Talked to Genentech, herceptin weekly or 3 wks.

[Chelee]

I talked to a women from Genentech today. I explained that I can't get a clear answer about whats better when it comes to weekly or every 3 week dose of herceptin? I told her I have asked two onc doc's I have had...and if I PUSH them on this issue... they will say weekly is better...but they always follow up with...but every 3 weeks is fine too. I also added the the infusion nurses I talk to all PUSH us herceptin gals to do the 3 week dose...telling us that is just the same.

I told her I wanted to know which it is? Weekly, or every 3 weeks? She said all she can tell me is that Genentech says weekly. That herceptin is not FDA approved...and weekly is how they recommend I get it. She said if I perferred every 3 weeks...to sit down with my onc doc and have a discussion about it...and go from there. (I told her...been there...done that.) lol She said they CAN'T tell me anything else other then weekly.

She said they have done no studies on every three weeks...so again...they will ONLY tell you to get herceptin weekly.

I was impressed with how nice these people were and even offered to send me some information on herceptin...and asked if I had any other questions they could help me with. Also said to call back any time.

So since my cancer center is close...I will go back to weekly...even though it was NICE this one time to do the three week dose.

But I DID notice with the three week dose...I have had more of a headache...and my nose will NOT stop running. Plus I have been sneezing like crazy. I have NEVER in my life had this problem...so I know its the herceptin. Plus something else I found interesting...I have brusies all over? When I did the weekly...I never found any bruses? I don't know why the difference...but I had been doing WEEKLY since Feb. 06 and never had the brusing problem till the three week dose. Strange things you notice.

Chelee

[Lee]

It was approved by the FDA back in 1998.

There have been some studies comparing weekly vs. every-three-week doses of herceptin, and none of them (so far) show any kind of statistical difference in outcomes. I'm guessing Genentech won't comment on anything but weekly because that is what they used in their own studies.

You have to do what you're comfortable with, and if you tolerate the weekly dose better and don't mind going in every week, that sounds like it might be best for you. This treatment stuff seems to be almost as much art as science!

Best of luck.

[Becky]

Chelee


What Genentech means by "not FDA approved" is that it is not approved yet for early breast cancer as an adjuvant. It is FDA approved for metastatic breast cancer.

The USA trials for use of Herceptin as an adjuvant for early bc used Herceptin weekly. The European HERA trial used Herceptin every three weeks. There is no difference. If you go to Sloan Kettering to get Herceptin as an adjuvant, you get the drug every 3 weeks. Sloan does not give it weekly (except for the first 12 doses with the taxol - after that, you are switched to every 3 weeks).

Therefore, Genentech cannot recommend anything else than weekly since all the trials in the USA are weekly. Roche Pharma licenses and markets Herceptin outside the USA so Genentech cannot make any other comment.

Kind regards

Becky

PS - after 15 weeklies, I switched to every 3 weeks. I will receive Herceptin as an adjuvant for 16 months (not 12) and have 4 left to go (3 after this Friday). The every 3 week regime is "freeing". The headaches and runny nose on the every 3 week regime fades away in time. Love and hugs to you.

[Jean]

Becky,

How are you? Great post and very informative - thank you for sharing.

Best Regards,
Jean

[Chelee]

Becky, Thanks for your post...I have to admit I wanted to ask this women from Genentech why she said herceptin was not FDA approved? I was LOST on that one. Now I see.... :)

I do know the women I spoke to wanted to make it clear that the trials they did here in the USA were weekly only. So she said they really could not say anything else to me. Thats why she referred me to my onc doc. Thats interesting to hear Sloan gives it in the 3 week dose.

You sure have alot of great information on this Becky. Thanks for posting it! I know I sure enjoyed having my herceptin in a 3 wk dose this time. I've had SO MANY doctors appts and tests that it was one less thing to do. Now I just might re-think this and STAY on the 3 wk dose.

You said the running nose and headache goes away in time. I wondered if it might get better because when I FIRST started WEEKLY herceptin I had ALL KINDS of sinus problems, crusty, bloody nose...you name it. But after having the weekly herceptin a while...it all went away. :) So maybe I will give it another shot and see what happens. I am so tired of living down there.

Great post Becky...thanks for all the great information. It was very helpful to me. (and no doubt many others.)

Chelee

[Joe]

Genentech and all other drug companies can only give out information about their drugs that has gone through the FDA approval process.

Many of you may or may not be aware that Roche distributes Herceptin throughout the world and Genentech only distributes it in the US. At Asco this year, I was not allowed into a portion of the Roche exhibit because it presented data about Herceptin hat was approved by the EU but not the FDA. At the time I was accompanied by Dr. Nils Eckhardt who is the International Medical Leader - Herceptin for Roche.

Regards
Joe

[astrid]

It is acceptable to switch between dosing but the loading dose should never be repeated. With the exception of the loading dose the protocol is the same so the same amount of Hercpetin is administered



The Weekly schedule is: Loading dose 4Mg/Kg IV (of body weight) followed by weekly dose of 2Mg/Kg.

3 Week schedule is: Loading dose 8Mg/Kg IV followed by a dose of 6Mg/Kg every 3 weeks.