Local toxicity patterns associated with intravesical bacillus Calmette-Guérin: a Southwest Oncology Group Study.
BACKGROUND
While the efficacy of bacillus Calmette-Guérin (BCG) immunotherapy has been demonstrated, the relative benefit, given a seemingly high incidence and severity of toxicities, remains an issue. Adequate understanding and management of toxicities can maximize the safety of the treatment and enable the administration of required doses of BCG intravesical therapy.


METHODS
All week-to-week symptoms recorded for the 143 immunotherapy-naive participants assigned to the BCG arm of SWOG-8216, BCG vs. Doxorubicin in Superficial Bladder Cancer were analyzed in order to document the pattern of toxicities in the first six week induction course of intravesical BCG treatments. The statistical analysis consisted of fitting logistic regression models to these data for the probability of irritative bladder symptoms (IBS).


RESULTS
In the optimal model, the probability of IBS depends only on whether there was IBS associated with the previous treatment, and not on which treatment. The estimated probability of having IBS when there were no IBS associated with the previous instillation is 0.136, whereas the estimated probability of having IBS when there was IBS associated with the previous instillation is 0.689.


CONCLUSIONS
Irritative bladder symptoms are unlikely in the week after the first intravesical BCG treatment. Once a patient experiences IBS, he or she is more likely to have IBS with the next and subsequent treatments. Clinicians can use the findings of this analysis when informing their patients about the treatment course and when making decisions about continuing treatments.
Berry
D L
DL
Biobehavioral Nursing and Health Systems, University of Washington, Seattle 98195-7266, USA.
Blumenstein
B A
BA
Magyary
D L
DL
Lamm
D L
DL
Crawford
E D
ED
D000283:Administration, Intravesical; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D002295:Carcinoma, Transitional Cell / Q000628:therapy*; D006801:Humans; D001749:Urinary Bladder Neoplasms / Q000628:therapy*; D014555:Urination Disorders / Q000209:etiology
D001500:BCG Vaccine