This was my last communication with Dr. lamn
BCG, BCG Maintenance or Cystectomy for a Young Man with High
Grade, TA Bladder Cancer with CIS?
Dear Sol,
Thank you for your good wishes and congratulations on your negative
cystoscopy and apparent complete response to 6 weeks of BCG. Early
response is a good sign, but High Grade TCC with CIS is a dangerous
disease that must be followed very carefully. You are at long term risk
of having the disease return in the bladder, lower ureters or prostate, so
these areas have to be carefully monitored. Some would recommend going
ahead and having the bladder removed now. The advantage of early
cystectomy is that it removes not only the bladder, but the lower ureters
and prostate as well, sites that are at risk of developing disease.
Personally, If I had the disease at your age I too would give BCG a try,
but only if 3 week maintenance and careful follow were given. I am not
sure what your doctor is referring to when he says that there is not much
data. To my reading the data are as good as they get: randomized clinical
trial and meta-analysis, the gold standard for medical evidence.
Here are some of the numbers: My Southwest Oncology Group study showed a
highly significant increase in complete response of CIS to 3 week
maintenance: from 68% with induction to 84% with just one additional 3
week course of BCG at 3 months. In patients with papillary disease who
were free of recurrence at 3 months, 3 weekly BCG instillations at 3, 6,
12, 18, 24, 30 and 36 months reduced long term tumor recurrence compared
with 6 week induction from 26% to 14% (P<0.001; reference: Lamm DL,
Blumenstein BA, Crissman JD, et al: MAINTENANCE BACILLUS CALMETTE-GUERIN
IMMUNOTHERAPY FOR RECURRENT TA, T1 AND CARCINOMA IN SITU TRANSITIONAL CELL
CARCINOMA OF THE BLADDER: A RANDOMIZED SOUTHWEST ONCOLOGY GROUP STUDY. J
Urol.163:1124, 2000). More importantly, disease worsening (T2
progression, cystectomy, radiation therapy or systemic chemotherapy) was
also significantly reduced. Our meta-analysis of all controlled BCG
therapy trials (Sylvester RJ, van der Meijden APM, Lamm DL. Intravesical
bacillus Calmette-Guerin reduces the risk of progression in patients with
superficial bladder cancer: a meta-analysis of the published results of
randomized clinical trials. J Urol. 2002;168:1964.) confirmed that BCG
significantly reduces disease progression when compared with other
treatments, but this 37% reduction in progression occurred only when
maintenance schedules were used. Since only 16% of patients on my SWOG
study received BCG at each of the scheduled intervals, I now reduce the
dose of BCG to 1/3 during maintenance and omit the 30 month treatment.
Further reductions are used if needed to prevent increasing side effects.
The long term results are very good, but because you need not a 15 year
cure but a 50 year cure, I would recommend extending the maintenance to
every year for the 4th, 5th and 6th year, then every other year for 8 more
years. There are data to suggest that even if someone fails maintenance
BCG and requires cystectomy, there risk of dying from bladder cancer is
significantly less (63%) if they have had 3 week maintenance BCG. Not
only that- but you get to keep your bladder and retain normal urinary and
sexual function.
Keep with the Oncovite as well- we will report, as soon as the numbers are
confirmed, a very highly significant reduction in recurrence in patients
on 3 week maintenance with the addition of Oncovite.
Best regards, and thanks for asking,
Don Lamm, MD