Pre-Surgical Chemotherapy May Improve Survival in Bladder Cancer
Chemotherapy before surgery nearly doubles survival rates in patients with locally advanced bladder cancer compared to surgery alone, according to a trial reported at the annual meeting of the American Society of Clinical Oncology in San Francisco on May 14, 2001. [Editor's note: final results from the study were later published in the August 28, 2003, issue of the New England Journal of Medicine; see the journal abstract.]
 Locally advanced bladder cancer (Stage II-III) has spread from the lining the bladder into the wall of the organ, but has not yet invaded other organs. Cystectomy -- surgery to remove the bladder -- is the standard treatment, but often is not curative, said Ronald Natale, M.D., of Cedars-Sinai Comprehensive Cancer Center in Los Angeles, who reported on the trial.
The trial compared cystectomy alone to cystectomy preceded by three rounds of chemotherapy with MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), a standard treatment for bladder cancer. A total of 317 patients were randomly assigned to one approach or the other. (See the protocol summary.)
In the group receiving chemotherapy before surgery, median survival -- the point at which half of the patients are still alive -- was 6.2 years. In contrast, median survival was 3.6 years in the patients who had surgery without chemotherapy.
Five-year survival rates were also improved -- 57 percent for the chemotherapy group compared to 42 percent for the surgery-only group. The side effects of MVAC were moderate to severe but did not increase the number or severity of surgical complications. There were no chemotherapy-associated deaths.
The study also raised the possibility that chemotherapy may make surgery unnecessary in some patients. The investigators found no evidence of cancer in 38 percent of the patients who had received preoperative chemotherapy. And in this population of patients, the five-year survival was 85 percent.
This finding "provides a strong rationale for considering a bladder-sparing approach in future studies," Natale said. He also suggested that future studies might look at other chemotherapy regimens, such as the combination of cisplatin and gemcitabine, which has fewer side effects than MVAC and is now also considered a standard therapy.
However, both Natale and other experts cautioned that more study was needed to confirm the benefits of preoperative treatment. Cora Sternberg, M.D., of the Vincenzo Pansadoro Foundation, pointed out that the study was relatively small. As one of the experts asked to comment on the findings after they were presented, she also pointed out that seven previous studies had not been able to detect any benefit to this approach.
"The results of a single clinical trial…does not change the standard of care," said Natale. But, he added, "the striking results of this study require that patients should at least be informed that preoperative chemotherapy might significantly change their survival."
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