By: Ed Susman
SAN FRANCISCO, CA – Treatment of patients with anal cancer with a mitomycin C regimen provides a significant overall survival benefit compared with a cisplatin-based therapy, according to long-term follow-up of the Radiation Trials Oncology Group 98-11 phase 3 trial presented at the 2011 Gastrointestinal Cancers Symposium.
Although earlier reported results showed an improvement in colostomy failure with mitomycin C, the new analysis found that treatment with the drug in combination with radiotherapy had a statistically significant overall survival and disease-free survival benefit, said Christopher Willett, MD, Duke University Medical School, Durham, North Carolina.
After 5 years, 80 of the 325 patients treated with 5-fluorouracil plus mitomycin C, and radiation died during the 5-year period compared with 108 of 324 patients treated with 5-fluorouracil plus cisplatin and radiation (P =.021), Dr. Willett said in discussing his poster presentation.
He said the patients who received the mitomycin C treatment experienced 117 disease-free survival failures compared with 156 patients in the cisplatin arm (P =.0044).
“Concurrent radiation with 5-fluorouracil and mitomycin C has a significant impact on disease-free survival and overall survival,” Dr. Willett said. “Radiation plus 5-fluorouracil and mitomycin C remains the standard of care for patients with anal canal carcinoma.”
The researchers also determined that being a man, presenting with tumours >5 cm in diameter, and having lymph node positive disease are all independent poor prognosis factors of overall survival and disease-free survival in anal cancer.
Dr. Willett said the researchers also noted that there were trends which did not achieve statistical significance in favour of mitomycin C for local/regional recurrence control (P =.089); colostomy-free relapse (P =.053); for colostomy failure (P =.075); and for distant metastases (P =.12).
The researchers originally enrolled 682 adult patients into the study; 649 were included in the analysis.
– MFP Wire Services