Monthly Archives: March 2008

And Now, The End Of The ESA Story (For Today)

(Author’s Note:


When reviewing this entry on April 11, I noted that a significant portion of this blog had not been posted in error.  I have now added that information.  It has not been edited or changed in any way from the original copy.  I suspect what happened was that in the midst of trying to get these posted in real time, I neglected to copy all the text and failed to proofread the post.  I apologize for this problem.)


 


Now the committee is getting into the finer details as to how ESAs should be used, and what changes may have to be made to the FDA label regarding serious risks.


The next question in front of the committee is whether or not ESAs should be limited only to patients with small cell lung cancer, which is the only cancer where there is proof that the drug doesn’t have serious adverse effects.


And the vote is: No, these drugs should be available to patients with other cancers as well. 


That vote was closer: 6 yes, 8 no.


Now the committee is considering the data I wrote about earlier as to whether the drugs are NOT indicated for patients with cancer … Continue reading →

And The Vote Is “Yes” Regarding ESAs

And now we get to the meat of the matter at today’s hearings on the safety and effectiveness of ESAs: the opportunity for the committee to weigh in on the issue as to whether or not ESAs should be removed from the market for treating cancer treatment-related anemia (CTA).


 


It is clear the landscape has changed regarding blood transfusions since 1993, when these drugs were first approved.


 


Transfusions back then were more risky.  But more blood was donated and available for the support of active cancer treatment.  However, there were significant and life-threatening infections passed through blood transfusions. There were other risks as well.


 


Time has passed on, now we have ESAs, and transfusions are less common in no small part because of the use of the drug.  As I write this, a transfusion expert on the panel is now saying, we can actually significantly reduce the blood level at which transfusions are required compared to what we thought previously.  And, he added, there is an adequate blood supply.


 


The theme that does weave through the comments is the lack of clear data, despite the information on the clinical trials presented this … Continue reading →

ESAs: Why Didn’t We Know This Earlier?

Over the past number of years, medicine has tried to develop more evidence and science based rationales for the treatments we recommend.


 


The data currently being presented at the FDA Oncologic Drug Advisory Committee hearing today suggests that when it comes to ESAs (see previous blog), we still have a way to go in developing the evidence of their safety and risks.  The testimony currently being presented by the FDA representative shows genuine concern that when the evidence is carefully examined, the outcomes may not be what we would have expected.


 


In short, there are now a number of closely analyzed studies that show patients who have received ESAs as part of their treatment regimen may have actually done worse than patients who did not receive the drugs, and who instead relied on transfusions to keep their red blood counts at an adequate level.


 


For example, in one clinical trial called PREPARE, women with breast cancers 2 cm or larger when they were diagnosed were treated with chemotherapy in an effort to reduce the size of the cancer before they underwent surgery.


 


Two different chemotherapy regimens were used, and within each chemotherapy regimen ½ the … Continue reading →

Should Procrit and Aranesp Use Stop?

As I write this I am sitting in a meeting room in a hotel in Gaithersburg, Maryland attending a hearing in front of the FDA’s Oncologic Drugs Advisory Committee.   The purpose of the meeting is to review the data about the safety and effectiveness of drugs called ESAs, or erythropoiesis-stimulating agents.  You may know the drugs by their trade names, Procrit and Aranesp.


 


In plain English, these are drugs that have been used since 1993 to reduce the need for transfusions in patients on active cancer chemotherapy (there are other uses in other diseases but these are not the focus of today’s meeting).


 


What makes today so important is that the FDA has made one of its recommendations removal of these drugs from the market in the United States.


 


As described in past blog entries (including a recent posting decribing increased deaths in patients receiving these drugs), these drugs have come under increased scrutiny over the past year as evidence has emerged that patients who receive ESAs may be at increased risk of premature death and thromboembolic events, such as deep vein thrombophlebitis (blood clots in the legs and other veins in the body) … Continue reading →

New Guidelines To Prevent And Detect Colon Cancer

Today, the American Cancer Society released its latest recommendations for the prevention and early detection of colorectal cancer. 


 


The published guidelines offer a detailed roadmap on what works in colorectal cancer screening.  They include the same approaches that have been recommended in the past—including testing the stool for blood, sigmoidoscopy, colonoscopy and barium enema—and add two new approaches to the “recommended list” with the addition of CT colonography and stool DNA testing.


 


The experts who analyzed the data and made these recommendations made an important new distinction about tests used to screen for CRC by sorting the available screening tests into two categories: tests that are primarily used to detect colorectal cancer (CRC), and tests that have the potential to prevent colorectal cancer. 


 


They also indicated their preference was for tests that prevent this disease.


 


Here is what the authors say about what you should do: “It is the strong opinion that colon cancer prevention should be the primary goal of CRC screening.  Tests that are designed to detect both early cancer and adenomatous polyps should be encouraged if resources are available and patients are willing to undergo an invasive test.”… Continue reading →

Hormones And Breast Cancer, Again

An article in today’s Journal of the American Medical Association (JAMA) is bound to add more confusion to the questions surrounding the impact of hormone replacement therapy (HRT) on the risk and incidence of breast cancer in post-menopausal women.


 


I have written several blogs previously on this topic, most of them discussing the reasoning behind the sudden and immediate drop in the incidence of breast cancer that was noted when the Women’s Health Initiative (WHI) study was discontinued in 2002.


 


Unlike previously published studies which showed a dramatic reduction in breast cancer incidence after the study was stopped and the use of post-menopausal HRT declined, the evidence in this report doesn’t come to the same conclusion.  But, unfortunately, it also doesn’t clarify the situation.


 


Today’s JAMA report is a follow-up on what happened to the 16,600 women who were part of a study evaluating the benefits and risks of post-menopausal women who received combined hormonal therapy with estrogen and progesterone for their post-menopausal symptoms.  Half of these women received HRT with the combination, and the other half took a placebo.  (There was a companion study of women who had had a hysterectomy and were treated only with … Continue reading →