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HEALTH PROFESSIONAL · SOURCE READING

EBRT with or without concomitant chemotherapy

Source: Bladder Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: May 2, 2025 · Captured 2026-09-09.

Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary.

Context: Treatment of Stages II and III Bladder Cancer / Treatment Options for Stages II and III Bladder Cancer

Definitive radiation therapy is a standard option that yields 5-year survival rates of approximately 30% to 40%.[26] When radiation therapy and chemotherapy are administered concomitantly, the results are better. However, while the addition of chemotherapy to radiation therapy has been shown to reduce local relapse rates, it has not been shown to result in increased survival, decreased mortality, or improved quality of life.

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Most protocols for bladder preservation that use combined chemotherapy and radiation therapy have followed a relatively complex algorithm. After the initial stage TUR of the bladder tumor, patients undergo a repeat TUR to maximally resect the tumor. The patient is then treated with synchronous chemoradiation therapy to a dose of roughly 40 Gy followed by a repeat cystoscopy with biopsies to assess for residual cancer. If residual cancer is detected histopathologically, then the chemoradiation therapy is judged to have failed and the patient is advised to undergo a radical cystectomy. If the biopsies at 40 Gy are benign, then chemoradiation therapy is completed to a dose of about 65 Gy.

With definitive radiation therapy, best results are seen in patients with solitary lesions and without carcinoma in situ or hydronephrosis.

After radiation therapy, approximately 50% of patients have dysuria and urinary frequency during treatment, which resolves several weeks after treatment, and 15% report acute toxic effects of the bowel.

Randomized trials that directly compare the bladder-preserving chemoradiation therapy approach with radical cystectomy have not been performed. The relative effectiveness of these two treatments is thus unknown.

Evidence (EBRT with or without concomitant chemotherapy):

TUR followed by chemoradiation therapy

A multicenter phase III trial randomly assigned 360 patients with muscle-invasive bladder cancer to radiation therapy with or without synchronous chemotherapy using fluorouracil and mitomycin.[26]

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A multicenter phase III trial randomly assigned 360 patients with muscle-invasive bladder cancer to radiation therapy with or without synchronous chemotherapy using fluorouracil and mitomycin.[26]

The 2-year locoregional DFS rate was higher in the chemoradiation therapy group (67% vs. 54%; HR, 0.68; 95% CI, 0.48–0.96; P = .03). The 5-year OS rate was 48% in the chemoradiation therapy group and 35% in the radiation therapy group, but the difference was not statistically significant (P = .16).

Similarly, synchronous chemoradiation therapy using other chemotherapy regimens, such as cisplatin alone or combined with fluorouracil, have reported 5-year OS rates of 50% to 60% and survival with an intact bladder in 40% to 45% of patients. These figures are higher than what has generally been reported in studies of radiation therapy alone.[27]

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TUR followed by chemoradiation therapy

In some nonrandomized studies, 50% or more of the patients who underwent bladder-preserving therapy (i.e., initial TUR of as much tumor as possible followed by concurrent chemoradiation therapy) were alive at 5 years, and 75% of those survivors had an intact bladder.[28-30]

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Radiation therapy and chemotherapy

A randomized controlled trial randomly assigned 99 patients with T2 to T4b urothelial carcinoma of the bladder to radiation therapy with or without three 14-day cycles of cisplatin (100 mg/m2 on day 1). Patients and their physicians chose whether the radiation therapy was definitive or given as precystectomy treatment.[31]

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A randomized controlled trial randomly assigned 99 patients with T2 to T4b urothelial carcinoma of the bladder to radiation therapy with or without three 14-day cycles of cisplatin (100 mg/m2 on day 1). Patients and their physicians chose whether the radiation therapy was definitive or given as precystectomy treatment.[31]

The pelvic relapse rate was reduced (multivariable regression model HR, 0.50; 90% CI, 0.29–0.86; P = .036) using concurrent cisplatin, but there was no difference in the occurrence of distant metastases or OS.

A randomized controlled trial randomly assigned 99 patients with T2 to T4b urothelial carcinoma of the bladder to radiation therapy with or without three 14-day cycles of cisplatin (100 mg/m2 on day 1). Patients and their physicians chose whether the radiation therapy was definitive or given as precystectomy treatment.[31]

The reduction in pelvic relapse was similar in patients who received definitive radiation therapy and precystectomy radiation therapy.

Neoadjuvant chemotherapy followed by chemoradiation therapy

In a phase III study (RTOG-8903), the Radiation Therapy Oncology Group evaluated the potential benefit of adding two cycles of neoadjuvant methotrexate, cisplatin, and vinblastine before concurrent cisplatin and radiation therapy.[32]

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In a phase III study (RTOG-8903), the Radiation Therapy Oncology Group evaluated the potential benefit of adding two cycles of neoadjuvant methotrexate, cisplatin, and vinblastine before concurrent cisplatin and radiation therapy.[32]

Neoadjuvant chemotherapy was associated with increased hematologic toxic effects and yielded no improvement in response rate, freedom from distant metastases, or OS compared with chemoradiation therapy alone.

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Preserved source evidence · Not medical advice