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Key Words

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

Summary

Women with relapsed ovarian cancer who were treated with both paclitaxel (Taxol) and a platinum-based drug lived a median of five months longer than those who received a platinum-based drug alone; both groups of women experienced about the same quality of life. These results apply only to women whose recurrent ovarian cancer is considered to be “platinum sensitive.”

Source

The Lancet, June 21, 2003 (see the journal abstract).

Background

Ovarian cancer is the fourth most common cancer in women. The disease often has no symptoms in its early stages. As a result, most patients have advanced disease at the time of diagnosis. Standard therapy for newly diagnosed ovarian cancer usually consists of surgery to remove the tumor, ovaries, and uterus, followed by chemotherapy with either paclitaxel alone, a platinum-based drug such as carboplatin or cisplatin, or both paclitaxel and a platinum-based drug.

Unfortunately, in most women with ovarian cancer the disease recurs within five years. Patients whose disease recurs within six months of completion of chemotherapy with a platinum-based drug are considered “platinum-resistant” and are usually re-treated with paclitaxel. If the disease recurs after more than six months, patients are considered “platinum-sensitive” and are usually re-treated with one of the platinum drugs.

Whether the addition of paclitaxel to platinum-based therapy would improve outcomes for women with relapsed, platinum-sensitive ovarian cancer was not known.

The Study

Between 1996 and 2002, 802 women with relapsed, platinum-sensitive ovarian cancer were randomly assigned to receive chemotherapy with either paclitaxel plus a platinum-based drug (carboplatin or cisplatin) or a platinum-based drug alone. The phase III randomized clinical trial was carried out at 119 hospitals in five European countries.

Results

The median follow-up period was 3.5 years. Median survival for women who received the combination paclitaxel-plus-platinum regimen was 29 months, compared with 24 months for women treated with platinum alone, a statistically significant difference. Disease progression was delayed for a median of 12 months in women treated with combination therapy, compared with 9 months in the platinum-only group.

Women in the combination-therapy group had higher rates of alopecia (hair loss). In addition, 20 percent of patients in this group had moderate to severe side effects such as hearing and memory loss, “pins and needles” sensations, and loss of fine motor function (which results in difficulty doing things like typing or buttoning). Women in the platinum-only group had higher rates of moderate to severe low blood cell counts.

About 500 women filled out quality-of-life questionnaires. Their responses were similar regardless of which treatment group they were assigned to. “We found no clear indication that one regimen is worse than the other for functional ability, symptomatic experience, or global health status,” wrote the study authors.

The study’s findings will likely result in more women with platinum-sensitive relapsed ovarian cancer being prescribed combination chemotherapy with platinum and paclitaxel, even if they received paclitaxel as part of their first-line treatment, said Edward L. Trimble, M.D., M.P.H., of the National Cancer Institute’s Cancer Therapy Evaluation Program.

Limitations

Women with platinum-resistant relapsed ovarian cancer will not benefit from paclitaxel-platinum combination chemotherapy. Paclitaxel alone is the recommended treatment for these patients.

The findings do not shed light on the effectiveness of combination chemotherapy regimens involving drugs other than paclitaxel. Further studies are needed to test the effectiveness of other combination regimens, commented S.B. Kaye, M.D., of the Royal Marsden Hospital in Sutton, England, in an accompanying editorial.

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 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. Also called Platinol.

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

The time from either diagnosis or treatment at which half of the patients with a given disease are found to be, or expected to be, still alive. In a clinical trial, median survival time is one way to measure how effective a treatment is. Also called median overall survival and median survival.

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 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.

A metal that is an important component of some anticancer drugs, such as cisplatin and carboplatin.

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.

A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

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