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Old 01-15-2009, 07:38 AM   #1
BearMan52
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Avastin, Her2, and insurance

Hey Gang,
We're needing to make a treatment switch in our recurrence battle. Have been on Taxotere/Carbo/Herceptin; Navelbine/Herceptin; Xeloda/Tykerb; Femara; with Zometa throughout.

What we planned next was Abraxene/Avastin, but our insurance (Anthem-BC/BS) denied the Avastin for two reasons:
1. no study data available for Avastin in Her2-positive (which we obviuosly are)
2. we're not using it as our first line

Any help? I see many on these boards have been on Avastin. Obviously some companies approved its use for Her2-pos?? And I'm wondering if anyone else had to fight for it.

Thanks for any help!
Barry
Caregiver Husband
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Old 01-16-2009, 01:32 PM   #2
chrisy
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Hi Barry,

The FDA approved indication for Avastin is, as you probably know, for first line. However many people have been able to get it - Sheila has been on Taxol/Avastin (her BCBS denied the Abraxane!) but I think that was just prior to the FDA approval. At any rate, it was "off label" when she got it.

I'm curious as to why no Her2 targeting agent is included in your proposed therapy?

This was a poster presented at San Antonio showing efficacy/safety of Avastin/Tykerb in Her2+ patients. I was on this study and did OK (stable for 8 months), but I know others here were on the same study until it closed and it was a very successful therapy.

More research is ongoing I'm sure, and there may be other data out there in other scenarios, but for your purposes this may serve as a small rebuttal to the "no study data available for Avastin in Her2+" excuse.

http://www.posters2view.com/sabcs08/viewp.php?nu=3133

Good luck, keep up the fight!
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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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Old 01-16-2009, 03:19 PM   #3
BearMan52
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Hi Chrisy,
Thanks much for the info...and some rebuttal ammo. Re. any Her2 targeted therapy at present, our doc is thinking we've burned through Herceptin and Tykerb, at least for now. Herceptin was in the regimen for a year, then Tykerb another year. Each did the trick for awhile, but then some progression. I do wonder about any adjuvant advantage---keeping the cancer from any new fronts, with the Her2 therapies.
Thanks!
Barry
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Old 01-16-2009, 03:31 PM   #4
Joe
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Barry,

You may wish to consider entering a clinical trial of Herceptin DM1. Several members are having great results and you will not be charged for the drug.

Clinical Trials

Regards
Joe
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Old 01-16-2009, 09:37 PM   #5
BearMan52
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Joe,
I'll give that a look...thanks much!
Barry
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Old 01-17-2009, 10:57 AM   #6
Sheila
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Barry
My insurance denied the Abraxane as it was too expensive , then denied the Avastin when they realized they were paying for something that wasn't approved by the FDA for breast cancer....I had excellent results from the combo of Taxol Avastin, Herceptin, but my Blood Pressure just kept on rising even with the addition of B/P meds...so best that I went off it...just a FYI...i have been on herceptin 5 1/2 years, 3 with chemo added...when i show progression in my nodes, they change the chemo and keep the Herceptin...so far still fighting!
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"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 01-17-2009, 09:13 PM   #7
BearMan52
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Hi Sheila,
Thanks for the info! That's interesting to hear about staying on Herceptin, even with progression. I like that idea...it makes sense. Thanks muhc!
Barry
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Old 01-18-2009, 10:16 PM   #8
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Hi Barry,

There have been studies showing that continuing Herceptin beyond progression improves survival. I believe that one of these studies may be in the abstracts from San Antonio. If it is not there, then it was probably presented at Asco.

Sorry, but I have no insight on your insurance question. But I would ask about continuing either Herceptin or Tykerb.

Best regards,


Jill
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Old 01-26-2009, 10:55 AM   #9
julierene
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An Open Label, Multicenter Extension Study of Trastuzumab-MCC-DM1 (T-DM1) in Patients Previously Treated With T-DM1 in a Genentech Sponsored T-DM1 Study

I am so confused! What is this study?
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Jan04: Bilateral Mastectomy at age 28
Initial DX: Left Breast: IDC 2cm, Grade 3, HER2+3, 0 Nodes +, ER/PR-. Right Breast: Extensive DCIS ER-/PR+; Stage 1-2a
Feb04-Apr04: 4 AC, dose dense
Aug 04: 4 Taxotere
Dec 05: Bone and Liver METS; Stage 4. Carboplatin/Taxol/Herceptin. DX with Li-Fraumeni Syndrome
Apr 06: NED, maintenance Herceptin
Apr 07: CA1503=14; masses in liver; Xeloda/Tykerb
Nov 07: NED, Tykerb maintenance
Sept 08: Liver mets again, on Tykerb/Xeloda again, CA=19 and 27
Nov 08: Progression, Tykerb/Gemzar, CA=25
Dec 08: Progression, Herceptin/Navelbine, CA=40, 57, and 130
Jan 09: Progression in bone, recession in liver, Herceptin/Carbo/Abraxane CA=135
June 09: CA27/29=24, chemo break
Sept 09: Progression, CA=24, waiting on clinical trial (4 weeks no treatment)
Nov 09: now have brain mets, trial "on hold", getting 14 WBR treatments starting 11/2/09
Dec 09: possible start on p53 trial
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Old 01-26-2009, 05:33 PM   #10
chrisy
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Julierene
This is a study to follow people who have "completed" a previous trial with T-DM1. This new study is to enable them to continue to follow these patients - I think the endpoints are time to progression and ocurrence of significant adverse events.

For example if you were on a T-DM1 study that had a protocol of you being treated for 1 year, when you complete the year you could roll over into the new study.
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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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Old 01-27-2009, 07:03 AM   #11
julierene
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Thanks for the information! That makes sense now.

I am actually getting ready to have the same problem likely with Blue Cross. I sure hope not. But will they rule any different here in Texas? My oncologist is warning me that it will be a fight to get Avastin. But my monthly scan is tomorrow and I hope to God there are some good results, or I will be fighting for the Avastin. What recourse do we have against the insurance company? Are there organizations out there who will pay for this? In my situation, I am running out of approved treatments. I can't afford to get in a trial and run to different cities and states. I have 3 children and I just feel like I will be out of options soon. Ugh!
__________________
Jan04: Bilateral Mastectomy at age 28
Initial DX: Left Breast: IDC 2cm, Grade 3, HER2+3, 0 Nodes +, ER/PR-. Right Breast: Extensive DCIS ER-/PR+; Stage 1-2a
Feb04-Apr04: 4 AC, dose dense
Aug 04: 4 Taxotere
Dec 05: Bone and Liver METS; Stage 4. Carboplatin/Taxol/Herceptin. DX with Li-Fraumeni Syndrome
Apr 06: NED, maintenance Herceptin
Apr 07: CA1503=14; masses in liver; Xeloda/Tykerb
Nov 07: NED, Tykerb maintenance
Sept 08: Liver mets again, on Tykerb/Xeloda again, CA=19 and 27
Nov 08: Progression, Tykerb/Gemzar, CA=25
Dec 08: Progression, Herceptin/Navelbine, CA=40, 57, and 130
Jan 09: Progression in bone, recession in liver, Herceptin/Carbo/Abraxane CA=135
June 09: CA27/29=24, chemo break
Sept 09: Progression, CA=24, waiting on clinical trial (4 weeks no treatment)
Nov 09: now have brain mets, trial "on hold", getting 14 WBR treatments starting 11/2/09
Dec 09: possible start on p53 trial
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Old 01-27-2009, 07:35 AM   #12
Joe
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Insurance Problems

To all:

I cannot recommend highly enough the Cancer Legal Resource Center .

Although they are located in Los Angeles, they assist cancer patients throughout the country and are pro-bono

Regards
Joe
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Old 03-26-2009, 06:40 AM   #13
julierene
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Avastin was approved, and will be next for me with Ixempra. After telling my onc that I had a very large area of red, warm skin above where my tumor was - he felt even more confident that my cancer will respond well to Avastin. I am getting pretty nervous. I just got my CT results, and the radiologist thinks the cancer is slightly increased because of the density. According to the scan two months ago, things look denser. But I just had a tumor marker drop 50 points a month ago. So the oncologist is crossing his fingers for a good tumor marker result by Friday. He said if it's dowm, then the denser look on the CT is from necrosis. Man, I am on pins and needles!
__________________
Jan04: Bilateral Mastectomy at age 28
Initial DX: Left Breast: IDC 2cm, Grade 3, HER2+3, 0 Nodes +, ER/PR-. Right Breast: Extensive DCIS ER-/PR+; Stage 1-2a
Feb04-Apr04: 4 AC, dose dense
Aug 04: 4 Taxotere
Dec 05: Bone and Liver METS; Stage 4. Carboplatin/Taxol/Herceptin. DX with Li-Fraumeni Syndrome
Apr 06: NED, maintenance Herceptin
Apr 07: CA1503=14; masses in liver; Xeloda/Tykerb
Nov 07: NED, Tykerb maintenance
Sept 08: Liver mets again, on Tykerb/Xeloda again, CA=19 and 27
Nov 08: Progression, Tykerb/Gemzar, CA=25
Dec 08: Progression, Herceptin/Navelbine, CA=40, 57, and 130
Jan 09: Progression in bone, recession in liver, Herceptin/Carbo/Abraxane CA=135
June 09: CA27/29=24, chemo break
Sept 09: Progression, CA=24, waiting on clinical trial (4 weeks no treatment)
Nov 09: now have brain mets, trial "on hold", getting 14 WBR treatments starting 11/2/09
Dec 09: possible start on p53 trial
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Old 03-26-2009, 07:08 AM   #14
BearMan52
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Julierene,
We KNOW those pins and needles...interesting about the red, warm skin and the Avastin connection.

We ended up getting a compassionate release from Genentech, but meanwhile were having good results from Abraxene alone, so we've stayed single-agent for now and will add Avastin if it looks like we need to add an extra punch.

Praying/hoping for a good tumor marker result on Friday!
Barry
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Old 03-26-2009, 08:36 AM   #15
julierene
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My onc said that Avastin and Herceptin wouldn't be approved b/c there wasn't enough data to support that it would even be well tolerated. He said the insurance co's wouldn't shell out $10K a week on a treatment that likely wouldn't do any better by seeing what they do by themselves. He said either Tykerb works or it doesn't. Either Herceptin works or it doesn't. Either Avastin works or it doesn't. Is it really that simple? He said if Herceptin doesn't work anymore, why keep taking it? I said, what about synnergy? He said if the receptors are killed off, the medicine won't work anymore... period.
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Jan04: Bilateral Mastectomy at age 28
Initial DX: Left Breast: IDC 2cm, Grade 3, HER2+3, 0 Nodes +, ER/PR-. Right Breast: Extensive DCIS ER-/PR+; Stage 1-2a
Feb04-Apr04: 4 AC, dose dense
Aug 04: 4 Taxotere
Dec 05: Bone and Liver METS; Stage 4. Carboplatin/Taxol/Herceptin. DX with Li-Fraumeni Syndrome
Apr 06: NED, maintenance Herceptin
Apr 07: CA1503=14; masses in liver; Xeloda/Tykerb
Nov 07: NED, Tykerb maintenance
Sept 08: Liver mets again, on Tykerb/Xeloda again, CA=19 and 27
Nov 08: Progression, Tykerb/Gemzar, CA=25
Dec 08: Progression, Herceptin/Navelbine, CA=40, 57, and 130
Jan 09: Progression in bone, recession in liver, Herceptin/Carbo/Abraxane CA=135
June 09: CA27/29=24, chemo break
Sept 09: Progression, CA=24, waiting on clinical trial (4 weeks no treatment)
Nov 09: now have brain mets, trial "on hold", getting 14 WBR treatments starting 11/2/09
Dec 09: possible start on p53 trial
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Old 03-26-2009, 11:00 AM   #16
Ellie F
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Hi can anyone explain what Julierene's onc meant about receptors being killed off. My new onc is very enthusiastic about synergy but I have never heard about the her2 receptors going.Does this happen if you have many different drug combos or just a particular drug. Anyone got info on this??Ellie
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Old 03-26-2009, 12:55 PM   #17
julierene
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I think it's just the theory that Herceptin and Tykerb block all the receptors, the immune system kills off all those cells, then you are left with whatever is left. They theorize that at microscopic levels, you can have many different types of cells, some having less receptors than others. Once you have effectively cleared out all the cancer with receptors, you can end up with cells that have different receptors. As receptors change to evade the immune system, so does the nature of the cancer. It's like the part of the cellular structure that works against people who have cancer. In normal healthy cells, this process is survival. But the natural programmed cellular structure, is now cancerous, and working against what we want. That's why Tykerb works when Herceptin fails. It's a new way to target when the receptors on the outside of the cell seem to not respond to Herceptin anymore. Then when Tykerb clears out the receptors that are on the inside, then there are cells left that don't respond to either... At that point, you start running out of targeted therapies. Avastin is a monoclonal antibody against vascular endothelial growth factor-A (VEGF-A).[1] It is used to inhibit tumor growth by blocking the formation of new blood vessels (angiogenesis). Since HER2 disease has shown trend to being very vascular, this makes sense. P53 targeted therapy also makes a lot of sense. But figuring out whichever direction you go after Tykerb and Herceptin fail, is a mystery to me.
__________________
Jan04: Bilateral Mastectomy at age 28
Initial DX: Left Breast: IDC 2cm, Grade 3, HER2+3, 0 Nodes +, ER/PR-. Right Breast: Extensive DCIS ER-/PR+; Stage 1-2a
Feb04-Apr04: 4 AC, dose dense
Aug 04: 4 Taxotere
Dec 05: Bone and Liver METS; Stage 4. Carboplatin/Taxol/Herceptin. DX with Li-Fraumeni Syndrome
Apr 06: NED, maintenance Herceptin
Apr 07: CA1503=14; masses in liver; Xeloda/Tykerb
Nov 07: NED, Tykerb maintenance
Sept 08: Liver mets again, on Tykerb/Xeloda again, CA=19 and 27
Nov 08: Progression, Tykerb/Gemzar, CA=25
Dec 08: Progression, Herceptin/Navelbine, CA=40, 57, and 130
Jan 09: Progression in bone, recession in liver, Herceptin/Carbo/Abraxane CA=135
June 09: CA27/29=24, chemo break
Sept 09: Progression, CA=24, waiting on clinical trial (4 weeks no treatment)
Nov 09: now have brain mets, trial "on hold", getting 14 WBR treatments starting 11/2/09
Dec 09: possible start on p53 trial
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Old 03-26-2009, 06:37 PM   #18
Becky
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A school of thought on Her2 targeted therapies (Herceptin and Tykerb) is that if you are Her2+, your regime should always contain one of the Her2 drugs. They help.

Second, I notice that Femara has always been in the mix. If this has never been changed, you should talk to your onc about trying Aromosin or even Faslodex. Your antihormonal could be the resistant culprit too.
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Kind regards

Becky

Found lump via BSE
Diagnosed 8/04 at age 45
1.9cm tumor, ER+PR-, Her2 3+(rt side)
2 micromets to sentinel node
Stage 2A
left 3mm DCIS - low grade ER+PR+Her2 neg
lumpectomies 9/7/04
4DD AC followed by 4 DD taxol
Used Leukine instead of Neulasta
35 rads on right side only
4/05 started Tamoxifen
Started Herceptin 4 months after last Taxol due to
trial results and 2005 ASCO meeting & recommendations
Oophorectomy 8/05
Started Arimidex 9/05
Finished Herceptin (16 months) 9/06
Arimidex Only
Prolia every 6 months for osteopenia

NED 18 years!

Said Christopher Robin to Pooh: "You must remember this: You're braver than you believe and stronger than you seem and smarter than you think"
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