VALSTAR® (valrubicin) may mean 18% complete response for BCG-refractory patients1
About 1 in 5 study patients was disease-free at 6 months1
18% (16) of patients achieved a complete response1*
29% of patients were judged to have derived a clinical benefit from VALSTAR treatment, as evidenced by downstaging of tumors1,2†
*Complete responders as defined by disease-free at both 3 and 6 months after initiation of treatment.1,2
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 was scheduled to receive 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.2
†18% of patients (16) achieved the primary endpoint of complete response (ie, were disease-free at both 3 and 6 months after treatment initiation). An additional 11% (10) of patients, who did not achieve a complete response at 6 months, were determined to have benefited from treatment because they had low-grade papillary tumors (Ta). Together, these account for 29% of patients deriving a clinical benefit from VALSTAR treatment.1,2
VALSTAR was studied in 90 patients with BCG-refractory CIS1,2
‡41% had received intravesical mitomycin C, 2% had received thiotepa, and 20% had received other intravesical treatments at some time in the past.2
Indication
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.
Patients receiving VALSTAR must be closely monitored for disease recurrence or progression. The recommended evaluation should include cystoscopy, biopsy, and/or urine cytology every 3 months.
Safety and effectiveness in pediatric patients have not been established.
Please see the full Prescribing Information.
REFERENCES:
1. VALSTAR Prescribing Information. Endo Pharmaceuticals. April 2009.
2. Steinberg G, Bahnson R, Brosman S, et al; and Valrubicin Study Group. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. J Urol. 2000;163:761-767.
VALSTAR® (valrubicin) may mean durable efficacy among complete responders*
Duration of response for patients achieving a complete response (n=16) was calculated using 2 different methods:
- The median duration of response was 13.5 months if measured from the first VALSTAR treatment to the last negative biopsy before a recurrence was observed1
Study design: Biopsies were performed approximately 6 weeks after last instillation of VALSTAR and every 3 months thereafter until month 12, and then annually or when suspicious lesions were noted on cystoscopy.2
11% (10 of 90) of patients developed metastatic or deeply-invasive bladder cancer; 4 patients, none of whom underwent cystectomy, died with metastatic bladder cancer and 6 developed stage progression to deeply-invasive disease (T3), with lymph node involvement in 1 patient, at cystectomy.1
- The median duration of response was 21 months if measured from the first VALSTAR treatment to documented recurrence1
- Time to recurrence was longer with VALSTAR than with previous intravesical treatments1†
*Complete responders as defined by disease-free at both 3 and 6 months after initiation of treatment.1,3
†Based on a retrospective analysis of the 16 patients who achieved a complete response.1
Indication
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.
Patients receiving VALSTAR must be closely monitored for disease recurrence or progression. The recommended evaluation should include cystoscopy, biopsy, and/or urine cytology every 3 months.
Safety and effectiveness in pediatric patients have not been established.
Please see the 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, et al; and Valrubicin Study Group. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. J Urol. 2000;163:761-767.
