1 (edited by PCL1029 Sat, 16 Jul 2011 22:02:12)

Topic: BILCAP-A Randomized trial by UK for capecitabine for resected CC pt

Hi,
I went  over the materials from ASCO 6.2011.I found this BILCAP poster study which may be of interest to those CC patients in UK. It was funded by the UK cancer research since 2006. This is a randomized trial evaluating adjuvant therapy with Xeloda(capecitabine) compared to expectant treatment alone following curative surgery for biliary tract cancer(BTC).
This study is on target to complete accrual early in 2013.Trial recruitment remain strong 225 pts of 360 have been successfully recruited to date;
The primary endpoint is progression free survival(DFS) at 2 years and the intention is to increase 2 year DFS from 15 % to 28%.Secondary end points are 5 years survival (12 month survival rate of 86.4% at the time of this interim analysis),toxicity (hand and foot Grade1,2=65% and GI toxicity most prevalent,as anticipated;no Grade 4 toxicities observed to date and all the toxicities are within expected levels.)and quality of life.the result will define the international standard of care for  resected BTC patients.

Additional info.
The treatment arm dose of Capecitabine is 1250mg/m2,for total of 8 cycles.
Toxicity(Grade1-2) and Grade3-4 in () include:
1.Fatigue=71% (13%)   2. Fever=13%(0%)  3.Weight loss=13%(0%) 
4. hand-foot reaction=65%(15%)           5.Diarrhea=54%(10%)
6. Mucositis/Stomatitis=41% (1%) 7. Nausea=48% (1%)8.Vomiting=20%(0%).
100 patients who are on Capecitabine have returned 571 treatment forms.

God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

2 (edited by PCL1029 Mon, 07 Nov 2011 09:45:05)

Re: BILCAP-A Randomized trial by UK for capecitabine for resected CC pt

Hi,
I copied the additional discussion with Richard here for the Bilcap.trial.
It may be of interest to you.

"I looked over my info.(the poster I got from the 2011 ASCO)and your poster. Based on the graph(overall survival % vs months of survival) ;You can get according to the graph, a 12 month survival rate of 86.4% as the poster had indicated or 75% of the patients had survived at least 18.6months.(projection only for the 75%)
I could not arrive the same conclusion of  24 month survival rate at 82% like you indicated.
As you may notice the graph is just short of the 24 month mark when they plotted the graph.They had indicated on the interim report that due to the MEDIAN follow up of alive patients is only 9.3months and as such the survival curves are not STABLE beyond this time point.(when this interim report was done.)
The primary goal for the BILCAP study is to measure the overall survival,try to detect an increase in 2 year survival from 20 to 32% from 360 patients using adjuvant therapy of capecitabine only."
God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

Re: BILCAP-A Randomized trial by UK for capecitabine for resected CC pt

Hi Percy,

Many thanks indeed for this on Bilcap and also for your notes from 2011 at ASCO. I think Bilcap is due to end in July 2014 and here is a link to the CRUK page on it.

http://cancerhelp.cancerresearchuk.org/ … allbladder

Also, Helen of AMMF was asked to attend a meeting with CRUK and those running the Bilcap trial at Southampton in Sept of this year and she put some of her notes from the meeting on her AMMF website here -

http://www.ammf.org.uk/2011/09/22/meeti … re-bilcap/

More info on Bilcap from Helen's site here -

http://www.ammf.org.uk/wp-content/uploa … JUNE-2.pdf

Many thanks of course go to Helen for all of her outstanding work with AMMF.

Gavin

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

4 (edited by PCL1029 Mon, 07 Nov 2011 14:47:33)

Re: BILCAP-A Randomized trial by UK for capecitabine for resected CC pt

Hi,
Thanks ,Gavin. Indeed a very deep appreciation for Helen 'work and post this BILCAP poster so other people can look at it and understand the graph.I also thank Helen for the questions she raised with the CRUK . From the way the CRUK cannot pin point about the number of patients who drop out from the treatment arm and when did that happened; and to the fact that this study had started five years ago and they can only report the interim findings as such, it may tell us recurrence is a problem for the effective collection of data and continuation of the BILCAP trial;and they still need qualified patients to further the study.I could be wrong on this,but this trial result will surely be important for theCCA patients in the future.;both for treatment and quality of life.
Lately I see quite a few CCA Patients on this board on Xeloda alone or in combo with Gemzar .
God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.