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Key Words

Ovarian cancer, carboplatin, docetaxel (Taxotere®), paclitaxel (Taxol®). (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary ³.)

Summary

Patients with ovarian cancer who received a carboplatin-containing chemotherapy regimen that uses the drug docetaxel (Taxotere) did as well as patients who received the standard regimen using paclitaxel (Taxol) and had lower rates of some serious side effects, an international clinical trial has found. While no survival difference was found at a two-year analysis, it is too early for a definitive statement as to whether substituting docetaxel for paclitaxel extends patients’ lives.

Source

Journal of the National Cancer Institute, November 17, 2004 (see the journal abstract).

Background

Combination chemotherapy with carboplatin and paclitaxel is currently considered the standard of care for the treatment of ovarian cancer in the United States. However, studies in patients with advanced breast cancer and preliminary studies in ovarian cancer patients have suggested that docetaxel, a chemical cousin of paclitaxel, may be equally effective with fewer of the more serious kinds of side effects.

The Study

The study involved 1,077 women with ovarian cancer that had not been previously treated. They were randomly assigned to treatment with either paclitaxel and carboplatin (standard therapy) or docetaxel and carboplatin. Patients filled out periodic questionnaires designed to evaluate their quality of life. The median follow-up period was 23 months.

The study was conducted at centers in the United Kingdom, several European countries, Australia, and New Zealand, as well as at limited sites in the United States. The research team was led by Stan Kaye, of the Royal Marsden Hospital, for the Scottish Gynaecological Cancer Trials Group.

Results

The median length of time until patients’ disease progressed was similar in the two treatment groups (14.8 months for patients treated with paclitaxel compared with 15 months for patients who received docetaxel). Equal numbers of patients in both groups responded to treatment - that is, their tumors shrank, no new tumors appeared, and tumor markers in blood returned to normal levels.

Overall survival after two years was 68.9 percent for patients treated with paclitaxel and 64.2 percent for patients who received docetaxel, a difference that was not statistically significant - that is, it could have occurred by chance. The follow-up period was too short to determine whether patients treated with docetaxel ultimately lived longer than those who received paclitaxel.

Patients treated with paclitaxel had higher rates of hair loss and muscle and joint pain, abdominal pain, and numbness or tingling in the hands and feet. Patients who received docetaxel, on the other hand, were more likely to have nausea and vomiting, mouth sores, and a low white blood cell count. Overall, however, patients in the two groups rated their quality of life as about the same.

Limitations

The study was not “powered", meaning it had too few patients to definitively show that docetaxel and paclitaxel are equally effective in ovarian cancer, says Elise Kohn, M.D., senior investigator and chair of the Gynecologic Malignancies Faculty with the Center for Cancer Research at the National Cancer Institute. “It is a safe interpretation, however, that the two regimens are similar.”

Comments

This study’s findings are unlikely to radically change the standard of care for the treatment of ovarian cancer in the United States, says Kohn. “However, if a patient has a contraindication to paclitaxel, such as an allergic reaction or a pre-existing neurological injury, doctors will feel comfortable substituting docetaxel.”

Glossary Terms

A drug that is used to treat advanced ovarian cancer that has never been treated or symptoms of ovarian cancer that has come back after treatment with other anticancer drugs. It is also used together with other drugs to treat advanced, metastatic, or recurrent non-small cell lung cancer and is being studied in the treatment of other types of cancer. Carboplatin is a form of the anticancer drug cisplatin and causes fewer side effects in patients. It attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Paraplatin.

A drug used together with other drugs to treat certain types of breast cancer, stomach cancer, prostate cancer, and certain types of head and neck cancer. It is also being studied in the treatment of other types of cancer. Docetaxel is a type of mitotic inhibitor. Also called Taxotere.

A statistics term. The middle value in a set of measurements.

A drug used to treat breast cancer, ovarian cancer, and AIDS-related Kaposi sarcoma. It is also used together with another drug to treat non-small cell lung cancer. Paclitaxel is also being studied in the treatment of other types of cancer. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. Also called Taxol.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with the standard of care. Also called best practice and standard therapy.