CONTACTS 

SUBJECTS
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0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 20 0000. ref SDS 19 0000.
040502 -
040503 -
040504 -
040506 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Background on biopsy status change test issue is shown in the record
040902 - last week on 081113, ref SDS 11 ED5J, citing Millie's letter to Kaiser
040903 - on 081111 requesting results on tests the past week, ref SDS 10 DJ6N,
040904 - to prepare for Millie to start treatment for cancer at UCSF on 081113.
040906 -  ..
040907 - Objectives for testing status change are reported in the record on
040908 - 081022 for the first biopsy at Kaiser. ref SDS 5 RS8M  Subsidiary
040909 - objective is to get actual pathology findings to compare with possible
040910 - modified criteria, reported on 071007. ref SDS 3 S68T
040911 -
040912 -        [...below in the record today on 081120 actual pathology lists
040913 -        conclusion of triple negative, ref SDS 0 LF4X, but does not
040914 -        present findings that support the conclusion. ref SDS 0 LF9R
040916 -  ..
040917 - Yesterday on 081119, Millie received a letter from Kaiser submitting
040918 - parts ofthe pathology report showing status has not changed, and
040919 - remains triple negative. ref SDS 14 5O8G
040921 -  ..
040922 - Millie sent Kaiser's letter to the medical team notifying that the
040923 - biopsy on 081107 shows status has not changed and so is still triple
040924 - negative, ref SDS 15 V14I, since the original biopsy on 020304,
040925 - reported at Kaiser on 020321. ref SDS 1 6Q6J
040927 -  ..
040928 - Millie's letter on 081119 also requested from Kaiser the complete
040929 - pathology report, ref SDS 15 L34X, citing objective to evaluate test
040930 - results agains possible changed criteria for Her2 neu. ref SDS 15 GH5I
040932 -  ..
040933 - This morning on 081120, Millie received a letter from Kaiser saying
040934 - the doctor wants Millie to have the entire pathology report.
040935 - ref SDS 18 VU9N  Since Millie needs the complete report, as requested
040936 - in her letter to Kaiser on 081119, ref SDS 15 L34X, and so far has
040937 - only received partial extracts, another letter was sent asking for
040938 - full reports again on biopsy tests on 081022, and on 081107,
040939 - ref SDS 19 VG3X, and further explaining the primary care physician
040940 - often sends test reports with Kaiser's internal email system.
040941 - ref SDS 19 VG3U
040943 -  ..
040944 - When Millie returned from hiking at Lafayette this afternoon, there
040945 - was a letter from Kaiser confirming plans to send biopsy reports with
040946 - Kaiser's internal system. ref SDS 20 OL5K
040948 -  ..
040949 - Millie checked Kaiser's email system, and found another letter...
040950 -
040951 -    1.  Subject:  results [pathology biopsy Oct 22 and Nov 7]
040952 -        Received: 11/20/08 9:40 AM
040959 -         ..
040960 -    2.  Here is the full report I have:
040961 -
040962 -        Sincerely,
040963 -
040965 -         ..
040968 -
040969 -
040970 -
040971 -
0410 -

SUBJECTS
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0503 -
050401 -  ..
050402 - Triple Negative ER PR HER2neu Negative Conclusion Pathology Report
050403 -
050404 -
050405 -    3.  Provider:
050407 -        Collected: 11/7/2008
050409 -        Immunohistochemistry Report
050410 -        FINAL PATHOLOGIC DIAGNOSIS
050411 -        IMMUNOHISTOCHEMISTRY (LEFT SUPRA CLAVICULAR LYMPH NODE,
050412 -        WCRS08-28763 A1)
050414 -         ..
050415 -    4.  Estrogen Receptor - negative, positive on-slide control
050416 -        Progesterone Receptor - negative, positive on-slide control
050417 -        Her2neu - negative, positive on-slide control
050418 -        [NOTE: Specimen sent for fluorescence in situ hybridization
050419 -        (FISH) analysis.]
050421 -  ..
050422 - This much aligns with Kaiser's report yesterday on 081119. ref SDS 14
050423 - UQ5P
050425 -  ..
050426 - Pathology report on biopsy 081107 continues...
050432 -         ..
050433 -    7.  Studies
050435 -         ..
050436 -    8.  [DISCLAIMER:  This immunoperoxidase panel was developed and its
050437 -        performance characteristics determined by the Regional
050438 -        Immunohistochemistry Laboratory/The Permanente Medical Group,
050439 -        Inc., Northern California.  It has not been cleared or approved
050440 -        by the U.S.  Food and Drug Administration (FDA).  The FDA has
050441 -        determined that such clearance or approval is not necessary.
050442 -        This test is used for clinical purposes.  It should not be
050443 -        regarded as investigational or for research.  This laboratory
050444 -        is certified under the Clinical Laboratory Improvement
050445 -        Amendments of 1988 (CLIA-88) as qualified to perform high
050446 -        complexity clinical laboratory testing.
050448 -         ..
050449 -    9.  Monoclonal antibodies (clones SP1, and PgR636) are used as part
050450 -        of an LSAB immunohistochemical assay to detect estrogen and
050451 -        progesterone receptors, respectively, on formalin-fixed
050452 -        paraffin-embedded tissue. The percentage of stained tumor
050453 -        nuclei is determined manually.  Specimens with less than 5% of
050454 -        tumor nuclei stained are considered negative.  Specimens with
050455 -        5% or greater of tumor nuclei stained are considered positive.
050456 -
050458 -  ..
050459 - HER2neu Status Criteria No Findings Support Conclusion of Negative
050460 -
050461 -
050462 -   10.  The PATHWAY9 HER2 (clone 4B5) test is used to assess HER2
050463 -        protein overexpression in formalin-fixed, paraffin-embedded
050464 -        tissue.
050466 -         ..
050467 -   11.  Staining, interpretation, and scoring of the PATHWAY9 test are
050468 -        performed in accordance with the Ventana PATHWAY9 package
050469 -        insert and the ASCO/CAP scoring criteria, wherein a HER2
050470 -        expression score is assigned (0-3+).
050472 -         ..
050473 -   12.  Positive cases (HER2 overexpression) are those with strong and
050474 -        complete membrane staining in greater than 30% of cancer cells
050475 -        (3+).
050477 -         ..
050478 -   13.  Negative cases are defined as those with no staining (0) or
050479 -        weak, incomplete membrane staining in any proportion of cells
050480 -        (1+).  Equivocal or indeterminate cases are those cases with
050481 -        strong staining in less than or equal to 30% of cells, or less
050482 -        than strong but complete membrane staining in any proportion of
050483 -        cells (2+).  This assay is FDA-cleared for in vitro diagnostic
050484 -        use as an aid in identifying patients for whom Herceptin9
050485 -        (trastuzumab) treatment is being considered.  Unless otherwise
050486 -        specified, the infiltrating component is evaluated.]
050488 -  ..
050489 - This part of the pathology report presents criteria, ref SDS 0 LF9R,
050490 - but does not show actual findings from the core biopsy specimen that
050491 - support a conclusion of HER2neu negative, per above. ref SDS 0 LF5V
050493 -  ..
050494 - On 071007 there was a report that criteria for HER2neu positive had
050495 - changed and were reduced from 2 to 1.6. ref SDS 3 S68T
050497 -  ..
050498 - Correlation between the report on 071007 of change in criteria for
050499 - HER2neu, and the pathology report received today for Millie's test on
050500 - 081107 is not clear at this time.
050502 -  ..
050503 - If the cells from Millie's biopsy show "no staining (0)," why not
050504 - state that finding?  If testing found strong staining in less than 30%
050505 - of the cells, why not state what percentage showed strong staining,
050506 - e.g., 10%, 25%, 29%?
050508 -  ..
050509 - What findings support the conclusion of HER2neu negative?
050510 -
050511 -            [On 081202 Millie's letter to medical team cites findings
050512 -            of triple negative and notes pathology report omits
050513 -            findings that support conclusion of triple negative status.
050514 -            ref SDS 21 AT4V
050516 -             ..
050517 -            [On 081202 Millie's letter to Doctor Daamen at Kaiser
050518 -            requests findings for pathology on biopsy on 081107 that
050519 -            support conclusion of triple negative status. ref SDS 22
050520 -            GZ3W
050522 -             ..
050523 -            [On 081202 1456 Kaiser submitted results of pathology for
050524 -            biopsy on 081107 showing HER2 neu FISH test = 1.1,
050525 -            ref SDS 23 FG5G, well below criteria for positive 2.0, and
050526 -            below change in criteria to 1.6 reported under
050527 -            consideration on 071007. ref SDS 3 S68T
050529 -  ..
050530 - Are there different tests for HER2neu; perhaps another type of test
050531 - correlates more closely with research reported on 071007? ref SDS 3
050532 - S68T
050534 -  ..
050535 - Pathology report on biopsy 081107 continues...
050536 -
050537 -   14.  Clinical History
050539 -         ..
050540 -   15.  72yoF, hx PD infiltr ductal ca L breast in 2002; now w/
050541 -        positive LN c/w met ca breast origin
050543 -         ..
050544 -   16.  Specimen(s) Received
050546 -         ..
050547 -   17.  A: I-2 CONSULT - ER/PR/HER2NEU - BREAST (WCRS08-28763 A1)
050548 -        1BK,1SL
050549 -
050562 -
050563 -
050564 -
050565 -
0506 -

SUBJECTS
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0603 -
060401 -  ..
060402 - FNA Biopsy 081022 Test Left Supclavicualr for Cancer
060403 -
060404 -
060407 -        Fine Needle Aspiration Cytology Report
060408 -        FINAL PATHOLOGIC DIAGNOSIS
060409 -        A: NECK, FNA - LEFT
060410 -        RED BLOOD CELLS, LYMPHOCYTES.
060412 -         ..
060413 -        LARGE MALIGNANT CELLS CONSISTENT WITH BREAST PRIMARY; PLEASE
060414 -        SEE COMMENT
060416 -  ..
060417 - This part of the pathology report aligns with Kaiser's report to the
060418 - medical team on 081023, ref SDS 6 4Q9Q, leading to Millie having to
060419 - stop treatment in the cetuximab and Carboplatin protocol, ordered by
060420 - the doctor, also, on 081023. ref SDS 7 D65G
060421 -
060427 -         ..
060428 -   22.  Comment
060430 -         ..
060431 -   23.  Her2Neu can only be done on formalin fixed biopsied material.
060432 -        ER and PR can be done directly on non-stained direct smears
060433 -        however all submitted smears were stained for cytologic
060434 -        evaluation.  Voicemail to Dr.  Damon on October 23 2008
060436 -         ..
060437 -   24.  Clinical History
060439 -         ..
060440 -   25.  OTHER PERTINENT CLINICAL INFO: Left supraclavicular neck mass,
060441 -        h/o metastatic breast ca on chemo, concerns for progression,
060442 -        please test for ERPR and for HER2
060444 -         ..
060445 -   26.  Gross Description
060446 -        Received: 2 slides fixed
060447 -        2 slides air-dried
060449 -         ..
060450 -   27.  Specimen(s) Received
060452 -         ..
060453 -   28.  A: NECK, FNA - LEFT
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