VALSTARTM (valrubicin) may mean 21 months of more moments that matter1
Durable efficacy in those who responded
to therapy1
- Demonstrated effectiveness in highly refractory patients1,2
- Complete response defined as disease-free at 6 months following initiation of treatment1
![Among complete responders, the median duration of response from start of treatment varied according to the method of analysis
13.5 months if measured to last bladder biopsy without tumor
21 months if measured until time of documented recurrence or study end*
* range 7-37 months.[2]](../images/hcp-medianduration.gif)
Study design: Three-year, open-label, noncomparative study. Forty-four investigators at 41 sites enrolled 90 patients with pathologically proven CIS. Patients were to have received at least 2 prior courses of intravesical therapy for CIS, including at least 1 course of BCG. Each patient received 800 mg of VALSTAR once a week for 6 weeks. Primary disease evaluation took place 6 weeks after the last instillation of VALSTAR. Subsequent evaluations for disease response occurred at 3-month intervals until the patient had a recurrence or the study ended.2
- Among complete responders (18%, n=16), time to recurrence was longer with VALSTAR than with previous intravesical treatments1
- At time of study cutoff (36 months), 9 patients were still responding to VALSTAR treatment2
- 10 study patients who did not achieve a complete response were found to have low grade papillary tumors at recurrence3
- These patients also derived a clinical benefit from VALSTAR3
VALSTAR is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
Important Safety Information
VALSTAR is contraindicated in patients with known hypersensitivity to anthracyclines or polyoxyl castor oil. VALSTAR should not be administered to patients with a perforated bladder, compromised bladder mucosa integrity, concurrent urinary tract infections, or small bladder capacity (unable to tolerate a 75 mL instillation). The integrity of the bladder should be confirmed prior to instillation of VALSTAR in those patients who have had procedures with the potential to compromise the bladder wall.
Patients should be informed that VALSTAR has been shown to induce complete response in about 1 in 5 patients with BCG-refractory CIS. Delaying cystectomy could lead to development of metastatic bladder cancer. If there is not a complete response of CIS to treatment after 3 months or if CIS recurs, cystectomy must be reconsidered.
VALSTAR should be administered using aseptic technique under the supervision of a practitioner experienced in the use of intravesical cancer chemotherapeutic agents. VALSTAR should be used with caution in patients with severe irritable bladder symptoms. Patients of reproductive age should be advised to use an effective contraception method.
In clinical trials, the most common local adverse events include urinary frequency, urinary urgency and dysuria. The most common systemic adverse events include urinary tract infection, abdominal pain, nausea, asthenia, headache, malaise and urinary retention.
Safety and effectiveness in pediatric patients have not been established.
Please see the accompanying full Prescribing Information.
REFERENCES:
1. VALSTAR Prescribing Information. Endo Pharmaceuticals. April 2009.
2. Data on file. Endo Pharmaceuticals.
3. Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guérin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol. 2000;163:761-767.
18% complete response may mean more time for highly refractory patients1
About 1 in 5 study patients was disease-free at 6 months1
41% (37) of patients were disease-free at 3 months2
18% (16) of patients were disease-free at 6 months1
29% (26) of patients derived a clinical benefit from VALSTARTM (valrubicin) treatment1,3*
Time to recurrence was longer with VALSTAR than with previous intravesical treatments1
Demonstrated effectiveness in highly refractory patients1
![MAJORITY OF PATIENTS STUDIED FAILED ³ 2 PRIOR COURSES OF BCG FOR CIS (N=90)
Median time from first TCC diagnosis = 39 months[3]
Median time from first CIS diagnosis = 25 months[3]
100% were nonresponsive to at least 1 course of BCG[1]
- 70% had ³2 prior courses of BCG
- 30% had 1 course of BCG and at least 1 additional course of intravesical treatment with other agent(s)
82% had ³4 prior TURBs2](../images/hcp-majorityofpatientsfailed.gif)
*In addition to the 16 complete responders, 10 study patients who did not achieve a complete response were found to have only low-grade papillary tumors at recurrence. Combining the 16 complete responders with the 10 additional patients yields a total of 26 patients (29%) who derived a clinical benefit from VALSTAR treatment.
†41% of patients had received intravesical mitomycin C, 22% had received thiotepa, and 20% had received other intravesical treatments at some time in the past.2
VALSTAR is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
Important Safety Information
VALSTAR is contraindicated in patients with known hypersensitivity to anthracyclines or polyoxyl castor oil. VALSTAR should not be administered to patients with a perforated bladder, compromised bladder mucosa integrity, concurrent urinary tract infections, or small bladder capacity (unable to tolerate a 75 mL instillation). The integrity of the bladder should be confirmed prior to instillation of VALSTAR in those patients who have had procedures with the potential to compromise the bladder wall.
Patients should be informed that VALSTAR has been shown to induce complete response in about 1 in 5 patients with BCG-refractory CIS. Delaying cystectomy could lead to development of metastatic bladder cancer. If there is not a complete response of CIS to treatment after 3 months or if CIS recurs, cystectomy must be reconsidered.
VALSTAR should be administered using aseptic technique under the supervision of a practitioner experienced in the use of intravesical cancer chemotherapeutic agents. VALSTAR should be used with caution in patients with severe irritable bladder symptoms. Patients of reproductive age should be advised to use an effective contraception method.
In clinical trials, the most common local adverse events include urinary frequency, urinary urgency and dysuria. The most common systemic adverse events include urinary tract infection, abdominal pain, nausea, asthenia, headache, malaise and urinary retention.
Safety and effectiveness in pediatric patients have not been established.
Please see the accompanying full Prescribing Information.
REFERENCES:
1. VALSTAR Prescribing Information. Endo Pharmaceuticals. April 2009.
2. Data on file. Endo Pharmaceuticals.
3. Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guérin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol. 2000;163:761-767.
