Quality of Life, Efficacy, and Safety of Sequential Intravesical Gemcitabine + Docetaxel versus BCG for Non-Muscle Invasive Urinary Bladder Cancer: A Pilot Study

Abstract

<b><i>Purpose:</i></b> Bacille Calmette-Guerin (BCG) is considered the most effective agent for non-muscle invasive bladder cancer (NMIBC). However, due to BCG-related toxicity, multiple studies have suggested the role of newer chemotherapeutic drugs. The aim of our study was to evaluate intravesical gemcitabine + docetaxel (Gem/Doce) versus BCG with respect to quality of life (QOL), safety, and efficacy in NMIBC. <b><i>Methods:</i></b> A total of 60 patients with NMIBC were evaluated between July 2019 and December 2020 in a prospective manner. The sample size calculation was done, keeping in mind the incidence of intravesical BCG-related complications of up to 50–60% and 20–30% for Gem/Doce combination. The <i>p</i> value of 0.05 was kept as statistically significant. The enrollment ratio was kept at 1, and power of study was aimed at 80%. The study population was alternatively assigned to two groups (BCG vs. Gem/Doce) of 30 patients each. Both the groups received 6 weekly doses of induction therapy followed by 6 monthly doses of maintenance therapy if no recurrence was noted at interim follow-up. QOL scores, safety, and efficacy were assessed at beginning of intravesical therapy, end of induction, and 6 months of maintenance therapy. Cystoscopy examination and cytology were performed at the end of induction therapy and 3-monthly thereafter. <b><i>Result:</i></b> The preliminary results at the end of 6 months following maintenance therapy showed that the demographic profile, histological stage, and grade were comparable between two groups. The QOL scores using QLQ-30 and QLQ-BLS-24 showed statistically significant differences with the Gem/Doce arm showing better outcomes. There were no progressions to higher stage, while one recurrence each was seen in both groups. Patient-related side effects measured by CTCAE (Common Terminology Criteria for Adverse Events)version 5 showed that the BCG group had higher toxicity profile as compared to Gem/Doce group. <b><i>Conclusion:</i></b> Gem/Doce combination intravesical therapy is a promising alternative to BCG for treatment of NMIBC, showing better QOL measures and lesser side effects.

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

“…Many similar AEs are a concern for gemcitabine and docetaxel therapy, but our results revealed that treatment discontinuation rates were lower for this chemotherapy doublet than for BCG. These findings are consistent with those of Pareek et al, who found in a prospective cohort of 60 patients that gemcitabine and docetaxel therapy was associated with better quality of life outcomes and fewer toxic effects when compared with BCG therapy. While overall tolerability was similar, patients in the present cohort who received gemcitabine and docetaxel were more likely to experience bladder spasms and nausea, while those who received BCG were more likely to experience distinct immunologic AEs, such as arthralgias and fatigue or flulike symptoms.…”

Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: a Promising Approach in Non-Muscle Invasive Bladder Cancer

“…MeElree et al published a large study of 312 patients, of which almost 44% had CIS (alone or in combination) and almost one-third of them had a Ta cancer with HG RFS in 71% of patients with BCG treatment and 85% of patients with Gem/Doce [32], which is actually the same as we found in our study confirming the efficacy of this therapy especially in older patients who may be increasingly immunosenescent and therefore less suitable for BCG treatment. These authors also demonstrated that patients were less likely to quit Gem/Doce treatment because they had better quality of life and less toxic effects compared to BCG [32], confirming the findings reported from other studies [35]. In our study, only one patient reported probably unrelated complication which postponed treatment, thus verifying the safety and tolerability of this treatment.…”

Intravesical Gemcitabine and Docetaxel Therapy for BCG-Naïve Patients: A Promising Approach to Non-Muscle Invasive Bladder Cancer

“…MeElree et al published a large study on 312 patients, of which almost 44% had CIS (alone or in combination) and almost a third had a Ta cancer, with HG RFS in 71% of the patients with BCG treatment and 85% of the patients with Gem/Doce [34], which is actually the same result as we found in our study, confirming the efficacy of this therapy especially in older patients who may be increasingly immunosenescent and, therefore, less suitable for BCG treatment. These authors also demonstrated that patients were less likely to quit Gem/Doce treatment because they had a better quality of life and experienced fewer toxic effects compared to BCG [34], confirming the findings reported by other studies [37]. In our study, only one patient reported a-probably unrelated-complication that postponed treatment, thus verifying the safety and tolerability of this treatment.…”