July 26, 2016
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Theracys

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Theracys




CLINICAL PHARMACOLOGY

Mechanism Of Action

When administered intravesically as a cancer therapy, BCG promotes a local acute inflammatory and sub-acute granulomatous reaction with macrophage and lymphocyte infiltration in the urothelium and lamina propria of the urinary bladder. The exact mechanism of action is unknown, but the anti-tumor effect appears to be T-lymphocyte-dependent.

Clinical Studies

The efficacy and safety of TheraCys were compared to doxorubicin hydrochloride in a multicenter, open-label, randomized clinical trial, in patients with carcinoma in situ (CIS) of the urinary bladder, recurrent Ta/T1 papillary tumors of any grade of the urinary bladder, or both. A total of 285 patients were randomized: 142 to treatment with doxorubicin (69 CIS and 73 non-CIS) and 143 to treatment with TheraCys (70 CIS and 73 non-CIS). All papillary tumors were completely resected prior to trial entry. TheraCys was administered intravesically weekly for 6 weeks, with additional single instillations at 3, 6, 12, 18, and 24 months following the initiation of treatment (total of 11 instillations over 2 years). The initial treatment with doxorubicin was given within 3 days of TUR, followed by 4 weekly treatments and then by 11 monthly treatments (total of 16 instillations over 1 year). Cytology and cystoscopy were obtained every 3 months for 2 years. Disease-free survival and 2-year disease-free survival were evaluated and an intent-to-treat analysis was performed.

The median age of patients treated with doxorubicin was 70 years (CIS; range 31-88 years) and 65 years (non-CIS; range 38-95 years), while the median age was 66 years (CIS; range 33-83 years) and 67 years (non-CIS; 24-95 years) in patients treated with Theracys. The racial distribution was 89% White, 5% Black and 6% Other in the doxorubicin treatment arm and 95% White, 3% Black and 2% Other in the Theracys treatment arm.

For patients with CIS, the complete response rate (i.e., negative biopsies and urine cytology) within 6 months of the initiation of treatment was 33% with doxorubicin and 71% with TheraCys (p < 0.001, Fisher's Exact Test). The probability of being disease-free at 2 years was 23% with doxorubicin and 51% with TheraCys (p < 0.001, Z Test). The median disease-free survival was 4.9 months for doxorubicin and 30 months for TheraCys (p < 0.001, Log Rank Test).

For patients with Ta/T1 papillary tumors only, the 2-year disease-free survival was 29% with doxorubicin and 50% with TheraCys (p = 0.008, Z Test). The median disease-free survival was 10.5 months with doxorubicin and 22.5 months with TheraCys (p = 0.001, Log Rank Test). The results are summarized in Table 2.

Table 2: TheraCys Efficacy in a Clinical Trial Conducted in the United States

  Carcinoma in situ Ta/T1 Papillary Tumors
Doxorubicin
N = 69
TheraCys
N = 70
Doxorubicin
N = 73
TheraCys
N = 73
Complete Response 23 (33%) 50 (71%) - -
Median Disease-free Survival* 4.9 Months 30 Months 10.5 Months 22.5 Months
2-Year Disease-free Survival* 23% 51% 29% 50%
95% Confidence Interval (15%, 35%) (41%, 65%) (20%, 41%) (39%, 63%)
* Based on Kaplan-Meier estimates.

Last reviewed on RxList: 2/4/2016
This monograph has been modified to include the generic and brand name in many instances.

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