Drugs to combat anemia in cancer patients increase risk of death

April 30, 2009

The use of drugs to encourage red blood cell formation (erythropoiesis-stimulating agents) in cancer patients with anemia increases the risk of death and serious adverse events such as blood clots, found a new study in CMAJ.

While the relative increased risk of death was only 15-16%, because of the high mortality rates in patients this increase might translate into significant numbers of people.

"These findings suggest that erythropoiesis-stimulating agents should not be routinely used as an alternative to in patients with chemotherapy-induced anemia unless future studies document safety and clinical benefits in this population," write Dr. Marcello Tonelli from the University of Alberta and coauthors.

Anemia in cancer patients can develop because of the cancer itself or because of treatments such as chemotherapy. Treatment with agents to stimulate formation has been widely used to improve quality of life for many patients and as an alternative to blood transfusions. However, these agents are expensive and reimbursement policies in Canada vary across provinces and territories.

The study, a meta-analysis of 52 clinical trials with 12,006 participants, was based on work done for the Canadian Agency for Drugs and Technologies in Health (CADTH) to summarize the benefits and harms of these agents in adults with cancer-related anemia.

The findings, which are consistent with studies from the United States and the United Kingdom, provide important information for clinicians treating cancer patients and for Canadian policy makers regarding drug reimbursement plans.

"Our findings suggest that existing practice guidelines should be revised to recommend against the routine use of erythropoiesis-stimulating agents as an alternative to blood transfusion in patients with cancer," conclude the authors. The authors add that erythropoiesis-stimulating agents may be warranted in situations where blood transfusions are not possible or practical.

Source: Canadian Medical Association Journal (news : web)

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not rated yet May 01, 2009
Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians' offices. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors' purchase price. I am reminded it is still a "chemotherapy concession."

Last year, U.S. Oncology, which funds, develops and helps manage 443 cancer centers in 39 states, complained that patients were harmed by new Medicare coverage policy for anemic cancer patients. The Centers for Medicare & Medicaid Services (CMS) decision limited ESA (erythropoiesis-stimulating agents) treatment to a maximum of eight weeks after a chemotherapy session. It also required physicians to wait until hemoglobin levels dropped below 10 g/dl before starting therapy.

Because CMS did not receive any documented cases of negative outcomes from the oncology community, it stuck to its decision. The FDA backed CMS' National Coverage Decision (NCD), which limited use of the drugs because they have been shown to spur tumor growth. The FDA believed the approved labeling and CMS' NCD were generally consistent in their recommendations regarding the use of pharmaceutical EPO in patients with cancer undergoing chemotherapy.

However, major insurance companies had not embraced the CMS protocol. It was a "shot over the bow" by the oncology community of government stepping directly into patients lives and saying that they know what is a better course of treatment than doctors. During the ensuing year, we found out that drugs, given by injection, had been heavily advertised, and there was gathering evidence that they had been overused, in part because oncologists could make money by using more of the drug.

Resulting studies had suggested the drugs may make the cancer worse. Much of that evidence came from studies in which patients were treated more aggressively than the drugs' labels recommended. The FDA found mounting evidence of documented effects on survival, tumor progression and thrombotic events which required reassessment of the net benefit of this class of drugs.

Gee, could it be that increased numbers of red cells deliver more oxygen to the tumor cells and thereby their activity across the board, including with respect to invasion, proliferation and metastasis? On one hand we're developing drugs to halt and reverse angiogenesis while on the other hand we're helping the tumor to obtain more oxygen with existing vasculature.

Having said all of this, physicians, scientists and the public occasionally apply their own judgement and determine when the existing evidence is sufficient to support a personal decision to adopt - as opposed to impose upon others - certain drug treatments. No wonder the National Coalition for Cancer Survivorship emphasized the need for drastic changes in how physicians are reimbursed for care. Reward doctors for whole patient care - not just treatments.

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