Gemcitabine Combination Therapies Evaluated in Bladder and Cervical Cancer Trials
Phase II trial finds adding gemcitabine to cisplatin does not improve outcomes in muscle-invasive bladder cancer, while separate study shows gemcitabine-lobaplatin interventional embolization benefits advanced cervical cancer patients.
A phase II randomized trial found that adding gemcitabine to cisplatin-based chemoradiotherapy did not improve outcomes in muscle-invasive bladder cancer patients. The study results should be interpreted cautiously due to early termination and insufficient accrual.
The trial (NCT01495676) enrolled 69 patients with pT2-pT3N0M0 muscle-invasive bladder cancer following macroscopically complete transurethral resection. Twenty-four patients received radiotherapy with cisplatin alone, while 45 received radiotherapy with cisplatin plus gemcitabine. Radiotherapy consisted of 63 Gy to the bladder and 45 Gy to the pelvis at 1.8 Gy per fraction. Cisplatin was administered at 20 mg/m2/day for 4 days every 21 days, with gemcitabine given at 25 mg/m2 twice weekly in the experimental arm.
At a median follow-up of 63 months, two-year disease-free survival was similar between groups: 58.3% (95% CI 36.6-77.9) for cisplatin alone versus 60.0% (95% CI 44.3-74.3) for the combination. Median disease-free survival was 29.8 months in the cisplatin arm compared to 37.4 months in the gemcitabine-cisplatin arm. Overall survival at 24 months was 91.3% (95% CI 69.5-97.8) for cisplatin alone and 66.7% (95% CI 50.2-78.8) for the combination. At 60 months, overall survival was 66.8% (95% CI 39.6-83.9) and 53.7% (95% CI 37.2-67.6), respectively. Toxicity profiles were comparable except for increased cytopenias in the gemcitabine arm.
In a separate study of advanced cervical cancer, gemcitabine combined with lobaplatin delivered via interventional embolization demonstrated significantly better outcomes than intravenous administration. Sixty patients were randomly assigned to either interventional embolization (30 cases) or intravenous drip (30 cases) of gemcitabine plus lobaplatin.
The interventional embolization group showed significantly better outcomes (P <0.05), with substantial changes in vaginal flora. The proportion of Gardnerella vaginalis in the therapy group decreased from 43.51% before treatment to 13.54% after treatment, and the rate of cell membrane formation was significantly shortened. However, no significant differences were found in colony content or cell membrane formation delay between the two groups.
The interventional embolization approach not only improved treatment efficacy and survival prognosis in patients with locally advanced cervical cancer but also modulated vaginal microbiota imbalance and inhibited biofilm formation of Gardnerella vaginalis. These findings provide a new theoretical basis for optimizing clinical treatment strategies for cervical cancer and exploring the relationship between cancer therapy and vaginal microecological balance.