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Old 02-23-2013, 03:20 PM   #21
ElaineM
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Wink Re: T DM-1 Approved !!

This is certainly wonderful news. I happened to be at my doctor's office when the nurse practioner came running out of her office to tell us the news !! She was very excited and jumping up and down. Many patients in Hawaii will benefit.
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Old 02-23-2013, 04:55 PM   #22
dearjilly
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Re: T DM-1 Approved !!

This is such great news!!
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[
Feb 2013 - NED
Mar 2013 - thought I had progression, watching brain.
April 2013 - GOT MARRIED!!!!
May 2013 - looks like no progression, but necrosis and bigger.
Oct-Dec 2013 - Avastin tx
Nov 2013 - MRI shows necrosis shrinkage!!!!
Jan 2014 - Lepto Mening. disease found
Feb 2014 - WBR
March - BLAHHHH
April 2014 - Liver mets found
April 2014 to present - Chemo again, whooohoo. Fun!
July 2014, scans look good.
Stay on Perjetand hercertin.
Nov. 2014 more lepto-mening disease more WBR.
Feb 2015 more lepto-mening disease in spine and neck. More radiation.
Start on TDM1 no more Perjeta stay on herceptin
March 2015 more radiation in my thoracic area, more lepto-meningial disease
April 2015 trying to walk again.
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Old 02-23-2013, 06:02 PM   #23
Barbara H.
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Re: T DM-1 Approved !!

I jumped for joy when I heard this news. I believe that I was one of the first to be given this drug on this website. It was truly a miracle drug for me. I was on a stage one trial and received it weekly at a higher does than is currently given. I started the trial in Sept. 2007. It put me into remission. I remain in remission but had to go off it after two years because I developed lung inflammation. I then received herceptin with Tykerb and continue to be remission. At one point my insurance refused to cover the Tykerb, but my oncologist was able to convince them to allow me to continue this combination. Sheila was also very helpful at the time and I will never forget her kindness. I am enclosing my first post after my first infusion. For those who are interested, you can go to my history.
Kind regards,
Barbara H.
Post from Sept. 2007
Trial Trastuzumab-MCC-DM1 (I think it's working)
Hi Everyone,
I just wanted to give an update of the trial I am on. I posted it on the trial section, but thought that some members might not read it there and decided to add it to this forum. I just received my second infusion last Thursday. I had been off all treatment since the end of May because you have to be off treatment for four weeks to qualify. Unfortunately, as a result of no treatment, my bone mets had really started to grow and become painful. By August it became very difficult for me to sleep. In fact, one night the week before I started the trial, I only had two hours of sleep before getting up and going to school. This was all due to pain. No pain relievers would help and prescription pain relievers make me nauseous. In reality, I had been off chemo other than Herceptin since November when I had to have brain surgery due to necrosis. I really felt as if I was in bad shape and was desperate to begin this trial

My first infusion took all day. The needed blood work, consultations, and the infusion took 1 and 1/2 hours. Then I needed to be observed for four hours with constant temperature and blood pressure monitoring. After a final blood test I could leave, but had to return on Friday, Saturday, and Sunday for additional blood tests. This is a problem for me because I have bad veins and the trial protocol will not allow blood tests from my port.

During my first infusion my nose started running and I felt quite achy. Unfortunately, that night I had to give a speech and meet will my parents at Curriculum Night. It was difficult, but I did it. The next day I felt pretty awful, but went to school. By that evening I had a fever of 101F. At first I thought is was a reaction to the new drug, but now I think I caught a virus from my students. Three were out that week with colds and fevers, and by the beginning of the past week two of the other third grade teachers had it. I probably will never know for sure.

This past Thursday I had my second infusion and it was quite uneventful. The following day I was tired, but went to see "Wicked" that night with no problem.

Here is the good news. By the second night after the first infusion I was able to sleep with virtually no pain. After being in pain for two months, this feels like a true miracle to me. My hip is still sore during the day and I favor it somewhat, but I feel that this treatment is quickly making a huge difference. It is also very easy to tolerate. Therefore, if you are looking for a treatment option, I would definitely investigate this trial. I also wonder if there is anyone else on this website how is taking this drug.

I will continue to give updates, and will know more after I have my scans later this month.

I give my best to everyone. I have read everyone's posts, but just haven't had time to respond. The beginning of the school year is always very hectic.

Best regards,
Barbara H.
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Old 02-23-2013, 07:04 PM   #24
A. L. Pendley
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Re: T DM-1 Approved !!

I too am excited. And I too am concerned about my brain mets - they're still talking whole-brain radiation. I heard I'll be stopping my Tykerb once I start on t-dm1, but the Tykerb was supposed to help with brain. I know it's crazy thinking I really need to sell my business and train a new person before treatments that could affect my cognition and energy level, but the value of my business is linked to my skills. What if I can't do what I said I could do? Then again, I'll be worth a lot less underground!! Yes, thanks to the women on the clinical trials!
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Old 02-23-2013, 07:46 PM   #25
Ceesun
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Thumbs up Re: T DM-1 Approved !!

So glad I logged on to see this!!!!!!!!!!!!!! WONderful!!!! Ceesun
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Old 02-23-2013, 08:47 PM   #26
NEDenise
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Re: T DM-1 Approved !!

Karen,
I'm sorry...I didn't understand what you wrote to me. Are you saying that I would benefit, or that I wouldn't? Or are you saying that if I didn't have cancer below the neck, it wouldn't be in my brain? Or did I miss the point completely?
Confused (but not surprised by it!)
Denise
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2/11-Lumpectomy/axillary node dissection - Stage 3c, ER/PR-14/17 nodes
3/11 - Post-op staph infection,cellulitis, lymphedema,seroma,ARRRGH!
4/12/11-A/C x 4, then T/H x 4, H only,Q3 weeks
8/26/11 finished Taxol!!!
10/7/11 mastectomy/DIEP recon
11/11 radiation x28
1/12/12 1st CANCER-VERSARY!
1/12 Low EF/Herceptin "Holiday" :(
2/12 EF up - Back on Herceptin, heart meds
4/2/1212 surgery to repair separated incision from DIEP recon
6/8/12 Return to work :)
6/17/12 Fall, shatter wrist,surgery to repair/insert plate :(
7/10/12 last Herceptin
7/23/12 Brain Mets %$&#! 3cm and 1cm
8/10/12 Gamma knife surgery, LOTS of steroids;start H/Tykerb
8/23/12 Back to work
12/20/12 Injure back-3 weeks in wheel chair
1/12/13 2nd CANCER-VERSARY!
1/14/13 herniate disk in back - surgery to repair
1/27/13 Radiation necrosis - edema in brain - back on steroids - but not back to work - off balance, poor cordination in right arm
5/3/13 Start Avastin to shrink necrosis
5/10/13 begin weaning steroids
6/18/13 Brain MRI - Avastin seems to be working!
6/20/13 quarterly CT - chest, abdomen, pelvis - All Clear!
7/5/13 finally off steroids!!
7/7/13 joined the ranks of the CHEMO NINJAS I am now Tekuto Ki Ariku cancer assassin!
7/13/13 Symptoms return - back on steroids
7/26/13 Back on Avastin - try again!
8/26/13 Not ready to return to classroom yet :( But I CAN walk without holding onto things! :)
9/9/13 Brain MRI - fingers crossed
“ Life is a grindstone, and whether it grinds you down or polishes you up is for you, and you alone, to decide. ” – Cavett Robert
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Old 02-23-2013, 10:52 PM   #27
chrisy
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Re: T DM-1 Approved !!

My take on what Karen said: if you are Ned in the head, and have the rest of you below the head controlled, new baddies are less likely to wander north to your brain
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June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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Old 02-23-2013, 11:39 PM   #28
NEDenise
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Re: T DM-1 Approved !!

Soooo...
Once I'm NED in the head (soon, God willing)...then I could try TDM-1 to stay that way? But won't I always have to worry about tiny cells remaining in my brain to rear their ugly heads again if I go off Tykerb?
And so far...I'm still NED everywhere except my brain...so TDM-1 isn't really on my radar yet. Am I getting that straight?

At any rate...it's still REALLY exciting that it's approved for those of us who DO need it!!
Denise
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1/11-needle biopsy
2/11-Lumpectomy/axillary node dissection - Stage 3c, ER/PR-14/17 nodes
3/11 - Post-op staph infection,cellulitis, lymphedema,seroma,ARRRGH!
4/12/11-A/C x 4, then T/H x 4, H only,Q3 weeks
8/26/11 finished Taxol!!!
10/7/11 mastectomy/DIEP recon
11/11 radiation x28
1/12/12 1st CANCER-VERSARY!
1/12 Low EF/Herceptin "Holiday" :(
2/12 EF up - Back on Herceptin, heart meds
4/2/1212 surgery to repair separated incision from DIEP recon
6/8/12 Return to work :)
6/17/12 Fall, shatter wrist,surgery to repair/insert plate :(
7/10/12 last Herceptin
7/23/12 Brain Mets %$&#! 3cm and 1cm
8/10/12 Gamma knife surgery, LOTS of steroids;start H/Tykerb
8/23/12 Back to work
12/20/12 Injure back-3 weeks in wheel chair
1/12/13 2nd CANCER-VERSARY!
1/14/13 herniate disk in back - surgery to repair
1/27/13 Radiation necrosis - edema in brain - back on steroids - but not back to work - off balance, poor cordination in right arm
5/3/13 Start Avastin to shrink necrosis
5/10/13 begin weaning steroids
6/18/13 Brain MRI - Avastin seems to be working!
6/20/13 quarterly CT - chest, abdomen, pelvis - All Clear!
7/5/13 finally off steroids!!
7/7/13 joined the ranks of the CHEMO NINJAS I am now Tekuto Ki Ariku cancer assassin!
7/13/13 Symptoms return - back on steroids
7/26/13 Back on Avastin - try again!
8/26/13 Not ready to return to classroom yet :( But I CAN walk without holding onto things! :)
9/9/13 Brain MRI - fingers crossed
“ Life is a grindstone, and whether it grinds you down or polishes you up is for you, and you alone, to decide. ” – Cavett Robert
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Old 02-24-2013, 05:15 AM   #29
marvass
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Re: T DM-1 Approved !!

WOW, so glad to hear this. It will save millions of woman by the time a new and better drug is out.
Mario
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Old 02-24-2013, 07:17 AM   #30
phil
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Re: T DM-1 Approved !!

Read Saturdays Boston Globe , " FDA Approves Powerful New Breast Cnace Drug ", the best article we hav seen on T DM-1 so far. read it, and pass it on , to counter FDA propaganda. only journalist to interview an actual Stage IV Survivor !
We and Chrisy predictedThis FDA would put out press release on a Friday , (hopingworld would never hear , media forget by Monday. sadly , its happening , so e-mail your past media contacts , ask " Are you going to question FDA ? interview actual t dm-1 responders ? the researchers that are silent press wise ( This FDA is a punitive, defensive FDA ), but say T DM-1 will " revolutionize ' the tx of her2+ , ? What has happened to investigative journalism in this 30 ' attention span tv world ?
our local ch. 5 abc reprter was away, the station ran abrief blip on " Kadcyla " , ( what a name ! ), never mentioned T DM-1 by name, its history, Pts Rights , Protests. so Globe article, not perfect , is by far the best we haveseen so far , Praise it , thank Rob Weisman. encourage your other media contacts to follow suit. should be a 60' type story. note Rob's estimate of it helping 15,000 pts this yr , sooo, would it have helped 30,000 plus during This FDA 's 2 yr delay ?
he did get one thing wrong, said protests end, we never said that , and Dr. Hmburg is comin to town March 15th ...stay tuned
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Old 02-24-2013, 07:20 AM   #31
phil
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Re: T DM-1 Approved !!

we also predicted that This FDA would play up side effects, and they did ! all chemos have s/e.'s. this one has less ! and now pts can flex tx dosing , schedule to lower s/e like plats, red counts more. Lorrraine wants to go to once amonth , at 3.0 dose and will.
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Old 02-24-2013, 07:21 AM   #32
phil
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Re: T DM-1 Approved !!

Write ltrs to editor too !
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Old 02-24-2013, 07:24 AM   #33
phil
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Re: T DM-1 Approved !!

our personal plan is to stay on as higha dose as possible, adjusting carefully to raise plats a bit more, and hope steady dose will prevent brain mets . for those w/ hx of brain mets,now we can add tyk , other appr. drugs, to t dm-1, right ?
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Old 02-24-2013, 08:23 AM   #34
phil
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Re: T DM-1 Approved !!

Our thanks to those who pioneer , sacrifice in Phase I safety, toxicity trials like Barbara H. some in those trials got doses as high as 4.0, higher ?, today highest dose is 3.6, and some got it ( and KDR 's trial now get it) weekly !
we are asking t dm-1 responders , 6 months plus, to do a short ( 2 ') bio video, of your t dm-1 results. e-mail it to me , pmccartinjr@comcast.net . i will have our young techie activist couple put it on our website, http://stageivsurvivor.webs.com. to refute This FDA , won't it be nice someday to look back and refer to them as " That FDA " , 2009- (early ? )2013 , instead of "This FDA " we are more sad than angry with them, its an impersonal , " We Know best " attitude, and the Washington Establishment 's intransigence to change. but change is coming, we can't have 4 more yrs of this !
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Old 02-24-2013, 10:17 AM   #35
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Re: T DM-1 Approved !!

Hi, Denise
What I've been told is that if you are NED from the neck down, it is unlikely that brain mets will occur. I guess it goes back to the circulating cell theory. And I don't think it's all to the story, or that it can blanket the population. Rather, it is a generally-held belief. Sorry if there was confusion there. I ask about it frequently as Kadcyla doesn't cross the BBB.
Wishing you the best,
Karen
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Old 02-24-2013, 10:20 AM   #36
KDR
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Re: T DM-1 Approved !!

Phil,
You are so right on so many fronts about dosing. It is not easy at the level I'm on, but my onco said this is the weekly dose. Problem is what happens if we do lower the dose and the cells get out of the net, if you will. It'll be interesting to see how the drug is RECOMMENDED to be administered as approved.

Warm wishes,
Karen
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Old 02-25-2013, 01:54 PM   #37
karen z
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Re: T DM-1 Approved !!

Wonderful news (wow, I kept hearing "February" at the conference- kind of pushing it but we will take it)!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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Old 02-25-2013, 02:45 PM   #38
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Re: T DM-1 Approved !!

In theory, being NED in body below the neck, can keep the brain clear, but often NOT in practice.

Note the increasing number of Brain As First Site of Mets we have reported here.

Note the number of us here who have stayed NED in body on maintenance Herceptin, then have had brain mets appear while remaining NED from neck down.

Mets can be seeded during active cancer and sit there for some years (as in my case).

Any treatment such as IT Kadcyla (T-DM1) seems a little harsh and WAY down the road to me. Perhaps Perjeta as a direct treatment to brain has a possibility, but have not yet heard of that happening.

I certainly hope Tykerb is working for you, Denise! It is very hard to say when and/or if we might be out of the woods with brain mets. I still get a brain MRI twice a year, and would get one immediately if I thought I had any symptoms.
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Live in the moment.

MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and all of 2017.
Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.
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Old 02-25-2013, 06:08 PM   #39
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Re: T DM-1 Approved !!

This is good news as it opens up options.
It was not an effective treatment for me so my excitement is somewhat tempered as I know of others with limited results from this drug. It, like most others, does not work for all - this needs to be understood. My oncologists believed that Kadcycla could be used again for me but I would need further blockade - possibly with perjeta or even avastin. While I am excited at another treatment possibility (I hope I get to use it again as it was quite tolerable), I believe the very real issue for those of us with stage4 her2 disease is overcoming herceptin resistance be this with dual blockade, PI3k inhibitors or something else. TDM1 does not expand upon the need to develop other ways of blocking the pathway, it is simply a new way of using Herceptin. To say that it should be used in adjuvant therapy without testing it's efficacy against the current treatments (anthracyclines and taxanes of TCH) is wrong as these treatments are currently saving many lives - they need to trial this to see if in fact it is as effective for adjuvant care. There was similar excitement with tykerb and the adjuvant trials have now shown it to be much less effective and many people in the tykerb group now have stage 4 disease.

Bunty - The BCNA are currently lobbying for a few drugs (affinitor is one though not for her2 girls and eribulen) though I don't believe Roche have yet applied for Perjeta or Kadcycla - I might have a chat and see when they will be. Roche have become more amenable to compassionate access though. We need to jump on this.
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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.
Fec*3, Taxotere and herceptin*2 - 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.
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Old 02-26-2013, 04:05 AM   #40
fullofbeans
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Re: T DM-1 Approved !!

great news just great news!
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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.



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