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Old 09-09-2019, 11:14 AM   #61
Becky
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Re: Whack-a-mole next...

Thinking about you 3000 miles away! Sending all my love and best best hugs.
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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 16 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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Old 09-10-2019, 09:20 AM   #62
jaykay
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Re: Whack-a-mole next...

Great news, Flori!
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March, 2000: 48, Post menopausal (5 yrs HRT) Left breast, IDC 3mm/DCIS 1.6cm, ER+/PR-/Her2+++, mod differentiated, MIB low, lumpectomy, node neg via SNB, rads=33 Stage 1a
June, 2000: Tamox 4.5 years,Femara for 5 years (end in Jan. 2010)
Sept, 2012: 61, Via mamm, ultrasound, biopsy, right breast, 2.3cm tumor, ER+/PR-/Her2+++, poorly diff, KI67 60-70%
BRCA 1 and 2 negative
October, 2012: Bi Mast with tissue expanders, port placement
Final Path: IDC 2.8cm, DCIS, 1/4 sentinal nodes positive (@#$%). Stage IIB
Nov 29, 2012: Begin TCH/6x/every 3 wks, H for 1 year/every 3 weeks.
March 14, 2013: Finished chemo
April 9, 2013: Begin radiation 28x
May 22, 2013: Finished rads
June 1st, 2013: Started Aromasin for 5 yrs.
July 15, 2013: Switched to Letrozole (Femara). Probably for the rest of my life
October 16, 2013: Exchange surgery
October 31, 2013: Finished Herceptin
December 5, 2013: Port removed
Glad this year is over!
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Old 09-11-2019, 08:10 PM   #63
Bunty
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Re: Whack-a-mole next...

That's fantastic Flori! Such a roller coaster ride, but I reckon you ride that roller coaster with great attitude and strength.
Best wishes
Marie
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Old 09-12-2019, 07:22 AM   #64
Catherine
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Re: Whack-a-mole next...

Flori, Flori Morning Glory, We are all so happy for this good news!

Lots of love and support coming your way!
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Catherine


Found my own lump in the shower
April 06 at the age of 58
Stage IIB, ER- PR- HER2+++ multi focal tumors, largest 2.3cm
Chemo first: AC/Taxol over 16 weeks
Bilateral mastectomy Sep 06
33 rads after the surgery
1 year of Herceptin completed Dec 07
13 years and no recurrence as of April 2019
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Old 09-12-2019, 07:26 AM   #65
Catherine
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Re: Whack-a-mole next...

Lani, your medical and drug reports are the best. I am going to print your recent post about Bayer’s research and their new test. A friend with a serious cancer Dx can maybe take and show her oncologist.

Thank you!
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Catherine


Found my own lump in the shower
April 06 at the age of 58
Stage IIB, ER- PR- HER2+++ multi focal tumors, largest 2.3cm
Chemo first: AC/Taxol over 16 weeks
Bilateral mastectomy Sep 06
33 rads after the surgery
1 year of Herceptin completed Dec 07
13 years and no recurrence as of April 2019
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Old 09-12-2019, 04:59 PM   #66
Lani
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Re: Whack-a-mole next...

Vantage Logo May 08, 2019
Astra and Daiichi lay out their plan for a better Herceptin


Jacob Plieth
The companies’ DS-8201 succeeds in breast cancer patients who had failed Kadcyla, and will go before the regulators later this year.

Breast cancer
There was a time, some years ago, when Roche’s Kadcyla was seen by the sellside as the pharma industry’s biggest upcoming launch. The bullish forecasts failed to materialise, but Kadcyla did spawn numerous other Her2-targeting projects seeking to become better versions of Herceptin.

Today one of these, Astrazeneca/Daiichi Sankyo’s DS-8201, succeeded in a phase II breast cancer trial that will serve as the basis for a second-half regulatory filing. More lucrative uses might follow, and the result could vindicate the UK company’s aggressive move to license DS-8201 from Daiichi.

That licensing deal had been roundly criticised both for its up-front element – $1.35bn seemed a huge amount for what was, ultimately, an early-stage project – and the fact that Astra raised equity to help finance it.

But the basis for the tie-up was phase I data that Astra called “unprecedented”, amounting to a 60% remission rate in Her2-positive breast cancer subjects who had failed on an average of seven therapies. The UK company highlighted DS-8201 on last week’s first-quarter financials call.

High-intensity conjugate

Like Kadcyla (trastuzumab emtansine) DS-8201 (trastuzumab deruxtecan) is an antibody-drug conjugate. What makes the Daiichi project unique, its makers argue, is a high-intensity payload and cell membrane permeability, which might enable it to target tumours that express Her2 at relatively low levels.

One line of thinking is that patients retain some degree of Her2 expression even after failing multiple anti-Her2 therapies, and the latest findings, from the Destiny-Breast01 study, suggest that DS-8201’s characteristics translate into a real clinical benefit.

Enrolees had failed two Her2-targeting drugs, Herceptin and Kadcyla, yet a 5.4mg/kg DS-8201 dose showed strong clinical activity in terms of overall remission, the trial’s primary efficacy measure, Astra said today.

Hard data are being held back for a scientific meeting. In addition to efficacy, safety will be closely scrutinised given the expression of Her2 on healthy as well as cancerous cells, the touted efficacy of DS-8201, and the off-tumour toxicity of some potent Her2-directed therapies like CAR-T.

Kadcyla was once thought by the sellside to be capable of bringing in 2020 sales of $4.5bn, but last year’s revenue only just breached $1bn, and the current 2024 forecast is $1.4bn, EvaluatePharma computes.

The main problem is that in Her2-positive breast cancer Kadcyla failed to broaden its approved reach beyond Herceptin-relapsed subjects. In the front-line Marianne study Kadcyla-containing regimens were non-inferior but failed to beat Herceptin.

Analysts at present see DS-8201 selling $1.8bn in 2024, but this will not come from Destiny-Breast01’s third-line use alone. For the drug to make its mark fully it must succeed in the second-line setting head-to-head against Kadcyla, and perhaps also in Her2-low subjects, a brand new use.

Selected trials of DS-8201 in breast cancer
Study Setting Detail Trial ID
DS8201-A-J101 ~8th line, Her2-positive 59.5% ORR NCT02564900
Destiny-Breast01 3rd-line, Her2-positive, post Herceptin & Kadcyla Clinically meaningful ORR NCT03248492
Destiny-Breast02 3rd-line, Her2-positive, phIII confirmatory trial Data in 2020+ NCT03523585
Destiny-Breast03 2nd-line, Her2-positive, post Herceptin, vs Kadcyla Data in 2020+ NCT03529110
Destiny-Breast04 Her2-low, vs physician's choice Data in 2020+ NCT03734029
While there are now several Her2-targeting antibody-drug conjugates in development the evolving situation will also be of great interest to Macrogenics, which is developing a naked anti-Her2 MAb, margetuximab, that has an optimised Fc region.

Margetuximab scored a surprising success in the Sophia trial in subjects who had all failed Herceptin and Roche’s Perjeta, and most of whom had also failed Kadcyla. The success was down to patients who carried the 158F allele, a genetic variant that promotes binding with Fc-optimised MAbs like margetuximab; full Sophia data are one of the big attractions of the upcoming Asco conference.

This subgroup-driven effect might not put margetuximab in direct competition with DS-8201, which Astra might now rely on, along with Tagrisso, to form the cornerstone of its oncology strategy. Given the travails of Imfinzi and tremelimumab in lung cancer the UK group needs all the breaks it can get.

Selected Her2-targeting industry projects
Product Company Pharmacology class
Marketed
Herceptin Roche Anti-Her2 MAb
Perjeta Roche Anti-Her2 MAb
Kadcyla Roche/Immunogen Anti-Her2 MAb-DM1 maytansinoid conjugate
Phase III
DS-8201 Daiichi Sankyo/Astrazeneca Anti-Her2 MAb-cytotoxic drug conjugate
Margetuximab Macrogenics Fc-optimised anti-Her2 MAb
BAT8001 Bio-Thera Solutions Anti-Her2 MAb-maytansinoid conjugate
Phase II
Tucatinib Array/Seattle Genetics Her2-selective TKI
TAS0728 Otsuka Holdings Her2-selective TKI
Phase I
RG6194 Roche Anti-Her2 bispecific MAb
PRS-343 Pieris Pharmaceuticals Anti-Her2 bispecific MAb
ARX788 Ambrx Anti-Her2 MAb-cytotoxic drug conjugate
FS102 F-star Anti-Her2 MAb
PF-06804103 Pfizer Anti-Her2 MAb-cytotoxic drug conjugate
MEN1309 Oxford Biotherapeutics/Menarini Anti-Her2 MAb-maytansinoid conjugate
Source: EvaluatePharma.
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Old 09-13-2019, 12:53 PM   #67
Cathya
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Re: Whack-a-mole next...

Congratulations Flori. Wonderful news.

God bless,

Cathy
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Cathy

Diagnosed Oct. 2004 3 cm ductal, lumpectomy Nov. 2004
Diagnosed Jan. 2005 tumor in supraclavicular node
Stage 3c, Grade 3, ER/PR+, Her2++
4 AC, 4 Taxol, Radiation, Arimidex, Actonel
Herceptin for 9 months until Muga dropped and heart enlarged
Restarting herceptin weekly after 4 months off
Stopped herceptin after four weekly treatments....score dropped to 41
Finished 6 years Arimidex
May 2015 diagnosed with ovarian cancer
Stage 1C
started 6 treatments of carboplatin/taxol
Genetic testing show BRCA1 VUS
Nice! My hair came back really curly. Hope it lasts lol. Well it didn't but I liked it so I'm now a perm lady
29 March 2018 Lung biopsy following chest CT showing tumours in pleura of left lung, waiting for results to the question bc or ovarian
April 20, 2018 BC mets confirmed, ER/PR+ now Her2-
Questions about the possibility of ovarian spread and mets to bones so will be tested and monitored for these.
To begin new drug Palbociclib (Ibrance) along with Letrozole May, 2018.
Genetic testing of ovarian tumour and this new lung met will take months.
To see geneticist to be retested for BRCA this week....still BRCA VUS
CA125 has declined from 359 to 12 as of Aug.23/18


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Old 09-21-2019, 06:04 PM   #68
Carol Ann
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Re: Whack-a-mole next...

Yay, wonderful news!!!

Carol
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July 24, 2013: "Infected" Right Nipple and benign cyst removed, pathology report revealed Paget's, DCIS, and ILC 1.25 cm, ER+/Pro+/HER2 equivocal, Grade 2 under benign cyst, previous diagnostic mammo/ultrasound said I was perfectly healthy in both breasts.

Aug 18, 2013: MRI report says Left breast is perfectly healthy "consistent with previous studies".

Sept 2013: I insist on a bilateral mastectomy anyway. Too nervewracking to let left breast remain with higher risk after 3 cancers in right, nipple in right is already gone anyhow.

Sept 18, 2013: Bilateral mastectomy, 11 right nodes removed, ALL negative BUT -- ER+/PRO+/HER2+ tumor, 1.0 cm, Grade 2 found in a piece of "grossly unremarkable" breast tissue from prophylactic mastectomy of left breast, no nodes removed.

Oct 25, 2013: 13 left side nodes removed, ALL negative, Stage 1 across the board, NO RADS needed, YAAAAY! Port also installed.

Nov 25, 2013 Begin 6 rounds TCH.

March 10, 2014 Just finished 6th and LAST Chemo today, YAAAAAY!

March 24, 2014 Echocardiogram to make sure I'm still good for Herceptin every 3 weeks.

March 31, 2014 Echo results NORMAL, first Herceptin all by itself. Now if only my eyes would stop streaming from the Taxotere ... :)

April 21, 2014 Started Arimidex and therapy for "mild" lymphedema in left hand and arm

May 2014 Therapy completed, I have sleeves and gloves for both arms, a Flexi touch lymph pump to hook up to for an hour every day, and I've become an arm bandaging expert. :)

June 2014 Begin Fosamax to prevent osteoporosis; bone scan revealed osteopenia

Nov 17, 2014 FINAL Herceptin!

Dec 4, 2014 My right thigh muscle has been extra achy for days ... I discover a blister rash cluster on the side of my right thigh while taking a shower. Port appointment cancelled until Dec 17, my doc is working me in tomorrow afternoon to see me and the rash. My muscle at least feels less achy.

Dec 5, 2014 Yep, I have shingles. Boo! I start acyclovir and also have a prescription for a painkiller just in case for over the weekend.

Dec 17, 2014 Port is OUT!

January 2016 Shingles again and this time it started where my left breast (where the hidden HER2+++ tumor was!) used to be. My onc nurse got me a same day appointment to see my doc when I called and told her I had a rash on the site. The antiviral meds are working once again, though, so that is good news. :)
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Old 10-31-2019, 06:28 AM   #69
Lucy
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Re: Whack-a-mole next...

Hey Flori,

I've been thinking about you and wondering how you were doing. I noticed you've updated your signature to show some stability but also some progression. How are you though? When you're up to us, please give us an update and let us know how you're doing. Hugs
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Old 01-17-2020, 07:09 PM   #70
Lucy
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Re: Whack-a-mole next...

Checking in again . . . Any updates Flori? Thinking about you.
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Old 01-22-2020, 04:29 PM   #71
ariana
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Re: Whack-a-mole next...

Lucy, I was wondering the same thing -----Flori, hope you are doing well.
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Old 01-22-2020, 04:38 PM   #72
Laurel
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Re: Whack-a-mole next...

Me, too! I have not wanted to be bothersome, but I am thinking of Flori all the time. Hoping you will chime in soon, Flori!
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Smile On!
Laurel


Dx'd w/multifocal DCIS/IDS 3/08
7mm invasive component
Partial mast. 5/08
Stage 1b, ER 80%, PR 90%, HER-2 6.9 on FISH
0/5 nodes
4 AC, 4 TH finished 9/08
Herceptin every 3 weeks. Finished 7/09
Tamoxifen 10/08. Switched to Femara 8/09
Bilat SPM w/reconstruction 10/08
Clinical Trial w/Clondronate 12/08
Stopped Clondronate--too hard on my gizzard!
Switched back to Tamoxifen due to tendon pain from Femara

11 Years NED
I think I just might hang around awhile....

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Old 02-18-2020, 10:31 AM   #73
Laurel
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Re: Whack-a-mole next...

Flori, Flori Morning Glory?????
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Smile On!
Laurel


Dx'd w/multifocal DCIS/IDS 3/08
7mm invasive component
Partial mast. 5/08
Stage 1b, ER 80%, PR 90%, HER-2 6.9 on FISH
0/5 nodes
4 AC, 4 TH finished 9/08
Herceptin every 3 weeks. Finished 7/09
Tamoxifen 10/08. Switched to Femara 8/09
Bilat SPM w/reconstruction 10/08
Clinical Trial w/Clondronate 12/08
Stopped Clondronate--too hard on my gizzard!
Switched back to Tamoxifen due to tendon pain from Femara

11 Years NED
I think I just might hang around awhile....

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