Sequential Intravesical Valrubicin and Docetaxel for the Salvage Treatment of Non–Muscle-Invasive Bladder Cancer

McElree, Ian M.; Packiam, Vignesh T.; Steinberg, Ryan L.; Mott, Sarah L.; Gellhaus, Paul T.; Nepple, Kenneth G.; O’Donnell, Michael A.

doi:10.1097/ju.0000000000002848

Cited by 10 publications

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“…Novel paradigms for sequencing of bladder-sparing therapies will be required when BCG shortage precludes its administration as either a first-line or salvage treatment. 38 …”

Section: Discussionmentioning

confidence: 99%

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Comparison of Sequential Intravesical Gemcitabine and Docetaxel vs Bacillus Calmette-Guérin for the Treatment of Patients With High-Risk Non–Muscle-Invasive Bladder Cancer

et al. 2023

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ImportanceDue to the ongoing bacillus Calmette-Guérin (BCG) shortage, sequential intravesical gemcitabine and docetaxel has been increasingly used as first-line therapy for high-risk non–muscle-invasive bladder cancer (NMIBC). However, data directly comparing these 2 therapies are lacking.ObjectiveTo compare the outcomes of patients with high-risk NMIBC treated with gemcitabine and docetaxel vs BCG.Design, Setting, and ParticipantsThis retrospective cohort study was conducted from January 1, 2011, to December 31, 2021. The median (IQR) duration of follow-up was 23 (12-33) months for patients receiving gemcitabine and docetaxel and 49 (27-79) months for patients receiving BCG. All patients were treated at the University of Iowa tertiary care center. A total of 312 patients with high-risk treatment-naive NMIBC were included; 174 patients were treated with BCG therapy and 138 were treated with gemcitabine and docetaxel therapy.ExposuresAfter undergoing complete transurethral resection of bladder tumor, patients received either sequential intravesical gemcitabine, 1 g, and docetaxel, 37.5 mg, or 1 vial of BCG. Induction treatments were administered once per week for 6 weeks. Maintenance regimens were initiated if the patient was disease free at the first follow-up visit.Main Outcomes and MeasuresThe primary outcome was high-grade recurrence-free survival (RFS). Survival probabilities were estimated using the Kaplan-Meier method. Cox regression models were used to evaluate the association of covariates with outcomes. Adverse events were reported using the Common Terminology Criteria for Adverse Events, version 5.ResultsAmong 312 patients, the median (IQR) age was 73 (66-79) years; 255 patients (81.7%) were male and 292 (93.6%) were White. Baseline clinicopathological characteristics such as sex, smoking status, and pretreatment tumor pathology were similar between treatment groups. High-grade RFS estimates were 76% (95% CI, 69%-82%) at 6 months, 71% (95% CI, 64%-78%) at 12 months, and 69% (95% CI, 62%-76%) at 24 months in the BCG group and 92% (95% CI, 86%-95%) at 6 months, 85% (95% CI, 78%-91%) at 12 months, and 81% (95% CI, 72%-87%) at 24 months in the gemcitabine and docetaxel group. Multivariable Cox regression analyses controlled for age, sex, treatment year, and presence of carcinoma in situ revealed that treatment with gemcitabine and docetaxel was associated with better high-grade RFS (hazard ratio, 0.57; 95% CI, 0.33-0.97; P = .04) and RFS (hazard ratio, 0.56; 95% CI, 0.34-0.92; P = .02) than treatment with BCG. Induction therapy for BCG was associated with greater treatment discontinuation than induction therapy for gemcitabine and docetaxel (9.2% vs 2.9%; P = .02).Conclusions and RelevanceIn this cohort study, gemcitabine and docetaxel therapy was associated with less high-grade disease recurrence and treatment discontinuation than BCG therapy. These findings suggest that, while awaiting results from an ongoing randomized clinical trial during the current BCG shortage, use of gemcitabine and docetaxel can be considered for recommendation in updated practice guidelines.

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“…Novel paradigms for sequencing of bladder-sparing therapies will be required when BCG shortage precludes its administration as either a first-line or salvage treatment. 38 …”

Section: Discussionmentioning

confidence: 99%

“…Next, further research to identify factors associated with response will aid in patient selection for BCG vs alternative treatments, particularly during the BCG shortage. Novel paradigms for sequencing of bladder-sparing therapies will be required when BCG shortage precludes its administration as either a first-line or salvage treatment …”

Section: Discussionmentioning

confidence: 99%

Comparison of Sequential Intravesical Gemcitabine and Docetaxel vs Bacillus Calmette-Guérin for the Treatment of Patients With High-Risk Non–Muscle-Invasive Bladder Cancer

et al. 2023

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“…The recurrence-free survival rate in low-and high-grade disease was 73% and 38%, respectively. Among patients with high-grade disease, overall, cancer-speci c, and cystectomy-free survivals were 87%, 96%, and 84% at 2 years, respectively [24]. Due to cumulative, synergistic or different antitumor mechanisms of action, combination chemotherapy given could reduce drug resistance and further diminish the recurrence rate, but one could also expect higher local toxicity [13,25].…”

Section: Discussionmentioning

confidence: 99%

Is switching intravesical chemotherapeutic agent beneficial in short-term recurrent high-risk non-muscle- invasive bladder tumors? A 5-year retrospective study

Chen

Sun

Chen

et al. 2023

Preprint

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Objective: To assess whether switching intravesical chemotherapeutic agent is beneficial in short-term recurrent high-risk non-muscle-invasive bladder cancer (NMIBC) after failure of previous intravesical therapy. Materials and methods: From June 2010 to October 2015, 215 patients with NMIBC, who had tumor recurrence within one year of first-line drugs for Intravesical chemotherapy (IVC), were assigned to two groups. After a second time complete TUR treatment, we immediately changed the intravesical instillation agent for 107 patients (group A), whereas the other 98 patients continued to use their original intravesical instillation agent (group B - control group). All patients received an immediate instillation of epirubicin (EPI), gemcitabine (Gem) or hydroxycamptothecin (HCPT) after TURBT and followed by regularly induction plus maintenance instillations. Recurrence rate and progression rate were assessed by Chi-square test, while recurrence-free survival and progression-free survival were calculated using the Kaplan–Meier method. Results: In this study, the recurrence rate was 49.5% (53/107) in group A and 50.0% (49/98) in group B, while progression rate was 18.7% (21/107) in group A and 23.5% (23/98) in group B. Neither recurrence nor progression rates showed any significant differences between the two groups. Median progression interval between two groups were 24 months and 17 months, respectively (p=0.044). Average progression time between two groups were 28.7months and 19.3 months, respectively (p=0.035). In the Kaplan–Meier plot, no difference was found with respect to recurrence-free survival and progression-free survival. Moreover, univariate analysis suggested that only tumor grade could be an independent risk factor related to recurrence (HR = 0.632; 95% CI 0.425-0.942; p = 0.024), while the presence of carcinoma in situ may be an independent risk factor related to progression (HR=0.159; 95% CI 0.037-0.683; p=0.013). Conclusions: Switching IVC agent can significantly prolong time of progression in patients with short-term recurrent high-risk NMIBC who are unavailability or unsuitability for BCG instillation. Furthermore, the finding may provide a new basis for drug selection in combination IVC.

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“…In this retrospective analysis, recurrent non-NMIBC (NMIBC) patients previously treated with BCG, Gem/Doce, or both were given sequential intravesical valrubicin and docetaxel (Val/Doce). [ 11 ] Each cycle comprised 800 mg valrubicin followed by 37.5 mg docetaxel. Induction comprised 6 weekly installations, and maintenance once monthly installations for up to 24 months.…”

Section: Sequential Intravesical Valrubicin and Docetaxel For The Sal...mentioning

confidence: 99%

Round up

Mandal

2023

Indian J Urol

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Sequential Intravesical Valrubicin and Docetaxel for the Salvage Treatment of Non–Muscle-Invasive Bladder Cancer

Abstract: Figure. High-grade (HG) recurrence-free survival (RFS) and progression-free survival (PFS) following valrubicin and docetaxel (Val/Doce) induction among patients presenting with high-grade disease.

Cited by 10 publications

References 22 publications

Comparison of Sequential Intravesical Gemcitabine and Docetaxel vs Bacillus Calmette-Guérin for the Treatment of Patients With High-Risk Non–Muscle-Invasive Bladder Cancer

Comparison of Sequential Intravesical Gemcitabine and Docetaxel vs Bacillus Calmette-Guérin for the Treatment of Patients With High-Risk Non–Muscle-Invasive Bladder Cancer

Is switching intravesical chemotherapeutic agent beneficial in short-term recurrent high-risk non-muscle- invasive bladder tumors? A 5-year retrospective study

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