"On December 16, 2014, the U. S. Food and Drug Administration approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroe"...
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.
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|
N = 69
N = 70
N = 73
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.
Additional Theracys Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.