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Background <p>Intravesical Bacillus Calmette-Guérin (BCG) is the standard adjuvant therapy for intermediate/high-risk non-muscle-invasive bladder cancer (NMIBC) but is limited by failure, toxicity, and global supply constraints. Sequential Intravesical gemcitabine–docetaxel (Gem/Doce) can offer a rational chemotherapy alternative.</p> Methods <p>In this prospective randomized, parallel-arm interventional study comparing efficacy and safety of Gem/Doce versus BCG in BCG-naïve intermediate/high-risk NMIBC, patients aged 18–80&#xa0;years with complete TURBT of primary localised bladder lesion(s) were included. Gem/Doce induction comprised weekly gemcitabine (1000&#xa0;mg) and docetaxel (40&#xa0;mg) Intravesical instillations for 6&#xa0;weeks, with monthly maintenance per risk group. BCG induction (weekly 80&#xa0;mg OncoBCG for 6&#xa0;weeks) was followed by risk-based maintenance as per SWOG protocol. Outcomes (RFS, high-grade RFS, PFS, CSS, OS) were evaluated post-induction, and at 6 and 12&#xa0;months. Adverse events were graded by CTCAE v5.0.</p> Results <p>91 patients (Gem/Doce n = 43; BCG n = 48) were evaluated. At 6 and 12&#xa0;months, RFS was 95.35% and 90.71% in Gem/Doce versus 83.33% and 77.08% in BCG. Intermediate-risk category had higher 12&#xa0;month RFS with Gem/Doce (93.55% vs 81.82%, p = 0.041). High-grade RFS was higher with Gem/Doce (97.67% and 93.02%) than BCG (93.75% and 89.58%). At 12&#xa0;months, PFS, CSS, and OS were superior with Gem/Doce: PFS 97.67% vs 95.83%, CSS 100% vs 97.92%, and OS 100% vs 95.83%. Fewer patients reported AEs with Gem/Doce (13.95% vs 35.42%), with fewer Grade 1–2 events (p &lt; 0.01) and no Grade ≥ 3 events vs. three in BCG. Dysuria, bladder spasm, and frequency were higher with BCG.</p> Conclusions <p>Sequential Gem/Doce is an effective and better-tolerated alternative to BCG in BCG-naïve NMIBC, demonstrating superior intermediate-risk RFS and comparable survival outcomes. Long–term validation through larger multi–centre studies is warranted.</p>

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Prospective comparative evaluation of clinical efficacy and safety of Intravesical gemcitabine–docetaxel versus BCG in adjuvant management of BCG-naive non-muscle invasive urothelial bladder cancer in Indian population

  • 期刊论文

  • 发表日期：

    2026年3月17日

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  • Aviral Srivastava,
  • Sameer Trivedi,
  • Yashasvi Singh,
  • Ujwal Kumar,
  • Lalit Kumar,
  • Sahil Data,
  • Anil Kumar,
  • Satya Narayan Sankhwar

摘要

Background

Intravesical Bacillus Calmette-Guérin (BCG) is the standard adjuvant therapy for intermediate/high-risk non-muscle-invasive bladder cancer (NMIBC) but is limited by failure, toxicity, and global supply constraints. Sequential Intravesical gemcitabine–docetaxel (Gem/Doce) can offer a rational chemotherapy alternative.

Methods

In this prospective randomized, parallel-arm interventional study comparing efficacy and safety of Gem/Doce versus BCG in BCG-naïve intermediate/high-risk NMIBC, patients aged 18–80 years with complete TURBT of primary localised bladder lesion(s) were included. Gem/Doce induction comprised weekly gemcitabine (1000 mg) and docetaxel (40 mg) Intravesical instillations for 6 weeks, with monthly maintenance per risk group. BCG induction (weekly 80 mg OncoBCG for 6 weeks) was followed by risk-based maintenance as per SWOG protocol. Outcomes (RFS, high-grade RFS, PFS, CSS, OS) were evaluated post-induction, and at 6 and 12 months. Adverse events were graded by CTCAE v5.0.

Results

91 patients (Gem/Doce n = 43; BCG n = 48) were evaluated. At 6 and 12 months, RFS was 95.35% and 90.71% in Gem/Doce versus 83.33% and 77.08% in BCG. Intermediate-risk category had higher 12 month RFS with Gem/Doce (93.55% vs 81.82%, p = 0.041). High-grade RFS was higher with Gem/Doce (97.67% and 93.02%) than BCG (93.75% and 89.58%). At 12 months, PFS, CSS, and OS were superior with Gem/Doce: PFS 97.67% vs 95.83%, CSS 100% vs 97.92%, and OS 100% vs 95.83%. Fewer patients reported AEs with Gem/Doce (13.95% vs 35.42%), with fewer Grade 1–2 events (p < 0.01) and no Grade ≥ 3 events vs. three in BCG. Dysuria, bladder spasm, and frequency were higher with BCG.

Conclusions

Sequential Gem/Doce is an effective and better-tolerated alternative to BCG in BCG-naïve NMIBC, demonstrating superior intermediate-risk RFS and comparable survival outcomes. Long–term validation through larger multi–centre studies is warranted.