Blood clots & Procrit & Aranesp

[CaroleHammett]

Since my dx in 01/07, I have been stating that, with one exception, all my conditions were related to treatment not cancer (neutropenia, anemia, radiation pneumonitis, osteoporosis, cataract, etc.). That one exception was the pulmonary embolism in my "good" lung in 03/07, and was considered (by me) to be an exception based on the fact that 15% of all cancer patients (regardless of type of cancer) experience blood clots.

Now, however, studies are showing (see news article below) that chemo patients taking meds such as Epogen/Procrit and Aranesp are more likely to experience blood clots, and it was in 03/07--shortly before my blood clot--that I took Procrit for anemia.

Ergo, it appears that my body's toxicity extended not only to chemo and radiation treatments, but also to the treatments for the treatments. Does that make me the exception to the exception to the rule, or do I just plain old rule?

Affectionately,

Carole

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http://www.oncologystat.com/home/news/Erythropoiesis-Stimulating_Agents__Survival_and_Thrombosis_Risks_Vary_by_Tumor_Type_US.html

Erythropoiesis-Stimulating Agents: Survival and Thrombosis Risks Vary by Tumor Type

Elsevier Global Medical News.

Jul 31 2008

K Wachter

CHICAGO (EGMN) - Erythropoiesis-stimulating agents appear to decrease survival and increase the risk of thrombosis in patients with solid tumors, with the degree of the effect depending on the tumor type, according to a meta-analysis of 17 studies involving more than 4,000 cancer patients.

Erythropoiesis-stimulating agents (ESAs) reduced survival of solid tumor cancer patients by 6% overall and increased overall thrombosis incidence by 3.8%, Dr. Harry Raftopoulos reported at the annual meeting of the American Society of Clinical Oncology. Head and neck cancers had the biggest reduction in survival, and pelvic cancers the greatest increase in thrombosis.

This meta-analysis included only randomized phase III cancer studies that were disease restricted (that is, had a homogenous population), in which an ESA was compared with placebo or control. The researchers excluded adjuvant and neoadjuvant studies because of insufficient follow-up.

"The majority of studies included in our evaluation were stopped early, most often due to negative toxicity or mortality findings in interim analyses, leading to incomplete reporting of results," wrote Dr. Raftopoulos of the Monter Cancer Center in Lake Success, New York, and his coauthors.

In all, 17 cancer studies were included: 4 breast, 4 head and neck, 1 limited-disease small-cell lung, 1 small-cell lung/non-small-cell lung, 1 non-small-cell lung, 2 small-cell lung, 1 gastric/rectal, 1 cervical, and 2 ovarian.

The absolute difference in survival with ESA use varied by tumor type. Among patients with head and neck cancer, those on ESAs were 7.8% less likely to survive than were those on placebo/control. Among patients with breast cancer, those on ESAs were 5.5% less likely to survive. The difference for lung cancer patients was not significant, and data were not available for pelvic cancer patients.

The absolute difference in thrombosis with ESA use also varied by tumor type. Among patients with pelvic cancer, those who used ESAs were 6% more likely to have thrombosis were than those on placebo/control. Among lung cancer patients, those on ESAs were 5% more likely to have thrombosis. Among breast cancer and head/neck cancer patients, those on ESAs were 4.1% and 1.6% more likely to have thrombosis, respectively.

The findings add to the controversy surrounding the use of ESAs for supportive care of cancer patients. In November 2007, the Food and Drug Administration approved new wording that strengthened the Boxed Warning and Warnings sections of the labeling for Epogen/Procrit (epoetin alfa) and Aranesp (darbepoetin alfa). The revised label sections included summaries of six studies showing decreased survival and/or tumor progression in patients with cancer receiving an ESA.

In January 2008, the FDA issued a communication that provided the findings from two additional clinical studies: the Preoperative Epirubicin Paclitaxel Aranesp (PREPARE) trial and Gynecology Oncology Group (GOG)-191 trial. These findings show an increase in mortality and shorter time to tumor progression in cancer patients receiving an ESA.

In March 2008, the FDA's Oncology Drugs Advisory Committee (ODAC) voted 13-1 that ESAs should continue to be marketed for chemotherapy-induced anemia despite concern that their use could have a negative impact on survival in cancer patients. The panel also voted, 11 to 2, with 1 abstention, that these agents should not be indicated for patients whose cancers are considered curable.

In May 2008, Amgen Inc., which makes Epogen/Procrit and Aranesp, submitted labeling supplements for these drugs to the FDA. These labeling changes were intended to clarify the FDA-approved conditions for use of ESAs in patients with cancer and to revise directions for dosing to state the hemoglobin level at which treatment with an ESA should not be initiated.

On July 30, 2008, FDA issued letters ordering the company to make additional changes clarifying the indications for the drugs and directions for dosing.

Other FDA approved indications for ESAs include the treatment of anemia associated with chronic renal failure; epoetin alfa has been approved for use with zidovudine therapy in patients with AIDS and for presurgical administration to reduce perioperative transfusion requirements.

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