Study: Pill as good as chemo for some patients

By Miriam Falco
CNN Medical News Managing Editor

(CNN) -- A cancer treatment that comes in a pill is as effective as the standard chemotherapy for lung patients who had previously been treated for their cancer, according to a study released Thursday.

The intravenous chemotherapy treatment had more severe side effects than the pill in this study.

Results of a large clinical trial were published in the British medical journal The Lancet.

The trial was designed to compare Iressa, a daily pill, to Taxotere, an IV-chemotherapy drug that's administered every three weeks.

This international study included more than 1,400 patients for whom standard chemotherapy had been ineffective.

"Iressa and Taxotere have same survival outcomes," according to Dr. Edward Kim, lead author of the study and assistant professor in M.D. Anderson Cancer Center's Department of Thoracic/Head and Neck Medical Oncology in Houston, Texas.

The study was paid for by the maker of Iressa, AstraZeneca. Kim says the Food and Drug Administration mandated that the pharmaceutical company conduct this clinical trial.

In the study, patients taking Iressa had an average survival of 7.6 months, and 32 percent survived one year, compared with patients getting the chemotherapy drug Taxotere. Their survival was an average of eight months; 34 percent of patients survived one year.

Kim says this is the largest study in lung cancer comparing an oral therapy with chemotherapy.

Dr. Bruce Johnson, a lung cancer specialist at the Dana-Farber Cancer Institute in Boston, Massachusetts, who was not involved in this research, says, "this study did what it intended to do in showing equivalency. I can't imagine any clearer evidence."

One significant difference between the two drugs is in side effects. Patients taking Iressa mainly experienced skin rashes and/or mild diarrhea. Patients on Taxotere had many more severe side effects, including hair loss, numbness in hands and feet, severe diarrhea, a drop in blood cells and nausea.

Given the difference, "the single pill trumps chemotherapy," said Dr. Paul Bunn, who heads the International Association for the Study of Lung Cancer Research and also was not involved in the clinical trial.

Johnson says that 5 to 10 percent of patients taking Taxotere will drop out every three weeks because of side effects. Kim points out that if the two treatments have the same survival benefit but one has fewer side effects and is easier to take, doctors want their patients to have the option for this treatment.

Currently, no new lung cancer patients can get Iressa, because doctors are no longer allowed to prescribe it.

In 2003, Iressa got fast-track FDA approval as a treatment for patients with non-small-cell lung cancer, specifically for patients in whom standard chemotherapy had failed. The approval was based on two small phase II clinical trials that showed Iressa was able to shrink tumors by about 10 percent, which led the FDA to believe that the drug would lead to a "positive effect on survival or benefits."

When the FDA gives a drug accelerated approval, it requires that the manufacturer continue testing it to determine whether there's a clinical benefit to the patient. If further studies can't show this type of benefit, the FDA has the power to withdraw that drug from the market.

But a year later, results were revealed from a larger, phase III clinical trial that compared Iressa with placebo in patients for whom chemotherapy was ineffective.

"Iressa was better but not statistically significant," said Bunn, who also directs the University of Colorado Cancer Center.

Given this information and because another lung cancer pill -- Tarceva -- had shown a survival benefit, the FDA decided that " it is not reasonable to start new patients on Iressa."

Since 2005, the FDA allows only those already getting Iressa prescribed or those enrolled in clinical trials that were under way at the time to continue taking Iressa.

All three lung cancer experts CNN spoke with regularly see patients and have treated them with Iressa or the other available lung cancer drugs. All said they couldn't predict whether the FDA would allow new patients to be treated with Iressa based on this and other recent studies.

Kim believes that based on this data, Iressa "is a valid treatment option for patients with pretreated non-small lung cancer."

Both Bunn and Johnson say that more choices in treatment will always benefit the patients.




 

If you tax big business, like oil companies for example, they have three options. They either eat the cost and take losses, lay off workers and force the remaining to work harder and longer for less pay, or they raise the prices of their good to cover the taxes making us eat the cost in the end. So folks, you may decry that you need to tax oil companies, but as long as you own a car or buy almost anything, you are dependent on the price of oil because oil is used either in or to produce almost anything.

With the recession we are entering we have a huge problem, inflation is high and unemployment is rising as well. The problem is, the only way to deal with inflation, monetary policy NOT fiscal policy is needed to sell bonds, reducing the money supply. This will unfortunately cause people to lose jobs, and life in general to suck for a few years. Inflation will be brought down and then the unemployment can be tackled by slowly inputting money into the economy by buying those bonds back, which will increase jobs and raise inflation levels slightly.

Yes, I will admit that the Federal Reserve has been under the control of Bush ever since Greenspan pissed him off and Ben Bernanke was appointed chairman of the federal reserve. Since Bernanke was a puppet, he listened and did what he was told, trying to prolong the amount of time before we went into a recession to try and keep a Republican in office. Folks though, every president tries to do this so don't start pulling this crap of Bush being the root of all evil. For those of you who haven't had basics of Macroeconomics, the fiscal policies (those that are affected by the President and Congress, versus monetary policies which is enacted by the Fed who actually can do good work) have a time delay of about 10 to 15 years. Hm, who was president 10 years ago? Oh yes, Clinton. He was praised for having government surplus and a booming economy, well folks that was Reagan's doing, not his. He may have created a little more due to taxes, but the foundation and main event didn't happen because of him.

Now folks this end my rant, it honestly felt good to just rant and rave *chuckles.* So yes, I am not happy with the way the election turned out, but unlike most people in this situation, I am not going to start insulting our future leader even if I didn't vote for him. I am not saying he is going to be a bad president, I am just saying that no change really is going to occur, that even though he may have been elected, it is his party who gets things done, not him. I just am partially annoyed at the people who insult the other candidate or the person in the office, but then when others do it to “their” candidate, it can't be tolerated.

Yes, I got a little heated on a couple points, and I apologize if people take offense, this is not my aim whatsoever. I am just expressing my views, along with some history and some economics behind it all. Feel free to comment and feedback, but understand that I will reply in kind. If you flame or try this holier than thou crap, I will fire right back. If you do intelligent discourse, I will as well.

Thank you.

There are a couple factors behind this, but I have to admit I really am divided on this. On one hand I miss all the old guildies; Ryans, Mike, Tony, Jen, Gil and the rest of you buggers. And I miss the game play, not to mention the new talents made me jealous =(. I also want to see what the raiding is going to be like due to some of the insane abilities, like the priest one to prevent someone from dying by sacrificing their spirit thingy. Also heavily interested in the artwork along with the lore that is being put in.

The side against going back in is simple. I'm glad that I have more time, that I'm not grinding reps or dungeons countless times for a single piece of gear. I'm happy that I have more time to spend with Jennifer, that we can do things off the fly and I'm not feeling obligated to raid every night. I won't have time except for at night seeing that I will be on campus during the day unless I steal the internet in her room when she's in class.

These are only the tip of the iceberg on the issue and I have to admit I would like feedback from anyone in any form. Everything will be weighed evenly, but please put it down here so I have a single place to come look at.