THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net


S U M M A R Y


DIARY: October 23, 2008 08:00 AM Thursday; Rod Welch

Millie 2nd treatment 9th cycle cetuximab Carboplatin 4th relapse IBC.

1...Summary/Objective
...Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
...Cetuxiab Alone Clinical Study
...Cetuxiab 81 and Carboplatin 14 Treatments Clinical Study 2nd Arm
2...Schedule Weekly Treatments Continue on Thursdays
3...Labs Blood Test
4...NEUTS 1.65 Decrease 2nd Week Chemotherapy Received
5...Chemotherapy Received Blood Counts Drop Significantly
6...Blood Counts Fall Significantly Chemotherapy Carboplatin Received
7...Neupogen Case Study Missed Carboplatin Treatments Low Blood Counts
8...Side Effects Neupogen Treatments Continue Mild Tolerance Acceptable
9...Coagulation Control INR 2.3 Within Range Treating Pulmonary Embolism


..............
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CONTACTS 

SUBJECTS
Cetuximab Carboplatin Clinical Study 2nd Arm 7th Cycle 1st Treatment

1003 -
1003 -    ..
1004 - Summary/Objective
1005 -
100501 - Follow up ref SDS I9 0000. ref SDS I2 0000.
100502 -
100503 -
100504 -
100505 -
100507 -  ..
1006 -
1007 -
1008 - Progress
1009 -
100901 - Background on Millie's treatment in the clinical study is reported on
100902 - 080508. ref SDS A1 TZ8I
100904 -    ..
100905 -   Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
100906 -
100907 -   Follow up ref SDS I9 X33O, ref SDS I2 X33O.
100908 -
100909 -   Millie had left mastectomy on 051021.  Biopsy at that time reported
100910 -   no findings of cancer.  Approximately 8 months later on 060707 the
100911 -   doctor diagnosed IBC relapse and prescribed treatment with
100912 -   capecitabine and Taxotere, which had been effective in 2005
100913 -   completely eliminating signs of IBC disease. ref SDS 5 PF3O
100914 -
100915 -    1.  Cycle 09 and 01 ................... 060721, ref SDS 6 407N
100916 -    2.  Cycle 10 and 02 ................... 060814, ref SDS 8 LY6O
100917 -    3.  Cycle 11 and 03 ................... 060908, ref SDS 8 407N
100918 -    4.  Cycle 12 and 04 ................... 060929, ref SDS 8 407N
100919 -    5.  Cycle 13 and 05 ................... 061020, ref SDS 9 407N
100920 -    6.  Cycle 14 and 06 ................... 061110, ref SDS 10 407N
100921 -    7.  Cycle 15 and 07 ................... 061201, ref SDS 11 407N
100923 -    ..
100924 -   Cetuxiab Alone Clinical Study
100925 -
100926 -   Follow up ref SDS I9 356I, ref SDS I2 356I.
100927 -
100928 -   After 7 cycles of treatment in 2006, the doctor diagnosed IBC
100929 -   disease was progressing, and so made referral to UCSF for referral
100930 -   in clinical study of Cetuximab and Carboplatin.  Millie was
100931 -   randominzed for treatment with Cetuximab alone, and began weekly
100932 -   treatments at UCSF on 080201.
100934 -                    ..
100935 -                   Total    Cetuximab
100936 -    8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 14 SG8I
100937 -    9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 15 SG8I
100938 -   10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 16 SG8I
100939 -   11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 17 SG8I
100940 -   12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 19 SG8I
100941 -   13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 21 7T3H
100942 -   14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 22 7T3H
100943 -   15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 23 7T3H
100944 -   16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 24 7T3H
100945 -   17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 25 7T3H
100946 -   18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 26 7T3H
100947 -   19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 27 7T3H
100948 -   20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 28 7T3H
100949 -   21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 29 7T3H
100950 -   22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 30 7T3H
100951 -   23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 31 7T3H
100952 -   24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 32 7T3H
100953 -   25.  Cycle 05 and 12 and 02 18.......... 070531, ref SDS 33 7T3H
100954 -   26.  Cycle 05 and 12 and 03 19.......... 070607, ref SDS 34 7T3H
100955 -   27.  Cycle 05 and 12 and 04 20.......... 070614, ref SDS 35 0001
100956 -   28.  Cycle 06 and 13 and 01 21.......... 070621, ref SDS 36 0001
100957 -   29.  Cycle 06 and 13 and 02 22.......... 070628, ref SDS 37 0001
100958 -   30.  Cycle 06 and 13 and 03 23.......... 070705, ref SDS 38 0001
100959 -   31.  Cycle 06 and 13 and 04 24.......... 070712, ref SDS 38 0001
100960 -   32.  Cycle 07 and 14 and 01 25.......... 070719, ref SDS 39 0001
100961 -   33.  Cycle 07 and 14 and 02 26.......... 070726, ref SDS 37 0001
100962 -   34.  Cycle 07 and 14 and 03 27.......... 070802, ref SDS 38 0001
100963 -   35.  Cycle 07 and 14 and 04 28.......... 070809, ref SDS 40 0001
100964 -   36.  Cycle 08 and 15 and 01 29.......... 070816, ref SDS 41 0001
100965 -   37.  Cycle 08 and 15 and 02 30.......... 070823, ref SDS 42 0001
100966 -   38.  Cycle 08 and 15 and 03 31.......... 070830, ref SDS 42 0001
100967 -   39.  Cycle 08 and 15 and 04 32.......... 070906, ref SDS 43 0001
100968 -   40.  Cycle 09 and 16 and 01 33.......... 070920, ref SDS 44 0001
100969 -   41.  Cycle 09 and 16 and 02 34.......... 070927, ref SDS 45 0001
100970 -   42.  Cycle 09 and 16 and 03 35.......... 071004, ref SDS 46 0001
100971 -   43.  Cycle 09 and 16 and 04 36.......... 071011, ref SDS 47 0001
100972 -   44.  Cycle 10 and 17 and 01 37.......... 071018, ref SDS 48 0001
100973 -   45.  Cycle 10 and 17 and 02 38.......... 071025, ref SDS 49 0001
100974 -   46.  Cycle 10 and 17 and 03 39.......... 071101, ref SDS 35 0001
100975 -   47.  Cycle 10 and 17 and 04 40.......... 071108, ref SDS 50 0001
100976 -   48.  Cycle 11 and 18 and 01 41.......... 071115, ref SDS 51 0001
100977 -   49.  Cycle 11 and 18 and 02 42.......... 071122, ref SDS 37 0001
100978 -   50.  Cycle 11 and 18 and 03 43.......... 071129, ref SDS 54 0001
100979 -   51.  Cycle 11 and 18 and 04 44.......... 071206, ref SDS 55 0001
100980 -   52.  Cycle 12 and 19 and 01 45.......... 071213, ref SDS 58 0001
100981 -   53.  Cycle 12 and 19 and 02 46.......... 071220, ref SDS 61 0001
100982 -   54.  Cycle 12 and 19 and 03 47.......... 071227, ref SDS 62 0001
100983 -   55.  Cycle 12 and 19 and 04 48.......... 080103, ref SDS 63 0001
100984 -   56.  Cycle 13 and 20 and 01 49.......... 080110, ref SDS 66 0001
100985 -   57.  Cycle 13 and 20 and 02 50.......... 080117, ref SDS 67 0001
100986 -   58.  Cycle 13 and 20 and 03 51.......... 080124, ref SDS 68 0001
100987 -   59.  Cycle 13 and 20 and 04 52.......... 080131, ref SDS 70 0001
100988 -   60.  Cycle 14 and 21 and 01 53.......... 080207, ref SDS 74 0001
100989 -   61.  Cycle 14 and 21 and 02 54.......... 080214, ref SDS 75 0001
100990 -   62.  Cycle 14 and 21 and 03 55.......... 080221, ref SDS 38 0001
100991 -   63.  Cycle 14 and 21 and 04 56.......... 080228, ref SDS 80 0001
100992 -   64.  Cycle 15 and 22 and 01 57 01  00... 080306, ref SDS 83 TZ8I
100994 -    ..
100995 -   Cetuxiab 81 and Carboplatin 14 Treatments Clinical Study 2nd Arm
100996 -
100997 -   Follow up ref SDS I9 5B6J, ref SDS I2 5B6J.
100998 -
100999 -   On 080207 doctor reports IBC may be spreading. ref SDS 73 GH5H
101000 -   Follow up examination on 080219 Doctor Rugo diagnosed progression of
101001 -   disease. ref SDS 95 3J4I  Photographs show spread of IBC rash, UCSF
101002 -   prescribed treatment under the 2nd Arm of the study so that Millie
101003 -   now gets weekly treatment with cetuximab and with Carboplatin 3
101004 -   weeks of each 4 week cycle.
101005 -
101006 -             2nd
101007 -             Arm              Cetuximab Carboplatin
101008 -   65.  Cycle 01 15 and 22 and 02 58 02  01... 080313, ref SDS 85 TZ8I
101009 -   66.  Cycle 01 15 and 22 and 03 59 03  01... 080320, ref SDS 86 TZ8I
101010 -   67.  Cycle 01 15 and 22 and 04 60 04  01... 080327, ref SDS 87 TZ8I
101011 -   68.  Cycle 02 16 and 23 and 01 61 05  02... 080403, ref SDS 88 TZ8I
101012 -   69.  Cycle 02 16 and 23 and 02 62 06  03... 080410, ref SDS 91 TZ8I
101013 -   70.  Cycle 02 16 and 23 and 03 63 07  03... 080417, ref SDS 93 TZ8I
101014 -   71.  Cycle 02 16 and 23 and 04 64 08  03... 080424, ref SDS 96 TZ8I
101015 -   72.  Cycle 03 17 and 24 and 01 65 09  04... 080501, ref SDS 99 5B6J
101016 -   73.  Cycle 03 17 and 24 and 02 66 10  05... 080508, ref SDS A1 5B6J
101017 -   74.  Cycle 03 17 and 24 and 03 67 11  05... 080515, ref SDS A2 5B6J
101018 -   75.  Cycle 03 17 and 24 and 04 68 12  05... 080522, ref SDS A3 5B6J
101019 -   76.  Cycle 04 18 and 25 and 01 69 13  06... 080529, ref SDS A6 5B6J
101020 -   77.  Cycle 04 18 and 25 and 02 70 14  07... 080605, ref SDS A7 5B6J
101021 -   78.  Cycle 04 18 and 25 and 03 71 15  08... 080612, ref SDS B0 5B6J
101022 -   79.  Cycle 04 18 and 25 and 04 72 16  08... 080619, ref SDS B3 5B6J
101023 -   80.  Cycle 05 19 and 26 and 01 73 17  09... 080626, ref SDS B8 5B6J
101024 -   81.  Cycle 05 19 and 26 and 02 74 18  10... 080703, ref SDS C3 5B6J
101025 -   82.  Cycle 05 19 and 26 and 03 75 19  11... 080710, ref SDS C6 5B6J
101026 -   83.  Cycle 05 19 and 26 and 04 76 20  11... 080717, ref SDS D2 5B6J
101027 -   84.  Cycle 06 20 and 27 and 01 77 21  12... 080724, ref SDS D9 5B6J
101028 -   85.  Cycle 06 20 and 27 and 02 78 22  13... 080731, ref SDS E3 5B6J
101029 -   86.  Cycle 06 20 and 27 and 03 79 23  14... 080807, ref SDS E9 5B6J
101030 -   87.  Cycle 06 20 and 27 and 04 80 24  14... 080814, ref SDS F5 5B6J
101031 -   88.  Cycle 07 21 and 28 and 01 81 25  14... 080821, ref SDS F7 5B6J
101032 -   89.  Cycle 07 21 and 28 and 02 82 26  15... 080828, ref SDS G5 5B6J
101033 -   90.  Cycle 07 21 and 28 and 03 83 27  16... 080904, ref SDS G7 5B6J
101034 -   91.  Cycle 07 21 and 28 and 04 84 28  16... 080911, ref SDS G9 5B6J
101035 -   92.  Cycle 08 22 and 29 and 01 85 29  17... 080918, ref SDS H4 5B6J
101036 -   93.  Cycle 08 22 and 29 and 02 86 30  18... 080925, ref SDS H7 5B6J
101037 -   94.  Cycle 08 22 and 29 and 03 87 31  19... 081002, ref SDS H9 5B6J
101038 -   95.  Cycle 08 22 and 29 and 04 88 32  19... 081009, ref SDS I2 5B6J
101039 -   96.  Cycle 09 23 and 28 and 01 89 33  20... 081016, ref SDS I9 5B6J
101040 -   97.  Cycle 09 23 and 28 and 02 90 34  21... 081023, ref SDS 0 5B6J
101042 -  ..
101043 - Millie has now had 90 total treatments with cetuximab.  Today is the
101044 - 2nd treatment of the 9th cycle with cetuximab and Carboplatin
101045 - together.  This is the 34th treatment overall with cetuximab on the
101046 - 2nd arm of the clinical study, but is only the 21st treatment with
101047 - Carboplatin due to low blood counts.
101049 -  ..
101050 - On 081016 UCSF presented a work plan to test for progression of
101051 - disease, and assess Millie continuing on the cetuximab Carboplatin
101052 - protocol, and in that case start a new treatment. ref SDS J0 J36R
101053 -
101054 -        [...in another record later today, on 081023 UCSF stops
101055 -        Millie's treatment with cetuximab because report on biopsy
101056 -        performed yesterday on 081022, was reported positive for
101057 -        progression of disease today. ref SDS J6 D65G
101059 -         ..
101060 -        [On 081113 UCSF prescribes new treatment with sunitinib .
101061 -        ref SDS K0 Q79M
101063 -         ..
101064 -        [On 081114 Millie begins treatment with sunitinib
101065 -        metronomic protocol. ref SDS K1 505G
101067 -         ..
101068 -        [On 081120 pathology report for FNA biopsy on 081022, seems
101069 -        to support UCSF decision today on 081023 that Millie has
101070 -        suffered progression of cancer, and so must end treatment
101071 -        with cetuximab, because this chemotherapy is no longer
101072 -        effective, ref SDS J6 D65G, and Millie needs immediate
101073 -        treatment with another chemotherapy drug. ref SDS J0 LG45
101075 -  ..
101076 - Catherine is Millie's nurse today.  She is feeling much better
101077 - recovering from an injury to her leg while running, about a month ago
101078 - on 080925. ref SDS H7 UQ6G
101079 -
101080 -
101081 -
101082 -
1011 -

SUBJECTS
Default Null Subject Account for Blank Record

1703 -
170401 -  ..
170402 - Schedule Weekly Treatments Continue on Thursdays
170403 -
170404 - Follow up ref SDS I9 1K7H, ref SDS I2 1K7H.
170406 -  ..
170407 - The schedule for Neupogen is listed on 081018. ref SDS J1 WJ4O
170409 -  ..
170410 - The current schedule through 090115 is listed on 080918. ref SDS H4
170411 - PN6F
170413 -  ..
170414 - Consideration on 081016 to change treatments may affect the schedule.
170415 - The doctor expects this will take affect after Millie returns from
170416 - Vacation the first week in November, and so instructed to continue the
170417 - current schedule in order to allocate time for the new treatment
170418 - protocol.
170419 -
170420 -
170421 -
170422 -
1705 -

SUBJECTS
Blood Tests Labs Infusion Clinic Evaluate Safe Chemotherapy 1st Trea

2503 -
2504 - 0750
250501 -  ..
250502 - Labs Blood Test
250503 -
250504 - Follow up ref SDS I9 FW5N, ref SDS I2 FW5N.
250505 -
250506 - Adding Carboplatin to the treatment protocol now requires weekly blood
250507 - tests to determine if the immune system is strong enough for safe
250508 - chemotherapy treatment, reported on 070201, ref SDS 14 XR40, and
250509 - citing the clinical study protocol received from UCSF on 070116.
250510 - ref SDS 13 5U7Z
250512 -  ..
250513 - Catherine performed the blood draw at 0800 in the Infusion Clinic on
250514 - the 5th floor, as shown in the schedule received on 080918.
250515 - ref SDS H4 1K7H
250517 -  ..
250518 - During treatment, Catherine submitted results of the test starting the
250519 - 9th cycle.  Scope is the same as for starting cycle 8 on 080918.
250520 - ref SDS H4 075H
250521 -
250536 -     ..
250537 -    Log#:                   081023 08:15
250538 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
250539 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
250540 -     ..
250541 -    CBC with DIFF & PLT CT                                     CBCD
250542 -     ..
250543 -    WBC COUNT               4.3    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
250544 -    RBC COUNT      L        3.93   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
250545 -    HEMOGLOBIN             13.0    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
250546 -    HEMATOCRIT             38.2    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
250547 -    MCV                    97      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
250548 -    MCH                    33.1    pg           26  -   34     MCH
250549 -    MCHC                   34.1    g/dL         31  -   36     MCHC
250550 -    PLATELETS             204      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
250551 -    ..
250552 -     (NEUTS x 1000 = ANC for Kaiser)
250553 -    NEUTS          L        1.65   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
250554 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
250556 -     ..
250557 -    LYMPHS                  1.98   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
250558 -    MONOS                   0.39   x10E9/L     0.2  -  0.8     M-A   Monocyte          %         0  -  11
250559 -    EOS                     0.20   x10E9/L     0.0  -  0.4     E-A   Esoinophils       %         1  -  5
250560 -    BASOS                   0.07   x10E9/L     0.0  -  0.1     B-A   Basophil          %         0  -  2
250561 -     ..
250562 -  * LUC/ATYP LYMPHS                x10E9/L     0.0  -  0.2     LALA
250564 -     ..
250565 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
250566 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
250567 -    PT            H        25.2    s          12.0  -  14.1    PT    PT, patient       sec     8.9  -  11.1
250568 -    INL NRM Ratio H         2.3                0.9  -  1.1     INR   INR                       2.0  -  3.0
250569 -
250570 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
250571 -        Francisco, CA  94115
250573 -     ..
250574 -  * PARTIAL
250575 -    THROMBOPLASTIN  H      32.6    s          22.2  - 34.2     INR   PTT
250576 -
250577 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
250578 -        Francisco, CA  94115
250580 -     ..
250581 -  * FIBRINOGEN                     mg/dL       202  - 430      FIB
250582 -
250583 -        New test added today, 080818; Catherine says similar to INR.
250585 -     ..
250586 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
250587 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
250588 -    ELECTROLYTE PANEL                                          LYTE
250589 -    SODIUM         L      133      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
250590 -    POTASSIUM               4.0    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
250591 -    CHLORIDE              101      mmol/L       98  -  107     CL
250592 -    CARBON DIOX TOTAL      24      mmol/L       23  -  32      CO2
250593 -    ANION GAP               8                    3  -  14      ANGA
250594 -     ..
250595 - *  UREA NITROGEN                  mg/dL         8  -  23      BUN   BUN               mg/dL     7  -  17
250596 -    GLUCOSE                        mg/dL        70  -  199     GLU   Glucose           mg/dL     ?  -   ?
250597 -    AST                            U/L          16  -  41      AST   AST (SGOT)        U/L      14  -  36
250598 -    ALT                            U/L          11  -  54      ALT   ALT (SGPT)        U/L      11  -  66
250599 -    BILIRUBIN, TOTAL               mg/dL       0.3  - 1.3      BILT  Bili Total        mg/dL   0.2  - 1.3
250600 -    ALKALINE PHOSPHATASE           U/L          29  - 111      ALKP  Alkaline Ph       U/L      38  - 126
250601 -     ..
250602 -    PROTEIN, TOTAL                 g/dL        5.8  - 8.0      TP    Protine Total     g/dL    6.3  - 8.2
250603 -    ALBUMIN                        g/dL        3.4  - 4.7      ALB   Albumin           g/dL    3.4  - 4.8
250604 -     ..
250605 -    CALCIUM                 8.8    mg/dL       8.7  - 10.1     CA    Calcium           mg/dL   8.4  - 10.2
250606 -    MAGNESIUM               2.0    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
250608 -     ..
250609 -    CREAT with eGFR
250610 -    CREATININE              0.54   mg/dL      0.42  - 1.06     CR    Creatinine        mg/dL   0.6  -  1.2
250611 -
250612 -      Note: Creatinine assay changed to IDMS standardization on
250613 -      February 4, 2008 causing decrease in results of approximately
250614 -      0.09 mg/dL
250616 -     ..
250617 -    eGFR if Caucasian     >60      mL/min                      GFRC
250618 -    eGFR if African Amer  >60      mL/min                      GFRA
250619 -
250620 -      eGFR corrected for 1.73 sq meters of body surface area
250621 -      Note:  eGFR is only an estimation. Please see online Lab Manual
250622 -      for potential limitations.
250623 -      Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
250624 -      CA  94115
250626 -     ..
250627 - *  Labs today 081023 included tests omitted on 081016 labs...
250628 -
250629 -            LUC/ATYP LYMPHS...................... ref SDS I9 Z47G
250631 -     ..
250632 -    Labs today 081023 omitted tests included on 081016 labs...
250633 -
250634 -            PARTIAL THROMBOPLASTIN............... ref SDS 0 GQ6F
250636 -     ..
250637 -    Labs included on 081016 tests omitted on 080918 labs...
250638 -
250639 -            LUC/ATYP LYMPHS...................... ref SDS I9 Z47G
250641 -     ..
250642 -    Labs omitted tests on 081016 included on 080918 labs...
250643 -
250644 -            PARTIAL THROMBOPLASTIN............... ref SDS H4 GQ6F
250645 -            FIBRINOGEN........................... ref SDS H4 VE6I
250647 -     ..
250648 -    Labs on 080821 omitted following tests...
250649 -
250650 -            GLUCOSE.............................. ref SDS F7 SE9J
250651 -            ALBUMIN.............................. ref SDS F7 GT9I
250652 -            PROTEIN, TOTAL
250654 -     ..
250655 -    Labs on 080726 omitted following tests...
250656 -
250657 -            GLUCOSE.............................. ref SDS D9 SE9J
250658 -            ALBUMIN.............................. ref SDS D9 GT9I
250660 -     ..
250661 -    Labs on 080626 omitted following tests...
250662 -
250663 -            GLUCOSE.............................. ref SDS B8 HS7I
250664 -            PROTEIN, TOTAL
250665 -            ALBUMIN
250666 -            CALCIUM
250668 -  ..
250669 - Case study on 080626 shows these four tests, which have been omitted
250670 - and included in various combinations the past 4 cycles, were
250671 - consistently included for the prevous 15 cycles. ref SDS B8 HS8F
250672 -
250673 -
250674 -
250675 -
250676 -
250677 -
2507 -

SUBJECTS
Absolute Neutrophils Count ANC 6850 Above 1500 NEUTS 6.85 Above 1.5

3403 -
340401 -  ..
340402 - NEUTS 1.65 Decrease 2nd Week Chemotherapy Received
340403 - Chemotherapy Received Blood Counts Drop Significantly
340404 - Blood Counts Fall Significantly Chemotherapy Carboplatin Received
340405 -
340406 - Follow up ref SDS I9 PU6K, ref SDS I2 PU6K.
340407 -
340408 - Blood counts decreased significantly this week, shown by the Lab
340409 - report today with NEUTS 1.65, ref SDS 0 QY6H, compared with NEUTS 2.55
340410 - last week on 081016, ref SDS I9 QY6H  This is still above UCSF
340411 - standard of 1.5 for Millie to safely get chemotherapy treatment.
340412 - Since today is the 2nd week in the new cycle, Millie had 2 Neupogen
340413 - treatments last week at Kaiser, reported on 081018, ref SDS J1 UZ7K,
340414 - and according to the schedule on 080920. ref SDS H5 SY8G
340416 -  ..
340417 - Neutropenia causes a "roller coaster" above and below specified target
340418 - from week to week, while getting Neupogen treatments in recent months,
340419 - is shown in case study below. ref SDS 0 OK67
340421 -  ..
340422 - Patient history getting cetuximab and Carboplatin is listed above.
340423 - ref SDS I9 5B6J
340425 -  ..
340426 - Side effects of Neupogen is listed below. ref SDS I9 SB8I
340428 -  ..
340429 - Fitness from hiking is listed in case study on 081021. ref SDS J4 8G5M
340430 -
340431 -
340432 -
340433 -
3405 -

SUBJECTS
Default Null Subject Account for Blank Record

3503 -
350401 -  ..
350402 - Neupogen Case Study Missed Carboplatin Treatments Low Blood Counts
350403 -
350404 - Follow up ref SDS I9 EP7N, ref SDS I2 EP7N.
350405 -
350406 - Case study on 060809 shows Millie has often received chemotherapy when
350407 - blood counts are below the standard for safe treatments, and on some
350408 - occassions has received Neupogen to increase blood counts. ref SDS 7
350409 - HV45
350411 -  ..
350412 - Research on neutropenia was reported on 070301, ref SDS 18 O59H, when
350413 - Doctor Rugo was concerned about holding blood counts with weekly
350414 - Carboplatin treatments. ref SDS 18 VF6O
350416 -  ..
350417 - With 2 treatments scheduled for this week, Millie will have received
350418 - 42 Neupogen treatments, and missed 4 chemotherapy treatments due to
350419 - rising neutropenia, shown in case study today on patient history.
350420 - ref SDS 0 V19M  She last missed Carboplatin treatment on 080821.
350421 - ref SDS F7 PU6K
350423 -  ..
350424 - Millie's letter to the medical team on 080307 asked about solving low
350425 - blood counts. ref SDS 84 HS6R  On 080423 Millie notified the medical
350426 - team to maintain a full dose of Carboplatin because these treatments
350427 - yielded favorable response. ref SDS 94 TY6Y  On 080501 a mixup in
350428 - communication reduced the dose of Carboplatin with the aim of not
350429 - missing treatments.  Adding Neupogen to avoid missing treatments might
350430 - have enabled maintaining full dose of Carboplatin to increase
350431 - recovery. ref SDS 98 CZ3N
350433 -  ..
350434 - Fitness from hiking is listed in case study on 081021. ref SDS J4 8G5M
350436 -  ..
350437 - Reduced treatment may relate to rising cancer marker CA 15-3 96 on
350438 - 080821. ref SDS F7 A16M
350440 -  ..
350441 - Previously, case study on 060810 shows Kaiser routinely gives Millie
350442 - treatment for cancer when ANC/NEUTS drops below safe levels, because
350443 - alternative risks losing control that cascades into death. ref SDS 7
350444 - HV45
350445 -
350446 -            [On 081205 case study shows blood counts, Neupogen, and
350447 -            missed treatments for 2008 and beginning 2009. ref SDS K5
350448 -            EC5N
350450 -  ..
350451 - Millie received only 17 of 21 total treatments prescribed with
350452 - Carboplatin, since starting the 2nd arm of the clinical study on
350453 - 080306...
350455 -        ..
350456 -                      Neupogen            Carboplatin
350457 -       Date    NEUTS  Cur Totl Cycl Trm  Rcvd   Missed
350458 -
350459 -        081023  1.65   2   42    9   2    21.......... ref SDS 0 QY6H
350460 -        081016  2.55   2   40    9   1    20.......... ref SDS I9 QY6H
350461 -        081009  1.98   2   38    8   4    19.......... ref SDS I2 QY6H
350462 -        081002  1.93   2   36    8   3    19.......... ref SDS H9 QY6H
350463 -        080925  3.82   2   34    8   2    18.......... ref SDS H7 QY6H
350464 -        080918  2.07   2   32    8   1    17.......... ref SDS H4 QY6H
350465 -        080911  1.43   2   30    7   4    16.......... ref SDS G9 QY6H
350466 -        080904  1.99   2   28    7   3    16.......... ref SDS G7 QY6H
350467 -        080828  3.09   2   26    7   2    15.......... ref SDS G5 QY6H
350468 -        080821  0.99   2   24    7   1    14      4... ref SDS F7 QY6H
350469 -        080814  1.37   0   22    6   4    14.......... ref SDS F5 QY6H
350470 -        080807  2.41   2   22    6   3    14.......... ref SDS E9 QY6H
350471 -        080731  1.92   2   20    6   2    13.......... ref SDS E3 QY6H
350472 -        080724  2.32   2   18    6   1    12.......... ref SDS D9 QY6H
350473 -        080717  2.47   1   16    5   4    11.......... ref SDS D2 QY6H
350474 -        080710  5.12   2   15    5   3    11.......... ref SDS C6 QY6H
350475 -        080703  2.90   2   13    5   2    10.......... ref SDS C3 QY6H
350476 -        080626  1.80   2   11    5   1    09.......... ref SDS B8 QY6H
350477 -        080619  0.74   1    9    4   4    08.......... ref SDS B3 QY6H
350478 -        080612  3.77   2    8    4   3    08.......... ref SDS B0 QY6H
350479 -        080605  1.55   2    6    4   2    07.......... ref SDS A7 QY6H
350480 -        080529  2.26   1    4    4   1    06.......... ref SDS A6 QY6H
350481 -        080522  0.96   0         3   4    05.......... ref SDS A3 QY6H
350482 -        080515  1.21   0         3   3    05      3... ref SDS A2 QY6H
350483 -        080508  5.41   1    3    3   2    05.......... ref SDS A1 QY6H
350484 -        080501  1.34   1    2    3   1    04.......... ref SDS 99 QY6H
350485 -        080424  1.34   0         2   4    03.......... ref SDS 96 QY6H
350486 -         ..
350487 -        080417  0.95   0         2   3    03      2... ref SDS 93 QY6H
350488 -        080410  6.85   0         2   2    03.......... ref SDS 91 QY6H
350489 -        080403  1.34   1    1    2   1    02.......... ref SDS 88 QY6H
350490 -        080327  2.30   0         1   4    01.......... ref SDS 87 QY6H
350491 -        080320  1.28   0         1   3    01      1... ref SDS 86 QY6H
350492 -        080313  2.05   0         1   2    01.......... ref SDS 85 QY6H
350493 -        080306  1.75   0         1   1    00.......... ref SDS 83 QY6H
350494 -
350495 -
3505 -

SUBJECTS
Default Null Subject Account for Blank Record

3603 -
360401 -  ..
360402 - Side Effects Neupogen Treatments Continue Mild Tolerance Acceptable
360403 -
360404 - Follow up ref SDS I9 SB8I, ref SDS I2 SB8I.
360405 -
360406 - Fitness from hiking is listed in case study on 081014. ref SDS I6 8G5M
360408 -  ..
360409 - Millie last reported side effects on 081011 experiencing bone pain,
360410 - headache, and fatigue associated with Neupogen and chemotherapy.
360411 - ref SDS I4 FL4H
360413 -  ..
360414 - Side effects of Neupogen may be lessening, reported on...
360415 -
360416 -               081011................, ref SDS I4 FL4H
360417 -               081010................, ref SDS I3 SB8I
360418 -               081006................, ref SDS I1 3E4K
360419 -               081004................, ref SDS I0 Y17L
360420 -               081002................, ref SDS H9 Y17L
360421 -               080930................, ref SDS H8 Y17L
360422 -               080923................, ref SDS H6 K16F
360423 -               080915................, ref SDS H1 9W9I
360424 -               080810................, ref SDS F3 9W9I
360425 -               080803................, ref SDS E4 9W9I
360426 -               080726................, ref SDS E1 9W9I
360427 -               080721................, ref SDS D6 9W9I
360428 -               080713................, ref SDS C9 RM94
360429 -               080629................, ref SDS C2 6Q5J
360430 -               080628................, ref SDS C0 6Q5J
360431 -
360432 -
360433 -
360434 -
360435 -
3605 -

SUBJECTS
Default Null Subject Account for Blank Record

5103 -
510401 -  ..
510402 - Coagulation Control INR 2.3 Within Range Treating Pulmonary Embolism
510403 -
510404 - Follow up ref SDS I9 K66J, ref SDS H4 K66J.
510405 -
510406 - Labs today show INR 2.3 have returned to the target range, ref SDS 0
510407 - PU7Y, and resolves elevated INT 4.2 recorded on the test last week on
510408 - 081016. ref SDS I9 PU7Y
510410 -  ..
510411 - At that time on 081016, Millie skipped Coumadin treatment for
510412 - pulmonary embolism, which influences INR levels. ref SDS I9 MQ65
510413 - After treatment, Millie notified Gloria at Kaiser Coagulation Control
510414 - Clinic in Martinez, that she did not take Coumadin. ref SDS J0 J37J
510415 - On 081019 Millie sent a follow up letter advising that Coumadin
510416 - treatment was resumed on 081017. ref SDS J2 TH8X
510418 -  ..
510419 - Results today show effective referral coordination with Kaiser's
510420 - Coagulation Control Clinic.
510421 -
510422 -     [On 081024 Gloria notified that Kaiser received Millie's letter on
510423 -     081016 reporting elevated INR 4.2. ref SDS J7 RF5I
510424 -
510425 -     [On 081024 Millie notified Gloria in the Kaiser Coagulation
510426 -     Control Clinic that the blood test today at UCSF shows INR
510427 -     returned to normal. ref SDS J8 6V5T
510429 -      ..
510430 -     [On 081024 Gloria updated Kaiser's records on Millie's treatments
510431 -     with Coumadin. ref SDS J9 IC4M
510433 -      ..
510434 -     [On 081126 Millie's INR 3.4 blood counts increased, possibly due
510435 -     to new cancer treatment with sunitinib; Millie notified the Kaiser
510436 -     Coagulation Control Clinic, ref SDS K3 J45H; Gloria, Millie's case
510437 -     manager sent a letter confirming changes to the dose of Coumadin
510438 -     required to manage Millie's chronic pulmonary embolism condition.
510439 -     ref SDS K4 VQ8V
510440 -
510441 -
510442 -
510443 -
510444 -
510445 -
510446 -
510447 -
510448 -
510449 -
5105 -