):  
Urinary Bladder ◽  
Transitional Cell Carcinoma ◽  
Cell Carcinoma ◽  
Group Performance ◽  
Performance Status ◽  
Single Agent ◽  
Transitional Cell ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Metastatic Setting

4574 Background: Antifolate agents have demonstrated activity in transitional cell carcinoma (TCC), a disease with very poor outcomes in advanced stages. Pralatrexate (FOLOTYN, Allos Therapeutics, Inc., Westminster, CO), a folate analogue targeting dihydrofolate reductase, is designed for enhanced uptake and accumulation in tumor cells. The objective of this study was to examine the activity and safety of pralatrexate in patients (pts) with advanced/metastatic TCC of the urinary bladder after failure of prior chemotherapy. Methods: Pts with histologically confirmed TCC (>50% TCC in tumor) received pralatrexate 190 mg/m² intravenously on days 1 and 15 of a 28‑day cycle supplemented with vitamin B12 and folic acid. Included pts had Eastern Cooperative Oncology Group performance status of 0–1, measurable disease, and prior treatment with ≤1 platinum- and/or methotrexate-based regimen in the recurrent/metastatic setting. Results: Thirty pts were enrolled and treated. All pts received prior platinum-based therapy, and 7 pts (23%) received methotrexate in a multidrug regimen. One pt had a confirmed partial response (PR); 4 additional pts had unconfirmed PRs. Twelve pts had stable disease. The median number of cycles received was 2 (range, 1–24), and median time on treatment was 56 days (range, 1–714). The median progression-free survival (PFS) and overall survival for all pts was 4.0 months (95% confidence interval [CI], 2.1–4.5) and 9.3 months (95% CI, 5.6–13.2), respectively. Eight pts (27%) had PFS >6 months and 3 pts (10%) had PFS >12 months. Eight pts (27%) underwent dose reductions, all due to mucositis. Six pts (20%) discontinued the study due to treatment-related adverse events (AEs)—mainly mucositis. The most frequent treatment-related AEs were stomatitis (77%), asthenia (30%), vomiting (27%), and anemia, nausea, and neutropenia (23% each). Conclusions: Pralatrexate showed evidence of activity and durable disease control when used as a single agent in pts with advanced bladder cancer, although the overall response rate was modest. Further study of pralatrexate in this setting should focus on improving drug delivery and evaluation of novel combination approaches.

847: Institutional Variability in Predictive Accuracy of Urinary Cytology for Prediction of Transitional Cell Carcinoma Recurrence

2005 ◽  
Vol 173 (4S) ◽  
pp. 230-230
Author(s):  
Serge Benayoun ◽  
Shahrokh F. Shariat ◽  
Paul Perrotte ◽  
Martin G. Friedrich ◽  
Craig D. Zippe ◽  
...  
Keyword(s):  
Transitional Cell Carcinoma ◽  
Cell Carcinoma ◽  
Predictive Accuracy ◽  
Transitional Cell ◽  
Urinary Cytology

A Squamous Cell Bladder Carcinoma with Karyotypic Abnormalities Reminiscent of Transitional Cell Carcinoma

1989 ◽  
Vol 142 (2 Part 1) ◽  
pp. 374-376 ◽  
Author(s):  
Rolf Lundgren ◽  
Peter Elfving ◽  
Sverre Heim ◽  
Ulf Kristoffersson ◽  
Nils Mandahl ◽  
...  
Keyword(s):  
Transitional Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Bladder Carcinoma ◽  
Transitional Cell

Transitional cell carcinoma of ureteral stump after radical nephrectomy in a patient with a history of bladder carcinoma

2004 ◽  
Vol 36 (3) ◽  
pp. 337-338 ◽  
Author(s):  
Konstantinos Haritopoulos ◽  
Konstantinos Stravodimos ◽  
Constantinos Banias ◽  
Vagelis Giaslakiotis ◽  
Christos Alamanis ◽  
...  
Keyword(s):  
Transitional Cell Carcinoma ◽  
Cell Carcinoma ◽  
Bladder Carcinoma ◽  
Radical Nephrectomy ◽  
Transitional Cell ◽  
History Of

Intravesical gemcitabine (G) single agent as adjuvant chemotherapy in superficial transitional cell carcinoma (TCC) of bladder

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 4601-4601
Author(s):  
K. Bouzid ◽  
R. Ferhat ◽  
A. Bounedjar ◽  
H. Mahfouf ◽  
F. Smaili ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Transitional Cell Carcinoma ◽  
Cell Carcinoma ◽  
Single Agent ◽  
Transitional Cell

Phase II trial of docetaxel in patients with advanced or metastatic transitional-cell carcinoma.

1997 ◽  
Vol 15 (5) ◽  
pp. 1853-1857 ◽  
Author(s):  
J A McCaffrey ◽  
S Hilton ◽  
M Mazumdar ◽  
S Sadan ◽  
W K Kelly ◽  
...  
Keyword(s):  
Transitional Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Single Agent ◽  
Transitional Cell ◽  
Survival Duration ◽  
Hematologic Toxicity ◽  
Hematopoietic Growth Factors ◽  
Cutaneous Toxicity

PURPOSE A phase II trial of docetaxel was conducted to assess its efficacy and toxicity in patients with advanced transitional-cell carcinoma (TCC) who had failed to respond to prior cisplatin-based therapy. PATIENTS AND METHODS Thirty assessable patients who had failed to respond to or relapsed after one prior cisplatin-containing regimen were treated with docetaxel 100 mg/m2 over 1 hour, every 21 days. All patients were premedicated with dexamethasone and diphenhydramine to reduce allergic reactions. Reductions of subsequent doses were made for severe hematologic toxicity. Prophylactic hematopoietic growth factors were not used. RESULTS Four of 30 patients (13.3%; 95% confidence interval [CI], 3.8% to 30.7%) demonstrated a partial response (PR), with durations of response ranging from 3 to 8 months. The estimated median survival duration for all patients is 9 months (95% CI, 6 to 12 months) with a median follow-up time of 14 months (range, 1 to 27). Hematologic toxicity included anemia, thrombocytopenia, neutropenia, and febrile neutropenia. Nonhematologic toxicity included alopecia and mucositis. Fluid retention was not observed and cutaneous toxicity was mild and infrequent. Dose reductions were necessary for adverse events in 18 patients (60%). CONCLUSION Docetaxel is an active single agent in previously treated patients with TCC of the urothelial tract. Therapy was well tolerated in this patient population but myelosuppression was frequent. Further study in previously untreated patients, both alone and in combination, is warranted.

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