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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 04/30/2008

Cisplatin No Better than Standard Therapy for Anal Canal Cancer

Adapted from the NCI Cancer Bulletin 1.

Replacing mitomycin with cisplatin in chemoradiotherapy for cancer of the anal canal failed to improve either disease-free survival or overall survival and resulted in more patients needing colostomies, according to a study in the April 23, 2008, issue of the Journal of the American Medical Association (see the journal abstract 2).

Current standard therapy for anal canal cancer consists of fluorouracil plus mitomycin and radiotherapy. Previous studies have established that chemoradiation is more effective for smaller tumors. Researchers wondered whether initial chemotherapy with fluorouracil and cisplatin could improve outcomes by shrinking tumors before they were treated with the same agents and radiotherapy.

In this randomized phase III clinical trial (see the protocol summary 3), 644 patients with anal canal cancer received standard treatment with fluorouracil plus mitomycin and concurrent radiotherapy or induction chemotherapy with fluorouracil plus cisplatin, followed by concurrent treatment with fluorouracil, cisplatin, and radiation.

After a median follow-up of 2.5 years, the estimated five-year disease-free survival rate was 60 percent for patients in the mitomycin group, compared with 54 percent in the cisplatin group. Estimated rates of overall survival, local recurrence, and distant metastasis were all worse for patients in the cisplatin group. In addition, at five years an estimated 19 percent of patients who received cisplatin needed colostomies, compared with 10 percent of patients who received mitomycin.

"These findings do not support the use of cisplatin in place of mitomycin in combination with fluorouracil and radiotherapy in the treatment of anal canal carcinoma," conclude principal investigator Dr. Jaffer A. Ajani of the University of Texas M.D. Anderson Cancer Center and his colleagues.

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Glossary Terms

chemoradiotherapy (KEE-moh-RAY-dee-oh-THAYR-uh-pee)
Treatment that combines chemotherapy with radiation therapy. Also called chemoradiation.
cisplatin (sis-PLA-tin)
A drug used to treat many types of cancer. Cisplatin contains the metal platinum. It kills cancer cells by damaging their DNA and stopping them from dividing. Cisplatin is a type of alkylating agent.
colostomy (koh-LOS-toh-mee)
An opening into the colon from the outside of the body. A colostomy provides a new path for waste material to leave the body after part of the colon has been removed.
disease-free survival (dih-ZEEZ ... ser-VY-vul)
In cancer, the length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Also called DFS and disease-free survival time.
distant cancer (DIS-tunt KAN-ser)
Refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes. Also known as distant metastasis.
fluorouracil (floor-oh-YOOR-uh-sil)
A drug used to treat cancers of the breast, stomach, and pancreas, and certain types of colorectal and head and neck cancers. It is also used in a cream to treat basal cell skin cancer and actinic keratosis (a skin condition that may become cancer). It is being studied in the treatment of other conditions and types of cancer. Fluorouracil stops cells from making DNA and it may kill cancer cells. It is a type of antimetabolite. Also called 5-fluorouracil, 5-FU, Adrucil, Efudex, and Fluoroplex.
induction therapy (in-DUK-shun THAYR-uh-pee)
Initial treatment used to reduce a cancer. Induction therapy is followed by other treatments, such as chemotherapy, radiation therapy, and hormone therapy to get rid of cancer that remains. Also called first-line therapy, primary therapy, and primary treatment.
median (MEE-dee-un)
A statistics term. The middle value in a set of measurements.
overall survival rate (... ser-VY-vul ...)
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after diagnosis or treatment. Also called survival rate.
phase III trial (fayz … TRY-ul)
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.
recurrence (ree-KER-ents)
Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrent cancer.
standard therapy (... THAYR-uh-pee)
Treatment that experts agree is appropriate, accepted, and widely used. Also called best practice, standard medical care, and standard of care.

Table of Links

1http://www.cancer.gov/ncicancerbulletin
2http://www.ncbi.nlm.nih.gov/pubmed/18430910
3http://www.cancer.gov/clinicaltrials/RTOG-9811
4http://www.cancer.gov/clinicaltrials/search
5http://www.cancer.gov/cancertopics/types/anal