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Mitomycin demonstrated superior results over cisplatin in patients with anal cancer

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In patients with anal canal carcinoma, cisplatin combined with fluorouracil and radiotherapy failed to improve disease-free survival, compared with mitomycin-based therapy, according to study results recently published in JAMA.

Researchers from various sites in the United States randomly assigned 682 patients with anal canal carcinoma to cisplatin-based therapy (n=341) and mitomycin-based therapy (n=341) to compare the efficacy of the two options. Outcomes in the U.S. Gastrointestinal Intergroup trial RTOG 98-11, a phase-3, randomized, controlled trial, included five-year disease-free survival, overall survival and time to relapse.

Patients in the standard treatment group received 1,000 mg/m² fluorouracil plus 10 mg/m² mitomycin and radiotherapy. Those in the experimental group received 1,000 mg/m² fluorouracil plus 75 mg/m² cisplatin (Platinol, Bristol-Myers Squibb) and radiotherapy.

In the standard treatment group, the five-year disease-free survival rate was 60% and in the experimental group, 54% (P=.17). The overall survival rate was 75% in the standard treatment group and 70% in the experimental treatment group (P=.10), according to the researchers.

In the standard treatment group, the distant metastasis rate was 25% (95% CI, 20%-30%) and the five-year local-regional recurrence rate was 15% (95% CI, 10%-20%). In the experimental treatment group, 33% of patients had distant metastasis (95% CI, 27%-40%) and the five-year local-regional recurrence rate was 19% (95% CI, 14%-24%).

Compared with the cisplatin group, those in the mitomycin group had a better cumulative rate of colostomy (P=.02). – by Stacey L. Adams

JAMA. 2008;299:1914-1921.

Click here to read comments on this study from one of the HemOncToday.com bloggers.

This is a good example of an instance where everyone assumed that contemporary treatment would trump old treatment. The original treatment — mitomycin-5-FU-radiotherapy — was very effective and everyone assumed that if we substituted a better chemotherapy, say cisplatin for mitomycin, we would improve outcome, yet we didn't. This is more of a message that novel treatments may not be better than the old.

– Alan P. Venook, MD

HemOnc Today Editorial Board member