HER2 Support Group Forums - View Single Post

Mandamoo · 05-02-2012, 08:55 PM

Phil - don't you have to have measurable disease to be eligible for any of the TDM1 trials - from what MJ'shusband has said, last scans showed no measurable disease. My understanding of measurable disease is a tumour of at least 2 cm measurable on standard CT with contrast, I think you can get in with a 1cm tumour using different 3d CT - it is usually according to RECIST criteria. I also believe to participate in theresa you have had to have tried Tykerb and xeloda combination to qualify.

Another consideration is that participation in a TDM1 trial - even if you draw the control arm and receive treatment of your physician's choice can exclude you from further TDM1 studies.

I recently participated in the Bolero 3 trial and we had to find something large enough to get me in (In the end we 'measured' an axilla node at 21mm) - my lung tumours were the concern - there were more than 40 but none over 1cm and not close to 2cm so ineligible by them when they are the life threatening ones.

For what it's worth - I am on Tykerb xeloda currently and have had a response when nothing else has reduced my lung tumours. I am managing side effects ok - with a slight dose reduction - every body is different. If I could I would have herceptin with the Tykerb but it is not funded in Australia to have the two combined and it would cost us $60 000 per annum to fund herceptin.

Let's hope the FDA approves TDM1 soon because we are usually about 3 years behind in approvals in Australia. Also want to see pertuzamab approved so there are more options to try.
Good luck,
Amanda

05-02-2012, 08:55 PM	#30
Mandamoo Senior Member Join Date: Jul 2011 Location: Melbourne, Australia Posts: 432	Re: Treatment Question Phil - don't you have to have measurable disease to be eligible for any of the TDM1 trials - from what MJ'shusband has said, last scans showed no measurable disease. My understanding of measurable disease is a tumour of at least 2 cm measurable on standard CT with contrast, I think you can get in with a 1cm tumour using different 3d CT - it is usually according to RECIST criteria. I also believe to participate in theresa you have had to have tried Tykerb and xeloda combination to qualify. Another consideration is that participation in a TDM1 trial - even if you draw the control arm and receive treatment of your physician's choice can exclude you from further TDM1 studies. I recently participated in the Bolero 3 trial and we had to find something large enough to get me in (In the end we 'measured' an axilla node at 21mm) - my lung tumours were the concern - there were more than 40 but none over 1cm and not close to 2cm so ineligible by them when they are the life threatening ones. For what it's worth - I am on Tykerb xeloda currently and have had a response when nothing else has reduced my lung tumours. I am managing side effects ok - with a slight dose reduction - every body is different. If I could I would have herceptin with the Tykerb but it is not funded in Australia to have the two combined and it would cost us $60 000 per annum to fund herceptin. Let's hope the FDA approves TDM1 soon because we are usually about 3 years behind in approvals in Australia. Also want to see pertuzamab approved so there are more options to try. Good luck, Amanda __________________ Amanda xx 40 year old Mum to three gorgeous kids - son 5 and daughters 8 and 11 Wife to my wonderfully supportive husband of 17 years! 22 February 2011 - Diagnosed Early Breast Cancer IDBC Stage2b (ER/PR -ve, Her2+ve +++) - 38 years old (L) skin sparing mastectomy with tissue expander, axilla clearance (2/14 affected) clear margins. Fec3, Taxotere and herceptin2 - stopped due to secondary diagnosis June 24 2011 Stage IV - Skin met, axilla node, multiple lung lesions Bolero3 trial - Navelbine, Hereptin weekly, daily Everolimus/Placebo February 2012 - July 2012 Tykerb and Xeloda - skin mets resolved, Lungs initially dramatically reduced but growing again August 2012 (turn 40!) tykerb and herceptin (denied compassionate use of TDM1) while holidaying in Italy! September 2012 - January 2013 TDM1 as part of the Th3resa trial - lymph nodes resolved, lungs slowly progressing. January 2013 - herceptin, carboplatin and Perjeta (compassionate access) April 2013 - Some progression in lungs and lymph nodes - Abraxane, Herceptin and Perjeta July 2013 - mixed response - dramatic reduction of most lung disease, progression of smaller lung nodules and cervical and hilar nodes - ? Add avastin.