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Comparable effect with minimal morbidity of low-dose Tokyo 172 strain compared with regular dose Connaught strain as an intravesical bacillus Calmette-Guérin prophylaxis in nonmuscle invasive bladder cancer: Results of a randomized prospective comparison.

Inamoto T, Ubai T, Nishida T, Fujisue Y, Katsuoka Y, Azuma H - Urol Ann (2013)

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, Osaka Medical College, Osaka, Japan.

ABSTRACT

Aim: The aim was to compare patients' morbidity and response of bacillus Calmette-Guérin (BCG) prophylaxis after the intravesical instillation of low-dose Tokyo 172 strain and regular dose Connaught strain in patients with nonmuscle invasive bladder cancer (NMIBC).

Patients and methods: This was a randomized, active-controlled, open-label, monocenter study. Thirty-eight, NMIBC patients were treated sequentially, in a random order, with low-dose Tokyo 172 strain and regular dose Connaught strain, receiving each therapy for 6 weeks. A total of 18 and 20 patients were randomly assigned to a Tokyo 172 strain arm and a Connaught strain arm, respectively. Complication, morbidity, and recurrence-free survival (RFS) after each treatment were compared.

Results: There was no significant difference in the 1-year RFS rate in patients treated with Tokyo 172 strain and Connaught strain (72.2% vs. 83.5%, respectively; P = 0.698). There were no significant differences in adverse events between the arms. Severe adverse events (>Grade 3) were seen in 15% of the Connaught strain group while no severe adverse events were observed as a result of Tokyo 172 strain.

Conclusion: Our results indicated that low-dose Tokyo 172 strain decreased adverse events although it was not significant, and the RFS difference was not statistically significant between the two arms. Further investigation is warranted.

No MeSH data available.


Related in: MedlinePlus

Recurrence-free survival (RFS) by the BCG strain. Solid curve indicates the Connaught strain. Broken curve indicates Tokyo 172. Vertical lines indicate censored
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Figure 1: Recurrence-free survival (RFS) by the BCG strain. Solid curve indicates the Connaught strain. Broken curve indicates Tokyo 172. Vertical lines indicate censored

Mentions: Thirty-eight patients were randomized between February 2008 and December 2009. Table 1 summarizes patient background characteristics for the patients by treatment group. A total of 18 patients on low-dose Tokyo 172 strain, and 20 on Connaught strain started treatment. The median follow-up was of 16.4 months in the Tokyo 172 strain group and 16.5 months in the Connaught strain group. The median age of the Tokyo 172 group was 73.5 years; 77.8% had primary tumors, 44.4% had solitary tumors, 44.4% had Ta tumors, and 27.8% had grade 3 tumors. The median age of the Connaught group was 72.5 years; 80.0% had primary tumors, 45.0% had solitary tumors, 30.0% had Ta tumors, and 40.0% had grade 3 tumors. Globally, in 26.3% recurrence was found, and no one progressed to muscle invasive disease or developed distant metastases, and no one died during follow-up. The number of recurrence or progression was 5 (27.9%) in the Tokyo 172 group, and 5 (25%) in the Connaught group. Patient characteristics were well balanced in the two treatment groups [Table 1]. As shown in Figure 1, the 1-year recurrence-free probability was 72.2% in the Tokyo 172 strain group and 83.5% in the Connaught strain group. There was no significant difference in the 1-year RFS between the treatment groups (P = 0.698). Because there was no beneficial effect of the low-dose Tokyo 172 strain over the regular dose Connaught strain [Figure 1], the main interest of the current study centered on the comparison of adverse events between two groups. Global adverse events were noted in 73.7% of all patients, of which most were mild and transient [Table 2]. Compared to the Connaught strain, and as summarized in Table 2, the low-dose Tokyo 172 strain did not reduce the global number of adverse events (P = 0.7718; Table 2). The most common adverse events were fever and pollakisuria during treatment sessions, followed by hematuria and micturition pain [Tables 2 and 3]. Of four common adverse events, which occurred more frequently (≥10%), number of micturition pain events stratified by the NCI-CTCAE grade was significantly lower in the Tokyo 172 strain group, compared with the Connaught strain group (Wilcoxon's signed-rank test, P = 0.0455; Table 3). Table 4 extracts the severe adverse events with grade 3 or greater and comparisons according to therapy. Although the analyses are exploratory and are based on very small numbers of cases, the results suggest that the number of severe adverse events at least was minimized, if not statistically significant, in the Tokyo 172 strain group as compared with the Connaught strain group.


Comparable effect with minimal morbidity of low-dose Tokyo 172 strain compared with regular dose Connaught strain as an intravesical bacillus Calmette-Guérin prophylaxis in nonmuscle invasive bladder cancer: Results of a randomized prospective comparison.

Inamoto T, Ubai T, Nishida T, Fujisue Y, Katsuoka Y, Azuma H - Urol Ann (2013)

Recurrence-free survival (RFS) by the BCG strain. Solid curve indicates the Connaught strain. Broken curve indicates Tokyo 172. Vertical lines indicate censored
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3643329&req=5

Figure 1: Recurrence-free survival (RFS) by the BCG strain. Solid curve indicates the Connaught strain. Broken curve indicates Tokyo 172. Vertical lines indicate censored
Mentions: Thirty-eight patients were randomized between February 2008 and December 2009. Table 1 summarizes patient background characteristics for the patients by treatment group. A total of 18 patients on low-dose Tokyo 172 strain, and 20 on Connaught strain started treatment. The median follow-up was of 16.4 months in the Tokyo 172 strain group and 16.5 months in the Connaught strain group. The median age of the Tokyo 172 group was 73.5 years; 77.8% had primary tumors, 44.4% had solitary tumors, 44.4% had Ta tumors, and 27.8% had grade 3 tumors. The median age of the Connaught group was 72.5 years; 80.0% had primary tumors, 45.0% had solitary tumors, 30.0% had Ta tumors, and 40.0% had grade 3 tumors. Globally, in 26.3% recurrence was found, and no one progressed to muscle invasive disease or developed distant metastases, and no one died during follow-up. The number of recurrence or progression was 5 (27.9%) in the Tokyo 172 group, and 5 (25%) in the Connaught group. Patient characteristics were well balanced in the two treatment groups [Table 1]. As shown in Figure 1, the 1-year recurrence-free probability was 72.2% in the Tokyo 172 strain group and 83.5% in the Connaught strain group. There was no significant difference in the 1-year RFS between the treatment groups (P = 0.698). Because there was no beneficial effect of the low-dose Tokyo 172 strain over the regular dose Connaught strain [Figure 1], the main interest of the current study centered on the comparison of adverse events between two groups. Global adverse events were noted in 73.7% of all patients, of which most were mild and transient [Table 2]. Compared to the Connaught strain, and as summarized in Table 2, the low-dose Tokyo 172 strain did not reduce the global number of adverse events (P = 0.7718; Table 2). The most common adverse events were fever and pollakisuria during treatment sessions, followed by hematuria and micturition pain [Tables 2 and 3]. Of four common adverse events, which occurred more frequently (≥10%), number of micturition pain events stratified by the NCI-CTCAE grade was significantly lower in the Tokyo 172 strain group, compared with the Connaught strain group (Wilcoxon's signed-rank test, P = 0.0455; Table 3). Table 4 extracts the severe adverse events with grade 3 or greater and comparisons according to therapy. Although the analyses are exploratory and are based on very small numbers of cases, the results suggest that the number of severe adverse events at least was minimized, if not statistically significant, in the Tokyo 172 strain group as compared with the Connaught strain group.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, Osaka Medical College, Osaka, Japan.

ABSTRACT

Aim: The aim was to compare patients' morbidity and response of bacillus Calmette-Guérin (BCG) prophylaxis after the intravesical instillation of low-dose Tokyo 172 strain and regular dose Connaught strain in patients with nonmuscle invasive bladder cancer (NMIBC).

Patients and methods: This was a randomized, active-controlled, open-label, monocenter study. Thirty-eight, NMIBC patients were treated sequentially, in a random order, with low-dose Tokyo 172 strain and regular dose Connaught strain, receiving each therapy for 6 weeks. A total of 18 and 20 patients were randomly assigned to a Tokyo 172 strain arm and a Connaught strain arm, respectively. Complication, morbidity, and recurrence-free survival (RFS) after each treatment were compared.

Results: There was no significant difference in the 1-year RFS rate in patients treated with Tokyo 172 strain and Connaught strain (72.2% vs. 83.5%, respectively; P = 0.698). There were no significant differences in adverse events between the arms. Severe adverse events (>Grade 3) were seen in 15% of the Connaught strain group while no severe adverse events were observed as a result of Tokyo 172 strain.

Conclusion: Our results indicated that low-dose Tokyo 172 strain decreased adverse events although it was not significant, and the RFS difference was not statistically significant between the two arms. Further investigation is warranted.

No MeSH data available.


Related in: MedlinePlus