Benefits of Drug Pump for Cancer Pain
Library: MED
Keywords: CANCER PAIN INTRATHECAL PUMP ONCOLOGY OPIOIDS RELIEF INFUSION
Description: When it comes to treating cancer pain with powerful painkillers, the delivery method can make a major difference in patient outcomes, according to the results of a landmark study. (J. of Clinical Oncology, 1-Oct-2002)



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E M B A R G O E D U N T I L T H U R S D A Y, S E P T . 2 6 , 2 0 0 2 A T 6 P M E T

STUDY REVEALS BENEFITS OF DRUG PUMP FOR CANCER PAIN

Delivering opioids through implantable infusion system provided better relief with smaller doses and fewer side effects than standard treatments alone

MINNEAPOLIS -- When it comes to treating cancer pain with powerful painkillers, the delivery method can make a major difference in patient outcomes, according to the results of a landmark study published in the Oct. 1 issue of the Journal of Clinical Oncology.

Sponsored by Medtronic, Inc. (NYSE: MDT), the study showed that opioids delivered through an implantable infusion system provided better relief from moderate to severe cancer pain with smaller doses and significantly fewer side effects than standard treatments (like pills, patches and shots) alone. Intrathecal infusion -- delivery of medication directly into the fluid surrounding the spinal cord, where nerve cells that regulate pain are located -- also improved quality of life for patients and caregivers, according to patient and family member surveys completed during the study. In addition, the data suggest that the same treatment, which uses a programmable drug pump, may have helped some patients live longer -- by about two months, on average. (While not statistically significant, the data on survival, which was not an endpoint, intrigued the investigators enough to warrant further study.)

The results of the study -- the first trial comparing intrathecal infusion to comprehensive medical management for intractable cancer pain -- may lead to new treatment guidelines for physicians and renewed hope for patients and their families.

"As an oncologist, I've seen firsthand how a patient's pain can hamper our efforts to treat the cancer itself and adversely affect the entire family," said Dr. Thomas J. Smith, chairman of hematology and oncology at Virginia Commonwealth University's Massey Cancer Center in Richmond, the study's oncology co-chairman and the manuscript's lead author. "By using the pump, we can deliver medication directly into the patient's spinal fluid, where small doses can have a big impact on pain. Put simply, less medication means fewer side effects, which makes life better not only for the patient but for the patient's family, too. And with the pain under control, we can focus on treating the cancer."

About one-third of people with cancer and two-thirds of people with advanced, including metastatic, disease experience pain, according to the American Cancer Society. But up to 15 percent of patients fail to get relief from oral opioids. For a subset of these patients -- approximately 50,000 Americans -- intrathecal pain therapy with a programmable drug pump represents a viable treatment option.

"Opioids such as morphine are extremely effective for treating severe pain," said cancer pain specialist Dr. Richard Boortz-Marx, director of pain medicine in the department of anesthesiology at the University of Minnesota, one of the study's investigators and a manuscript author. "Unfortunately, in high doses they can also cause sedation, clouded thinking, constipation and fatigue -- a constellation of side effects that lead many physicians to under-prescribe these drugs and many patients to under-use them. With this study, we've shown that by altering how we deliver the medications, we can provide better pain relief, minimize the side effects, and perhaps even help patients to live longer."

According to the American Cancer Society, 1.3 million new cases of cancer will be diagnosed in 2002, and a new report published in a recent issue of the journal Cancer predicts the incidence of the disease will double over the next five decades due to greater life expectancy. As a result, treating the disease and the pain associated with its progression and treatment will continue to be a challenge for patients, caregivers and clinicians.

"The pain was gnawing like a toothache in my bones, but no matter how much medication I took, I couldn't stop the pain," said Doreen Russo, a breast cancer survivor who now uses intrathecal infusion therapy to manage her pain. "I had no life at all. I would just lay in my recliner in pain, popping pills all the time, which made my head all fuzzy. I was unable to drive because I would fall asleep at the steering wheel, but after receiving the pump I'm doing great. I no longer have terrible pain, and I'm able to do everything that I used to do, like housework, shopping and gardening. My pain is under control without the awful side effects from the medication, and I'm able to enjoy time with my family again." (Russo's experience is unique to her. Results with intrathecal pain therapy vary by patient.)

Worldwide, 202 patients from 21 medical centers participated in the prospective, multicenter, randomized clinical study. The main objectives of the study were pain control and reduction in drug side effects. Researchers defined clinical success as at least a 20 percent reduction in visual analog scale (VAS) pain scores or equal pain scores with a minimum 20 percent reduction in toxicity (side effects of pain medication).

At four weeks, the pain scores for patients assigned to treatment with the pump in addition to conventional pain therapy fell 52 percent, compared with a 39-percent drop in patients who received only conventional therapy (p=0.055). The pump group's composite drug-related toxicity scores dropped by 50 percent compared with a 17-percent decrease in the conventional group (p=0.004). Importantly, the researchers found statistically significant reductions in fatigue and sedation in patients assigned to the pump when compared with patients in the group receiving conventional therapy alone (p<0.05).

Additionally, 54 percent of patients in the pump group were alive after six months of treatment, compared with 37 percent in the conventional therapy group (p=0.06). While survival was not a planned endpoint in the study, this finding is of great interest and enough to warrants further evaluation.

During this trial, complications with the infusion system were similar to those seen in typical clinical use. Because the drug pump is surgically placed, surgical complications, such as infections, are possible. The catheter could be dislodged or blocked, or in rare cases, the pump could stop working. This could cause a reduction in or loss of pain relief.

The Medtronic SynchroMed(r) EL Infusion System, the intrathecal drug delivery system used in this study, consists of a programmable pump and a catheter that are implanted during an hour-long surgical procedure, which can be performed on an outpatient basis or may require a brief hospital stay. The pump is placed just under the skin of the abdomen and is connected to a small, flexible catheter that delivers pain medication directly to the intrathecal space.

In oncology, Medtronic infusion systems are also used to treat colorectal liver metastases and primary liver cancer by delivering chemotherapy directly to the liver.

Medtronic, Inc. (http://www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. More information about Medtronic's cancer pain therapy can be found online at http://www.cancerhurts.com and by calling Medtronic Patient Services at 1-800-510-6735.

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Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 26, 2002. Actual results may differ materially from anticipated results.

Editor's Note: Additional information and graphics related to the study and intrathecal pain therapy are available through Medtronic's online newsroom: http://www.medtronic.com/newsroom/me...ancerPain.html.

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