Back to the question about Zytiga and when to take it. I did a deep dive on this site and Google and there seems to be no good answer. Without food vs. with a meal? High vs. low fat meal? Best time/meal to take it with? Almost all agree that the dosage if with food should be lower, but by half or more? Almost all agree that Prednisone should be taken with a meal and no later than mid-afternoon since it can disrupt sleep.
My MO at Dana Farber is starting me on Zytiga and said without food. When I asked about with food, he said that's fine too, but you take less. His words were "fewer pills, not as financially toxic." He said high fat though. Breakfast at Denny's every morning? I didn't want to push my luck and say I think there are some studies that suggest low fat meals and Zytiga work too.
So, why not just take one half to one quarter of the amount with breakfast and pop the Prednisone pill while we're at it. Am I missing something? Is it really better away from food or with a high fat meal?
Josh
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Yesterday, we were offered Zytiga and was told we had the option to take it as follows: 1 pill with 5 mg pred. in the morning with lowfat breakfast. She said the standard was 4 pills empty stomach with pred. in the AM, but now there is an option. with our insurance it is $325 a month for the 4 pills a day. I am curious when they do all there 'studies' on a drug, don't they try it at lower dosages and different ways? SUCH a $$ money maker. Wish there was a way to really know the truth about all of this.
It’s great that your insurance has a copay of only $325 a month. Many insurances force an initial structure of, for example, $6000 out of pocket before full coverage or ongoing 10% copay (e.g. $800 a month) kicks in. Actual prices are about $8000 a month (for 3 pills a day for example (don’t know what 4 pill daily dose would be). So $325 would be a less than 4% copay for a 3 pill daily dose - still way too much for a life prolonging drug. The costs are ridiculously high. I am not sure why more docs don’t recommend fewer pills with meals.
325 better than my 500 per month. Wonder how they figure out the different prices?
I discussed this with my doctor, and he agreed that less could be taken with food. The problem he has is that when you are taking it with food, you are introducing variables so your dose is not consistent or really even known. If you take it without food, you are getting a consistant dose, that's important with any drug.
Suppose you have a problem with it. Maybe you want to lower the dose, but what was the starting point? Then what are you going to? It makes things more difficult. I think most doctors feel that way which is why they recommend the full dose with fasting. That's also the only "approved" way to take it.
Makes sense. Thanks. I understood the bioavailability with food was about 4x the fasting uptake, but I suppose it does vary and the range may be big enough that inconsistent dosing could be significant.
Thank you. I did see these in an earlier discussion, but as you say these are small studies so I was looking around for more conclusive information that would indicate the best way to do this. There are other studies that basically say the same things. It does sound like there is higher absorption with a high-fat meal than low-fat or modified fasting state, but still no conclusions one way or the other so that leaves us self-experimenting, watching, and self-regulating. The conclusion always seems to be "additional studies are indicated to assess the long-term efficacy of this approach."
If the price of Zytiga is too much, it may be worth tracking how the reduced dose with increased fat meal is working for you. If money is not an issue - or if you are already past the donut hole, take the full dose in the fasting state. There's more data to support that.
The only study I know of on the subject was done by the University of Chicago. They tracked two groups....one group taking four pills on an empty stomach and the other group taking one pill with a light breakfast. They found that at the end of the study the results were about the same. However, the study was too small to cause a change in the standard of care. Given the potential enormous savings of $10,000 per patient per month I can’t believe that Medicare and insurers aren’t pushing for more studies. Obviously, the drug company won’t be.... Interesting is the fact that this drug was invented in England 20 or so years ago but wasn’t found effective for whatever purpose it was then intended for. The company making it now bought it off the shelf, so to speak, so had no r & d investment. You can Google it’s history....
I did see there was a clinical trial at University fo Chicago that was looking at this. They concluded that taking the medicine while fasting is wasteful and certainly advocate for taking with a low-fat meal, but also say the trial data "should be validated with a larger trial with more robust clinical endpoints.”
I read the history of Zytiga development. Very interesting.
I also started to fixate on the side effects. Very disturbing.
I have been taking Zytiga with prednisone for eight months. During that time my blood sugar went sky high, my bone density worsened and I developed atrial fibrillation. But....no hot flashes!
One of the authors of the UoC study is my MO. He initially had me on the standard dose. My liver has not handled that very well, and he just suspended my use. Said that after my liver enzymes come down in a week or two, we will resume at a reduced dose. Will let you all know what the specific reduced dose instructions will be. Insurance is not an issue.
Nice to have that MO who is studying the best way to take Zytiga and the dosing.
After reading the history and clinical trials it seems like 1,000mg/day was determined to be the maximum acceptable (necessary or generally tolerable) dose to achieve the PSA response rate reduction goal(s) originally established for the study. An empty stomach (modified fasting) was too reduce adsorption variables. It was more control for the study. 1,000mg, modified fasting became the "standard". I wonder if there will be new data in the next few years about lower doses being just as effective in the long run. With food, etc... The PSA response rate is apparently a little slower with a lower dose, but still controlled the PSA.
Just curious, did he recommend with food per their University of Chicago study or 1,000mg/day away from food?
The MO, Russell Szmulewitz, told me that since his small study did not measure overall survival, he was telling his patients that the standard of care was to rake 1000 mg / day on an empty stomach unless there was an economic necessity to reduce the dose.
From the CT my husbands liver showed a bit an issue, so that is one consideration for the lower dose. So does it stand to reason other side effects would be less with a smaller dose?
That happened to me he cut it down to 750 mg. That was almost 7 months ago . all of my blood work has been normal. PSA undetectable no significant side effects that can't be tolerated.
Instructions on my bottles say 1 hr before or 2 hrs after meal. I generally take it in morning when I get up. I agree you want a consistent dose so fasting is likely best.
My MO does not want me to mess with the high fat breakfast w/ 250 mg Zytiga. Wants me to stay the course on a reduced dosage of 750 mg because of elevated liver enzymes. I'm, not a patient of Dana, can I ask who is your MO? Thank you
I see Dr. Sweeney at DFCI. Very bright and up to speed on a lot of the data, but understandably constrained by the boundaries of the institution and evidence-based medicine. Though... to his credit, he is willing to switch me to Zytiga even though there are no good data supporting use in hormone-sensitive, oligometastatic disease.
Some data suggest 250mg with a low-fat meal is almost as good as high-fat meal and as good as standard dose away from food.
Are you going to do 250mg with food or 1000mg without or have you decided? My husband did Casodex for 14 days and just started his second month of Lupron. Doc says he is either oligometastic or stage 3 as bone scan is not totally conclusive. Though his PSA at its highest before ADT was 74. After a month it’s 2.47.
Good response to ADT. That should be very encouraging. I hope it continues to go well.
For now, I have decided to do the 1000mg without food until I hear some compelling data/reasons to change. That's what the doctor says to do. With food might be fine, but the only reasons I find to do that is to either save money or make the pill schedule more reasonable. In my case the meds are paid for and I don't mind waiting an hour or two to eat after I get up and take the pills so will do standard dose as prescribed.
I was on a drug trial with Zytiga and I was told to take it two hours before or two hours after eating. For all I know they have had half the participants taking the drug with food.
I went to my Oncologist for one reason to save my life or at the very least extend it with a somewhat decent quality. I was prescribed by him Zytiga,Prednisone,Eligard, and Xgeva for bone Mets. He asked that I take it as follows:
Zytiga at 6:00 AM with a full bottle of water in an empty stomach.
Prednisone at 8:00 AM or so with Breakfast.
My vitamin, calcium Etc. At 11:00 that's my choice.
You make a good point. I tend to over-analyze and try to understand all the options, but there is no reason not to follow the standard protocol. Given what I have learned in the last few days from my research and this discussion, I believe I will also use the medication exactly like the Dr. prescribes it, just like you, until I hear some more compelling reasons not to. Thank you.
Bloody Hell .... I've always envied you guys in the States, for some of the lifestyle options you have ... but with stage 4 PCa I am lovin' it down here in Aus. As a pensioner, my cost for Zytiga is just A$5-40 per month. Makes the little bit of extra tax I paid all worthwhile now!! I'm still trying to get a straight answer from anyone about this exact issue. Good luck to you all and stay strong!
Everything up in the air. Follow mfg and fda recommendations. Zytiga in am no food lots water. Predisone one hour later with food. I eat raisin brand skim milk bowl loaded w fresh figs, lots blueberries and strawberries. In 1/18 psa was 12,000 and pain and weakness. Now .3 and some back pain but living guarded but normal life Lots of boating.
As your MO said, jdm3, a low fat breakfast with one tablet “is fine too” and less toxic financially. Leswell took four tablets of Zytiga with a low fat breakfast for three months; his PSA rose to 237. This month he’s taking it while fasting to see if that makes a difference. We have listened to those recommending consistency.
Next Tuesday we see our APC specialist and will discuss the trial described below with him. Bottom line? How long should Les continue taking Zytiga if his PSA keeps going up? What does the fact that he feels well have to do with anything? That this is a puzzlement is an understatement. P.S. So far we’ve paid on average $1000 per month. Our cost did reduce to $500/month after we reached catastrophic. “In the hole” it was $2564 out of pocket for thirty days.
Agreeing with Tall_Allen that randomized clinical trials are crucial in our decision-making, I will print the two pages I just read about one such that was publicly posted at the end of March from the University of Chicago Medical Center. It is the same one referred to by a number of you in this discussion, but, for me, these two pages are especially persuasive and sympathetic, fiscally speaking. Perhaps this will help some patient and MO decide. Where is Job’s wisdom when we need it? Leswell and spouse
PUBLIC RELEASE: 28-MAR-2018
Taking a standard prostate cancer drug with food boosts impact, lowers cost
Savings per patient could reach as high as $300,000
UNIVERSITY OF CHICAGO MEDICAL CENTER
By taking a high-cost drug with a low-fat meal--instead of on an empty stomach, as prescribed--prostate cancer patients could decrease their daily dose, prevent digestive issues and cut costs by 75 percent, according to a new study in the March 28, 2018, issue of the Journal of Clinical Oncology (JCO).
Abiraterone acetate, marketed as Zytiga®, is the standard medicine used to treat metastatic castration-resistant prostate cancer. Patients taking Zytiga are told to take four of the 250 milligram pills first thing in the morning. Then, having gone without food overnight, they must wait at least one more hour before eating breakfast.
"This schedule is not only inconvenient for patients, it's also wasteful, in several ways," said the study's lead author, Russell Szmulewitz, MD, associate professor of medicine at the University of Chicago and a prostate cancer specialist.
A one-month supply of the recommended dose of abiraterone costs $8,000 to $11,000 when purchased wholesale. That adds up to a little more than $100,000 each year. Many patients take the drug for two to three years.
So Szmulewitz and colleague Mark Ratain, MD, the Leon O. Jacobson professor of medicine and director of the Center for Personalized Therapeutics at the University of Chicago Medicine, designed a randomized clinical trial to see if the drug could be used more efficiently and at less expense.
Abiraterone, approved in 2011 for the treatment of metastatic prostate cancer, has a "food effect" that is greater than any other marketed drug. The amount of abiraterone that gets absorbed and enters the blood stream can be multiplied four or five times if the drug is swallowed with a low-fat meal (7 percent fat, about 300 calories). That can increase to 10 times with a high-fat meal (57 percent fat, 825 calories).
Working with colleagues at the University of Chicago as well as researchers at the National Cancer Institute, Emory University, Illinois Cancer Care in Peoria, Illinois, and the National University Cancer Institute, Singapore, the team designed a clinical trial that could compare the cost, risks and benefits of taking this drug with or without breakfast.
The study launched in 2012. The team enrolled 72 patients with advanced prostate cancer. Half of those patients agreed to take the recommended dose of 1,000 milligrams: four pills each morning with water on an empty stomach. They had to wait an hour afterwards before they could eat breakfast.
The other half were told to take one-fourth of the standard dose, a single 250-milligram pill, with a low-fat breakfast such as cereal with skim milk. Patients were advised to avoid high-fat items such as bacon or sausage.
Four patients, two from each group, dropped out before the study began.
The researchers found that the lower dose with breakfast kept the disease under control as well as the recommended dose. Abiraterone's ability to lower levels of prostate-specific antigen, a surrogate marker for prostate cancer, was slightly greater for patients in the low-dose with food group when measured at 12 weeks.
Progression-free survival for patients in both the low- and high-dose groups was identical, about 8.6 months. Despite the small size of the study, the authors were confident that the low-dose arm was comparable to the standard dose. It was also slightly more convenient and much less expensive, cutting costs by as much as $300,000 per patient.
"The patient gets a simplified schedule, slightly more control over his daily life, the convenience of eating whenever he chooses and the opportunity to share the cost-savings with his insurance company," Szmulewitz said. "Taking this medicine while fasting is wasteful."
"Although it should be validated with a larger trial with more robust clinical endpoints," he added, "given the pharmacoeconomic implications, these data warrant consideration by prescribers, payers and patients."
"If this study were enlarged and repeated successfully, the resulting cost saving would be in the billions of dollars," according to Allen Lichter, MD, author of a related commentary in the JCO, former CEO of the American Society of Clinical Oncology and board chair of the Value in Cancer Care Consortium (Vi3C).
Abiraterone, taken with prednisone to prevent side effects, "represents a new standard of care for metastatic disease," according to a recent review article in the New England Journal of Medicine. The authors were concerned, however, that the "duration and cost of treatment may influence clinical decision making."
At a per-patient cost of about $10,000 a month, "this is a textbook example of what we now call 'financial toxicity'," Ratain said, referring to the economic burden placed on patients by the high cost of care. "At least three-quarters of this expensive drug is wasted," he added. "It's excreted and flushed away."
###
Additional authors of the study were Abiola Ibraheem, Elia Martinez, Mark Kozloff, Chadi Nabhan, Theodore Karrison and Walter Stadler from the University of Chicago; Cody Peer and William Figg from the National Cancer Institute; Bradley Carthon and Donald Harvey from Emory University; Paul Fishkin from Illinois Cancer Care, in Peoria; and Wei Peng Yong and Edmund Chiong from the National University Cancer Institute, Singapore
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