Treatment changes sometimes come with alterations, large and small, in medical device usage. And while a newly-recommended shift in delivery of chemotherapy to treat advanced ovarian cancer may be small, the benefits of this change would appear to be huge.

The National Cancer Institute (NCI), part of the National Institutes of Health (NIH; both Bethesda, Maryland), last week recommended increased and adjunctive use of intraperitoneal (IP) chemotherapy, bannering it as a way to extend the survival for women with such cancers for up to a year.

The IP method utilizes the delivery of chemotherapy with an abdominal catheter, and the NCI recommended that it be used as an adjunct to the usual delivery of chemotherapy into the bloodstream via the traditional, and basic, intravenous (IV) method.

The NCI announcement of the treatment's success coincided with publication of study data, in The New England Journal of Medicine, by Deborah Armstrong, MD, medical oncologist and associate professor at Johns Hopkins Kimmel Cancer Center (Baltimore) and her colleagues in an NCI-supported research network known as the Gynecologic Oncology Group.

Armstrong's recommendation is that surgeons should adopt the combination method of delivering chemo for this treatment, and it was picked up by national news media, as an important treatment change.

There wasn't much said, however, about the relatively simple device involved in the combined delivery method.

Dr. Joan Walker, MD, professor and chief, section gynecology oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center (Oklahoma City), and author of a recent article on IP in Gynecologic Oncology, told Medical Device Daily that, with the IP procedure, “the abdominal cavity needs to be irrigated with chemotherapy.“

“What we use now is a venous access device that we have taken from its original intended use and are using it in the peritoneal cavity,“ Walker said.

She said that in her study, researchers put the port at the “lower aspect of the rib cage, just above the abdominal cavity“ before tunneling the catheter through the subcutaneous tissues before arriving in the lower abdomen and inserting the device into the peritoneal cavity.

“The belly is a cavity, and so the bowels are all inside that cavity, wiggling around inside, and the catheter could change positions,“ she said. “It's not attached to anything. It's just dangling in there.“

When IP first began being studied, Walker said that researchers in this area “just stole this device from the dialysis catheter makers.“

Now, though researchers in her study weren't restricted to a device with a specific brand, she said that, for her, the preferred device is the Bard 9.6 venous access device made by CR Bard (Murray Hill, New Jersey).

The reason: “It doesn't kink, it doesn't obstruct as much as the smaller size devices. It comes in both an attachable and an attached version.“

Although Deltec (St. Paul, Minnesota) developed a peritoneal port specifically for IP, Walker said, “We haven't been happy with that device. We think that the fact that it has a hundred different little holes actually allows the body to invade those holes with fibroblasts that causes it to adhere to the bowels.“

However, she said the company has made some changes to the product since that time.

In a prepared statement, Armstrong said that IP therapy for this application “is not a new treatment approach, but it has not been widely accepted as the gold standard for women with ovarian cancer. There has been a prejudice against IP therapy in ovarian cancer because it's an old idea, it requires skill and experience for the surgery and for the chemotherapy, and it's more complicated than IV chemotherapy.“

And a key barrier to this treatment will probably continue to be complications, such as infections, related to device implantation.

But Armstrong indicated that such concerns are overridden by the obvious clinical benefits: “[N]ow we have firm data showing that we should use a combination of IP and IV chemotherapy in most women with advanced ovarian cancer who have had successful surgery to remove the bulk of their tumor.“

Armstrong continued: “In our trial, women who received part of their chemotherapy via an IP route had a median survival time 16 months longer than women who received only IV chemotherapy.“

IP-delivered chemotherapy would appear to be more effective in killing cancer cells in the peritoneal cavity, perhaps because the delivery system enables higher doses and more frequent administration of drugs. And it is delivered to the area where ovarian cancer is likely to spread or recur first.

The Armstrong trial involved 429 women with Stage III ovarian cancer who were given chemotherapy following the successful surgical removal of tumors. It compared two treatment regimens: first, IV paclitaxel followed by IV cisplatin; and second, IV paclitaxel followed by IP cisplatin and subsequent administration of IP paclitaxel.

Standard treatment for women with Stage III ovarian cancer has been surgical removal of the tumor, followed by six to eight courses of IV chemotherapy given every three weeks with a platinum drug, such as cisplatin or carboplatin, and a taxane drug, such as paclitaxel.

The 205 women treated via the IP route fared better, even though most of them received fewer than the six planned treatments. Complications associated with the abdominal catheter used to deliver the IP chemotherapy were the main reason only 86 of the women completed all six IP treatments.

“For most women who have had successful surgical removal of tumors to less than one centimeter in size, we now know that the longest survival may be achieved by giving their chemotherapy directly into the abdomen,“ said Beth Karlan, MD, president of the Society of Gynecologic Oncologists (Chicago) and director of Gynecologic Oncology and the Gilda Radner Ovarian Cancer Program at Cedars-Sinai Medical Center (Los Angeles).