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5-FU, mitomycin-C confirmed as standard of care in anal cancer
Trial also found no added benefit of maintenance chemotherapy.
Six-month complete response rates were similar among patients with squamous cell anal carcinoma who received radiation therapy plus 5-FU in combination with either mitomycin-C or cisplatin, according to the results of the ACT II trial presented at the 2009 ASCO Annual Meeting.
These data reinforce the utility of 5-FU plus mitomycin-C, which has been the standard-of-care for squamous cell carcinoma of the anus for the last 20 years.
“Overall outcome for patients in this trial is excellent, with a 95% complete response at six months and an 85% survival at three years, which are very good results relative to the international trials completed so far,” said Roger James, MD, a radiation oncologist at Maidstone Hospital in Kent, United Kingdom.
The ACT II trial, which enrolled 940 patients, was designed to examine two questions: whether treatment with cisplatin instead of mitomycin-C would improve survival and whether maintenance therapy would reduce recurrence.
At six months, response rate was 94% in the mitomycin-C group vs. 95% in the cisplatin group. Patients treated with cisplatin had fewer grade-3/4 hematologic toxicities compared with patients who received mitomycin-C (13.4% vs. 24.7%, P<.001).
Additional data from the trial indicated that recurrence-free survival was the same among patients who received two cycles of maintenance therapy (n=448) with cisplatin/5-FU compared with those who did not. Similarly, OS at three years was about 85% in both groups.
“Maintenance chemotherapy does not improve disease control or survival,” James said. –by Nicole Blazek
We can conclude from this study that the standard of care remains 5-FU/mitomycin radiation. There is no benefit to substitute cisplatin for mitomycin and there's no benefit for additional cycles of maintenance chemotherapy with 5-FU/cisplatin. A disappointing study, but it just substantiates the standard of care that is already in place. You can't always assume that a new treatment is better unless you compare it to a standard. Negative studies are very important because they show that these different treatment strategies like changing chemotherapy drugs or adding additional chemotherapy show no benefit.
- David Ilson, MD
HemOnc Today Editorial Board member
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