Adjuvant BCG offers no benefit in upper tract TCC

August 1, 2007

Adjuvant bacillus Calmette-Guerin appears to provide no benefit for improving the oncologic outcome of patients with upper tract transitional cell carcinoma undergoing nephroureterectomy.

Key Points

Anaheim, CA-Adjuvant bacillus Calmette-Guerin (BCG [TheraCys, TICE BCG]) appears to provide no benefit for improving the oncologic outcome of patients with upper tract transitional cell carcinoma undergoing nephroureterectomy, according to a retrospective analysis by urologists at the Smith Institute for Urology, North Shore-Long Island Jewish Health System, New Hyde Park, NY.

Data were analyzed for incidence of and time to recurrence in the BCG and no-BCG groups. With recurrence defined as a positive biopsy after the third-look nephroscopy, the overall recurrence rate was 34% in patients treated with BCG and 29% in the controls. With outcomes data stratified by tumor grade, between-group comparisons showed no significant differences in either incidence of or time to recurrence.

The mean age of patients included in this analysis of recurrence outcomes was 71 years. Mean follow-up averaged close to 61 months. The majority of the patients (92%) had Tx, Ta, or T1 disease.

"There are many published series on use of BCG for CIS indicating it is beneficial. Including CIS disease in this study would have introduced bias in favor of BCG. However, we wanted to primarily investigate its potential role in superficial Ta and T1 disease," Dr. Rastinehad said.

The BCG and no-BCG groups were similar with respect to tumor grade distribution. Overall, 22% (19) of the tumors were grade 1, 34% (30) were grade 2, and 44% (39) were grade 3.

When recurrence data were analyzed with the tumors in each group stratified by grade, the rates increased with increasing grade in both the BCG and no-BCG groups. In BCG-treated patients, the recurrence rate increased from 30% for grade 1 tumors to 39.1% for grade 3 tumors. In the no-BCG group, corresponding recurrence rates were 22.2% and 37.5%.

No pattern for time to recurrence to decrease with increasing tumor grade was reported in either the BCG or no-BCG group. Mean time to recurrence was al-most two-fold longer in the no-BCG group than in the BCG group for G1 tumors (35.9 vs. 21.2 months) and about twice as long for G3 tumors (28.7 vs. 15.1 months). However, for the G2 tumors, mean time to recurrence was almost threefold longer in the BCG group compared with the untreated group (42.3 vs.15.7 months). Due to the small number of cases in each group, none of the differences were statistically significant.

Some declined BCG

Dr. Rastinehad noted that the decision of whether or not to administer BCG was based partly on patient preference and temporal assessment by Dr. Smith.

"The goal was to use BCG in most patients, but some patients declined the treatment based on the potential risks of the antegrade therapy," said Dr. Rastinehad.

Complications associated with BCG in the treated patients included single cases of sepsis-related death and BCGosis, along with testicular granulomas and cystitis.

The investigators postulate that complete resection of the tumors combined with the antegrade method of BCG delivery and upper tract fluid dynamics account for the lack of an observed oncologic benefit of adjuvant BCG therapy in this study.

"In contrast to the use of BCG in bladder cancer, we cannot predict how long the dwell time is in the upper tract," Dr. Rastinehad said.