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 16, 2008 09:00 AM Thursday; Rod Welch

Millie 1st 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...Cancer Marker CA 15-3 95 Stable for 8 Weeks Remarkable Unusual
5...NEUTS 2.55 Increase 1st Week Chemotherapy Received
6...Chemotherapy Received Blood Counts Rise Significantly
7...Blood Counts Rise Significantly Chemotherapy Carboplatin Received
8...Neupogen Case Study Missed Carboplatin Treatments Low Blood Counts
9...Side Effects Neupogen Treatments Continue Mild Tolerance Acceptable
10...Coagulation Control INR 4.2 Abnormally High PT 41.1 High
11...Cetuximab Chemotherapy Order for 7th Cycle
....Medication: (plan to give weekly)
....Laboratory work:
12...Carboplatin Chemotherapy Orders
....Error Dates Treatment Should Include 3 Days
....Antimetics:
....Chemotherapy (plan to treat weekly for 3 out of 4 weeks).
....Carboplatin Dose Reduced May Aid Blood Counts Maintain Treatments
....Laboratory Work:
....Neupogen Prescribed in Chemotherapy Orders


..............
Click here to comment!

CONTACTS 

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

1003 -
1003 -    ..
1004 - Summary/Objective
1005 -
100501 - Follow up ref SDS I2 0000, ref SDS H9 0000.
100502 -
100503 -
100504 -
100505 -
100506 -
100508 -  ..
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 I2 X33O, ref SDS H9 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 I2 356I, ref SDS H9 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 I2 5B6J, ref SDS H9 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 0 5B6J
101041 -  ..
101042 - Today is the 1st treatment of the 9th cycle with cetuximab and
101043 - Carboplatin together.  This is the 33rd treatment overall with
101044 - cetuximab on the 2nd arm of the clinical study, but is only the 20th
101045 - treatment with Carboplatin due to low blood counts.
101047 -  ..
101048 - Doctor Rugo discussed today finding possible progression of cancer
101049 - based on palpation of swelled lymph node in the left supraclavicular,
101050 - and increased intensity of IBC on left arm.  Began considering
101051 - changing treatment to Sunitinib clinical study.
101053 -  ..
101054 - After meeting with the doctor on the 2nd floor, and during treatment
101055 - in the Infusion Clinic, Glenna, the coordinatory for the Sunitinib
101056 - study, brought the Consent documents for Millie to review.
101057 -
101058 -            [On 081021 Consent document sent to primary care physician
101059 -            to prepare for meeting on 081024. ref SDS I1 7L5S
101061 -  ..
101062 - Catherine has returned from medical leave; however, she is still
101063 - struggling with an injured leg, and so Diane was Millie's nurse
101064 - today.
101065 -
101066 -
101067 -
1011 -

SUBJECTS
Default Null Subject Account for Blank Record

1703 -
170401 -  ..
170402 - Schedule Weekly Treatments Continue on Thursdays
170403 -
170404 - Follow up ref SDS I2 1K7H, ref SDS H9 1K7H.
170406 -  ..
170407 - The schedule for Neupogen is listed on 081004. ref SDS I0 WJ4O
170409 -  ..
170410 - The current schedule through 090115 is listed on 080918. ref SDS H4
170411 - PN6F
170413 -  ..
170414 - Consideration today on switching 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
170417 - the 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 I2 FW5N, ref SDS H9 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 - Diane performed the blood draw as shown in the schedule received on
250514 - 080918. ref SDS H4 1K7H
250516 -  ..
250517 - The doctor's order for lab work, including 7 vials for the trial, was
250518 - ready in the Infusion Clinic today, implementing Millie's notice
250519 - yesterday on 081015 sent to Jill and the medical team. ref SDS I8 435O
250521 -  ..
250522 - There was a staff meeting underway at 0750 in the Infusion Clinic,
250523 - when Millie was arrived for a scheduled blood draw in time to have the
250524 - test report available for review by the doctor on the 2nd floor at
250525 - 0830.  Diane left the meeting for 10 - 15 minutes to draw blood for
250526 - Millie's test.  This presented exigent service, and may account for
250527 - omitting the INR test.
250529 -  ..
250530 - Diane was therefore rushed.  She drew 6 of the 7 study blood vials.
250531 - The 7th vial which has a multi-colored top, was filled only half-way
250532 - because blood flow slowed, which is typical.  It usually takes longer
250533 - to fill that 7th vial than to fill the first.  Diane said to mention
250534 - this to the medical team during the meeting, and to let her know if
250535 - they need another draw to get a full vial for the 7th tube.
250537 -             ..
250538 -            [...below, the Chemotherapy Order seems to describe the 7th
250539 -            study vial as a "1 cell saver." ref SDS 0 QD7H
250541 -  ..
250542 - After the blood draw, Diane flushed the Power Port with Heparin for
250543 - standard of care to maintain the port.  Millie went to the Breast Care
250544 - Clinic on 2nd floor for a meeting with the medical team at 0830.
250545 - During the meeting, the report on the tests for the blood draw was
250546 - reviewed using the computer in the Examination room.
250548 -  ..
250549 - The report on the blood test showed that INR was missing, further
250550 - reflecting that things were rushed in the Infusion Clinic due to the
250551 - staff meeting. ref SDS 0 GP7O
250553 -  ..
250554 - Brigid asked that the Infusion Clinic do the 7th vial again for a full
250555 - test tube of blood, in addition to a blood draw for the INR test.
250557 -  ..
250558 - When Millie returned to the Infusion Clinic on the 5th floor at 1020
250559 - after meeting with the medical team on the 2nd floor at 0830,
250560 - Catherine asked Diane to do another blood draw for Millie to get a
250561 - full vial of blood for the 7th study tube, and also to test INR.
250562 -
250563 -        [...below, INR 4.2 significantly higher than normal for past 24
250564 -        months, ref SDS 0 K66J, possibly due to making the draw for INR
250565 -        after flushing with Heparin to maintain the port following the
250566 -        main blood draw. ref SDS 0 X68G
250567 -
250568 -
250569 -
250571 -  ..
2506 -
2507 -
2508 - 1020
2509 -
250901 - The meeting on the 2nd floor with the medical team ran longer than
250902 - normal.  There was about a 40 minute delay after Brigid completed
250903 - initial work up, and submitted the new Chemotherapy Orders.  Millie
250904 - waited in the examination room for the doctor to arrive about 0945.
250905 - The doctor's review took about 10 minutes, and then Millie dressed;
250906 - she waited for another 5 minutes, while Megan looked for the protocol
250907 - for treatment the doctor proposed during the meeting.  Megan came into
250908 - the examination room about 1005 and reported she could not find the
250909 - protocol, but would look further and bring to the Infusion Clinic.
250911 -  ..
250912 - Millie returned to the Infusion Clinic on the 5th floor about 1020,
250913 - for treatment by Diane.
250915 -  ..
250916 - During treatment, Catherine submitted results of the test starting the
250917 - 9th cycle.  Scope is the same as for starting cycle 8 on 080918.
250918 - ref SDS H4 075H
250919 -
250934 -     ..
250935 -    Log#:                   081016 08:25
250936 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
250937 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
250938 -     ..
250939 -    CBC with DIFF & PLT CT                                     CBCD
250940 -     ..
250941 -    WBC COUNT               4.9    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
250942 -    RBC COUNT      L        3.89   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
250943 -    HEMOGLOBIN             12.8    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
250944 -    HEMATOCRIT             38.2    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
250945 -    MCV                    98      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
250946 -    MCH                    33.1    pg           26  -   34     MCH
250947 -    MCHC                   33.7    g/dL         31  -   36     MCHC
250948 -    PLATELETS             215      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
250949 -
250950 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
250951 -        Francisco, CA  94115
250952 -    ..
250953 -       (posted 081023, ref SDS J2 VK6H)
250954 -    CA 15-3      H*        95      U/mL             <  33     CA153  CA 15-3                        <  39
250955 -
250956 -         Note new reference range [<33 changed from <31] and change in
250957 -         methodology effective March 1, 2008.  Performed using the
250958 -         Siemens Centaur Chemiluminesence method.  CA 15-3 result using
250959 -         the Roche Elecsys assay is 75 U/mL.  Ref range <31 U/mL.  This
250960 -         rebaseline value provided at no additional charge.
250962 -          ..
250963 -         This new note updates explanation of tests prior to 080301,
250964 -         e.g., on 080207. ref SDS 74 A16M
250965 -    ..
250966 -     (NEUTS x 1000 = ANC for Kaiser)
250967 -    NEUTS                   2.55   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
250968 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
250970 -     ..
250971 -    LYMPHS                  1.62   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
250972 -    MONOS                   0.27   x10E9/L     0.2  -  0.8     M-A   Monocyte          %         0  -  11
250973 -    EOS                     0.25   x10E9/L     0.0  -  0.4     E-A   Esoinophils       %         1  -  5
250974 -    BASOS                   0.05   x10E9/L     0.0  -  0.1     B-A   Basophil          %         0  -  2
250975 -     ..
250976 -  * LUC/ATYP LYMPHS         0.13   x10E9/L     0.0  -  0.2     LALA
250978 -     ..
250979 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
250980 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
250981 -    PT            H        41.1    s          12.0  -  14.1    PT    PT, patient       sec     8.9  -  11.1
250982 -    INL NRM Ratio H         4.2                0.9  -  1.1     INR   INR                       2.0  -  3.0
250983 -
250984 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
250985 -        Francisco, CA  94115
250987 -     ..
250988 -  * PARTIAL
250989 -    THROMBOPLASTIN  H              s          22.2  - 34.2     INR   PTT
250990 -
250991 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
250992 -        Francisco, CA  94115
250994 -     ..
250995 -  * FIBRINOGEN                     mg/dL       202  - 430      FIB
250996 -
250997 -        New test added today, 080818; Catherine says similar to INR.
250999 -     ..
251000 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
251001 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
251002 -    ELECTROLYTE PANEL                                          LYTE
251003 -    SODIUM                136      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
251004 -    POTASSIUM               3.8    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
251005 -    CHLORIDE              104      mmol/L       98  -  107     CL
251006 -    CARBON DIOX TOTAL      24      mmol/L       23  -  32      CO2
251007 -    ANION GAP               8                    3  -  14      ANGA
251008 -     ..
251009 -    UREA NITROGEN          10      mg/dL         8  -  23      BUN   BUN               mg/dL     7  -  17
251010 -    GLUCOSE               122      mg/dL        70  -  199     GLU   Glucose           mg/dL     ?  -   ?
251011 -    AST                    34      U/L          16  -  41      AST   AST (SGOT)        U/L      14  -  36
251012 -    ALT                    21      U/L          11  -  54      ALT   ALT (SGPT)        U/L      11  -  66
251013 -    BILIRUBIN, TOTAL        0.8    mg/dL       0.3  - 1.3      BILT  Bili Total        mg/dL   0.2  - 1.3
251014 -    ALKALINE PHOSPHATASE   99      U/L          29  - 111      ALKP  Alkaline Ph       U/L      38  - 126
251015 -     ..
251016 -    PROTEIN, TOTAL          6.7    g/dL        5.8  - 8.0      TP    Protine Total     g/dL    6.3  - 8.2
251017 -    ALBUMIN                 4.1    g/dL        3.4  - 4.7      ALB   Albumin           g/dL    3.4  - 4.8
251018 -    CALCIUM                 8.8    mg/dL       8.7  - 10.1     CA    Calcium           mg/dL   8.4  - 10.2
251019 -     ..
251020 -    MAGNESIUM               1.9    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
251022 -     ..
251023 -    CREAT with eGFR
251024 -    CREATININE              0.53   mg/dL      0.42  - 1.06     CR    Creatinine        mg/dL   0.6  -  1.2
251025 -
251026 -      Note: Creatinine assay changed to IDMS standardization on
251027 -      February 4, 2008 causing decrease in results of approximately
251028 -      0.09 mg/dL
251030 -     ..
251031 -    eGFR if Caucasian     >60      mL/min                      GFRC
251032 -    eGFR if African Amer  >60      mL/min                      GFRA
251033 -
251034 -      eGFR corrected for 1.73 sq meters of body surface area
251035 -      Note:  eGFR is only an estimation. Please see online Lab Manual
251036 -      for potential limitations.
251037 -      Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
251038 -      CA  94115
251040 -     ..
251041 - *  Labs today included tests omitted on 080918 labs...
251042 -
251043 -            LUC/ATYP LYMPHS...................... ref SDS 0 Z47G
251045 -     ..
251046 -    Labs today omitted tests included on 080918 labs...
251047 -
251048 -            PARTIAL THROMBOPLASTIN............... ref SDS H4 GQ6F
251049 -            FIBRINOGEN........................... ref SDS H4 VE6I
251051 -     ..
251052 -    Labs on 080821 omitted following tests...
251053 -
251054 -            GLUCOSE.............................. ref SDS F7 SE9J
251055 -            ALBUMIN.............................. ref SDS F7 GT9I
251056 -            PROTEIN, TOTAL
251058 -     ..
251059 -    Labs on 080726 omitted following tests...
251060 -
251061 -            GLUCOSE.............................. ref SDS D9 SE9J
251062 -            ALBUMIN.............................. ref SDS D9 GT9I
251064 -     ..
251065 -    Labs on 080626 omitted following tests...
251066 -
251067 -            GLUCOSE.............................. ref SDS B8 HS7I
251068 -            PROTEIN, TOTAL
251069 -            ALBUMIN
251070 -            CALCIUM
251072 -  ..
251073 - Case study on 080626 shows these four tests, which have been omitted
251074 - and included in various combinations the past 4 cycles, were
251075 - consistently included for the prevous 15 cycles. ref SDS B8 HS8F
251076 -
251077 -
251078 -
2511 -

SUBJECTS
Default Null Subject Account for Blank Record

2603 -
260401 -  ..
260402 - Cancer Marker CA 15-3 95 Stable for 8 Weeks Remarkable Unusual
260403 -
260404 - Follow up ref SDS H4 VK6H, ref SDS F7 VK6H.
260405 -
260406 - Results of the blood test today for the cancer marker CA 15-3 95,
260407 - ref SDS 0 A16M, were reported a week later on 081023. ref SDS J2 VK6H
260409 -  ..
260410 - Background on CA 15-3 is reported for starting cycle 8 on 080918.
260411 - ref SDS H4 VK6H
260413 -  ..
260414 - Seems unusual for a blood test to be identical 4 weeks apart.  The
260415 - month previous, CA 15-3 96 on 080821, ref SDS F7 VK6H, indicates
260416 - remarkable stability
260418 -  ..
260419 - Stable cancer marker aligns with CT test on 080911.  Review the next
260420 - day on 080912 shows no affirmed adenopathy; and swelled nodes in the
260421 - right axilla have been very small and stable without growth for 7
260422 - months. ref SDS H0 OO6M
260424 -  ..
260425 - Similarly, there has been no significant growth of a node in the left
260426 - supraclavicular, at least since the CT test on 080718; review of the
260427 - test report on 080723 shows not findings, ref SDS D7 4K5H, prior to
260428 - examination on 080821 that reported swelling. ref SDS F6 4C6O  The
260429 - next test on 080911 also did not identify adenpathy in the left
260430 - supraclavicular, shown by review on 080912. ref SDS H0 5O6N
260431 - Examination on 080918 did not find swelled lymph nodes in the left
260432 - supraclavicular. ref SDS H3 4C6O
260434 -  ..
260435 - Stable cancer marker CA 15-3 95 today, aligns with examination by the
260436 - medical team today finding stable to reduced rash at most IBC sites.
260437 - This, however, conflicts with rising intensity on the left arm and new
260438 - nodules in the breast bone area, ref SDS I9 J34U, and further with
260439 - concern about swelled lymph nodes palpated today in the left
260440 - supraclavicular. ref SDS I9 J34X
260442 -  ..
260443 - Concern about progression of cancer today resulted in a work plan to
260444 - change treatment from cetuximab and Carboplatin to a sunitinib
260445 - clinical study. ref SDS I9 J36R
260446 -
260447 -
260448 -
260449 -
260450 -
2605 -

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

3503 -
350401 -  ..
350402 - NEUTS 2.55 Increase 1st Week Chemotherapy Received
350403 - Chemotherapy Received Blood Counts Rise Significantly
350404 - Blood Counts Rise Significantly Chemotherapy Carboplatin Received
350405 -
350406 - Follow up ref SDS I2 PU6K, ref SDS H9 PU6K.
350407 -
350408 - Blood counts increased this week, shown by the Lab report today with
350409 - NEUTS 2.55, ref SDS 0 QY6H, compared with NEUTS 1.98 last week on
350410 - 081009, ref SDS I2 QY6H  This is well above UCSF standard of 1.5 for
350411 - Millie to safely get chemotherapy treatment.  Since today is the 1st
350412 - week in the new cycle, Millie had 2 Neupogen treatments last week at
350413 - Kaiser, reported on 081011, ref SDS I4 UZ7K, and according to the
350414 - schedule on 080920. ref SDS H5 SY8G
350416 -  ..
350417 - Neutropenia causes a "roller coaster" above and below specified target
350418 - from week to week, while getting Neupogen treatments in recent months,
350419 - is shown in case study below. ref SDS 0 OK67
350421 -  ..
350422 - Patient history getting cetuximab and Carboplatin is listed above.
350423 - ref SDS 0 5B6J
350425 -  ..
350426 - Side effects of Neupogen is listed below. ref SDS 0 SB8I
350428 -  ..
350429 - Fitness from hiking is listed in case study on 081014. ref SDS I6 8G5M
350430 -
350431 -
350432 -
350433 -
3505 -

SUBJECTS
Default Null Subject Account for Blank Record

3603 -
360401 -  ..
360402 - Neupogen Case Study Missed Carboplatin Treatments Low Blood Counts
360403 -
360404 - Follow up ref SDS I2 EP7N, ref SDS H9 EP7N.
360405 -
360406 - Case study on 060809 shows Millie has often received chemotherapy when
360407 - blood counts are below the standard for safe treatments, and on some
360408 - occassions has received Neupogen to increase blood counts. ref SDS 7
360409 - HV45
360411 -  ..
360412 - Research on neutropenia was reported on 070301, ref SDS 18 O59H, when
360413 - Doctor Rugo was concerned about holding blood counts with weekly
360414 - Carboplatin treatments. ref SDS 18 VF6O
360416 -  ..
360417 - With 2 treatments scheduled for this week, Millie will have received
360418 - 40 Neupogen treatments, and missed 4 chemotherapy treatments due to
360419 - rising neutropenia, shown in case study today on patient history.
360420 - ref SDS 0 V19M  She last missed Carboplatin treatment on 080821.
360421 - ref SDS F7 PU6K
360423 -  ..
360424 - Millie's letter to the medical team on 080307 asked about solving low
360425 - blood counts. ref SDS 84 HS6R  On 080423 Millie notified the medical
360426 - team to maintain a full dose of Carboplatin because these treatments
360427 - yielded favorable response. ref SDS 94 TY6Y  On 080501 a mixup in
360428 - communication reduced the dose of Carboplatin with the aim of not
360429 - missing treatments.  Adding Neupogen to avoid missing treatments might
360430 - have enabled maintaining full dose of Carboplatin to increase
360431 - recovery. ref SDS 98 CZ3N
360433 -  ..
360434 - Fitness from hiking is listed in case study on 081014. ref SDS I6 8G5M
360436 -  ..
360437 - Reduced treatment may relate to rising cancer marker CA 15-3 96 on
360438 - 080821. ref SDS F7 A16M  Millie has received only 17 of 21 total
360439 - treatments prescribed with Carboplatin, since starting the 2nd arm of
360440 - the clinical study on 080306...
360442 -        ..
360443 -                      Neupogen            Carboplatin
360444 -       Date    NEUTS  Cur Totl Cycl Trm  Rcvd   Missed
360445 -
360446 -        081016  2.55   2   40    9   1    20.......... ref SDS 0 QY6H
360447 -        081009  1.98   2   38    8   4    19.......... ref SDS I2 QY6H
360448 -        081002  1.93   2   36    8   3    19.......... ref SDS H9 QY6H
360449 -        080925  3.82   2   34    8   2    18.......... ref SDS H7 QY6H
360450 -        080918  2.07   2   32    8   1    17.......... ref SDS H4 QY6H
360451 -        080911  1.43   2   30    7   4    16.......... ref SDS G9 QY6H
360452 -        080904  1.99   2   28    7   3    16.......... ref SDS G7 QY6H
360453 -        080828  3.09   2   26    7   2    15.......... ref SDS G5 QY6H
360454 -        080821  0.99   2   24    7   1    14      4... ref SDS F7 QY6H
360455 -        080814  1.37   0   22    6   4    14.......... ref SDS F5 QY6H
360456 -        080807  2.41   2   22    6   3    14.......... ref SDS E9 QY6H
360457 -        080731  1.92   2   20    6   2    13.......... ref SDS E3 QY6H
360458 -        080724  2.32   2   18    6   1    12.......... ref SDS D9 QY6H
360459 -        080717  2.47   1   16    5   4    11.......... ref SDS D2 QY6H
360460 -        080710  5.12   2   15    5   3    11.......... ref SDS C6 QY6H
360461 -        080703  2.90   2   13    5   2    10.......... ref SDS C3 QY6H
360462 -        080626  1.80   2   11    5   1    09.......... ref SDS B8 QY6H
360463 -        080619  0.74   1    9    4   4    08.......... ref SDS B3 QY6H
360464 -        080612  3.77   2    8    4   3    08.......... ref SDS B0 QY6H
360465 -        080605  1.55   2    6    4   2    07.......... ref SDS A7 QY6H
360466 -        080529  2.26   1    4    4   1    06.......... ref SDS A6 QY6H
360467 -        080522  0.96   0         3   4    05.......... ref SDS A3 QY6H
360468 -        080515  1.21   0         3   3    05      3... ref SDS A2 QY6H
360469 -        080508  5.41   1    3    3   2    05.......... ref SDS A1 QY6H
360470 -        080501  1.34   1    2    3   1    04.......... ref SDS 99 QY6H
360471 -        080424  1.34   0         2   4    03.......... ref SDS 96 QY6H
360472 -         ..
360473 -        080417  0.95   0         2   3    03      2... ref SDS 93 QY6H
360474 -        080410  6.85   0         2   2    03.......... ref SDS 91 QY6H
360475 -        080403  1.34   1    1    2   1    02.......... ref SDS 88 QY6H
360476 -        080327  2.30   0         1   4    01.......... ref SDS 87 QY6H
360477 -        080320  1.28   0         1   3    01      1... ref SDS 86 QY6H
360478 -        080313  2.05   0         1   2    01.......... ref SDS 85 QY6H
360479 -        080306  1.75   0         1   1    00.......... ref SDS 83 QY6H
360480 -
360481 -
3605 -

SUBJECTS
Default Null Subject Account for Blank Record

3703 -
370401 -  ..
370402 - Side Effects Neupogen Treatments Continue Mild Tolerance Acceptable
370403 -
370404 - Follow up ref SDS I2 SB8I, ref SDS H9 SB8I.
370405 -
370406 - Fitness from hiking is listed in case study on 081014. ref SDS I6 8G5M
370408 -  ..
370409 - Millie last reported side effects on 081011 experiencing bone pain,
370410 - headache, and fatigue associated with Neupogen and chemotherapy.
370411 - ref SDS I4 FL4H
370413 -  ..
370414 - Side effects of Neupogen may be lessening, reported on...
370415 -
370416 -               081011................, ref SDS I4 FL4H
370417 -               081010................, ref SDS I3 SB8I
370418 -               081006................, ref SDS I1 3E4K
370419 -               081004................, ref SDS I0 Y17L
370420 -               081002................, ref SDS H9 Y17L
370421 -               080930................, ref SDS H8 Y17L
370422 -               080923................, ref SDS H6 K16F
370423 -               080915................, ref SDS H1 9W9I
370424 -               080810................, ref SDS F3 9W9I
370425 -               080803................, ref SDS E4 9W9I
370426 -               080726................, ref SDS E1 9W9I
370427 -               080721................, ref SDS D6 9W9I
370428 -               080713................, ref SDS C9 RM94
370429 -               080629................, ref SDS C2 6Q5J
370430 -               080628................, ref SDS C0 6Q5J
370431 -
370432 -
370433 -
370434 -
370435 -
3705 -

SUBJECTS
Default Null Subject Account for Blank Record

5203 -
520401 -  ..
520402 - Coagulation Control INR 4.2 Abnormally High PT 41.1 High
520403 -
520404 - Follow up ref SDS H4 K66J, ref SDS F7 K66J.
520405 -
520406 - Labs today show INR 4.2 well above the prescribed range. ref SDS 0
520407 - PU7Y   This is significantly above INR 2.1 reported for the test on
520408 - 080918. ref SDS H4 K66J
520410 -  ..
520411 - As a precaution, pending advice from Gloria at the Kaiser Coagulation
520412 - Control Clinic in Martinez, Millie skipped Coumadin today.
520414 -  ..
520415 - Patient history shows Millie's INR blood counts have been within range
520416 - for the past 24 months.  The report today is a significant change in
520417 - patient condition.  There has been no change in diet or medical
520418 - symptoms that account for such a significant change.
520419 -
520420 -        [On 081126 Millie's INR 3.4 blood counts increased, possibly
520421 -        due to new cancer treatment with sunitinib; Millie notified the
520422 -        Kaiser Coagulation Control Clinic, ref SDS J3 J45H; Gloria,
520423 -        Millie's case manager sent a letter confirming changes to the
520424 -        dose of Coumadin required to manage Millie's chronic pulmonary
520425 -        embolism condition. ref SDS J4 VQ8V
520427 -  ..
520428 - INR increased above the target range only once before in 8 years of
520429 - treatment.  On 061214 INR reached 6.4 due to a conflict in
520430 - medications. ref SDS 12 4O5H  At that time, Gloria reported that INR
520431 - above 6 presents seriouos health risks.  Today, 4.2 seems well below
520432 - this high risk threshold.
520434 -  ..
520435 - The cause of sudden elevation after 2 years on the same Coumadin
520436 - regimen is unclear in the record.
520438 -  ..
520439 - INR test today was performed out of sequence due a hectic schedule,
520440 - reported above. ref SDS 0 GP7O  This may have caused a mistake by
520441 - mixing up blood vials, or data entry on test results.
520443 -  ..
520444 - Another possibility is that INR blood draw was performed after the
520445 - port catheter was maintained with Heparin following the initial blood
520446 - draw, when Millie returned to the Infusion Clinic on the 5th floor
520447 - meeting with the medical team on the 2nd floor.  Catherine discussed
520448 - possibility that flushing the port with Heparin could have
520449 - contaminiate the sample drawn for INR, per above. ref SDS 0 LO4O
520450 - Since Heparin reduces coagulation, this would be reflected by elevated
520451 - INR.
520453 -  ..
520454 - Millie has significantly increased exercise the past number of months,
520455 - shown in the report on 081014. ref SDS I6 8G5M
520457 -  ..
520458 - On Sunday, 081012 her pulse which is normally 55, walking around, and
520459 - about 110 when exercising elevated to over 200 during exercise.  Pulse
520460 - averaged about 184 instead of 110 for about 2 hours, and then settled
520461 - back to about 110 for a 3rd lap. ref SDS I5 4I8M
520463 -  ..
520464 - On 080827 Millie reported INR results for the blood test on 080821 in
520465 - a letter to Gloria at Kaiser Coagulation Control Clinic in Martinez,
520466 - CA. ref SDS G1 504R  Later that day on 080827, Kaiser notified Millie
520467 - that the report on INR was received, and advised Millie to continue
520468 - the same regimen for Coumadin to treat pulmonary embolism. ref SDS G4
520469 - VD7O
520471 -  ..
520472 - On 081015 (yesterday) Millie received a letter dated 081009 notifying
520473 - that Kaiser has not received the report for the blood test on 080918.
520474 - ref SDS I7 YG5H
520475 -
520476 -        [On 081016 notified Gloria at Kaiser Coagulation Control Clinic
520477 -        in Martinez, that did not take Coumadin. ref SDS I9 J37J
520479 -         ..
520480 -        [On 081019 Millie notified Gloria that Coumadin treatment
520481 -        was resumed the next day on Friday, 081017. ref SDS J0 TH7T
520482 -
520483 -
520484 -
520485 -
520486 -
520487 -
520488 -
5205 -

SUBJECTS
Default Null Subject Account for Blank Record

5303 -
530401 -  ..
530402 - Cetuximab Chemotherapy Order for 7th Cycle
530403 -
530404 - Follow up ref SDS H4 MM6N, ref SDS F7 MM6N.
530405 -
530406 - Chemotherapy Orders for cetuximab were not submitted today, because
530407 - the Chemotherapy Orders on 080821 are specified for 8 weeks.
530408 - ref SDS F7 YS86
530410 -     ..
530411 -    Outpatient Infusion Orders
530413 -     ..
530414 -    45772381    Name:  Buck, Mildred
530415 -    DOB:  January 21, 1936               F COPAY 0
530416 -    FSC 302   Plan: Medicare part A&B XAB
530417 -    ATTG MD:  Unknown Sched 99996
530418 -    Ref MD:  Johnson, Robert A Jr MD 2194
530419 -    Auth#                                     Stor BCC LOC
530420 -    Visit:                       DOS
530422 -  ..
530423 - This chemo order does not have a stamped document ID in the top right
530424 - corner with a visit # and DOS date, which is on prior chemo order for
530425 - 080821, ref SDS F7 MM6N,
530427 -  ..
530428 - Chemotherapy Order for Cetuximab continues...
530429 -
530430 -    Date:  20081016
530432 -     ..
530433 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
530434 -    in combination with Carboplatin in ER-negative, PR-negative,
530435 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers.
530437 -     ..
530438 -    Arm:  2 - Cetuximab + Carboplatin
530440 -     ..
530441 -    Dates to be given: 20081016
530443 -     ..
530444 -    Allergies:  NKDA
530446 -     ..
530447 -    Height:  62 inches
530449 -     ..
530450 -    Weight:  136.5 pounds
530452 -  ..
530453 - There is handwriting next to this part of the form that shows...
530454 -
530455 -              [not 10% wt [delta symbol for "change"]
530457 -  ..
530458 - See explanation of weight change in the record on 080821. ref SDS F7
530459 - 4E6V
530461 -  ..
530462 - Chemotherapy Order for Cetuximab continues...
530464 -     ..
530465 -    BSA:
530467 -     ..
530468 -    Diagnosis:  Breast Cancer (IBC)
530470 -     ..
530471 -    ICD-9 codes: 174.9 198.5 198.3
530473 -  ..
530474 - Chemotherapy Order for cetuximab on 080821 shows ICD-9 codes 174.9 and
530475 - 198.5 and 198.3, ref SDS F7 SH6H, rather than the codes in the
530476 - cetuximab order today.
530478 -  ..
530479 - Chemotherapy Order for Cetuximab continues...
530480 -
530481 -    Cycle:  9
530483 -     ..
530484 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
530486 -     ..
530487 -    x  Diphenhydramine 25 mg IV
530488 -
530489 -       Benadryl............... explained on 070201. ref SDS 11 DC7J
530491 -     ..
530492 -    Medication:  (plan to give weekly)
530493 -
530494 -    x  Cetuximab - Erbitux - (study supply) (maintenance)
530495 -
530496 -       250 mg/m*m = 428 mg
530498 -     ..
530499 -    Maximum infusion rate is 5 ml/minute. (concentration 2 mg/ml)
530501 -     ..
530502 -    Infuse once weekly for 8 weeks.  First dose is to be given on date
530503 -    081016.
530505 -     ..
530506 -    Cetuximab is administered undiluted through a low protein binding
530507 -    0.22 micro in-line filter.  Use NS soution to flush the line at
530508 -    the end of the Infusion.
530510 -     ..
530511 -    Arm 2:  Administer carboplatin if vital signs are unremarkable one
530512 -    hour after cetuximab infusion.
530514 -     ..
530515 -    Vital signs at baseline, upon cetuximab completion and one hour
530516 -    after cetuximab.
530517 -
530518 -    **** please not start and stop times ****
530519 -
530521 -     ..
530522 -    Laboratory work:
530523 -
530524 -       See carboplatin orders.
530525 -       Notify MD for dose modifications if patient has severe acne
530526 -       form rash
530527 -       CBC with differential and plateletes every 4 weeks
530528 -       Creatinine and magnesium every 4 weeks
530529 -       BUN, AST, Alk Phos, ALT, total bilrubin, electrolytes every
530530 -       8 weeks
530532 -  ..
530533 - No laboratory work is checked on the form.  Lab scope was specified
530534 - with the Chemotherapy Order issued today for Carboplatin, shown below.
530535 - ref SDS 0 PWPW
530537 -  ..
530538 - Chemotherapy Order Cetuximab continue...
530539 -
530540 -    If levels are outside of normal laboratory values notify
530541 -
530542 -                Lynn Beach (MD/RN) at  415 443 1887
530544 -  ..
530545 - Chemotherapy Order Cetuximab continue...
530547 -     ..
530548 -    x  Physician has discussed risks/benefits of chemotherapy with the
530549 -       patient.  Consent, form obtained.
530550 -
530551 -       x  Yes  O2 [oxygyn] by nasal cannula at 2 liters/min prn for chest pain or SOB
530553 -           ..
530554 -       x  Yes  Diphenhydramine 50 mg IV prn x 1 unticaria pruntis, SOB
530555 -               (this is Benadryl)
530557 -        ..
530558 -       x  Yes  Hydrocrotisone 100 mg IV prn x 1 unticaria pruntis, SOB
530560 -        ..
530561 -       x  Yes  Aubterol inhaler 2 - 4 puffs prn SOB or chest tightness
530563 -        ..
530564 -       x  Yes  Epnephnna nhaler 2 - 4 puffs prn SOB or chest tightness
530566 -  ..
530567 - Chemotherapy Order Cetuximab continue...
530569 -        ..
530570 -       breast CC05752  cetuximab 081009
530571 -       Approved 060615
530573 -        ..
530574 -       Physician Signature
530575 -
530576 -                Hope Rugo   Provider # 35513
530577 -
530578 -                Date:  080815
530580 -        ..
530581 -       Nurse Signature:
530582 -
530583 -                Catherine Mitsuoka
530584 -
530585 -                Date:  081013
530587 -  ..
530588 - No nurses signature is shown in the copy received from UCSF; may have
530589 - been entered and filed in UCSF records later.
530590 -
530591 -
530592 -
530593 -
530594 -
530595 -
5306 -

SUBJECTS
Default Null Subject Account for Blank Record

5403 -
540401 -  ..
540402 - Carboplatin Chemotherapy Orders
540403 -
540404 - Follow up ref SDS H4 N54I, ref SDS F7 N54I.
540406 -  ..
540407 - No evident difference between chemotherapy orders today and for last
540408 - month starting cycle 7 on 080918. ref SDS H4 N54I
540410 -     ..
540411 -    45772381    Name:  Buck, Mildred
540412 -    DOB:  January 21, 1936               F COPAY 0
540413 -    FSC 302   Plan: Medicare part A&B XAB
540414 -    ATTG MD:  Unknown Sched 99996
540415 -    Ref MD:  Johnson, Robert A Jr MD 2194
540416 -    Auth#                                     Stor BCC LOC
540417 -    Visit:                       DOS
540419 -  ..
540420 - This chemo order does not have a stamped document ID in the top right
540421 - corner with a visit # and DOS date, which is on prior chemo order for
540422 - 080821, ref SDS F7 MM6N,
540424 -  ..
540425 - Chemotherapy Order Carboplatin continues...
540426 -
540427 -    Date:  20081016
540429 -     ..
540430 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
540431 -    in combination with Carboplatin in ER-negative, PR-negative,
540432 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers.
540434 -     ..
540435 -    Arm:  2 - Cetuximab + Carboplatin
540437 -     ..
540438 -    Error Dates Treatment Should Include 3 Days
540439 -
540440 -    Follow up ref SDS H4 PVQX, ref SDS F7 PVQX.
540441 -
540442 -    Dates to be given: 20081016
540443 -                       20081023
540444 -                       20081030  ** on vacation **
540446 -  ..
540447 - This order conflicts with planning for Millie to be on vacation on
540448 - 081030.  The schedule for treatment in the Infusion Clinic on 080918
540449 - shows there is no treatment on 081030. ref SDS H4 5N4F
540451 -  ..
540452 - Chemotherapy Order Carboplatin continues...
540453 -
540454 -    Allergies:  NKDA
540456 -     ..
540457 -    Height:  62 inches
540459 -     ..
540460 -    Weight:  136.5 pounds
540462 -  ..
540463 - There is handwriting that says...
540464 -
540465 -                    not 10% wt. [delta symbol = "change"]
540467 -  ..
540468 - Brigid prepared the Chemotherapy Order today during the meeting on
540469 - the 2nd floor with the medical team.
540471 -  ..
540472 - See the record on 080918 for explanation of weight in determining the
540473 - dose of Carboplain. ref SDS H4 PVRW
540475 -  ..
540476 - Chemotherapy Order Carboplatin continues...
540477 -
540478 -    Diagnosis:  Metastatic breast cancer (IBC)
540480 -     ..
540481 -    ICD-9 codes: 174.9, 198.2
540483 -  ..
540484 - This ICD-9 codes section aligns with assignments in Chemotherapy
540485 - Order for last month (cycle)...
540486 -
540487 -               080918.....174.9, 198.2................. ref SDS H4 PVSS
540489 -  ..
540490 - This ICD-9 codes section conflicts with assignments in Chemotherapy
540491 - Order for the past 2 months (cycles)...
540492 -
540493 -               080821.....174.9, 198.5, 198.3, 196.2... ref SDS F7 PVSS
540494 -               080724.....174.9, 198.5, 196.2 ......... ref SDS D9 PVSS
540495 -
540496 - ...and is the same as cycle 5...
540497 -
540498 -               080626.....174.9, 198.2................. ref SDS B8 PVSS
540500 -  ..
540501 - Chemotherapy Order Carboplatin continues...
540502 -
540503 -    Cycle:  9
540505 -     ..
540506 -    Days:  1, 8, 15  (arm 2)
540508 -  ..
540509 - This aligns with "Dates to be given" section shown above. ref SDS 0
540510 - PVQX
540512 -  ..
540513 - Chemotherapy Order Carboplatin continues...
540515 -     ..
540516 -    Antimetics:
540517 -
540518 -    Follow up ref SDS H4 PVTT, ref SDS F7 PVTT.
540519 -
540520 -    x  Dexamethasone    10 mg   IV     (Decadron)
540521 -    x  Ondansetron  8 mg   IV          (Zofran)
540522 -
540524 -     ..
540525 -    Chemotherapy (plan to treat weekly for 3 out of 4 weeks).
540526 -    Carboplatin Dose Reduced May Aid Blood Counts Maintain Treatments
540527 -
540528 -    Follow up ref SDS H4 PVUQ, ref SDS F7 PVUQ.
540529 -
540530 -    May administer Carboplatin if vital signs are unremarkable one
540531 -    hour after cetuximab infusion..
540532 -
540533 -    ** Please note start and stop times **
540535 -     ..
540536 -    Carboplatin (commercial supply) AUC 1.5 = 175 mg in D5W 250 ml
540538 -  ..
540539 - Chemo orders today seem to show the same dose specified for cycle 4
540540 - started on 080529 and marked "error," ref SDS A6 PVUQ, reviewed on
540541 - 080626. ref SDS B7 2X5L  At that time, the medical chart was
540542 - confusing, because Brigid could not find the Chemotherapy Order for
540543 - 080529 marked "error." ref SDS B7 RF4J  UCSF planned to investigate
540544 - the error in the Chemotherapy Order. ref SDS B7 RF53
540546 -  ..
540547 - On 080403 cycle 2 showed weight increase of 1 pound, less than 1% of
540548 - 139 pounds recorded for cycle 1 on 080313, and resulted in increasing
540549 - dose about 10%.
540551 -  ..
540552 - Since Millie's weight decreased 1 pound from the prior cycle of 140
540553 - pounds to 139 pounds today, per above, ref SDS H4 PVRW, then comparable
540554 - analysis should reduce the dose today from 175 to about 150 mg.
540556 -  ..
540557 - Chemotherapy Orders continue...
540558 -
540559 -    IV over 30 minutes weekly x 3 doses followed by 1 week rest.
540561 -  ..
540562 - [hand writting...]
540563 -
540564 -               Carbo dose to remain the same unless CR > 1.3
540566 -  ..
540567 - [...where CR = "Creatinine"]
540568 -
540569 -            Carboplatin dose in mg = (desired AUC)(GFR+25)
540570 -
540571 -        GFR (estimated) =
540572 -
540573 -               (140-age in years)(weight in kg)(for females x 0.85)
540574 -               ----------------------------------------------------
540575 -                         (Cr in mg/dL)(72)
540577 -  ..
540578 - Unlike previous Chemotherapy Orders issued on 080403 which showed
540579 - handwritten values in the dosage formula, ref SDS 88 NV9H, there is
540580 - no similar handwriting on the Chemotherapy Orders received today from
540581 - UCSF.
540583 -  ..
540584 - Chemotherapy Orders continues...
540586 -     ..
540587 -    Laboratory Work:
540588 -
540589 -    Follow up ref SDS H4 PWPW, ref SDS F7 PWPW.
540590 -
540591 -    x  CBC with differential and platelets
540592 -       Creatinine, magnesium every 4 weeks
540593 -       BUN, AST, Alk phos, Alt, Total bilirubin, eletrolytes every 8 weeks
540595 -  ..
540596 - The Chemotherapy Order does not check the scope on the form for
540597 - Creatinine, magnesium, and BUN, AST, etc., which have checked for
540598 - every blood test Millie has received the past 2 years, illustreated by
540599 - the order issued on 080918. ref SDS H4 PWPW
540601 -  ..
540602 - The lab performed today starting cycle 9, ref SDS 0 075H, was the same
540603 - as starting the prior cycle 8 on 080918. ref SDS H4 075H
540605 -  ..
540606 - Before meeting with the medical team this morning, Millie got a blood
540607 - draw in the Infusion Clinic, per above, ref SDS 0 439L, as planned in
540608 - Millie's letter to UCSF yesterday on 081015 submitting an agenda for
540609 - meeting with the medical team. ref SDS I8 435O
540611 -  ..
540612 - Chemotherapy Orders continues...
540613 -
540614 -    If ANC >= 1.5 x 1000/L, platelets >= 75 x 1000/L give 100% of dose
540616 -     ..
540617 -    If ANC <  1.5 x 1000/L, platelets <  75 x 1000/L....
540618 -
540619 -            call Brigid Miralda, FNP (MD/RN) at 415 443 4730
540621 -  ..
540622 - The Chemotherapy Order today does not enter Brigid's name and number
540623 - to call; but this is actually unchanged for the past 2 years.
540625 -  ..
540626 - Chemotherapy Orders continues...
540627 -
540628 -    x  See cetuximab orders.
540630 -  ..
540631 - The section checked to see cetuximab orders refers to the Chemotherapy
540632 - Order for cetuximab, per above. ref SDS 0 MM6N
540634 -  ..
540635 - Chemotherapy Orders continue...
540636 -
540637 -    x  Study tubes  6 purple top 1 cell "saver"
540639 -  ..
540640 - Work today improves Chemotherapy Order for 080918 that omitted
540641 - specifying study tubes scope. ref SDS H4 QD7H   The handwriting for
540642 - cell "saver" is unclear.  On 080724 the handwriting was interpreted as
540643 - "cell saver," ref SDS D9 QD7H, which may be what was intended today.
540645 -  ..
540646 - During the blood draw this morning, Diane was hurried because of a
540647 - staff meeting that was underway when Millie arrived at 0800, per
540648 - above. ref SDS 0 GP7O  As a result, the 7th study tube for "cell
540649 - saver" was only have full.  The medical team asked for a full study
540650 - tube for the 7th vial, so this was done again in the Infusion Clinic,
540651 - per above.
540653 -  ..
540654 - Chemotherapy Orders continue...
540656 -     ..
540657 -    Neupogen Prescribed in Chemotherapy Orders
540658 -
540659 -    Follow up ref SDS H4 PWSY, ref SDS F7 PWSY.
540660 -
540661 - During the meeting with the medical team on the 2nd floor at 0830 this
540662 - morning, Brigid added to the Chemotherapy Order for today
540663 - handwriting that shows...
540664 -
540665 -        Neupogen 480 mcg SQ on D2 & 3
540667 -  ..
540668 - This reflects handwritten prescription in the Chemotherapy Order for
540669 - Carboplatin received on 080918. ref SDS H4 PWSY
540671 -  ..
540672 - Further reflects instructions that Neupogen is only given on the 3
540673 - days in the cycle when Millie gets Carboplatin, and so is skipped for
540674 - the 4th treatment in the cycle when Millie gets only cetuximab.
540676 -  ..
540677 - On 080609 Zan in the Kaiser Oncology Pharmacy set up an account for
540678 - Millie to get Neupogen treatments in the Kaiser Infusion Clinic based
540679 - on Chemotherapy Orders showing the UCSF prescription.  At that time,
540680 - Zan used the Chemotherapy Orders for 080529 which show a prescritpion
540681 - for 2 Neupogen treatments per week. ref SDS A9 L16I
540683 -  ..
540684 - Brigid indicated during the meeting with the medical team on 080918
540685 - that Neupogen on the bye week could be reduced to just 1 treatment, if
540686 - NEUTS seem high enough.  The handwritten prescription reflects this
540687 - flexibility by omitting the 2nd criteria of only 3 treatments.
540688 - ref SDS H4 PWSY, which aligns with the order for starting the prior
540689 - cycle 8 on 080918. ref SDS H4 PWSY
540691 -  ..
540692 - Chemotherapy Orders continue...
540694 -     ..
540695 -    x  Physician has discussed risks/benefits of chemotherapy with the
540696 -       patient.  Consent, form obtained.
540697 -
540698 -       x  Yes  O2 [oxygyn] by nasal cannula at 2 liters/min prn for chest pain or SOB
540700 -           ..
540701 -       x  Yes  Diphenhydramine 50 mg IV prn x 1 unticaria pruntis, SOB
540702 -               (this is Benadryl)
540704 -        ..
540705 -       x  Yes  Hydrocrotisone 100 mg IV prn x 1 unticaria pruntis, SOB
540707 -        ..
540708 -       x  Yes  Aubterol inhaler 2 - 4 puffs prn SOB or chest tightness
540710 -        ..
540711 -       x  Yes  Epnephnna nhaler 2 - 4 puffs prn SOB or chest tightness
540713 -        ..
540714 -       Physician Signature
540715 -
540716 -                Hope Rugo   Provider # 35513
540717 -
540718 -                Date:  081013
540720 -        ..
540721 -       Nurse Signature:
540722 -
540723 -                Catherine Mitsuoka
540724 -
540725 -                Date:  081013
540727 -  ..
540728 - No nurses signature is shown in the copy received from UCSF; may have
540729 - been entered and filed in UCSF records later.
540730 -
540731 -
540732 -
540733 -
540734 -
540735 -
540736 -
540737 -
540738 -
540739 -
540740 -
540741 -
540742 -
540743 -
540744 -
5408 -