14 replies to this topic

[mariebow]

I read about Bosutinib and it says that it is actually better than the other tki's in that it causes less severe side effects than the others.  I think I would like to have tried this first, if possible.

[GerryL]

I'd still stick with Gleevec, better the devil you know, plus a few side effects have improved since I've dropped to 300mg.

[pamsouth]

Read Trey's Thread and you might change your mind??

http://community.lls...e/151821#151821

PamSouth

[pamsouth]

Gerry,

You took the words right out of my mouth. 

My primary doc said unless you absolutely have to, wait until a drug has been out for a few years.

I believe  they only studied, what,  5 hundred and some patients,  and what was the time frame, only 13 months?

PamSouth

[TeddyB]

GerryL: How long have you been PCRU, and how long have you been on Gleevec?

(I know you have mentioned it earlier, i just couldnt seem to find it right now)

[TeddyB]

Im on Gleevec as well, but after reading recent studies on how well the newer drugs are in first line treatment compared to Gleevec, i feel i am on less superior drug, and kind of feel jealous for those on the newer drugs as they seem to work faster, and for more people.

It now seems that Tasigna is the first line treatment drug of choice for the most new cases of CML. (Correct me if im wrong)

Also the fact that if Gleevec fails, and i start second gen tki, i will have less chance of success than if i started directly on a second gen tki.

But i guess if i meet all my response goals on Gleevec i should be fine, and i feel safe with the fact that G has been out for so long and has been widely tested.

Also, taking the drug once pr day, instead of 2 times pr day, and with no fasting required is also a bonus.

This is just how i feel right now, but please feel free to tell me how wrong i am, and that Gleevec is GREAT

[Trey]

As of Sep 2012, Bosutinib has only been approved for those who fail the other drugs.

[CallMeLucky]

I think the definition of failure is pretty subjective since they used the terms resistance or intolerance.  One patient's threshold for tolerating side effects is likely very different from the next patient's.  If you tell your doctor I can't "tolerate" the way I feel on this drug it would seem that would be sufficient.  Now how your insurance company chooses to deal with that may be a different story, but I would be surprised if a doctor prescribed bosutinib if anyone would come along from the FDA and say you have to prove your intolerance.

I'm still tossed up about the side effect profile and trying to figure out exactly what they are saying.  In one section they state that the incidence rate for diarrhea was 84%, which sounds exceptionally high, but then in another section they state the median duration for diarrhea was one day with a median number of three episodes.  So if you are telling me I have an 84% chance of diarrhea but only for a day or so during the first few days of taking it and then it goes away, that's not too bad.  So the question on any of these side effects is if they are transient or long term.

I think like the other drugs it will take some time to figure out how things are going to play out once more people start taking it.

Regardless it is always good to see more drugs coming out to treat our disease.  One thing that I found of particular interest while I am waiting to find out if I might have prostate cancer are the studies showing that Sprycel and bosutinib may slow or stop the progression of prostate cancer.  If God forbid I do have prostate cancer, maybe I can get a two for one deal! (that would be funny if it wasn't so messed up!)

• The most common all grade adverse reactions (ARs) observed in the chronic phase of Study 200 included diarrhea (84 percent), nausea (46 percent), abdominal pain (40 percent), thrombocytopenia (40 percent) and vomiting (37 percent). Grade 3/4 ARs included thrombocytopenia (26 percent), neutropenia (11 percent), diarrhea (9 percent), anemia (9 percent) and rash (8 percent).¹

• BOSULIF is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance, or intolerance to prior therapy.
• Contraindication: Hypersensitivity to BOSULIF. Anaphylactic shock occurred in less than 0.2 percent of treated patients.
• Gastrointestinal Toxicity: Diarrhea, nausea, vomiting and abdominal pain have been observed. Median time to onset for diarrhea was two days, median duration was one day and median number of episodes per patient was three. Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce, or discontinue BOSULIF as necessary.
• Myelosuppression: Thrombocytopenia, anemia and neutropenia have been observed. A complete blood count should be performed weekly for the first month and then monthly or as clinically indicated. Withhold, dose reduce, or discontinue BOSULIF as necessary.
• Hepatic Toxicity: Twenty percent of patients experienced an increase in either ALT or AST. Liver enzyme elevation usually occurs early in treatment. Perform monthly hepatic enzyme tests for the first three months and as clinically indicated. In patients with transaminase elevations, monitor liver enzymes more frequently. Drug induced liver injury has occurred. Withhold, dose reduce, or discontinue BOSULIF as necessary.
• Fluid Retention: Fluid retention has been reported and may cause pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Monitor and manage patients using standards of care. Interrupt, dose reduce or discontinue BOSULIF as necessary.
• Embryofetal Toxicity: BOSULIF may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving BOSULIF.
• The most common adverse reactions observed in greater than 20 percent of the patients in the Phase 1/2 safety population (n=546) were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia and fatigue.
• The most common Grade 3-4 adverse reactions and laboratory abnormalities observed in greater than 10 percent of patients were thrombocytopenia, anemia and neutropenia.
• Drug Interactions: Avoid concurrent use with strong or moderate CYP3A4 inhibitors or inducers.
• Proton Pump Inhibitors: Consider using short-acting antacids or H2 blockers instead of PPIs. Separate antacid or H2 blocker dosing and BOSULIF dosing by more than two hours.
• Substrates of P-glycoprotein: BOSULIF may increase the plasma concentrations of drugs that are P-gp substrates, such as digoxin.
• Nursing mothers: Given the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or BOSULIF.
• Hepatic Impairment: Treat with a dose of 200 mg daily in patients with any baseline hepatic impairment.

[Happycat]

Teddy,

Gleevec works well for many people, at least 75%, and those who ditch it often do so for,side effects, and not suboptimal response.

For me, it is working well. I'm winning the race with this horse, and he's not even kicking a lot of mud in my eyes!  (few side effects)

So I'm happy to keep riding this horse. When it turns into an old nag or it starts biting me, then I'll switch.

Traci

[GerryL]

Hi Teddy,

I started taking Gleevec in July 2010 and have been PCRU since my test in October 2011.

[nathaliece]

Gerry,

How long after PCRU did your onc agree to lower your dosage to 300 mg?  I was dx in 11/10 and reached PCRU in 3/12.  My side effects have gotten tougher over the past two months and plan to ask my onc to consider a lower dosage late this month.

Nat

[pamsouth]

Happy Cat,

that is so cute' I'm still laughing. 

>>For me, it is working well. I'm winning the race with this horse, and he's not even kicking a lot of mud in my eyes!  (few side effects)  So I'm happy to keep riding this horse. When it turns into an old nag or it starts biting me, <<

PamSouth

[mariebow]

Trey is right it is kinda new, and do not know all the side effects maybe one day they will make the almost perfect tki drug with almost 0 side effect.

[GerryL]

Hi Nat,

I waited until I got the second PCRU and then spoke to him. He wasn't jumping for joy at the idea and starting talking about Tasigna to me, but I told him Tasigna wasn't going to take me any further than Gleevec and I didn't want to potentially get new side effects. I will get my next blood test done early November so will find out if I am maintaining PCRU. I still had some Gleevec 400mg left so took those on the weekend and the 300mg during the week until I had used up all the 400mg, that took another two months. I started taking the 300mg the last week of May, the first thing I noticed was I felt stronger in my muscles and could actually stretch without fear of hurting myself. I don't tend to get any GI issues and last weekend I found I actually had some energy to get a few things done (hopefully this is permanent and not something cycling through). Fluid retention is still hanging around though.

Good luck with talking with your doctor.