Larger trial helps make the case for adjuvant chemo in bladder cancer patients
- A European Organization for Research and Treatment of Cancer (EORTC) trial has produced data regarding survival rates associated with adjuvant chemotherapy in high-risk bladder cancer patients.
- In the trial, progression-free survival increased significantly with immediate versus delayed post-surgical chemotherapy.
- There is still debate over whether adjuvant chemotherapy in this population offers a clear survival advantage.
When it comes to chemotherapy for high-risk bladder cancer, there is solid evidence supporting neo-adjuvant treatment (before surgery). However, researchers are still attempting to gather evidence regarding adjuvant chemotherapy in this population. One major problem is gathering enough subjects in the trial to produce significant results either way. Data reported at the ASCO-sponsored 2014 Genitourinary Cancer Symposium cited an astounding fact: Almost one-fifth of adult cancer clinical trials fail to reach completion, mainly because of accrual (failure to have enough subjects).
This trial is the largest reported randomized trial involving adjuvant chemotherapy in patients with muscle-invasive bladder cancer. Even so, recruiters failed to achieve their initial goal of recruiting 1,344 patients for a trial comparing immediate versus deferred cisplatin-based chemotherapy in this high-risk group of bladder cancer patients. The trial ended up closing early with 284 patients in 13 countries. However, after six years of study, researchers have produced valuable data that can help build the evidence base.
In patients who had chemotherapy immediately following surgery, compared with patients who were treated later, there was a significant improvement in progression-free survival rates. Likewise, respective median overall survival rates in these two groups were 6.75 years versus 4.6 years--however, the 22% reduction in the relative risk of death did not produce significant results. The takeaway is that the jury is still out, but researchers are determined to draw more definitive conclusions be aggregating data from this trial with other trials.