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.
RCT Entities:
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.
Authors: Patrick Vianna Garcia; Letícia Montanholi Apolinário; Petra Karla Böckelmann; Iseu da Silva Nunes; Nelson Duran; Wagner José Fávaro Journal: Int J Clin Exp Pathol Date: 2015-05-01
Authors: Shahrokh F Shariat; Daher C Chade; Pierre I Karakiewicz; Douglas S Scherr; Guido Dalbagni Journal: Immunotherapy Date: 2010-05 Impact factor: 4.196
Authors: Wagner J Fávaro; Odilon S Nunes; Fabio Rf Seiva; Iseu S Nunes; Lisa K Woolhiser; Nelson Durán; Anne J Lenaerts Journal: Infect Agent Cancer Date: 2012-06-18 Impact factor: 2.965
Authors: Patrick Vianna Garcia; Fábio Rodrigues Ferreira Seiva; Amanda Pocol Carniato; Wilson de Mello Júnior; Nelson Duran; Alda Maria Macedo; Alexandre Gabarra de Oliveira; Rok Romih; Iseu da Silva Nunes; Odilon da Silva Nunes; Wagner José Fávaro Journal: BMC Cancer Date: 2016-07-07 Impact factor: 4.430