Important re Tykerb alone in Adjuvant setting
 

Friends,
I was in a trial for evaluating Tykerb vs. Herceptin in the adjuvant setting. The study had four arms: one herceptin alone for a year, one tykerb alone for a year one herceptin followed by tykerb for a year total and one of tykerb and herceptin together for a year. I drew the tykerb alone arm, however the tykerb did not agree with me, and I ended up coming off of tykerb and then doing a year of Herceptin. The technical name of the study is N063D/BIG 2-06 Altto: Adjuvant Lapatinib and/orTrastuzumab Opitmization Study.

In any event, even though I am off of the study, I guess I am on their mailing list and today I received a letter that advised that based on data to date, persons who were on the arm for only lapatinib (tykerb is the trade name) were "not likely to do as well as those assigned to Trastuzumab alone." It further advised that persons on this arm should stop and get Herceptin, and if they had finished their year of Tykerb, to go back to their doctor and get Herceptin. All others could continue with their options.

I am posting this to inform persons who are considering options or who may have received tykerb alone, but for some reason did not get a letter.

Also to give thanks to God for me personally -- when I got sick on the Tykerb, I was very disappointed to have to leave the study and not get the new cutting edge treatments. But, as it turned out, this was a good thing!

I am cross referencing this post in clinical trials.

Re: Important re Tykerb alone in Adjuvant setting
 

Hi Estelle
I posted a thread on this on the main board under ALLTO trial last week as I was concerned that some sisters might not be contacted by their oncs or the drug company.
Glad you have been contacted so you can make an informed decision as to what to do.
Sorry if this news has caused you distress.
Ellie

Re: Important re Tykerb alone in Adjuvant setting
 

Dear Estelle

Even though this did not apply to me, I want to thank you for your post and informing others who may have missed the letter. You may have prevented someone on this board for getting in harm's way.

Thank you

Re: Important re Tykerb alone in Adjuvant setting
 

Thank you !!

Re: Important re Tykerb alone in Adjuvant setting
 

Estelle,

Thank you for the post. I went June and July on Tykerb alone, and my HER2 level went to 112 using the ELISA test.

Amelia

Re: Important re Tykerb alone in Adjuvant setting
 

Estelle,
I also want to thank you for the post. I was in the phase II study that preceeded the Allto trial. I received both Tykerb and Herceptin. To me, the conbination makes the most sense. I hope everyone who only recieved Tykerb gets this message and also gets Herceptin. You have certainly done your part! Thanks again for thinking of others.
Sandra

Re: Important re Tykerb alone in Adjuvant setting
 

I have just started tykerb/xeloda. Should I also ask my onc to add Herceptin back into it again?

Re: Important re Tykerb alone in Adjuvant setting
 

Thanks for the info.





























Thanks for the info. Right now I am freaked out I was on that arm and finished 5-10.Have been feeling crummy for several months went to my oncologists and a breast cancer oncology specialist they both say I don't need any scans and there is no reason to think cancer is back neither one has ever done any testing after treatment with this I am very concerned. Have not recieved a letter. Does anyone have more info on this? I was dx stage 3 to start with so I'm freaking! No one to call til Monday

Re: Important re Tykerb alone in Adjuvant setting
 

I would see if anyone would give you a year of Herceptin alone. I took Herceptin alone well after chemo and rads were complete because it was not available when I started treatment. It is an easy drug to tolerate alone. I had a headache after the first treatment which was a loading dose. It can't hurt to ask and then get other opinions.

Re: Important re Tykerb alone in Adjuvant setting
 

cecw,
Your post is very upsetting to me. Are you not being followed by the doctor that placed you in the trial? Are you in the Allto trial?

I was in a phase II trial down at Mayo in Jacksonville and Dr. Edith Peerez was head of my trial and she and a Dr. from Denmark are head of the Allto trial which in the phase III trial. As you can see below, I have had a number of scans and follow-ups. I was seen about every three months to begin with and have now moved to every six months. I was told I would be followed for 15 years (I told them I liked the sound of that!) since I had been in the trial.

I sincerely encourage you to request scans and blood work including tumor markers ASAP. After all, this is your life they are dealing with. I cannot believe this trial would not also require the physician to follow basicially the same monitoring schedule.

Good luck. We care
Sandra

Re: Important re Tykerb alone in Adjuvant setting
 

Sandra,
thank you for your concern. I am being seen by the doc who enrolled me in the Allto trail and by specialist from IU med center.All I keep getting are mugas and some blood draws because they are part of the trail.I have been very uncomfortable with no scans but they both tell me they are not needed and would be just more stress. Now I feel like I don't know who to turn to or what to do. I guess I'll call both of them tomorrow and be a lot more demanding. I don't understand why I haven't been notified about the trial concerns. I've done all follow ups my last one was May next one is scheduled for Dec

Re: Important re Tykerb alone in Adjuvant setting
 

CECW,

A scan would be "more stress"? Who are these people who think we do not have stress anyway??? I was not in the Altto study for long because of reaction to tykerb, but while I was in it, I was not being followed with scans on a regular basis. However, I was told if I had a persistent symptom, then I would get a scan. I quoted the letter I got, which advised that persons who had already finished the tykerb only arm should talk to their doc about getting herceptin. I believe you should insist on this. We go in trials to help out, if the trial has an unexpected result (tykerb not as effective) we should then get the standard treatment (herceptin). Don't wait for a letter. Tell you doc you have heard this -- I'm sorry I got rid of my letter after reading (since I've now had a year of herceptin) because if I had it I would fax or pdf you a copy.

Estelle

Re: Important re Tykerb alone in Adjuvant setting
 

Dawn,
Although the Altto study involved using tykerb in the stage 2 or 3 ajuvant setting, I would still discuss the results with my doc. Docs/scientist always want imperical data; I say that's fine but don't check common sense at the door. Case in point, in 1960, when they first announced smoking/lung cancer connection, I asked my 5th grade teacher, whether it would efffect people around people who smoke. Now how long did it take the scientists to confirm what a 5th grader knew instinctively?? (Second hand smoke is dangerous) Raise the tykerb alone issue with your doc and specifically ask about adding herceptin. Make her/him explain it.

Estelle

Re: Important re Tykerb alone in Adjuvant setting
 

Ladies,
thanks for all your advice. Saw onc doc today. PET scan and first herceptin scheduled for next week.

Re: Important re Tykerb alone in Adjuvant setting
 

Hi everyone

This is my first post. I only found the site yesterday.

I am on the ALLTO trial - lapatanib/tykerb only arm - and have only just been informed of the current situation. I was really surprised to see that GK released the info at the beginning of September, though at my hospital, they are only now informiing the patients and offering a year's worth of herceptin.
I finished taking the lapatanib pills 18 months ago so this feels like a massive step back. I have to attend the chemo ward to get the infusion. I know that I'm in a lucky position compared to many as I am still clear and also qualify for herceptin. But can't help feeling v. low. Since hearing, I've started getting breast pains and odd lumps again ...definitely psychosomatic. I thought I'd finally put it all behind me, even started writing about the experience, which I haven't been able to do up to now and then this...! Sorry for the moan. I'm sure you'll understand.
I'm interested to hear others reaction to herceptin before I commit to it. Thanks in advance.
Also apologies in advance if I'm using the board wrongly. I'm finding it slightly complicated.

Re: Important re Tykerb alone in Adjuvant setting
 

Judy,
I've had 6 rounds of Herceptin, and except for a runny nose, I haven't had any side effects at all. Compared to all other aspects of my treatment...Anthracycline, cytoxin, taxol, surgery, radiation...Herceptin is a pleasant 30 minutes to read a good book or chat with the nurses. A breeze!
Hope this helps!
Denise

Re: Important re Tykerb alone in Adjuvant setting
 

Judy, I so know where you're coming from. I finished lapatinib only arm may 2010. Have had 2 herceptin tx so far. I just feel like Seriously am I back here again. got pet scan results NED which is great! But like you my thoughts are I thought this was over! First tx I had nausea diarrhea x 1 day then severe itching for 4 days all relieved by left over chemo side effect meds. 2nd tx much better only slight effects so thinking all will be okay but a year back here seems like a long time right now.

Re: Important re Tykerb alone in Adjuvant setting
 

judylondon-I've had 3 Herceptins so far and I have found it a breeze. The infected toenail I had during Tykerb is back and I have a runny/crusty nose, but that is all. Yes, you have to plan your life around the once-every-3-weeks visit to the hospital, but since I take either the whole day or half a day off, I think of it as a little breathing time in my too busy life. After the infusion, I feel kind of groggy and sleepy so I take a nap. Around 5 o'clock I start feeling more chipper. Last time I worked from 5 to 9 p.m. (I am a musician and had a rehearsal I didn't want to miss), and though I wasn't quite my best, it was alright. I think they are showing good results for Tykerb and Herceptin together and this is a wonderful chance for us to get both of them, even if it is sequentially. I'm thinking that we come out ahead compared to the 'standard of care' which is only Herceptin.

Re: Important re Tykerb alone in Adjuvant setting
 

Bumping up this important thread about Tykerb.

Re: Important re Tykerb alone in Adjuvant setting