Bladder Cancer

ROCKVILLE, Md--TICE BCG vaccine (Organon Teknika Corp.) has won the backing of the Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) as a prophylaxis against recurrent papillary carcinoma of the urinary bladder.

Superficial bladder cancer can be a frustrating disease for both the patient and physician. It has been referred to as a "nuisance disease" because of its propensity for recurrence, necessitating frequent cystoscopies and trips to the operating room for resection of recurrent disease. In addition, however, there looms for the patient and physician the 10% to 15% probability of disease progression, often requiring cystectomy to achieve local control and placing the patient at much greater risk for disease mortality. The challenge is to predict which patients will benefit from adjuvant therapy in order to avoid disease progression and, secondarily, disease recurrence.

Dr. Grossman's article provides a well-organized review of the literature on the treatment of superficial bladder cancer. At the time of diagnosis, approximately 80% of patients with bladder cancer have superficial tumors (limited to the urothelial lining of the bladder or the underlying lamina propria). In such patients, the risk of distant disease is low, and the natural history of bladder cancer is based on two separate, but related processes: tumor recurrence and progression to a higher stage of disease.

GAITHERSBURG, Md--Faced with significant differences between FDA staff and company-associated scientists in the analysis of data from two clinical studies, the FDA's Oncology Drugs Advisory Committee (ODAC) declined to vote either way on whether to recommend approval of Pharmacia & Upjohn's Remisar (bropirimine tablets) for the treatment of patients with BCG-refractory or BCG-intolerant urinary bladder carcinoma in situ (CIS).

ROCKVILLE, Md--In recent actions, the FDA approved two new diagnostic tests--for bladder cancer and colorectal cancer--and extended the indications for an antiandrogen agent in the treatment of prostate cancer.

REDMOND, Wash--The FDA has given premarket approval to a new tumor antigen test for detecting bladder cancer recurrence, and an FDA advisory panel has recommended approval of a second bladder cancer assay that measures nuclear matrix proteins.

The safety and efficacy of a new chemoradiation approach to treating bladder cancer, which is designed to effect a cure while

Very few people have the level of expertise Dr. Lamm does with the use of bacillus Calmette-Guérin (BCG) for the treatment of superficial bladder cancer. His enthusiasm is based on a large, solid experience with the vaccine. He has pushed the therapeutic effectiveness of BCG to new levels and has reviewed the world literature on the subject frequently and conscientiously. The current review covers most areas of interest in depth. A few key points deserve emphasis, however.

Dr. Lamm's review of bacillus Calmette-Guérin (BCG) in the treatment of carcinoma in situ (CIS) of the bladder reflects one of the largest personal experiences of any investigator worldwide, and he should be congratulated for being one of those most responsible for the improved quality of life of many people due to the widespread use of BCG in bladder cancer. It is clear that BCG therapy allows a majority of patients with CIS to avoid cystectomy, and that it prevents progression to muscle involvement in many high-risk patients with papillary tumors.

Lamm describes a success story in oncology that he helped create, namely, the favorable therapeutic effect of intravesical bacillus Calmette-Guérin (BCG) against carcinoma in situ (CIS) of the bladder. Virtually every study conducted over the past decade reports complete responses in 70% or more patients treated with BCG, which are often durable for years [1]. Such results have been documented empirically in prospective controlled trials without complete understanding of the mechanism of action of BCG or the optimal dose and treatment regimen. More importantly, not only may BCG eradicate CIS but also it may delay or prevent tumor progression and improve patient survival [2]. Conversely, patients failing to respond to an adequate trial of BCG therapy are at increased risk for disease progression and death from bladder cancer. We now realize that the natural history of CIS in the bladder has been significantly altered by intravesical BCG.

Prior to the advent of BCG immunotherapy, bladder carcinoma in situ often progressed to muscle invasion. Intravesical chemotherapy completely eradicates the disease in 50% of patients, but fewer than 20% remain disease free after 5 years. Complete responses have been reported in 70% or more of BCG treated patients, nearly two-thirds of which are durable.