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Old 04-26-2012, 04:26 AM   #21
schoolteacher
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Join Date: Feb 2008
Location: Georgia
Posts: 1,486
Re: TDM-1 news

FOB,

Glad to hear from you. Glad your platelets are coming back up.

Amelia
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Old 04-27-2012, 12:07 PM   #22
phil
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Join Date: Nov 2010
Posts: 393
Re: TDM-1 news

Lorraines plats were checked 2 days before each 3 week tx. If they werent up enough, she delayed another 1-3 weeks, which is the limit in the old exp. access protocol. ( 6 weeks total ) Gen clinical team gave her even more extra time after sepsis ( saved her life probably ). And shes cruising on 3.0 every 3 weeks. plats 70,000-80,000 +. She gets a platelet rash , which is achain of red spots on neck, and red bumps on wrist. She also gets little red bumps in various places like FOB describes. Plats that rebound above 100,000 is great in our opinion, we hope L. gets back there someday.
But for all tdm-1'ers , plats need to be watched ., at least 30% have that issue , dropping below 100,000 ( i think maybe even more than 30 % ). below 100, 000 they have to be watched if they dont rebound before next dose . If they didnt rebound over 75,000, that meant another reduction , to 3.0, if they continued to drop, to 2.4 ( which L. narrowly avoided ) below that - you're Dropped from tx !! So, read up on protocol , ask questions !
In L's old protocol , , like many trials , once you go down in dose you cant go back up. Until approval, when we can be done w/ This FDA . Oh, how I want to be done w/ This FDA for ever ! meaning get rid of Pazdur and his tdm-1 " advisors ".
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Old 04-28-2012, 06:52 AM   #23
fullofbeans
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Join Date: Jan 2007
Location: UK
Posts: 617
Re: TDM-1 news

Phil mine are back to 117 after 2 weeks. I would expect them to be normal by next thursday (my next TDM1). I hope Lorraine will get back there, but the drug is working and as far as thing stay like they are all is good.

A phase one trial of TDM1 shows that platelets are lowest in the first 8 daysthe point of nadir.

platelets rash.. now I know what it is from it first appeared on my breast bone just above the sternum scarry.. but yes I looked up and it matches..one more thing elucidated..thanks.

Praying for my platelet to be 150 by Monday so I can have the angio. and get my face back if all goes to plan.

I can understand your dislike for your FDA, in my opinion one of the most openly corrupt governemental organisation of the western world, yet very powerful.
__________________

35 y/o
June 06: BC stage I
Grade 3; ER/PR neg
Her-2+++; lumpectomies

Aug 06: Stage IV
liver mets: 6 tumours
July 06 to Jan 07: 2*FEC+6*Taxotere; 3*TACE; LITT
March 07- Sept 07: Vaccination trial (phase 2, peptide based) at the UW (Seattle).
Herceptin since 2006
NED til Oct 09
Recurrence Oct 2009: to internal mammary gland since October 2009 missed on Oct and March 2010 scan.. palpable nodes in May 2010 when I realised..
Nov 2011:7 mets to lungs progressing fast failed hercp/tykerb/xeloda combo..

superior vena cava blocked: stent but face remains puffy

April 2012: Teresa Trial, randomised to TDM1
Nov 2012 progressing on TDM1
Dec 2012 blockage of my airways by tumours, obliteration of these blocking tumours breathing better but hoping for more- at mo too many tumours to count in the lungs and nodes.

Dec 2012 Starting new trial S-222611 phase 1b dual egfr her2+ inhibitor.



'Under no circumstances should you lose hope..' Dalai Lama
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Old 04-29-2012, 05:19 AM   #24
phil
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Join Date: Nov 2010
Posts: 393
Re: TDM-1 news

I am so happy that you get to try this amazing drug, hers praying for a response even better than Lorraines ! And hers was, and is more and more , pretty amazing !
Watch those plats , as Lorraines went up after each dose , but not as high as the dose before. As i said before, maybe wouldnt have had as low a drop if she had reduced to 3.0 after about 5 -6 3.6 level doses. As plats first dropped below 90,000 around the 5th dose. . But the first scan showed great results , after 3 doses at 3.6 , 7 tumors were reduced to 4. Then plats and sepsis delayed , interrupted doses from around March , 2011 until July. Since then regular 3.0 level doses every 3 weeks steadily reduced cancer to one tumor in Sept, Since Nov, no detectable disease. 20 doses all told, 18 months of stability, great QOL. When its all approved, hope to go to 2.4, maybe w/ pert as well. Good luck !
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