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05-29-2011, 08:44 AM
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#1
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Just received this information from the Patient Advocate at Genentech. They are working to amend the protocol for the EAP (T-PAS) to allow SOME of the actual treatments to be adminstered locally. They are still not opening any new study sites...but those who, say live in Boston and would have to travel to Fairfax (or in Seattle traveling to So Cal or in Austin going to Denver) may have an option, once they are established in the trial, to get some infusions locally. This is still probably a few months away to get the amendment done and approved.
Still not as good a FDA approval of the drug...but may provide some relief in the interim...
The message she sent me is below:
Genentech has been contacted by multiple patients requesting T-DM1 from their local oncologist as part of T-PAS or seeking individual access. We know that many people have to travel long distances, and we recognize this significant burden, especially considering their advanced cancer. We are trying to do the right thing for patients while ensuring we are being fair, and also not impacting the clinical trials we need to conduct in order to get the medicine approved. Therefore, we are planning to amend the T-PAS protocol, allowing people who are enrolled in the trial and responding to T-DM1 to receive some T-DM1 doses locally. Additional details of the protocol amendment are not yet final, but we are working as quickly as possible and hope to have the amendment in place within 90 days. Our primary goal remains getting T-DM1 approved so access is not an issue for patients.
While we understand it can be difficult and costly to travel long distances, our hope is the amendment alleviates some of the burden by allowing some doses to be administered by a local oncologist. While we are working to get the amendment approved, we recommend people who continue to face travel challenges to contact an organization that may be able to provide travel assistance:
· Air Care Alliance, www.aircareall.org, 888-260-9707
· Air Charity Network, www.aircharitynetwork.org, 877-621-7177
· Airlines of the Web Medical Air Services, www.flyaow.com/airmed.htm
· American Cancer Society (Road to Recovery), www.cancer.org, 800-ACS-2345
· Angel Flight Central, www.angelflightcentral.org, 866-569-9464
· Angel Flight for Cancer Patients, www.angelflightforcancerpatients.org, 800-296-1217
· AVONCares Program, www.cancercare.org, 800-813-HOPE
· CancerCare, www.cancercare.org, 800-813-HOPE
· Chai Lifeline, www.chailifeline.org
· Corporate Angel Network, www.corpangelnetwork.org, 866-328-1313
· Hospitality Homes, www.hosp.org, 888-595-4678
· Joe’s House, www.joeshouse.org, 877-JOESHOU
· Lazarex Cancer Foundation, www.lazarex.org/lookingforhelp.html
· Lifeline Pilots, www.lifelinepilots.org, 800-822-7972
· National Patient Travel Helpline, www.PatientTravel.org, 800-296-1217
__________________
Chris in Scotts Valley
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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05-29-2011, 11:41 AM
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#2
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Senior Member
Join Date: May 2006
Posts: 3,142
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Thanks !! This is certainly great news for all of us.
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05-29-2011, 11:42 AM
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#3
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Senior Member
Join Date: Oct 2005
Posts: 3,519
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Yep... I got the email from her just after she sent it to you! This is fantastic new... every little bit helps. My local onc is happy too, that I may not have the expense of traveling so often. I love Genentech.
__________________
Brenda
NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)
Nov'03~ dX stage 2B
Dec'03~ Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~ Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~ micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~ micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg
Apr'07~ MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~ Started Tykerb/Xeloda, no WBR for now
June'07~ MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~ MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~ PET/CT & MRI show NED
Apr'08~ scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~ MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~ dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~ Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~ new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~ new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~ 25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.
"I would rather be anecdotally alive than statistically dead."
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05-29-2011, 02:35 PM
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#4
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Thanks becky or Steph whoever stickied this!
__________________
Chris in Scotts Valley
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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05-29-2011, 03:08 PM
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#5
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Senior Member
Join Date: Feb 2006
Location: Southern, CA
Posts: 2,511
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Hi Chris,
I just replied to this post from you down in clinical trials. lol Didn't know this thread was up here already. It's nice to see someone tacked this up here...it's better suited in the main forum since it's such a hot topic to so many of us.
Thanks Chris for sharing the news. And thanks to whomever moved this to the main board for all to see.
Chelee
__________________
DX: 12-20-05 - Stage IIIA, Her2/Neu, 3+++,Er & Pr weakly positive, 5 of 16 pos nodes.
Rt. MRM on 1-3-06 -- No Rads due to compromised lungs.
Chemo started 2-7-06 -- TCH - - Finished 6-12-06
Finished yr of wkly herceptin 3-19-07
3-15-07 Lt side prophylactic simple mastectomy. -- Ooph 4-05-07
9-21-09 PET/CT "Recurrence" to Rt. axllia, Rt. femur, ilium. Possible Sacrum & liver? Now stage IV.
9-28-09 Loading dose of Herceptin & started Zometa
9-29-09 Power Port Placement
10-24-09 Mass 6.4 x 4.7 cm on Rt. femur head.
11-19-09 RT. Femur surgery - Rod placed
12-7-09 Navelbine added to Herceptin/Zometa.
3-23-10 Ten days of rads to RT femur. Completed.
4-05-10 Quit Navelbine--Herceptin/Zometa alone.
5-4-10 Appt. with Dr. Slamon to see what is next? Waiting on FISH results from femur biopsy.
Results to FISH was unsuccessful--this happens less then 2% of the time.
7-7-10 Recurrence to RT axilla again. Back to UCLA for options.
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05-29-2011, 03:34 PM
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#6
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Senior Member
Join Date: Feb 2006
Location: Southern, CA
Posts: 2,511
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Chris,
Yesterday schoonder posted a message from a blog down in the "Articles of Interest" forum that some might be interested in reading? I hope schoonder doesn't mind me adding it up here? Obviously Genentech is feeling the pressure and being swamped by calls for T-DM1. Here is "schoonder" post below.
--------------------------------------------------------------------------------
Easier access to the drug?
Posted yesterday on assertivecancerpatient blog.
"
'The Straw That Broke the Camel's Back'
Dr. Lee called me at about 1 this afternoon to report on his phone call with Dr. Sandra Horning and Terry Rugg at Genentech.
One thing he said is that he thinks my asking to get T-DM1 on compassionate use was "the straw that broke the camel's back," because Genentech has been hearing from so many women recently who are in my situation: they could be helped by T-DM1, but they can't travel to the nearest clinical trial site.
(Remember, there are only 12 phase II trial sites, and there were supposed to be 20, including one in Seattle at the University of Washington Medical Center--that one never opened.)
I assume that the folks at Genentech were discussing the issue before I came along, otherwise I don't think they could have come up with a solution in 48 hours--which is the amount of time that has passed between Dr. Lee's first phone call with Genentech on Wednesday and today's call.
Not that I'm not delighted to have been that straw, if that was indeed the case. My friends may call me "Straw" now and in the future.
So, this is what they told Dr. Lee:
* Genentech is--or has been--working on a broad program for local delivery. (Translation: I could get T-DM1 at Dr. Lee's office. No more traveling to S. California every three weeks.)
* One piece of this will be demonstrating the drug's safety for the women who get it at their local oncologist's office.
I'm not quite sure what that involves, but proving that the drug is safe for me is a cake walk--I got the drug for seven months with no serious side effects of any kind. Any problems I had during that time were not caused by the T-DM1, except that my platelets did drop, but never low enough that Dr. Ibrahim had to cut my dose. And certainly not low enough to put me in any danger.
Also, let's not forget that I am in remission for the first time in years--five or more, I believe--because of the T-DM1.
* Any hospital or cancer center that wants to offer this to their patients will have to do an IRB. I don't know much about IRBs, except to say that these are review boards within a facility that have to approve the plan. Sometimes this can take time.
* Doctors such as Dr. Lee and their cancer centers or clinics will have to be approved and then the doctors will be added to the trial as principal investigators.
* The FDA will have to approve Genentech's plan.
Next week, let's start lobbying the FDA and also the Congressional committee(s) that oversee the FDA.
* The timeline is about three months.
Now, this is amazing, but what am I supposed to do between now and then? My cancer could come back aggressively within the five months or so since my last T-DM1 treatment and the time this program is up and running.
* Dr. Lee thought of that, and asked about it. The answer: Genentech will allow me to return to the trial in Highland, California, even though I have broken the rules by skipping two (three by now, if not four) treatments.
That is truly amazing!
They did say I would have to get to Highland (Ontario airport) on my own, and they are faxing Dr. Lee a list of organizations that they think might help me financially. I'll get that list from Dr. Lee next week, but how much do you want to bet that I've already contacted most of them? I'm not expecting much help there.
So back to fundraising. Sigh. However, three months is only four treatments/trips, so about $4,000. I think I can raise that much.
I can't begin to say how happy this news makes me. I'm going to have a wonderful summer after all! And my life expectancy is pushed out another year, if not longer.
Thanks, Genentech.
And thanks to Dr. Lee. He put a lot of time into this, and he's going to put in a lot more before we have this plan in place. What can I say? He is the most wonderful doctor.
Read more: T-DM1
Feeling generous? See: My Cancer Travel Fund
@ Jeanne Sather 2011"
__________________
DX: 12-20-05 - Stage IIIA, Her2/Neu, 3+++,Er & Pr weakly positive, 5 of 16 pos nodes.
Rt. MRM on 1-3-06 -- No Rads due to compromised lungs.
Chemo started 2-7-06 -- TCH - - Finished 6-12-06
Finished yr of wkly herceptin 3-19-07
3-15-07 Lt side prophylactic simple mastectomy. -- Ooph 4-05-07
9-21-09 PET/CT "Recurrence" to Rt. axllia, Rt. femur, ilium. Possible Sacrum & liver? Now stage IV.
9-28-09 Loading dose of Herceptin & started Zometa
9-29-09 Power Port Placement
10-24-09 Mass 6.4 x 4.7 cm on Rt. femur head.
11-19-09 RT. Femur surgery - Rod placed
12-7-09 Navelbine added to Herceptin/Zometa.
3-23-10 Ten days of rads to RT femur. Completed.
4-05-10 Quit Navelbine--Herceptin/Zometa alone.
5-4-10 Appt. with Dr. Slamon to see what is next? Waiting on FISH results from femur biopsy.
Results to FISH was unsuccessful--this happens less then 2% of the time.
7-7-10 Recurrence to RT axilla again. Back to UCLA for options.
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05-29-2011, 05:17 PM
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#7
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Way to go Jeanne!
And good on genentech, too!
How many "straws" will it take to bend the FDA?
__________________
Chris in Scotts Valley
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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05-29-2011, 05:32 PM
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#8
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Senior Member
Join Date: Nov 2004
Location: Misty woods of WA State
Posts: 4,128
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
I got your post stickied, Chris.
Think we will need more like cannon balls for the FDA - don't have time to wait for straws to accumulate!
__________________
"When I hear music, I fear no danger. I am invulnerable. I see no foe. I am related to the earliest times, and to the latest." H.D. Thoreau
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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05-29-2011, 08:52 PM
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#9
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Senior Member
Join Date: May 2006
Posts: 3,142
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Way to go !!!!!!!!!!
If someone is starting a petition I will sign.
I heard about Seattle. My medical group in Hawaii was signing up patients for Seattle, but then found out the whole thing fell apart.
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06-04-2011, 12:18 PM
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#10
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Senior Member
Join Date: Oct 2005
Posts: 3,519
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
I am excited about the possibility, but in reality I am only cautiously optimistic. I won't be devastated if it doesn't come to pass.
From what I understand, it basically takes moving small mountains to make this kind of thing happen. But that doesn't mean it's impossible. Independent/Ethical review boards (and setting them up) is no piece of cake and doesn't happen just because folks click their heels together and wish it so. It seems that for so many different independent clinical docs to be approved to be principal investigators (who aren't already trial docs) will be a bear, but not impossible. I assume they also won't be allowed to accrue, they will only be treating patients who are already on the trial.
And then there's the FDA component. Sigh.
I am not saying it won't happen, I have no way of knowing. I have utmost hope! But I just know it's going to be a difficult journey and as I said, I am cautiously optimistic.
And regardless, I am ready, willing, able and happy to continue to fly to Denver to get my treatments if that turns out to be my only option, until it gets approved.
Best wishes to Genentech for taking this on and trying though! I love them!!
__________________
Brenda
NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)
Nov'03~ dX stage 2B
Dec'03~ Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~ Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~ micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~ micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg
Apr'07~ MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~ Started Tykerb/Xeloda, no WBR for now
June'07~ MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~ MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~ PET/CT & MRI show NED
Apr'08~ scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~ MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~ dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~ Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~ new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~ new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~ 25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.
"I would rather be anecdotally alive than statistically dead."
Last edited by hutchibk; 06-06-2011 at 10:41 AM..
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06-05-2011, 11:02 PM
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#11
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Senior Member
Join Date: May 2006
Location: California
Posts: 668
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Chrisy,
Thank you so much for the news. It's nice to hear you are doing great!!!!!!!
Love,
Adriana
__________________
1994 - rt brst, .lump, underarm node dissection,chemo+rad 1.2 cms, Grade 3.
28 nodes neg
Er,Pr, Positive HER2 status unknown
2003- Recur to rt lung.July 16 ( B-Day!)
Her2+++ Er,Pr, Negative
2003 - Aug04--Navelbine + Herceptin
2004- 2007--NED - Herceptin, only
2007 Feb-April Xeloda added to hereceptin
2007-May Back on Navelbine+Herceptin
2008-Feb-Mar 15 Ses Rad to Rt. Lung
2008- Oc 17 Add Tykerb to Herceptin
2009- June-- Discont Tykerb
2009 July 7--Current Taxol + Herceptin
2009 Dec--Discontinued treatment due to progression. Looking into cyberknife.
2010-Aug Accepted to TDM1, no SE, except liver count went up.
2010-2011 September got kicked out of the trial, due to a small spot found on lung.
2011- 2012 September thru early 2013 on Herceptin
2013- March Bone density shows small spot on 5th rib.
2013 - April 4th appt with onc. will post after discussing course of treatment.
2013-March-April Cyber knife to brain and radiation to rib. Chest --base line before chemo-CT-Scan stable for lung issue. CA2729 Normal.
2013 April Herceptin- TDMI
2013 Sept Herceptin + Perjeta . CA2729 within normal range. Brain and Pet scans October 31st. will post results.
2013 October Brain MRI- mixed response. Will see Onc/rad on Halloween.
2013 October/November Brain-MRI nothing new. Repeat MRI next year in May.
2013 December Continue Herceptin and Perjeta. Stable at the moment.
2014 February Brain MRI -clear!
2014 January Added Taxotere to Perjeta+Herceptin.
2014 March Stopped chemo-chest ct-scan next.
2014- March Scans shows tumor's larger, CA2729 higher. Discontinue Herceptin.
2014 April Perjeta+ Halaven
2014 April CA2729 went down 60 points after one cycle. Cough does not want to go away.
2014 June Continue on Perjeta + Halaven-- no more cough. Stable
2014 June Back on Herceptin + abraxane
Last edited by Adriana Mangus; 06-05-2011 at 11:05 PM..
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06-18-2011, 09:32 AM
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#12
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Member
Join Date: Mar 2011
Location: Atlanta, Ga
USA
Posts: 6
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
This is great news, Chrisy! I am participating in the T-DM1 trial in Charleston, SC, traveling there from Atlanta every 3 weeks. Yesterday, I had my first scan after starting the trial. Good news! All tumors had either shrunk or remained stable. I had mixed feelings about the results, because the road trips had been more grueling than I had anticipated they would be when I signed on to the trial. And I was thinking that if the results were not good, that I could get a tried and true, although not as promising treatment AT HOME in Atlanta. But now that I've read your thread, I have hope of soon being able to get the T-DM1 treatments in Atlanta!!!!! I'm thrilled! Thank you so much for posting.
On a side note, for this treatment I was flown, for the first time, by Angel Flight Soars, a local nonprofit that flies patients to treatments all over the Southeast. It was a big improvement to driving.
Ann
__________________
5/05-2 lumpectomies, cancer in 3 sentinel nodes,
9 nodes removed. HER2+++, ER/PR-.
7/05-bilateral mastectomy, reconstruction from thighs.
Port placement in chest.
7/05 to 12/06-Chemo: A/C, Taxol, Herceptin. NED. Port removed.
12/05-silicone implant.
5/08-METS to liver, bones, nodes in chest wall & around kidneys. Power Port placed in chest. Chemo: Xeloda, plus Zomeda, Herceptin.
2/11-CT showed new tumors inside pelvic wall. Largest 2 cm.
4/11-CT shows largest tumor had grown to 3 cm. Started T-DM1 trial.
6/11-CT shows largest Tumor shrank. Others stable.
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09-16-2011, 04:30 PM
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#13
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Senior Member
Join Date: Oct 2005
Posts: 3,519
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
UPDATE as of today, 9/15/2011, from Genentech:
Genentech would like to provide an update on the protocol amendment to the T-DM1 patient access study (called T-PAS or TDM4884g) that may allow some patients enrolled in the study to receive T-DM1 closer to their homes. We submitted the proposed amendment to the FDA on August 8, 2011, and have received no questions or concerns to date that would require re-evaluation or revision. As a result, we are proceeding with this amendment. All of the study sites involved have been informed, and the next step is for each site to approve and implement it within their own institutions.
The T-PAS protocol amendment provides T-PAS patients the option to enroll into another, ongoing Genentech/Roche study (called the “extension study” or TDM4529g), which, in essence, doubles the number of sites and locations where T-PAS patients can receive T-DM1.. This option is only available to patients currently enrolled in T-PAS. Transferring to one of the extension study sites is optional and available to patients who have completed at least six cycles (18 weeks) of treatment, are determined stable by their doctor (i.e., not progressing and tolerating T-DM1 without major side effects) and meet other required criteria for the TDM4529g study. Current T-PAS patients interested in receiving T-DM1 at a site closer to home should contact the T-PAS study coordinator at their current site. The study coordinator can help determine if one of the extension study sites is closer and begin the transfer process to the new site. Since the amendment requires IRB approval at each of the original T-PAS and extension study sites, some sites may be able to accommodate the transfer of T-PAS patients more quickly than others.
People not enrolled in T-PAS but still interested in T-DM1 should talk to their doctor about their eligibility for the other T-DM1 studies currently enrolling patients.
__________________
Brenda
NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)
Nov'03~ dX stage 2B
Dec'03~ Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~ Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~ micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~ micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg
Apr'07~ MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~ Started Tykerb/Xeloda, no WBR for now
June'07~ MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~ MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~ PET/CT & MRI show NED
Apr'08~ scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~ MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~ dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~ Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~ new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~ new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~ 25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.
"I would rather be anecdotally alive than statistically dead."
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09-19-2011, 07:49 AM
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#14
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Senior Member
Join Date: Jul 2011
Location: ottawa canada
Posts: 367
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Am attempting to look up terms for Criteria. Have footnoted each of below terms. hope the microsoft word footnoting program translates here as cut and paste. if it doesn't i will post the terms next post.
Inclusion Criteria:
• Histologically or cytologically documented breast cancer
• Locally advanced or metastatic breast cancer
• HER2-positive breast cancer documented as FISH-positive, IHC 3 + or CISH-positive by local laboratory assessment
• Prior treatment with an anthracycline and a taxane given in the neoadjuvant, adjuvant, or metastatic setting, or as treatment for unresectable locally advanced disease
• Prior treatment with capecitabine or infusional 5-fluorouracil and at least two HER2-targeted agents, including trastuzumab and lapatinib , in the metastatic and/or unresectable locally advanced setting
• Patients must have had disease progression during their most recent treatment regimen
• Adequate hematologic and end organ function
• Agreement to use an effective form of birth control throughout the study
• Life expectancy ≥ 90 days as assessed by the investigator
__________________
fall 2008: mammo of rt breast worrisome so am asked to redo mammo and have ultrasound of rt breast.I delay it til january 2009 and the results are "no cancer in rt breast. phew."
found plum sized lump in right breast the day before my dad died: April 17th 2011. saw it in mirror, while i was wearing a top, examining my figure after losing 10 lbs on dr. bernstein diet.
diagnosed may 10 2011
mast/lymphectomy: june 7 2011, 5/20 cancerous nodes. stage 3a before radiation oncologist during our first mtg on july 15th says he found cancer on the lymph node of my breast bone. Now stage 3b.
her2+++, EN-, PN-. Rt brst tumors:3 at onset, 4.5 cm was the big one
chemos: 3fec's followed by 3 taxotere, total of 18 wks chemo. sept: halfway thru chemo the mastectomy scar decides to open and ooze pus. (not healed before chemo) eventually with canasten powder sent by friend in ny (illegal in canada) it heals.
radiations:although scheduled to begin 25 january 2012, I am so terrified by it (rads cause other cancers) I don't start til february, miss a bunch, reschedule them all and finally finish 35 rads mid april. reason for 7 extra atop the 28 scheduled is that when i first met my rads oncologist he said he saw a tumor on the lymph node of my breastbone. extra 7 are special kind of beam used for that lymphnode. rads onc tells me nobody ever took so long to do rads so he cannot speak for effectiveness. trials had been done only on consecutive days so......we'll see.....
10 mos of herceptin started 6 wks into chemo. canadian onc says 10 mos is just as effective as the full yr recommended by dr. slamon......so we'll see..completed july 2012.
Sept 18 2012: reconstruction and 3 drains. fails. i wear antibiotic pouch on my job for two months and have 60 consecutive days visiting a nursing centre where they apply burn victims' silver paper and clean the oozing infection daily. silicone leaks out daily. plastic surgeon in caribbean. emergency dept wont remove "his" work. He finally appears and orders me in into an emergency removal of implant. I make him promise no drains and I get my way. No infection as a result. Chest looks like a map of Brazil. Had a perfectly good left breast on Sept 17th but surgeon wanted to "save another woman an operation" ? so he had crashed two operations together on my left breast, foregoing the intermediary operation where you install an expander. the first surgeon a year earlier had flat out refused to waste five hours on his feet taking both boobs. flat out refusal. between the canadian health system saving money and both these asses, I got screwed. who knows when i can next get enough time off work (i work for myself and have no substitute when my husband is on contract) to get boobs again. arrrgh.
I have a blog where I document this trip and vent.
www.nora'scancerblog.blogspot.com . I stopped the blog before radiation. I think the steroids made me more angry and depressed and i just hated reading it anymore
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09-19-2011, 07:50 AM
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#15
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Senior Member
Join Date: Jul 2011
Location: ottawa canada
Posts: 367
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
1. The anthracyclines include daunorubicin (Cerubidine), doxorubicin (Adriamycin, Rubex), epirubicin (Ellence, Pharmorubicin), and idarubicin (Idamycin).
2. Taxanes include paclitaxel (Taxol) and docetaxel (Taxotere). Paclitaxel was originally derived from the Pacific yew tree.
3. capecitabine: used in combination with docetaxel, after failure of anthracycline-based treatment. Also as monotherapy, if the patient has failed paclitaxel-based treatment, and if anthracycline-based treatment has either failed or cannot be continued for other reasons (i.e., the patient has already received the maximum lifetime dose of an anthracycline).
4. Fluorouracil (5-FU or f5U) (sold under the brand names Adrucil, Carac, Efudix, Efudex and Fluoroplex) is a drug that is a pyrimidine analog which is used in the treatment of cancer. It is a suicide inhibitor and works through irreversible inhibition of thymidylate synthase.
5. trastuzumab: also known as Herceptin
6. lapatinib: also known as Tykerb It has been approved as front-line therapy in triple positive breast cancer and as an adjuvant therapy when patients have progressed on Herceptin.[3]
__________________
fall 2008: mammo of rt breast worrisome so am asked to redo mammo and have ultrasound of rt breast.I delay it til january 2009 and the results are "no cancer in rt breast. phew."
found plum sized lump in right breast the day before my dad died: April 17th 2011. saw it in mirror, while i was wearing a top, examining my figure after losing 10 lbs on dr. bernstein diet.
diagnosed may 10 2011
mast/lymphectomy: june 7 2011, 5/20 cancerous nodes. stage 3a before radiation oncologist during our first mtg on july 15th says he found cancer on the lymph node of my breast bone. Now stage 3b.
her2+++, EN-, PN-. Rt brst tumors:3 at onset, 4.5 cm was the big one
chemos: 3fec's followed by 3 taxotere, total of 18 wks chemo. sept: halfway thru chemo the mastectomy scar decides to open and ooze pus. (not healed before chemo) eventually with canasten powder sent by friend in ny (illegal in canada) it heals.
radiations:although scheduled to begin 25 january 2012, I am so terrified by it (rads cause other cancers) I don't start til february, miss a bunch, reschedule them all and finally finish 35 rads mid april. reason for 7 extra atop the 28 scheduled is that when i first met my rads oncologist he said he saw a tumor on the lymph node of my breastbone. extra 7 are special kind of beam used for that lymphnode. rads onc tells me nobody ever took so long to do rads so he cannot speak for effectiveness. trials had been done only on consecutive days so......we'll see.....
10 mos of herceptin started 6 wks into chemo. canadian onc says 10 mos is just as effective as the full yr recommended by dr. slamon......so we'll see..completed july 2012.
Sept 18 2012: reconstruction and 3 drains. fails. i wear antibiotic pouch on my job for two months and have 60 consecutive days visiting a nursing centre where they apply burn victims' silver paper and clean the oozing infection daily. silicone leaks out daily. plastic surgeon in caribbean. emergency dept wont remove "his" work. He finally appears and orders me in into an emergency removal of implant. I make him promise no drains and I get my way. No infection as a result. Chest looks like a map of Brazil. Had a perfectly good left breast on Sept 17th but surgeon wanted to "save another woman an operation" ? so he had crashed two operations together on my left breast, foregoing the intermediary operation where you install an expander. the first surgeon a year earlier had flat out refused to waste five hours on his feet taking both boobs. flat out refusal. between the canadian health system saving money and both these asses, I got screwed. who knows when i can next get enough time off work (i work for myself and have no substitute when my husband is on contract) to get boobs again. arrrgh.
I have a blog where I document this trip and vent.
www.nora'scancerblog.blogspot.com . I stopped the blog before radiation. I think the steroids made me more angry and depressed and i just hated reading it anymore
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03-27-2012, 06:11 AM
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#16
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Member
Join Date: Mar 2012
Posts: 5
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
I'm meeting a specialist in Indianapolis tomorrow to discuss my candidacy for this TDM-1. Has anyone here been on this?
__________________
Dx: April 2008 HER2+ - Age 35
Bilateral Mast: April 2008
34 Lymph nodes removed 19+
3mos chemo> Carboplatin, Taxotere, Avastin & Neulasta
30 Rounds of radiation
Recurrence March 2010 - Fractured spine with disease; ovaries removed in May
6mos more chemo> Navelbine > more radiation which led to a weeks worth of hospitalization due to radiation enteritis
6 mos Tykerb and Fasoldex
Being sent to Indianapolis for clinical TDM-1
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03-27-2012, 12:30 PM
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#17
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Senior Member
Join Date: Nov 2010
Posts: 393
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
My wife, Lorraine, is doing great on it, just started her 17th month. You can see her on youtube ' FDA Blocks Life -Saving Cancer Drug ", Part 4. ( google the petition by the same title, sign and pass on ). While there , take a look at peter in Part 3. hes doing great on the pertuzumab/t dm-1/taxol trial. Where evryone gets t dm-1 . The next best trial is Theresa, becuase 2 out of 3 get t dm-1. The other trials are 50/50 .
If your cancer strongly overexpresses her 2, t dm-1 seems to work better. My wifes FISH Scale measurement of her2 was a 6.0, anything over 3.0 is considered significant.
There is a s/e of platelet drops. my wifes did, and she took a dose reduction from 3.6 to 3.0. Probably should have done it sooner . Her plats barely stabilized in time to stay in the Study. She got 7 doses at 3.6, now has had 11 at 3.0. Hinsight , maybe 4 -5 doses at 3.6 then dropping to 3.0.
We have not been afraid to speak up, to both Gen. top brass, our Partners Health care Insurers, FDA, Congress. pressure put on us to drop to the lowest dose , 2.4 , by Gen. top brass, even by our own doc, who we love, she had never used it, was nervous , . We refused , its Lorraines life, and we want the strongest dose , until its approved, becuase of the rules. We wrer right ! with 3.0 every 3 weeks, plats slowly stabilized at 65,000 -80,000, slowly rising . And most importantly , the cancer shrunk away. No sign of it on CT's since November !
Another consequence of This FDAs' bureaucratic, political , denial of approval , is that pts continue to be forced into trials with rigid dosing rules ( once you reduce you cant go back up ), and timing ( more than 6 weeks betw. doses, and you may get dropped ). So the s/e of platelet drop is made worse by This FDA ! I know this may sound scary, but want people to be informed. It is a great , breakthrough Drug for metastatic her2 . !! QOL is awesome ! Good luck !
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03-27-2012, 01:57 PM
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#18
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Member
Join Date: Mar 2012
Posts: 5
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Thanks for the info, Phil. Do you have a link? I can't find it on youtube!
__________________
Dx: April 2008 HER2+ - Age 35
Bilateral Mast: April 2008
34 Lymph nodes removed 19+
3mos chemo> Carboplatin, Taxotere, Avastin & Neulasta
30 Rounds of radiation
Recurrence March 2010 - Fractured spine with disease; ovaries removed in May
6mos more chemo> Navelbine > more radiation which led to a weeks worth of hospitalization due to radiation enteritis
6 mos Tykerb and Fasoldex
Being sent to Indianapolis for clinical TDM-1
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03-27-2012, 05:57 PM
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#19
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Senior Member
Join Date: Nov 2010
Posts: 393
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
Try http://www.youtube.com/watch?v=JlsrTqwUL6g
I google : " FDA Blocks Life -Saving Cancer Drug Rally "
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05-08-2012, 08:50 AM
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#20
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Senior Member
Join Date: Mar 2012
Location: New York, new york
Posts: 73
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Re: TDM1 EAP - Good news for those in TDM1 EAP study who need to travel
How do you get on trials? I was on Herceptin for 9 months now stopped working...Tumor markers rapidly rising 86 now..started tykerb 1500 with Herceptin, not working..PET scan proved everything doubled in size.....
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