This N.Y. hospital makes anemia treatment guidelines work

HEALTH-SYSTEM EDITION
CLINICAL PRACTICE

This N.Y. hospital makes anemia treatment guidelines work

Before national guidelines to help standardize the management of chemotherapy-induced anemia in patients with nonmyeloid malignancies existed, Memorial Sloan-Kettering Cancer Center (MSKCC) had set up its own clinical practice guidelines for the condition. The goal: to use the then-new agent epoetin alfa (Procrit, Ortho Biotech) most effectively to raise the Hgb level to at least 12 gm/dl, and avoid RBC transfusion.

That was three years ago, after months of analysis of MSKCC's own treatment practices and the latest developments in anemia therapy in the literature. "Today we're still using the same guidelines," reported Raymond J. Muller, M.S., R.Ph., FASHP, associate director, division of pharmacy services, MSKCC, at the recent National Comprehensive Cancer Network conference in Hollywood, Fla.

In his presentation, Muller focused on the MSKCC guidelines that suggest pharmacists and nurses be in charge of monitoring the dosage of epoetin alfa along with the Hgb level of each patient. He directly attributed the "excellent compliance with dosage recommendations and a shorter duration of anemia treatment" at MSKCC, compared with other hospitals, to his hospital's nurse/pharmacist roles. "The oncologists in our interdisciplinary team concentrate on the efficacy of antineoplastic treatment and, following the guidelines, leave monitoring of supportive care to [pharmacists and nurses]," he further explained in an interview.

"Patients start on epoetin alfa when the Hgb is under 10 gm/dl, and we keep adjusting the dosage as needed throughout the administration of chemotherapy until Hgb can be maintained at 12 gm/dl," Muller said. "We found this to be the best plan to relieve the extreme fatigue brought on by cancer chemotherapy and restore the patient's quality of life during treatment."

Unlike other medical centers, where guidelines suggest that all anemic cancer patients whose Hgb is 10 gm/dl or less receive 40,000 units subcutaneously once a week, MSKCC recommends this dosage only for outpatients; inpatients receive 10,000 units three times a week subcutaneously. "We do this to contain costs," Muller explained. "This guideline helped our center reduce spending by nearly $500,000 a year."

If, however, after four weeks of epoetin therapy, a patient's Hgb level has not risen from baseline by more than 1 gm/dl, the dose should be increased to 60,000 units. And if, after eight weeks, the Hgb has not risen by 2 gm/dl—or if RBC transfusion frequency has not decreased—epoetin therapy should be discontinued, say the guidelines. They also recommend discontinuing therapy when the Hgb level hits 12 gm/dl or higher, "primarily for reimbursement reasons," Muller noted.

Still another recommendation is that all patients receive oral iron supplementation. "The pharmacy computer system tracks all doses of chemotherapy and supportive care, inpatient and outpatient. This allows close monitoring of the guidelines," Muller added. "We can see within seconds when a patient received a certain dose, what it was, and how it matched with his or her Hgb level at the time. Thus we can always assess the impact of any drug on an individual patient."

According to Muller, before guidelines were established, only 5% of 500 inpatients a month received 10,000 units of epoetin alfa three times a week. Later, 71% of 1,000 inpatients a month received and continue to receive that regimen. Additionally, after MSKCC adopted the guidelines, he told Drug Topics, the number of patients with an Hgb level over 12 gm/dl who continued to receive epoetin dropped from 11% to 0.3%. "This was because the pharmacists could adjust the dose to maintain the Hgb at the effective level of 10-12 gm/dl throughout the administration of chemotherapy," he said.

On the other hand, one major problem with epoetin alfa persists: "While it works well in 60%-70% of anemic cancer patients, the agent doesn't work at all in the other 30%-40%," said Muller. "That's a lot of patients who rely on transfusions to treat their anemia or go untreated." But when asked about trying the new antianemia compound darbepoetin alfa (Aranesp, Amgen) as an alternative in the nonresponders, he said that MSKCC is not ready. "First we want to see the results of large controlled studies," he said. "We feel there are not enough data yet."

By contrast, Fox Chase Medical Center currently has both Procrit and Aranesp on the hospital's formulary, said Dwight Kloth, Pharm.D., director of pharmacy in a telephone interview. In November 2002, the Philadelphia hospital updated its guidelines to include use of darbepoetin, he said, "to treat the anemia of chemotherapy outpatients in the ambulatory setting when extended dosing is more convenient for them.

"These patients—some of whom live far away—come in every 14 days and receive a dose of darbepoetin alfa 4.5-5 mcg/kg, based on the 2.25-mcg/kg dosing regimen in the pivotal registration trial for cancer anemia submitted to the Food & Drug Administration," said Kloth. "This regimen is approved by the FDA and described in the package insert."

Naomi Pfeiffer

Naomi PFEIFFER. This N.Y. hospital makes anemia treatment guidelines work.

Drug Topics

May 19, 2003;147:HSE16.