Long-term outcomes from this trial confirm the benefit of treatment with chemoradiotherapy over chemotherapy alone for patients with muscle-invasive bladder cancer.
Chemoradiotherapy continued to show benefit in patients with muscle-invasive bladder cancer compared with radiotherapy alone over a 10-year period, according to findings from a phase 3 trial.
It was previously determined that adding the chemotherapy drugs fluorouraciland mitomycin C to radiotherapy improved locoregional disease control (a rate free from recurrence in the bladder or pelvic nodes) in patients with muscle-invasive bladder cancer; however, long-term data on recurrence risk were limited.
Results of an updated analysis demonstrated that chemoradiotherapy continued to improve local-regional control at the 9.9-year median follow up, as well as invasive local-regional control. Specifically, five-year recurrence-free survival rates were 63% for patients treated with chemoradiotherapy and 49% for those treated with radiotherapy.
Treatment for muscle-invasive bladder cancer is either surgery or radiotherapy; however, these updated results support the notion to utilize chemoradiotherapy as an effective treatment option for some patients.
“This updated report from a large randomized trial with 10-year follow-up provides strong evidence for co-current chemoradiotherapy using (mitomycin C) and (fluorouracil) as a standard of care for patients opting for organ-preservation therapy for muscle-invasive bladder cancer,” the study authors wrote.
This phase 3 study, which was published in the European Association of Urology, included 458 patients who were assigned radiotherapy (178 patients), chemoradiotherapy (182 patients), standard whole-bladder radiotherapy (108 patients), or reduced high-dose volume radiotherapy (111 patients).
The five-year overall survival rates were 49% with chemoradiotherapy and 37% with radiotherapy alone. Ten-year overall survival rates were 30% and 26%, respectively.
There was also a benefit observed in disease-free survival (the measure of time after treatment during which no sign of cancer is found) and bladder cancer-specific survival with chemoradiotherapy, although they were not significant.
Additionally, patients who received chemoradiotherapy were able to avoid cystectomy (a surgery to remove all or part of the bladder) longer than those on radiotherapy alone. Specifically, the five-year cystectomy rate was 14% for the chemoradiotherapy group versus 22% for the chemotherapy alone group.
Of note, patient-reported outcomes were previously published and showed that health-related quality of life improved for most patients receiving chemoradiotherapy from the beginning of the study. In addition, there were no significant side effects.
“These results support organ preservation as a valid alternative to radical cystectomy for this patient group,” the study authors concluded.
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