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Old 07-18-2012, 09:58 AM   #1
MikeF
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Location: Shelby, N.C.
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Anxiously Waiting

Apparently Barbs doctor has called Genentech and asked for compassionate access to TDM-1. They have responded with an OK to give her the drug so now we are waiting for the hospital treatment center here and Genentech to hammer out the details. We are told there is a lot of paper work, Barb will be the first patient to receive the drug here. My only concern at this point is the financial end, were not sure what to expect. Is there any experience out there with compassionate use of TDM-1? How does most insurance handle this? I dont want to call my insurance company just yet they have been known to slam the door on us in the past.
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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Old 07-18-2012, 11:03 AM   #2
schoonder
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Re: Anxiously Waiting



Are there costs associated with expanded access, sometimes called "compassionate use"?

Investigational drugs are expensive to manufacture. Some companies provide the drug for free to patients. Other companies charge patients costs associated with the manufacture of the drug. Most insurance companies will not pay for access to an investigational drug. In addition, there may be additional costs associated with administration and monitoring of the investigational drug by healthcare professionals.

http://www.fda.gov/ForConsumers/ByAu.../ucm176098.htm

It's probably wise to discuss who will carry burden of cost for treatment with Genentech.
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Old 07-18-2012, 04:22 PM   #3
KDR
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Re: Anxiously Waiting

Mike, that's a win! Yes! Please keep us posted on your progress, and I hope Barb is feeling well. You wrote an incredibly moving post on "Who We Are." You really need this break.
Warmly,
Karen
__________________
World Trade Center Survivor (56th Floor/North Tower): 14 years and still just like yesterday.
Graves Disease, became Euthyroid via Radioactive Iodine, June 2001.
Thyroid Eye Disease. 2003. Decompression surgery in 2009; eyelid lowering surgery in 2010.
Diagnosed: June 2010, liver mets. ER-/PR+10%; HER2+++.
July 2010: Begin Taxol/Herceptin. Eliminate sugar from diet. No surgery or radiation.
January 2011: NED
April 2011: Progression in liver only. Other previous affected areas eradicated. Stop Taxol/Herceptin after 32 infusions.
May 2011: Brain MRI: clear.
May 2011: Begin Tykerb daily, Xeloda twice per day for one week on, one week off, and Herceptin.
November 2011: Progression in liver. All other tumors remain eradicated.
December 2011: BEGIN TRIAL #09-093 Taxol, MCC-DM1 (T-DM1), Perjeta.
Trial requires scans every six weeks, bloodwork and infusions weekly.
Brain MRI: clear.
January 2012: NED. Liver mets, good riddance!
March 2012: NED. Developed SMA (rare blood clot) in intestinal artery and loss of sight in right eye due to optical nerve neuropathy. Resolved when Taxol removed this month.
Continue Protocol of T-DM1 weekly and Perjeta every 3 weeks.
May 2012: NED.
June 2012: Brain MRI: clear.
June-December 2012: NED.
December 2012: TRIAL CONCLUDED; ENTER TRIAL EXTENSION #09-037. CT, Brain MRI, bone scan: clear. NED.
January-March 2013: NED.
June 2013: Brain MRI: clear. CEA upticking; CT shows new met on liver.
July 3, 2013: DISASTER STRIKES during liver ablation: sloppy surgeon cuts intercostal artery and I bleed out, lose 3.5 liters of blood, have major hemothorax, and collapsed lung requiring emergency resuscitative thoracotomy, lung surgery, rib rearrangement and cutting deep connective tissue, transfusion. Ablation incomplete. This life-saving procedure would end up causing me unforgiving pain with every movement I make, permanently, otherwise known as forever.
July 26, 2013: Try Navelbine/Herceptin. Body too weak after surgery and transfusion. Fever. CEA: Normal.
August 16, 2016: second dose Navelbine/Herceptin; CEA: Normal. Will skip doses. Watching and waiting.
September 2013: NED, Herceptin only. CEA: Normal. Started Arimidex.
October-November 2013: NED. Herceptin and Arimidex. CEA, CA125, 15-3: Normal.
December 2013: Something brewing. PET lights up on little spot on liver; CEA upward trend, just outside normal. PET and triphasic liver scan confirm Little Met. Restart Perjeta with Herceptin, stay on Arimidex. Genomic sequencing completed for future treatments, if necessary.
January 2014: Ablate Little Met on the 6th. Happy New Year.
March 2014: Brain MRI: clear. PET/CT reveal liver mets return; new lung mets. This is not funny.
March 2014: BEGIN TRIAL #10-005 A(11)-Temsirolimus plus Neratinib.
April 2014: Genomic testing indicated they could work, they did not. Very strange drug combo for me, felt weird.
April 2014: Started Navelbine and Herceptin. Needed something tried and true, but had significant progression.
June 2014: Doxil and Herceptin.
July 2014: Progression. Got nothing out of it. Brain: NED.
July 2014: Add integrative medical hematologist-oncologist to my team. Begin supplements. These are tumor-busting, immune system boosters. Add glutathione, lysine and taurine IV infusions every three weeks.
July 2014: Begin Gemzar, Herceptin & Perjeta. Happy.
August 2014: ECHO perfect.
January 2015: Begin weekly Vitamin D Analog infusions. 25 mcg. via port.
February 2015: CT: stable.
April 2015: Gem working, but not 100%. Looking into immunotherapy. Finally, treatments for the 21st century!
April 2015: Penn Medicine. Dendritic cell immunotherapy.
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Old 07-18-2012, 04:35 PM   #4
hutchibk
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Re: Anxiously Waiting

I/insurance doesn't pay Genetech for the drug for compassionate use to the best of my knowledge, Genetech pays to administer it and collect data... I am only responsible for travel (I go from TX to CO every 3 weeks) and insurance is responsible for scans (every 12 weeks I have to get a CT of neck down and an Echocardiogram of the left ventricle - LVEF, done by my cardiologist... it has to record above 50%).

Best of luck.
__________________
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; 07-20-2012 at 07:02 AM..
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Old 07-18-2012, 05:50 PM   #5
ElaineM
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Wink Re: Anxiously Waiting

Keeping my fingers crossed for you !!
__________________
Peace,
ElaineM
12 years and counting
http://her2support.org/vbulletin/showthread.php?t=48247
Lucky 13 !! I hope so !!!!!!
http://her2support.org/vbulletin/showthread.php?t=52807
14 Year Survivor
http://her2support.org/vbulletin/showthread.php?t=57053
"You never know how strong you are until being strong is the only choice you have." author unknown
Shared by a multiple myeloma survivor.
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Old 07-19-2012, 05:11 AM   #6
Sheila
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Re: Anxiously Waiting

Mike, when I was on the TDM1 EAP, Indid not pay for anything except my scans, I did have to sign aa lot of paperwork, and was monitored quite closely...even my LVEF was below 50 but the Dr persisted and Iwas still able tomet the drug...hoping you get it soon with no issues, and that it is the perfect drug!
__________________
"Be kinder than necessary, for everyone you meet
is fighting some kind of battle."



Hugs & Blessings
Sheila
Diagnosed at age 49.99999 2/21/2002 via Mammography (Calcifications)
Core Biopsy 2/22/02
L. Mastectomy 2/25/2002
Stage 1, 0.7cm IDC, Node Neg from 19 nodes Her2+++ ER PR Neg
6/2003 Reconstruction W/ Tissue Expander, Silicone Implant
9/2003 Stage IV with Mets to Supraclavicular nodes
9/2003 Began Herceptin every 3 weeks
3/2006 Xeloda 2500mg/Herceptin for recurrence to neck nodes
3/2007 Added back the Xeloda with Herceptin for continued mets to nodes
5/2007 Taken Off Xeloda, no longer working
6/14/07 Taxol/Herceptin/Avastin
3/26 - 5/28/08 Taxol Holiday Whopeeeeeeeee
5/29 2008 Back on Taxol w Herceptin q 2 weeks
4/2009 Progression on Taxol & Paralyzed L Vocal Cord from Nodes Pressing on Nerve
5/2009 Begin Rx with Navelbine/Herceptin
11/09 Progression on Navelbine
Fought for and started Tykerb/Herceptin...nodes are melting!!!!!
2/2010 Back to Avastin/Herceptin
5/2010 Switched to Metronomic Chemo with Herceptin...Cytoxan and Methotrexate
Pericardial Window Surgery to Drain Pericardial Effusion
7/2010 Back to walking a mile a day...YEAH!!!!
9/2010 Nodes are back with a vengence in neck
Qualified for TDM-1 EAP
10/6/10 Begin my miracle drug, TDM-1
Mixed response, shrinking internal nodes, progression skin mets after 3 treatments
12/6/10 Started Halaven (Eribulen) /Herceptin excellent results in 2 treatments
2/2011 I CELEBRATE my 9 YEAR MARK!!!!!!!!!!!!!
7/5/11 begin Gemzar /Herceptin for node progression
2/8/2012 Gemzar stopped, Continue Herceptin
2/20/2012 Begin Tomo Radiation to Neck Nodes
2/21/2012 I CELEBRATE 10 YEARS
5/12/2012 BeganTaxotere/ Herceptin is my next miracle for new node progression
6/28/12 Stopped Taxotere due to pregression, Started Perjeta/Herceptin
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Old 07-19-2012, 09:22 AM   #7
MikeF
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Location: Shelby, N.C.
Posts: 114
Re: Anxiously Waiting

Now were told it will take 6 weeks to get the TDM-1 under compassionate use at our location. Apparently the drug has never been administered here so there are some hoops that have to be jumped through. I cant imagine us sitting back for six weeks and doing nothing. Her doctors office went so far as to recommend looking into the Th3resa Study but my understanding is Barbs enrollment in the Emelia study last year would exclude her even though she technically did not participate because she was randomly assigned the Tykerb leg and we already had a script for the Tykerb. We decided to not get the Tykerb filled because it would have excluded her from the Emelia Study. It really is ridiculous to have to go through all this to get a drug that could really help. I was also told by an administrator at the hospital that if we pursue the Trial she would be excluded from further compassionate use. So if I understand all the crap they have thrown at us today we have no choice but to sit and wait 6 weeks for compassionate use.
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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Old 07-19-2012, 09:28 AM   #8
Ellie F
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Join Date: Feb 2009
Posts: 1,526
Re: Anxiously Waiting

Mike
Just wanted to say how sorry I am to hear that you will have 6 more anxious weeks to wait till you get this drug. It is soul destroying that we have to jump through numerous hoops to get potentially life saving drugs,it's just so unfair.
Please try and not let this blip grind you down.
Ellie
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Old 07-19-2012, 07:58 PM   #9
sassy
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Re: Anxiously Waiting

Mike,

I see you are in Shelby NC. Where are you receiving treatment?
__________________
Rhonda (Sassy)
dx age 45
DX 2/15/05 Stage IIb (at surgery)restaged IIIa
Left mast .9cm tumor 5 of 14 nodes
Triple Positive
4 DD A/C
12 Taxol/Herceptin
33Rads
Strange infect mast site one year aft surg, hosp 1 wk
Herceptin for total of 18 months
Lupron Monthly 4 yrs
Neurontin for aches, pains and hot flashes(It works!)
Ovaries removed 11/09 stop Lupron and Neurontin
Arimidex 6 yrs (tried Femara, no SE improvement)
Tried Exemestane-hips got so bad could hardly walk
Back to Arimidex for year seven
Zometa 2X Annual for 7years, Lasix
Stop Arimidex 5/13
Stop Zometa 7/13-Bi-lateral Stress Fractures in Femurs from Zometa
5/14 Start Tamoxifen
3/15 Stem cell transplant to stimulate femur bone growth/healing
5/15 Complete fracture of right femur/Titanium rods both femurs
9/16 Start Evista stopTamoxifen
3/17 Stop Evista--unwelcome side effects!
NED and no meds.......
14YEARS NED!
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Old 07-20-2012, 07:06 AM   #10
hutchibk
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Re: Anxiously Waiting

If she is on Tykerb, like your signature shows, then there would be a washout period anyway from the Tykerb? Ask your Onc about this while you are waiting for your location to be set up. There may be a silver lining...
__________________
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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Old 07-22-2012, 10:15 PM   #11
Pray
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Posts: 1,173
Re: Anxiously Waiting

Mike and Barb you are in my prayers. Gods blessings to you. Peace
__________________
dx 11/12/09 IDCI
Stage 3a
ER 98% PR 80%
Her2 +3
4/12 nodes
6 rounds TCH
Herceptin 12 months 3weeks
Rad. 30 tx
Tamoxifin 6 months stopped
Arimedex stopped 9/12 (side effects)
Aromasin 10/12
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Old 07-24-2012, 05:36 AM   #12
MikeF
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Posts: 114
Re: Anxiously Waiting

Talked to the Hospital coordinator and the Onco Nurse were still waiting for the final word. Apparently this drug has never been administered here so theres a lot of hoops to jump through. Barbs Onco. was under the impression there was a three week clean out period so she hasnt had anything since the end of June. The three week clean out appears to apply to clinical trials Emelia and Th3resa. Compassionate access doesnt require this. She will start back on the Navelbine and Herceptin till the TDM-1 comes in were told possible another week or two.
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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Old 08-01-2012, 05:52 PM   #13
schoolteacher
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Location: Georgia
Posts: 1,486
Re: Anxiously Waiting

Mike,

I wanted to let you know that papers for me to cross over to TDM1 were waiting for me two weeks ago when I went to the oncologists. Women who got the Xeloda and Tykerb are be considered to get the drug now. Something was said about data in October and the medicine in December. I need the medicine sooner. Please let me know if you hear anything about this.

Amelia
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Old 08-01-2012, 07:18 PM   #14
hutchibk
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Posts: 3,519
Re: Anxiously Waiting

See if Sonali at Genentech has any info for you... she is a patient advocate and extremely helpful.

Sonali Padhi, MBA, MPH
Associate Director, Advocacy Relations
Genentech, Inc.
Office: 650.467.0842
Mobile: 415.269.7040
sonalip@gene.com
__________________
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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Old 08-02-2012, 06:59 AM   #15
phil
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Join Date: Nov 2010
Posts: 393
Re: Anxiously Waiting

My wife is doing excellent on t dm-1 , in her 21st month. wirks best in straight up high her2 overexpression, but may not work as well w/ other hormone factors mixed in , ER + for ex.
My understanding is that Gen. pays for the drug itself in comp use, but ins, must pay for scans, labs etc.
If you are in NC, are you near Duke ? Thats where the principal investigator for EMILIA, Dr. Kim Blackwell, did her work. So thyey may do comp use quicker.
If you are in NC, call your Sen Hagans office , ask for the aide who works w/ healthcare issues, and call their counterpart in thier DC office. She seems to be intersted in helping cancer pts , is sponsoring a Bill , the TREAT ACT , to overhaul FDA approval process. She is on HELP Committee , which oversees FDA. Remember, if This FDA had done its job in 2010, T DM-1 would have been approved then. And we wouldnt be in this struggl;e. Put in a word for us as activists w/ Sen Hagan. my wife , Lorraine , and I, Phil McCartin, are well known by our senators staff, Sen. Kerry, ( megan thompson ) Sen. Brown ( chris holt ) . We have asked thier staff to arrange for us to meet w/ Sen hagan about her Bill. But we are not from her home state , so its dragging out . Good luck. have your Sen. push your hospital IRB too , ( internal review board , who approve " off protocol ", and comp use at thier facility ), and push your ins co , if they give you trouble . We had our Sen offices call Gen. , and later our hospital IRB , it helps to let Big Business, Big Govt, Big Hospitals, and Big Ins , know that they are being watched for thier roles in the War On Cancer . think about contacting media too, to expose the awful hassles that curent comp use bureaucracy causes us.
So if your hosp[ital drags it out much more, maybe sw itch to a research hosp like Duke ? if your wife hasnt been on navelbine before, it worked for my wife for about 9 months, ( tykerb worked for about 6 months , s/e were bad, i think comp use may only require a2 week washout ?, and i dont hink using tyk or nav precludes comp use ? , not sure ). good response w/ Nav. or Tyk gets you closer to the t dm-1 approval time-frame . Maybe by Dec. We activists will continue to Push This FDA to make it evn quicker .
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Old 08-03-2012, 12:17 PM   #16
MikeF
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Re: Anxiously Waiting

Brenda;
I talked to Sonali today she was very helpful, I also heard from our hospital. Barb had an echo done this afternoon this was needed for the FDA approval of comp. use. They are telling us if all goes well we should see the drug sometime next week. Barb has had several echos done in the last two years and has had no problems at all. Hopefully we will get good news next week.
Phil
Thanks for your response I will see what I can do to talk to Kay Hagan I really appreciate all you have done and continue to do for this cause. I wish I could be as proactive as you have been it just seems like I get paralyzed at times and dont know where to turn.
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Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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Old 08-03-2012, 02:30 PM   #17
Pray
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Re: Anxiously Waiting

Mike you are doing an awesome job taking great care of your wife? Your great love for her shines through every post you write! God, love knowledge and support is your best defense. Awesome!

Barb and you are in my prayers. Gods blessings to your beautiful family.

Peace my friend,

Nancy
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dx 11/12/09 IDCI
Stage 3a
ER 98% PR 80%
Her2 +3
4/12 nodes
6 rounds TCH
Herceptin 12 months 3weeks
Rad. 30 tx
Tamoxifin 6 months stopped
Arimedex stopped 9/12 (side effects)
Aromasin 10/12
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Old 08-04-2012, 05:09 AM   #18
phil
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Re: Anxiously Waiting

We are so happy that your wife gets a shot at this wonderful drug ! I will never forget the look on our onc's face when she came back from San Antonio 's Conference in 2009 ! 2009 ! saying ' this could be a home run ' for pts w/ strong overexpression of her 2. For Lorraine , she was exactly right so far ! For me, I was ready to get it. my first wife and i talked our way into atrial in 90. so i already had some experience w/ the "System ". So i looked into comp use, called FDA in Spring , 2010. What arude awakening ! N0 help whatsoever. So we tried to get it at farber. All set to go ; FDA pulled the rug out in Sept 2010 ! talked w/ anurse at farber. Nurses tell it like it is, they dont have to kiss This FDA or Big Business you know what , like the Silent docs in this country. Again , i'll never forget the look on Lorraines face after talking w/ the nurse. Tough Southie RN, Said " Honey , we share trial slots w/ 3 other hospitals, it could be months . If you have to go to Va to get this drug , GO , GET THE DRUG ! " The tone of voice said it all ! So there we were in DC, down the street from Cap Hill. Give Lorraine the credit, still suffering fro another battle w/ adria, riding the chilly subway to the Hill. You should have seen the look on the Senate aides faces when they heard her story ! Your story has Power . You t dm-1 success stories need to Meet them , tell your story to media, Congress. Mike , right now your job is to fight for your wife and family, you will tell your story later , im sure . God Bless ! You have our Prayers for more Healing , Blessings !
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Old 08-04-2012, 10:05 AM   #19
hutchibk
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Re: Anxiously Waiting

Wonderful Mike... glad Sonali was able to help you!
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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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Old 08-08-2012, 09:02 AM   #20
MikeF
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Re: Anxiously Waiting

Heres the latest on Barbs situation, we met with her Dr. Monday afternoon. Right now the FDA is asking for a written statement from Genentech stating Barb may have the TDM-1. We already know the Dr. has talked to Genentech and they said yes but apparently thats not prim and proper to the FDA GRRRRR. We also learned that Barbs white count is slightly low so if we had the TDM-1 today she couldnt have it and her Dr. will be out of town for 1 week next week so it will be at least the 20th before she can get TDM-1 if all goes well. Shes scheduled for Navelbine next week after a week off but were told if the TDM-1 is approved to pass on the Navelbine and clean out so she can have the good stuff when he gets back.
__________________
Diag. Aug. 2010
ER- PR- Her-2 +++ Stage IV
Mets to T 6th Vertabrae
Radiation to spine
10/23/10StartNavelbine
11/19/10 Port installed
11/22/10 Started 2nd cycle
1/10/11 Finished 2nd cycle
1/24/11 Herceptin Only
3/7/11 progression, start Taxol/Herceptin
4/18/11 Skin mets appear increase treatments to weekly
rash spreads to right breast
7/5/11 enroll in TDM-1 study
7/29/11 randomly assigned Tykerb drop out of trial and start Tykerb /Herceptin no Xeloda skin mets gone Tykerb working
1/31/12 Skin mets return add Xeloda
5/9/12 Stop Tykerb skin mets back
5/17/12 Return to Navelbine/Herceptin
6/26/12 start process for TDM-1 compassionate access
8/28/12 Start TDM-1
10/9/12 third TDM-1 no response yet
10/23/12 Start Haloven
1/17/12 Start Perjeta/ Herceptin/Taxotere
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