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Old 11-18-2009, 12:56 PM   #1
Joe
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T-DM! News
I received this info today in a newsletter:

Clinical findings from the trastuzumab-DM1 (T-DM1) Phase II trial have been accepted for presentation at the San Antonio Breast Cancer Symposium in December
2009. Roche has indicated that, if compelling, these data could enable a T-DM1 marketing application to be filed in 2010.
Regards
Joe
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Old 11-18-2009, 07:08 PM   #2
alicem
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Re: T-DM! News
Wonderful news Joe!!
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9/15/08 (age 52) - Mammo: calcifications
9/22/08 - Biopsy: DCIS, grade 3. ER,PR status: Pos. in 75-90% of tumor cells.
10/01/08 - Ob/Gyn appt.: found complex, mostly cystic mass on right ovary - 11cmx12cmx 8cm
10/15/08 - Hysterectomy & Oophorectomy, Lumpectomy: Cyst on uterus, not ovary - all was benign. Breast - 5 of 6 bad margins. 2 Sentinel Lymph nodes removed, both negative. Stage 0, Tis, N0
12/11/08 - Mastectomy & DIEP reconstruction: Surprise! 2 cm Invasive DC, grade 2 found. One benign internal mammary lymph node. Stage 1, T1c, N0, all clean margins. ER+ (Proportion Score = 2/5, Intensity Score = 2/3) and PR+(Proportion Score = 3/5, Intensity Score = 2/3)
HER2 score = 3+
1/09/09 - Oncotype DX: Recurrence S/core of 60 !?!?! ER status is NEG!! PR staus is NEG! HER2 score = 12.2 (still positive, greater than 11.5 is positive).
1/20/09 - Started chemo: TCH
5/26/09 - FINISHED CHEMO!
1/05/10 - FINISHED HERCEPTIN!
1/22/10 - Port-a-catheter removed!
3/07/18 - Still NED
9/10/23 - Still NED
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Old 11-18-2009, 08:57 PM   #3
Lori R
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Re: T-DM! News
Joe,
Based on your experience what does this mean in terms of "general availability". Does a marketing application mean that if approved by the FDA that my onc could offer this to me as early as next year?

Any idea on how long the application and approval process takes? (months, years)

I realize you don't have a crystal ball, just wondering from a very high level perspective.

Thank you so much for keeping us updated. I am anxiously awaiting this as a possible option.

Lori
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2007
Oct - Diagnosed - Stage IV
5 c.m. IDC - Left Side er/pr- Her2+++
Node + 2/14 - Single Liver Met
Double Mastectomy
Nov - Begin T+H
2008
Feb-Complete 6 cycles- T&H- NED
March - Continue - Herceptin Only
April - Rads for 6 weeks
2009
Continue Herceptin - Continue NED
April - Recurrance- 3 cm. Liver Met
May - Cryosurgery
June - November - Abraxane + Herceptin
Aug - PET/CT - CTC = 0 Back to NED
2010
January - Continue NED
July - Recurrance - 3 cm Liver Met CTC=1
August - Cryosurgery #2
August - November Navelbine
November - Back to NED - End Navelbine
2011
Feb - Recur - 4 cm Liver Met - Same Left Lobe
March Surgery it is -Couldn't get a clean margin
July - Confirmed continued liver involvement
August - Begin Herceptin + Tykerb
October - Mixed results from H+T
Add Abraxane + H + T - Nov - April
2012
January PET Scan - It's working!!
April - Back to NED
July - Recurrance
August - Begin TDM-1 Trial (Taxol + TDM-1)
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Old 11-19-2009, 12:49 PM   #4
Joe
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Re: T-DM! News
Herceptin results were originally announced at the 1998 ASCO meeting and it was FDA approved in October 1998

Herceptin Adjuvant results were announced in June 2005 and FDA approval was in November 2006

Tykerb results were announced in June of2006, It was FDA appoved in March 2007.

All three drugs were fast tracked by the FDA. Also note that these drugs became available for compassionate use shortly after Genentech and GSK applied for approval.

Regards
Joe
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Old 11-19-2009, 01:20 PM   #5
Lori R
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Re: T-DM! News
Joe,
I really appreciate such a prompt and informative response.

This is good news indeed.

Thank you...thank you!!! Lori
__________________
2007
Oct - Diagnosed - Stage IV
5 c.m. IDC - Left Side er/pr- Her2+++
Node + 2/14 - Single Liver Met
Double Mastectomy
Nov - Begin T+H
2008
Feb-Complete 6 cycles- T&H- NED
March - Continue - Herceptin Only
April - Rads for 6 weeks
2009
Continue Herceptin - Continue NED
April - Recurrance- 3 cm. Liver Met
May - Cryosurgery
June - November - Abraxane + Herceptin
Aug - PET/CT - CTC = 0 Back to NED
2010
January - Continue NED
July - Recurrance - 3 cm Liver Met CTC=1
August - Cryosurgery #2
August - November Navelbine
November - Back to NED - End Navelbine
2011
Feb - Recur - 4 cm Liver Met - Same Left Lobe
March Surgery it is -Couldn't get a clean margin
July - Confirmed continued liver involvement
August - Begin Herceptin + Tykerb
October - Mixed results from H+T
Add Abraxane + H + T - Nov - April
2012
January PET Scan - It's working!!
April - Back to NED
July - Recurrance
August - Begin TDM-1 Trial (Taxol + TDM-1)
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