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Key Words

Ovarian cancer, intraperitoneal chemotherapy, side effects, quality of life, paclitaxel ³ (Taxol®), cisplatin. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary ⁴.)

Summary

Women with ovarian cancer treated with a combination of intraperitoneal (IP) and intravenous (IV) chemotherapy reported more side effects and a lower quality of life during their treatment compared to women receiving IV chemotherapy only. However, at the end of one year only neurological symptoms (such as tingling in the hands and feet) remained worse for the IV/IP chemotherapy group; otherwise, the women’s quality of life was about the same.

Source

Journal of Clinical Oncology, February 1, 2007 (see the journal abstract).
(J Clin Oncol 2007 Feb 1;25(4):437-43)

Background

Several clinical trials have shown that intraperitoneal (IP) chemotherapy, in which anticancer drugs are delivered directly into the abdomen, extends survival for women with ovarian cancer compared to chemotherapy delivered only by vein (IV). In the most recent of these clinical trials, women who received a combination of IP and IV chemotherapy lived an average of 16 months longer than women who received only IV chemotherapy. These and other results prompted the National Cancer Institute to release a clinical announcement ⁵ encouraging doctors to use the combined IP/IV approach when initially treating women with advanced ovarian cancer.

IP/IV chemotherapy causes more side effects than IV chemotherapy alone. However, these side effects have not been comprehensively studied. A more complete understanding will help doctors determine which treatment would be most appropriate for individual patients.

The Study

In 2006, the Gynecologic Oncology Group reported the results of a phase III clinical trial called GOG 172 that showed a significant survival advantage for IP/IV chemotherapy compared to IV chemotherapy only in women with advanced ovarian cancer (see the related NCI press release ⁶ and the trial's protocol summary ⁷).

To assess the impact of side effects, researchers with the study also compiled information about the patients’ health-related quality of life during and after treatment. The quality-of-life results are described here.

All women enrolled in the main clinical trial were invited to participate in the side-effects study. Investigators used questionnaires completed by the women to assess neurological side effects (such as numbness or tingling in the hands or feet), abdominal discomfort, and overall quality of life, including physical, social, emotional, and functional well-being. Participants filled out the questionnaires at four points during the trial: before random assignment, before the fourth cycle of chemotherapy, three to six weeks after treatment, and 12 months after treatment.

Results

Investigators enrolled 415 eligible women into the trial and randomly assigned them to one of two groups: 210 received IV chemotherapy only (paclitaxel plus cisplatin) and 205 received a combination of IP/IV chemotherapy (IV paclitaxel plus IP paclitaxel and cisplatin). Ninety-six percent of all participants completed the questionnaire before random assignment. Almost 81 percent of participants completed at least three questionnaires, and 54 percent completed all four. Fewer women in the IP/IV group completed the questionnaires overall, but the difference in participation did not significantly increase over time.

During treatment, women in the IP/IV group experienced significantly reduced overall quality of life compared to women in the IV group. However, by 12 months after treatment, patients in both groups were reporting a similar quality of life.

Patients in the IP/IV group experienced significantly more neurological side effects and abdominal discomfort. Abdominal discomfort began to improve for both groups during treatment, and no differences in discomfort remained soon after the end of treatment. However, neurological side effects remained worse in patients in the IP/IV group, even at one year after treatment.

Comments

“This is the first study, to our knowledge, to assess comprehensive patient-reported outcomes in an IP chemotherapy trial,” noted the trial’s researchers, including patients’ personal experiences and perceptions related to specific disease and treatment-related symptoms.

“Both doctors and patients can look at this data and have a better idea of what to expect during IP chemotherapy,” explained Edward L. Trimble, M.D., M.P.H., of the National Cancer Institute’s Cancer Therapy Evaluation Program. “It makes clear, from the patients’ perspective, what they experienced on the two arms of the trial. We know that IP chemotherapy seems to have more side effects, but a year after starting treatment the side effects have largely gone away.”

Meanwhile, researchers are looking for ways to reduce the side effects of IP chemotherapy while maintaining the survival benefit. “We are doing studies now to see if we can modify the intraperitoneal regimen somewhat, so as to decrease toxicity,” said Trimble.

Glossary Terms

The area of the body that contains the pancreas, stomach, intestines, liver, gallbladder, and other organs.

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 type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

Treatment in which anticancer drugs are put directly into the abdominal cavity through a thin tube.

Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called IV.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.