A new study suggests that a combination of radiation therapy and immune checkpoint inhibitors (ICIs) may offer a less invasive alternative to bladder removal for patients with muscle-invasive bladder cancer (MIBC).
The findings, published in Clinical Cancer Research, come from the phase II IMMUNOPRESERVE clinical trial.
MIBC is a serious form of bladder cancer that has spread into the muscle layer of the bladder wall. The standard treatment is a radical cystectomy, which involves surgically removing the entire bladder.
While this procedure is often effective in treating cancer, it comes with major challenges. Patients must adapt to using a urostomy bag or a reconstructed bladder, which can significantly impact their quality of life.
Dr. Xavier Garcia-del-Muro, a medical oncologist at the University of Barcelona and senior author of the study, explained the need for alternative treatments. “Radical cystectomy is a highly invasive surgery that can greatly affect patients’ quality of life,” he said.
“We need more conservative approaches that can effectively treat the cancer while preserving the bladder.”
Researchers have been investigating different ways to treat MIBC without removing the bladder. One approach involves using chemotherapy with radiation after removing the tumor through surgery. While this method has shown promising results, chemotherapy can cause severe side effects, and many patients cannot tolerate it.
This study tested a different strategy—using radiation therapy combined with two immunotherapy drugs, durvalumab (Imfinzi) and tremelimumab (Imjudo).
These drugs help the immune system fight cancer by targeting specific proteins (PD-L1 and CTLA-4) that allow cancer cells to evade immune detection. Preclinical studies have suggested that radiation therapy may enhance the effects of immunotherapy by stimulating the immune system.
The IMMUNOPRESERVE trial enrolled 32 patients with localized MIBC who either could not undergo or chose to avoid bladder removal surgery. These patients received three doses of durvalumab and tremelimumab over a 12-week period, along with radiation therapy.
Among the 28 patients who could be evaluated, 26 (93%) had a complete response, meaning their cancer was no longer detectable. After a follow-up period of 27 months, 30 of the 32 patients were able to keep their bladders. Only two patients eventually needed bladder removal surgery due to cancer recurrence.
The study also found that after two years:
- 84% of patients were still alive
- 83% remained free from distant metastases (cancer spreading to other organs)
- Five patients (16%) experienced cancer spreading beyond the bladder
- Seven patients (22%) had cancer return in the bladder
Overall, the treatment was considered well-tolerated, but some patients did experience side effects. Severe side effects (grade 3 or 4) occurred in 31% of patients, and one patient died due to treatment-related complications. Additionally, 25% of patients were unable to receive all three planned doses of immunotherapy because of side effects.
These results suggest that a combination of radiation and immunotherapy could be an effective way to treat MIBC while preserving the bladder. Patients in this study had high survival rates and good bladder preservation outcomes, making this a promising alternative to surgery.
However, this was a small, early-stage study, and there are still limitations. The study did not compare this treatment directly to standard options like chemotherapy and radiation. More research is needed, including larger trials with longer follow-ups, to confirm whether this approach is as effective as or better than existing treatments.
Dr. Garcia-del-Muro remains optimistic. “This approach is promising because it offers a way to maintain quality of life without compromising survival,” he said. “We hope future studies will confirm these findings and provide more treatment options for patients with bladder cancer.”
While further research is necessary, these results mark an important step toward developing less invasive and more patient-friendly treatments for bladder cancer.
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The research findings can be found in Clinical Cancer Research.
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