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: August 21, 2008 09:00 AM Thursday; Rod Welch

Millie 1st treatment 7th 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...Labs Blood Test
3...Cancer Marker CA 15-3 96 Increases Over 4 Weeks from 71
4...NEUTS 0.99 Decrease 4th Week Unexpectedly Chemotherapy Withheld
5...Chemotherapy Carboplatin Withheld Blood Counts Fall Significantly
6...Blood Counts Fall Significantly Chemotherapy Carboplatin Withheld
7...Neupogen Case Study Missed Carboplatin Treatments Low Blood Counts
8...Side Effects Neupogen Treatments Continue Mild Tolerance Acceptable
9...Coagulation Control INR 2.4 Normal Stable PT 26.2 High
10...Cetuximab Chemotherapy Order for 7th Cycle
....Medication: (plan to give weekly)
....Laboratory work:
11...Carboplatin Chemotherapy Orders
....Error Dates Treatment Should Not Include Today
....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


..............
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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 F4 0000. ref SDS E8 0000.
100502 -
100503 - Millie got a blood draw this morning at 0800 on the 5th floor in the
100504 - Infusion Clinic in time for results to be reviewed by the medical team
100505 - durng the meeting on the 2nd floor at 0830. ref SDS 0 LO4G  There was
100506 - a problem using the Huber needle to draw blood. ref SDS 0 LO5F  Diane
100507 - was able to complete the procedure, similar to difficulties Kaiser had
100508 - doing the CT test last month.  This underscores the need to line up
100509 - skilled personnel for accessing the Power Port for the next CT test in
100510 - a few weeks. ref SDS 0 A66O  Results of the blood test today NEUTS
100511 - 0.99, ref SDS 0 QY6H, reported later during the meeting with the
100512 - medical team prevented Millie from getting Carboplatin chemotherapy
100513 - today. ref SDS 0 PU6K  The study on Neupogen shows rising neutropenia
100514 - has caused Millie to miss a total to 4 chemotherapy treatments.
100515 - ref SDS 0 EP7N
100516 -
100517 -
100518 -
100519 -
100520 -
100521 -
100522 -
100524 -  ..
1006 -
1007 -
1008 - Progress
1009 -
100901 - Background on Millie's treatment in the clinical study is reported on
100902 - 080508. ref SDS A0 TZ8I
100904 -    ..
100905 -   Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
100906 -
100907 -   Follow up ref SDS F4 X33O, ref SDS E8 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 F4 356I, ref SDS E8 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 13 SG8I
100937 -    9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 14 SG8I
100938 -   10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 15 SG8I
100939 -   11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 16 SG8I
100940 -   12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 18 SG8I
100941 -   13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 20 7T3H
100942 -   14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 21 7T3H
100943 -   15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 22 7T3H
100944 -   16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 23 7T3H
100945 -   17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 24 7T3H
100946 -   18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 25 7T3H
100947 -   19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 26 7T3H
100948 -   20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 27 7T3H
100949 -   21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 28 7T3H
100950 -   22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 29 7T3H
100951 -   23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 30 7T3H
100952 -   24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 31 7T3H
100953 -   25.  Cycle 05 and 12 and 02 18.......... 070531, ref SDS 32 7T3H
100954 -   26.  Cycle 05 and 12 and 03 19.......... 070607, ref SDS 33 7T3H
100955 -   27.  Cycle 05 and 12 and 04 20.......... 070614, ref SDS 34 0001
100956 -   28.  Cycle 06 and 13 and 01 21.......... 070621, ref SDS 35 0001
100957 -   29.  Cycle 06 and 13 and 02 22.......... 070628, ref SDS 36 0001
100958 -   30.  Cycle 06 and 13 and 03 23.......... 070705, ref SDS 37 0001
100959 -   31.  Cycle 06 and 13 and 04 24.......... 070712, ref SDS 37 0001
100960 -   32.  Cycle 07 and 14 and 01 25.......... 070719, ref SDS 38 0001
100961 -   33.  Cycle 07 and 14 and 02 26.......... 070726, ref SDS 36 0001
100962 -   34.  Cycle 07 and 14 and 03 27.......... 070802, ref SDS 37 0001
100963 -   35.  Cycle 07 and 14 and 04 28.......... 070809, ref SDS 39 0001
100964 -   36.  Cycle 08 and 15 and 01 29.......... 070816, ref SDS 40 0001
100965 -   37.  Cycle 08 and 15 and 02 30.......... 070823, ref SDS 41 0001
100966 -   38.  Cycle 08 and 15 and 03 31.......... 070830, ref SDS 41 0001
100967 -   39.  Cycle 08 and 15 and 04 32.......... 070906, ref SDS 42 0001
100968 -   40.  Cycle 09 and 16 and 01 33.......... 070920, ref SDS 43 0001
100969 -   41.  Cycle 09 and 16 and 02 34.......... 070927, ref SDS 44 0001
100970 -   42.  Cycle 09 and 16 and 03 35.......... 071004, ref SDS 45 0001
100971 -   43.  Cycle 09 and 16 and 04 36.......... 071011, ref SDS 46 0001
100972 -   44.  Cycle 10 and 17 and 01 37.......... 071018, ref SDS 47 0001
100973 -   45.  Cycle 10 and 17 and 02 38.......... 071025, ref SDS 48 0001
100974 -   46.  Cycle 10 and 17 and 03 39.......... 071101, ref SDS 34 0001
100975 -   47.  Cycle 10 and 17 and 04 40.......... 071108, ref SDS 49 0001
100976 -   48.  Cycle 11 and 18 and 01 41.......... 071115, ref SDS 50 0001
100977 -   49.  Cycle 11 and 18 and 02 42.......... 071122, ref SDS 36 0001
100978 -   50.  Cycle 11 and 18 and 03 43.......... 071129, ref SDS 53 0001
100979 -   51.  Cycle 11 and 18 and 04 44.......... 071206, ref SDS 54 0001
100980 -   52.  Cycle 12 and 19 and 01 45.......... 071213, ref SDS 57 0001
100981 -   53.  Cycle 12 and 19 and 02 46.......... 071220, ref SDS 60 0001
100982 -   54.  Cycle 12 and 19 and 03 47.......... 071227, ref SDS 61 0001
100983 -   55.  Cycle 12 and 19 and 04 48.......... 080103, ref SDS 62 0001
100984 -   56.  Cycle 13 and 20 and 01 49.......... 080110, ref SDS 65 0001
100985 -   57.  Cycle 13 and 20 and 02 50.......... 080117, ref SDS 66 0001
100986 -   58.  Cycle 13 and 20 and 03 51.......... 080124, ref SDS 67 0001
100987 -   59.  Cycle 13 and 20 and 04 52.......... 080131, ref SDS 69 0001
100988 -   60.  Cycle 14 and 21 and 01 53.......... 080207, ref SDS 73 0001
100989 -   61.  Cycle 14 and 21 and 02 54.......... 080214, ref SDS 74 0001
100990 -   62.  Cycle 14 and 21 and 03 55.......... 080221, ref SDS 37 0001
100991 -   63.  Cycle 14 and 21 and 04 56.......... 080228, ref SDS 79 0001
100992 -   64.  Cycle 15 and 22 and 01 57 01  00... 080306, ref SDS 82 TZ8I
100994 -    ..
100995 -   Cetuxiab 81 and Carboplatin 14 Treatments Clinical Study 2nd Arm
100996 -
100997 -   Follow up ref SDS F4 5B6J, ref SDS E8 5B6J.
100998 -
100999 -   On 080207 doctor reports IBC may be spreading. ref SDS 72 GH5H
101000 -   Follow up examination on 080219 Doctor Rugo diagnosed progression of
101001 -   disease. ref SDS 94 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 84 TZ8I
101009 -   66.  Cycle 01 15 and 22 and 03 59 03  01... 080320, ref SDS 85 TZ8I
101010 -   67.  Cycle 01 15 and 22 and 04 60 04  01... 080327, ref SDS 86 TZ8I
101011 -   68.  Cycle 02 16 and 23 and 01 61 05  02... 080403, ref SDS 87 TZ8I
101012 -   69.  Cycle 02 16 and 23 and 02 62 06  03... 080410, ref SDS 90 TZ8I
101013 -   70.  Cycle 02 16 and 23 and 03 63 07  03... 080417, ref SDS 92 TZ8I
101014 -   71.  Cycle 02 16 and 23 and 04 64 08  03... 080424, ref SDS 95 TZ8I
101015 -   72.  Cycle 03 17 and 24 and 01 65 09  04... 080501, ref SDS 98 5B6J
101016 -   73.  Cycle 03 17 and 24 and 02 66 10  05... 080508, ref SDS A0 5B6J
101017 -   74.  Cycle 03 17 and 24 and 03 67 11  05... 080515, ref SDS A1 5B6J
101018 -   75.  Cycle 03 17 and 24 and 04 68 12  05... 080522, ref SDS A2 5B6J
101019 -   76.  Cycle 04 18 and 25 and 01 69 13  06... 080529, ref SDS A5 5B6J
101020 -   77.  Cycle 04 18 and 25 and 02 70 14  07... 080605, ref SDS A6 5B6J
101021 -   78.  Cycle 04 18 and 25 and 03 71 15  08... 080612, ref SDS A9 5B6J
101022 -   79.  Cycle 04 18 and 25 and 04 72 16  08... 080619, ref SDS B2 5B6J
101023 -   80.  Cycle 05 19 and 26 and 01 73 17  09... 080626, ref SDS B7 5B6J
101024 -   81.  Cycle 05 19 and 26 and 02 74 18  10... 080703, ref SDS C2 5B6J
101025 -   82.  Cycle 05 19 and 26 and 03 75 19  11... 080710, ref SDS C5 5B6J
101026 -   83.  Cycle 05 19 and 26 and 04 76 20  11... 080717, ref SDS D1 5B6J
101027 -   84.  Cycle 06 20 and 27 and 01 77 21  12... 080724, ref SDS D8 5B6J
101028 -   85.  Cycle 06 20 and 27 and 02 78 22  13... 080731, ref SDS E2 5B6J
101029 -   86.  Cycle 06 20 and 27 and 03 79 23  14... 080807, ref SDS E8 5B6J
101030 -   87.  Cycle 06 20 and 27 and 04 80 24  14... 080814, ref SDS F4 5B6J
101031 -   88.  Cycle 07 21 and 28 and 01 81 25  14... 080821, ref SDS 0 5B6J
101033 -  ..
101034 - Today is the 1st treatment of the 7th cycle with cetuximab and
101035 - Carboplatin together.  This is the 25th treatment overall with
101036 - cetuximab on the 2nd arm of the clinical study, but is only the 14th
101037 - treatment with Carboplatin due to low blood counts.  Today Millie was
101038 - scheduled for the 15th treatment of Carboplatin to start a new cycle,
101039 - but treatment was withheld due to low blood counts again today.
101040 - ref SDS 0 PU6K
101042 -  ..
101043 - Catherine is the nurse today.  She was late arriving in the clinic,
101044 - so Heather started the blood draw.
101045 -
101046 -
101047 -
101048 -
101049 -
101050 -
1011 -

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

1803 -
1804 - 0750
180501 -  ..
180502 - Labs Blood Test
180503 -
180504 - Follow up ref SDS F4 FW5N, ref SDS E8 FW5N.
180505 -
180506 - Adding Carboplatin to the treatment protocol now requires weekly blood
180507 - tests to determine if the immune system is strong enough for safe
180508 - chemotherapy treatment, reported on 070201, ref SDS 13 XR40, and
180509 - citing the clinical study protocol received from UCSF on 070116.
180510 - ref SDS 12 5U7Z
180512 -  ..
180513 - Catherine was late coming into the office this morning.  Diane was
180514 - busy with another patient in a private room, so Heather started the
180515 - blood draw.  The medical team in the Breast Care Clinic on the 2nd
180516 - floor had already submitted the order for the blood draw, including 7
180517 - vials needed for the study, as requested in Millie's letter to UCSF
180518 - early this morning submitting an agenda for work today. ref SDS F5
180519 - 6Y5K
180521 -  ..
180522 - There were difficulties using Millie's Power Port for the blood draw
180523 - today.  Blood was not flowing through the port and the Huber needle.
180524 - After several attemps to correct the problem, Heather left the room
180525 - and asked Diane to try, since Diane has been treating Millie along
180526 - with Catherine for 18 months.
180527 -
180529 -  ..
1806 -
1807 -
1808 - 0810
1809 -
180901 - Diane asked Heather to finish with her patient, while Diane tried to
180902 - do the blood draw for Millie.  Heather explained that she may not have
180903 - inserted the Huber needle fully into the port.  This was cited as a
180904 - possible problem using Millie's Power Port on 080718, ref SDS D2 LK41,
180905 - when difficulties caused failure of a CT test. ref SDS D2 LK3R
180907 -  ..
180908 - Diane started over with a new Huber needle, and was successful on the
180909 - first attempt accessing the Power Port and getting blood to flow for
180910 - the lab test.  She explained that avoiding and solving port access
180911 - problems is mainly a matter of "feel" from experience working with
180912 - Power Ports regularly.
180914 -  ..
180915 - Millie asked if Heather could have selected the wrong Huber needle,
180916 - and this caused the failure today?  Millie recalled that on 080731
180917 - Diane gave Millie a specification on Huber needles used for CT tests
180918 - at UCSF, and had been left a week earlier by Catherine in the medical
180919 - chart for Millie. ref SDS E2 QY3G  The actual specification reported
180920 - in the record on 080724 says...
180921 -
180922 -            Lifeguard
180923 -            Safety Needle
180925 -             ..
180926 -            The following Lifeguard Safety Infusion Set models may be
180927 -            used for Power Injection of Contrast Media with the Smart
180928 -            Port CT Power Injectable Ports:, ref SDS D8 N79U
180930 -             ..
180931 -            LG-20-100
180933 -  ..
180934 - Millie asked if Heather could have selected the wrong needle today,
180935 - causing blood flow problems, per above? ref SDS 0 LO5F
180937 -  ..
180938 - Diane seemed to say that UCSF has standardized on everyone using the
180939 - same Huber needle in order to avoid mistakes.
180940 -
180941 -            [On 080904 Catherine seemed say that nurses must select
180942 -            from a range of different Huber needles available for
180943 -            treatment in the Infusion Clinic, per Angiodynamics
180944 -            manufacturer's Lifeguard Safety needles listed on 080724,
180945 -            ref SDS D8 N79U; Catherine plans to use the needle
180946 -            specified for high pressure injections to treat Millie at
180947 -            UCSF on the day when the same needle will be used later in
180948 -            the same day at Kaiser for a CT test. ref SDS G4 V64G
180950 -  ..
180951 - This record suggests some nurses are more experienced using Huber
180952 - needle technology with Power Port devices, and that experience level
180953 - has a big impact on performance of this work, which is essential for
180954 - Millie's next CT test in a few weeks.
180955 -
180956 -            [On 080826 Kaiser called and advised that the CT department
180957 -            in Oakland, scheduled by Arlette on 080822, to perform
180958 -            Millie's next CT test, ref SDS F6 N66E, after research
180959 -            showed on 080805 they have experience using Huber needles
180960 -            with Power Port technology to inject contrast medium,
180961 -            ref SDS E4 5U7G, had sent order for Millie's test back to
180962 -            Kaiser in Walnut Creek, ref SDS F7 VU64, which has no
180963 -            experience, reported on 080711, ref SDS C6 JQ55, and failed
180964 -            on the prior CT test performed 080718. ref SDS D2 LK3R
180966 -  ..
180967 - After the blood draw, Millie went to the Breast Care Clinic on 2nd
180968 - floor for a meeting with the medical team at 0830. ref SDS F5 YY3N
180969 -
180970 -
180971 -
180972 -
180974 -  ..
1810 -
1811 -
1812 - 1010
1813 -
181301 - After examination on the 2nd floor, Millie returned to the Infusion
181302 - Clinic on the 5th floor for treatment by Catherine.
181304 -  ..
181305 - During treatment, Catherine submitted results of the test starting the
181306 - 7th cycle.  Scope is the same as for starting cycle 6 on 080724.
181307 - ref SDS D8 075H
181308 -
181323 -     ..
181324 -    Log#:                   080821 08:15
181325 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
181326 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
181327 -     ..
181328 -    CBC with DIFF & PLT CT                                     CBCD
181329 -     ..
181330 -    WBC COUNT      L        2.8    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
181331 -    RBC COUNT      L        3.66   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
181332 -    HEMOGLOBIN             12.2    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
181333 -    HEMATOCRIT             36.4    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
181334 -    MCV                   100      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
181335 -    MCH                    33.7    pg           26  -   34     MCH
181336 -    MCHC                   33.9    g/dL         31  -   36     MCHC
181337 -    PLATELETS             206      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
181338 -
181339 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
181340 -        Francisco, CA  94115
181341 -    ..
181342 -       (posted 080828, ref SDS G2 3T4O)
181343 -    CA 15-3      H*        96      U/mL             <  33     CA153  CA 15-3                        <  39
181344 -
181345 -         Note new reference range [<33 changed from <31] and change in
181346 -         methodology effective March 1, 2008.  Performed using the
181347 -         Siemens Centaur Chemiluminesence method.  CA 15-3 result using
181348 -         the Roche Elecsys assay is 75 U/mL.  Ref range <31 U/mL.  This
181349 -         rebaseline value provided at no additional charge.
181351 -          ..
181352 -         This new note updates explanation of tests prior to 080301,
181353 -         e.g., on 080207. ref SDS 73 A16M
181354 -    ..
181355 -     (NEUTS x 1000 = ANC for Kaiser)
181356 -    NEUTS         L         0.99   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
181357 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
181359 -     ..
181360 -    LYMPHS                  1.38   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
181361 -    MONOS          L        0.19   x10E9/L     0.2  -  0.8     M-A   Monocyte          %         0  -  11
181362 -    EOS                     0.13   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
181363 -    BASOS                   0.04   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
181365 -     ..
181366 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
181367 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
181368 -    PT            H        30.6    s          12.0  -  14.1    PT    PT, patient       sec     8.9  -  11.1
181369 -    INL NRM Ratio H         2.9                0.9  -  1.1     INR   INR                       2.0  -  3.0
181370 -
181371 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
181372 -        Francisco, CA  94115
181374 -     ..
181375 -    PARTIAL
181376 -    THROMBOPLASTIN  H      37.0    s          22.2  - 34.2     INR   PTT
181377 -
181378 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
181379 -        Francisco, CA  94115
181381 -     ..
181382 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
181383 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
181384 -    ELECTROLYTE PANEL                                          LYTE
181385 -    SODIUM                137      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
181386 -    POTASSIUM               4.3    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
181387 -    CHLORIDE              103      mmol/L       98  -  107     CL
181388 -    CARBON DIOX TOTAL L    16      mmol/L       23  -  32      CO2
181389 -    ANION GAP         H    18                    3  -  14      ANGA
181390 -     ..
181391 -    UREA NITROGEN          13      mg/dL         8  -  23      BUN   BUN               mg/dL     7  -  17
181392 - *  GLUCOSE                        mg/dL        70  -  199     GLU   Glucose           mg/dL     ?  -   ?
181393 -    AST               H    46      U/L          16  -  41      AST   AST (SGOT)        U/L      14  -  36
181394 -    ALT                    24      U/L          11  -  54      ALT   ALT (SGPT)        U/L      11  -  66
181395 -    BILIRUBIN, TOTAL        1.1    mg/dL       0.3  - 1.3      BILT  Bili Total        mg/dL   0.2  - 1.3
181396 -    ALKALINE PHOSPHATASE   72      U/L          29  - 111      ALKP  Alkaline Ph       U/L      38  - 126
181397 -     ..
181398 - *  PROTEIN, TOTAL                 g/dL        5.8  - 8.0      TP    Protine Total     g/dL    6.3  - 8.2
181399 - *  ALBUMIN                        g/dL        3.4  - 4.7      ALB   Albumin           g/dL    3.4  - 4.8
181400 -    CALCIUM         L       8.4    mg/dL       8.7  - 10.1     CA    Calcium           mg/dL   8.4  - 10.2
181401 -     ..
181402 -    MAGNESIUM               1.8    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
181404 -     ..
181405 -    CREAT with eGFR
181406 -    CREATININE              0.56   mg/dL      0.42  - 1.06     CR    Creatinine        mg/dL   0.6  -  1.2
181407 -
181408 -      Note: Creatinine assay changed to IDMS standardization on
181409 -      February 4, 2008 causing decrease in results of approximately
181410 -      0.09 mg/dL
181412 -     ..
181413 -    eGFR if Caucasian     >60      mL/min                      GFRC
181414 -    eGFR if African Amer  >60      mL/min                      GFRA
181415 -
181416 -      eGFR corrected for 1.73 sq meters of body surface area
181417 -      Note:  eGFR is only an estimation. Please see online Lab Manual
181418 -      for potential limitations.
181419 -      Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
181420 -      CA  94115
181422 -     ..
181423 - *  Labs today omit following tests...
181424 -
181425 -            GLUCOSE.............................. ref SDS 0 SE9J
181426 -            ALBUMIN.............................. ref SDS 0 GT9I
181427 -            PROTEIN, TOTAL
181428 -
181430 -     ..
181431 -    Labs on 080726 today omitted following tests...
181432 -
181433 -            GLUCOSE.............................. ref SDS D8 SE9J
181434 -            ALBUMIN.............................. ref SDS D8 GT9I
181436 -     ..
181437 -    Labs on 080626 omitted following tests...
181438 -
181439 -            GLUCOSE.............................. ref SDS B7 HS7I
181440 -            PROTEIN, TOTAL
181441 -            ALBUMIN
181442 -            CALCIUM
181444 -  ..
181445 - Case study on 080626 shows these four tests, which have been omitted
181446 - and included in various combinations the past 3 cycles, where
181447 - consistently included for the prevous 15 cycles. ref SDS B7 HS8F
181448 -
181449 -
1815 -

SUBJECTS
Default Null Subject Account for Blank Record

1903 -
190401 -  ..
190402 - Cancer Marker CA 15-3 96 Increases Over 4 Weeks from 71
190403 -
190404 - Follow up ref SDS D8 TR4K, ref SDS B7 PW7I.
190405 -
190406 - Results of the blood test today for the cancer marker were delayed for
190407 - several days.  Received a week later on 080828, the cancer marker
190408 - increased from 71 on 080724, ref SDS D8 A16M, to CA 15-3 96 today, per
190409 - above. ref SDS 0 A16M
190411 -  ..
190412 - This shows a continuing trend of increase, though on the prior cycle
190413 - there was a 1 point decline from 72 to 71.
190415 -  ..
190416 - The test at Kaiser on 080708 shows CA 15-3 141, but the sepcimen was
190417 - slightly hemolyzed, ref SDS C3 L74K, which can affect the result.
190418 - ref SDS C3 05YW  As noted, labs at UCSF a few weeks later on 080724
190419 - yielded CA 15-3 71.  The new test today seems more in line with
190420 - results indicated on 080708.
190422 -  ..
190423 - Findings during examination today of swelling in the left
190424 - supraclavicular area may align with rising cancer marker. ref SDS F5
190425 - 4C6O
190427 -  ..
190428 - Case study today of rising neutropenia showing Millie has missed over
190429 - 20%, i.e., 4 of 18, prescribed chemotherapy treatments due to low
190430 - blood counts, ref SDS 0 EP7N, may suggest that if Carboplatin
190431 - treatments can be regularized with Neupogen, then the current regimen
190432 - can slow or reverse possible progression of disease.
190433 -
190434 -            [On 080827 Millie sets agenda for follow up examination by
190435 -            primary care physician on 080829, and focus of next CT test
190436 -            on 080912. ref SDS F8 509S
190438 -             ..
190439 -            [On 080827 Millie cancels vacation plans due to concern
190440 -            about new lump signaling progression of disease, with
190441 -            requirements to change treatments. ref SDS G0 K377
190443 -             ..
190444 -            [On 080829 Millie notified medical team the primary care
190445 -            physician approved her for going on vacation. ref SDS G3
190446 -            RP7Y
190447 -
190448 -
190449 -
190450 -
190451 -
190452 -
1905 -

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

2803 -
280401 -  ..
280402 - NEUTS 0.99 Decrease 4th Week Unexpectedly Chemotherapy Withheld
280403 - Chemotherapy Carboplatin Withheld Blood Counts Fall Significantly
280404 - Blood Counts Fall Significantly Chemotherapy Carboplatin Withheld
280405 -
280406 - Follow up ref SDS F4 PU6K, ref SDS E8 PU6K.
280407 -
280408 - Blood counts decrease this week, shown by the Lab report today with
280409 - NEUTS 0.99, ref SDS 0 QY6H, compared with NEUTS 1.37 last week on
280410 - 080814, ref SDS F4 QY6H  This is too far below UCSF minimum of 1.5 for
280411 - Millie to safely get chemotherapy treatment.  As a result, the doctor
280412 - ordered Carboplatin chemotherapy withheld today, and approved adding
280413 - treatment with Neupogen tomorrow and Saturday in order to increase
280414 - blood counts enough for safe chemotherapy next week, as reported in
280415 - the record meeting with the medical team in the Breast Care Clinic on
280416 - the 2nd floor. ref SDS F5 4B84
280418 -  ..
280419 - Case study on 060809 shows Millie has often received chemotherapy when
280420 - blood counts are below the standard for safe treatments, and on some
280421 - occassions has received Neupogen to increase blood counts. ref SDS 7
280422 - HV45
280424 -  ..
280425 - Decrease in blood counts today demonstrates rising neutropenia that
280426 - causes a "roller coaster" above and below the specified target from
280427 - week to week while getting Neupogen treatments in recent months.
280429 -  ..
280430 - Research on neutropenia was reported on 070301, ref SDS 17 O59H, when
280431 - Doctor Rugo was concerned about holding blood counts with weekly
280432 - Carboplatin treatments. ref SDS 17 VF6O
280434 -  ..
280435 - Approval for Millie to get Neupogen this week was discussed during the
280436 - meeting with the medical team on the 2nd floor before treatment today.
280437 - ref SDS F5 RV93  The prescription for Neupogen is shown in the
280438 - Chemotherapy Order for cetuximab, per below, ref SDS 0 RU7O, and was
280439 - previously scheduled by Donna at the Kaiser Infusion Clinic on 080809.
280440 - ref SDS F1 WJ4O
280442 -  ..
280443 - Patient history getting cetuximab and Carboplatin is listed above.
280444 - ref SDS 0 5B6J
280445 -
280446 -
280447 -
2805 -

SUBJECTS
Default Null Subject Account for Blank Record

2903 -
290401 -  ..
290402 - Neupogen Case Study Missed Carboplatin Treatments Low Blood Counts
290403 -
290404 - Millie has received 24 Neupogen treatments, and missed 4 chemotherapy
290405 - treatments due to rising neutropenia.  Millie's letter to the medical
290406 - team on 080307 asked about solving low blood counts. ref SDS 83 HS6R
290407 - On 080423 Millie notified the medical team to maintain a full dose of
290408 - Carboplatin because these treatments yielded very favorable response.
290409 - ref SDS 93 TY6Y  On 080501 a mixup in communication reduced the dose
290410 - of Carboplatin with the aim of not missing treatments.  Adding
290411 - Neupogen to avoid missing treatments might have enabled maintaining
290412 - full dose of Carboplatin to increase recovery. ref SDS 97 CZ3N
290413 -
290414 -            [On 080918 case study shows 2 Neupogen treatments on
290415 -            each of all 4-weeks in the chemotherapy cycle avoids
290416 -            missing chemotherapy treatments. ref SDS G5 OK67
290418 -  ..
290419 - Reduced treatment may relate to rising cancer marker today, 080821.
290420 - ref SDS 0 A16M  Millie has received only 14 of 18 total treatments
290421 - prescribed with Carboplatin, since starting the 2nd arm of the
290422 - clinical study on 080306...
290424 -        ..
290425 -                      Neupogen            Carboplatin
290426 -       Date    NEUTS  Cur Totl Cycl Trm  Rcvd   Missed
290427 -
290428 -        080821  0.99   2   24    7   1    14      4... ref SDS 0 QY6H
290429 -        080814  1.37   0   22    6   4    14.......... ref SDS F4 QY6H
290430 -        080807  2.41   2   22    6   3    14.......... ref SDS E8 QY6H
290431 -        080731  1.92   2   20    6   2    13.......... ref SDS E2 QY6H
290432 -        080724  2.32   2   18    6   1    12.......... ref SDS D8 QY6H
290433 -        080717  2.47   1   16    5   4    11.......... ref SDS D1 QY6H
290435 -             ..
290436 -            On 080718 2 Neupogen treatments were cancelled at Kaiser,
290437 -            ref SDS D2 9W9I, because the day before at UCSF on 080717
290438 -            NUETS were high, and there was no Carboplatin chemotherapy
290439 -            treatment given for the 4th week in the cycle on 080717.
290441 -             ..
290442 -            On 080719 the day after CT testing, Millie went to Kaiser
290443 -            and received 1 Neupogen treatment as a precaution ordered
290444 -            by Kaiser after bleeding trauma during failed CT test using
290445 -            the Power Port the day before on 080718. ref SDS D3 SR37
290447 -         ..
290448 -                      Neupogen            Carboplatin
290449 -       Date    NEUTS  Cur Totl Cycl Trm  Rcvd   Missed
290451 -         ..
290452 -        080710  5.12   2   15    5   3    11......... ref SDS C5 QY6H
290453 -        080703  2.90   2   13    5   2    10......... ref SDS C2 QY6H
290454 -        080626  1.80   2   11    5   1    09......... ref SDS B7 QY6H
290455 -        080619  0.74   1    9    4   4    08......... ref SDS B2 QY6H
290456 -        080612  3.77   2    8    4   3    08......... ref SDS A9 QY6H
290458 -             ..
290459 -            On 080609 Kaiser orders 2 Neupogen treatments per week in
290460 -            Infusion Clinic, ref SDS A8 IL6I, for UCSF prescription in
290461 -            Chemo Orders on 080529, ref SDS A8 L16I, which were
290462 -            received on 080605. ref SDS A6 JN38
290464 -         ..
290465 -                      Neupogen            Carboplatin
290466 -       Date    NEUTS  Cur Totl Cycl Trm  Rcvd   Missed
290468 -         ..
290469 -        080605  1.55   2    6    4   2    07......... ref SDS A6 QY6H
290470 -        080529  2.26   1    4    4   1    06......... ref SDS A5 QY6H
290471 -        080522  0.96   0         3   4    05......... ref SDS A2 QY6H
290472 -        080515  1.21   0         3   3    05      3.. ref SDS A1 QY6H
290473 -        080508  5.41   1    3    3   2    05......... ref SDS A0 QY6H
290474 -        080501  1.34   1    2    3   1    04......... ref SDS 98 QY6H
290475 -        080424  1.34   0         2   4    03......... ref SDS 95 QY6H
290476 -         ..
290477 -        080417  0.95   0         2   3    03      2.. ref SDS 92 QY6H
290478 -        080410  6.85   0         2   2    03......... ref SDS 90 QY6H
290479 -        080403  1.34   1    1    2   1    02......... ref SDS 87 QY6H
290480 -        080327  2.30   0         1   4    01......... ref SDS 86 QY6H
290481 -        080320  1.28   0         1   3    01      1.. ref SDS 85 QY6H
290482 -        080313  2.05   0         1   2    01......... ref SDS 84 QY6H
290483 -        080306  1.75   0         1   1    00......... ref SDS 82 QY6H
290484 -
290485 -
2905 -

SUBJECTS
Default Null Subject Account for Blank Record

3003 -
300401 -  ..
300402 - Side Effects Neupogen Treatments Continue Mild Tolerance Acceptable
300403 -
300404 - Follow up ref SDS F4 SB8I.
300405 -
300406 - Side effects of Neupogen may be lessening, reported on...
300407 -
300408 -               080810................, ref SDS F2 9W9I
300409 -               080803................, ref SDS E3 9W9I
300410 -               080726................, ref SDS E0 9W9I
300411 -               080721................, ref SDS D5 9W9I
300412 -               080713................, ref SDS C8 RM94
300413 -               080629................, ref SDS C1 6Q5J
300414 -               080628................, ref SDS B9 6Q5J
300415 -
300416 - ...suggesting increased ability to tolerate 2 Neupogen treatments per
300417 - week.
300418 -
300419 -
300420 -
3005 -

SUBJECTS
Default Null Subject Account for Blank Record

4503 -
450401 -  ..
450402 - Coagulation Control INR 2.4 Normal Stable PT 26.2 High
450403 -
450404 - Follow up ref SDS D8 K66J.
450405 -
450406 - The labs today show INR 2.9 at the high end of the scale, but still
450407 - continuing within the prescribed range. ref SDS 0 PU7Y
450409 -  ..
450410 - On 080804 Millie responded to a letter from Kaiser dated 080730 asking
450411 - about results of the test on 080724. ref SDS E6 WQ6I
450412 -
450413 -            [On 080827 Millie reported INR test results to Gloria at
450414 -            Kaiser Coagulation Control Clinic in Martinez, CA.
450415 -            ref SDS F8 504R
450417 -             ..
450418 -            [On 080827 Millie received a letter notifying that Kaiser
450419 -            received the report on INR results for the blood test
450420 -            today, and advising Millie to continue the same regimen for
450421 -            Coumadin to treat pulmonary embolism. ref SDS G1 VD7O
450422 -
450423 -
450424 -
450425 -
4505 -

SUBJECTS
Default Null Subject Account for Blank Record

4603 -
460401 -  ..
460402 - Cetuximab Chemotherapy Order for 7th Cycle
460403 -
460404 - Follow up ref SDS D8 MM6N. ref SDS B7 MM6N.
460406 -     ..
460407 -    Outpatient Infusion Orders
460409 -     ..
460415 -    Auth#                                     Stor BCC LOC
460416 -    Visit:  14587572             DOS 20080821
460418 -     ..
460419 -    Date:  20080815
460421 -     ..
460422 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
460423 -    in combination with Carboplatin in ER-negative, PR-negative,
460424 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers.
460426 -     ..
460427 -    Arm:  2 - Cetuximab + Carboplatin
460429 -     ..
460430 -    Dates to be given: 20080821 - 20080910
460432 -     ..
460433 -    Allergies:  NKDA
460435 -     ..
460436 -    Height:  62 inches
460438 -     ..
460439 -    Weight:  141 pounds
460441 -  ..
460442 - There is handwriting next to this part of the form that shows...
460443 -
460444 -              [0 with line drawn through] 10% weight change
460446 -  ..
460447 - This may reflect that the dose of cetuximab is only changed with 10%
460448 - change in weight, and this criteria is not met today, so the dose is
460449 - the same as for the prior Chemotherapy Order on 080724, because there
460450 - has not been a 10% change in weight.  UCSF did not submit the
460451 - Chemotherapy Order for treatment starting cycle 7 on 080724; there was
460452 - a Chemotherpay Order for cycle 6 starting on 080626.  At that time
460453 - weight was 140 pounds compared to 141 today, which seems to reconcile
460454 - the handwriting on the form today. ref SDS B7 4E6V
460456 -  ..
460457 - Chemotherapy Order for Cetuximab continues...
460459 -     ..
460460 -    BSA:   1.67
460462 -     ..
460463 -    Diagnosis:  Breast Cancer (IBC)
460465 -     ..
460466 -    ICD-9 codes: 174.9 198.5 198.3
460468 -  ..
460469 - Chemotherapy Order for cetuximab on 080501 shows ICD-9 codes 174.4 and
460470 - 198.2, ref SDS 96 SH6H, the Chemotherapy Order on 080626 shows 174.9
460471 - and 198.2, ref SDS B7 SH6H, rather than the codes in the cetuximab
460472 - order today.
460474 -  ..
460475 - Chemotherapy Order for Cetuximab continues...
460476 -
460477 -    Cycle:  7
460479 -     ..
460480 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
460482 -     ..
460483 -    x  Diphenhydramine 25 mg IV
460484 -
460485 -       Benadryl............... explained on 070201. ref SDS 11 DC7J
460487 -     ..
460488 -    Medication:  (plan to give weekly)
460489 -
460490 -    x  Cetuximab - Erbitux - (study supply) (maintenance)
460491 -
460492 -       250 mg/m*m = 428 mg
460494 -     ..
460495 -    Maximum infusion rate is 5 ml/minute. (concentration 2 mg/ml)
460497 -     ..
460498 -    Infuse once weekly for 8 weeks.  First dose is to be given on date
460499 -    080821.
460501 -     ..
460502 -    Cetuximab is administered undiluted through a low protein binding
460503 -    0.22 micro in-line filter.  Use NS soution to flush the line at
460504 -    the end of the Infusion.
460506 -     ..
460507 -    Arm 2:  Administer carboplatin if vital signs are unremarkable one
460508 -    hour after cetuximab infusion.
460510 -     ..
460511 -    Vital signs at baseline, upon cetuximab completion and one hour
460512 -    after cetuximab.
460513 -
460514 -    **** please not start and stop times ****
460515 -
460517 -     ..
460518 -    Laboratory work:
460519 -
460520 -    x  See carboplatin orders.
460521 -    x  Notify MD for dose modifications if patient has severe acne
460522 -       form rash
460523 -    x  CBC with differential and plateletes every 4 weeks
460524 -    x  Creatinine and magnesium every 4 weeks
460525 -       BUN, AST, Alk Phos, ALT, total bilrubin, electrolytes every
460526 -       8 weeks
460527 -  ..
460528 - Chemotherapy Order Cetuximab continue...
460529 -
460530 -    If levels are outside of normal laboratory values notify
460531 -
460534 -  ..
460535 - Chemotherapy Order Cetuximab continue...
460537 -     ..
460538 -    x  Physician has discussed risks/benefits of chemotherapy with the
460539 -       patient.  Consent, form obtained.
460540 -
460541 -       x  Yes  O2 [oxygyn] by nasal cannula at 2 liters/min prn for chest pain or SOB
460543 -           ..
460544 -       x  Yes  Diphenhydramine 50 mg IV prn x 1 unticaria pruntis, SOB
460545 -               (this is Benadryl)
460547 -        ..
460548 -       x  Yes  Hydrocrotisone 100 mg IV prn x 1 unticaria pruntis, SOB
460550 -        ..
460551 -       x  Yes  Aubterol inhaler 2 - 4 puffs prn SOB or chest tightness
460553 -        ..
460554 -       x  Yes  Epnephnna nhaler 2 - 4 puffs prn SOB or chest tightness
460556 -  ..
460557 - There is handwriting at this part of the form which says...
460558 -
460559 -          Neupogen 480 mcg SQ on D2, D3 & each does chemo [unrecognizable letters]
460560 -               Receive at Kaiser
460561 -
460562 -                   [...this comment prescribing Neupogen on
460563 -                   Chemotherapy Order for cetuximab that does not
460564 -                   affect blood counts, reflects doctor's consideration
460565 -                   during a meeting with the medical team earlier this
460566 -                   morning on 080821 to increase Neupogen treatment
460567 -                   this week based on significant decline in blood
460568 -                   counts from chemotherapy 2 weeks ago. ref SDS F5
460569 -                   4B62
460571 -                    ..
460572 -                   [...see below Chemotherapy Order for Carboplatin was
460573 -                   received a week later, and shows the same
460574 -                   prescription for Neupogen. ref SDS 0 PWSY
460576 -  ..
460577 - Chemotherapy Order Cetuximab continue...
460579 -        ..
460580 -       breast CC05752  cetuximab 080814
460581 -       Approved 060615
460583 -        ..
460584 -       Physician Signature
460585 -
460588 -                Date:  080815
460590 -        ..
460591 -       Nurse Signature:
460592 -
460595 -                Date:  080313
460597 -  ..
460598 - No nurses signature is shown in the copy received from UCSF; may have
460599 - been entered and filed in UCSF records later.
460600 -
460601 -
460602 -
4607 -

SUBJECTS
Default Null Subject Account for Blank Record

4703 -
470401 -  ..
470402 - Carboplatin Chemotherapy Orders
470403 -
470404 - Follow up ref SDS D8 N54I, ref SDS B7 N54I.
470405 -
470406 - Chemotherapy Order for Carboplatin was not submitted today, because
470407 - Millie's blood counts were too low for safe treatment, per above.
470408 - ref SDS 0 PU6K
470410 -  ..
470411 - Chemotherapy Order was received from UCSF a week later on 080828.
470412 - ref SDS G2 N54I
470413 -
470414 -        [On 080827 Millie notified UCSF to prepare Chemotherapy Order
470415 -        for Carboplatin treatment tomorrow. ref SDS F9 KU5J
470416 -
470417 -        [On 080828 Chemotherapy Order for Carboplatin was submitted to
470418 -        the Infusion Clinic, ref SDS G2 N54I, and the order for labs
470419 -        was ready for Millie's treatment. ref SDS G2 FW5N
470421 -  ..
470422 - No evident difference between chemotherapy orders today and for last
470423 - month starting cycle 6 on 080724. ref SDS D8 N54I
470425 -     ..
470431 -    Auth#                                     Stor BCC LOC
470432 -    Visit:  14587572             DOS 20080828
470434 -     ..
470435 -    Date:  20080821
470437 -     ..
470438 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
470439 -    in combination with Carboplatin in ER-negative, PR-negative,
470440 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers.
470442 -     ..
470443 -    Arm:  2 - Cetuximab + Carboplatin
470445 -     ..
470446 -    Error Dates Treatment Should Not Include Today
470447 -
470448 -    Dates to be given: 20080821  *** error ***
470449 -                       20080828
470450 -                       20080904
470452 -  ..
470453 - Chemotherapy Order for 080821 listed all three dates
470454 - the doctor ordered not Carboplatin
470455 - today, per above. ref SDS 0 PU6K
470457 -  ..
470458 - Looks like a data entry error.
470460 -  ..
470461 - Millie did not get Carboplatin today, and this is shown correctly
470462 - further in the Chemotherapy Order under "Days", ref SDS 0 PVSW
470464 -  ..
470465 - Chemotherapy Order Carboplatin continues...
470466 -
470467 -    Allergies:  NKDA
470469 -     ..
470470 -    Height:  62 inches
470472 -     ..
470473 -    Weight:  140 pounds
470475 -  ..
470476 - Not clear why Chemotherapy Order for cetuximab shows 141 pounds,
470477 - ref SDS 0 4E6V, and this Cheotherapy Order for Carboplatin shows 140
470478 - pounds; may reflect that different people did the orders, and one
470479 - person used diagnostics taken today, and the other used the number
470480 - from the form for the prior Carboplatin cycle last month; however,
470481 - last month on 080724 the weight was 138 pounds. ref SDS D8 PVRW
470483 -  ..
470484 - Chemotherapy Order Carboplatin continues...
470485 -
470486 -    Diagnosis:  Metastatic breast cancer (IBC)
470488 -     ..
470489 -    ICD-9 codes: 174.9, 198.5, 198.3, 196.2
470491 -  ..
470492 - This ICD-9 codes section conflicts with assignments in Chemotherapy
470493 - Order for 080724, ref SDS D8 PVSS and for 080626. ref SDS B7 PVSS
470494 -
470496 -  ..
470497 - Chemotherapy Order Carboplatin continues...
470498 -
470499 -    Cycle:  7
470501 -     ..
470502 -    Days: xxx 8, 15  (arm 2)
470504 -  ..
470505 - Note that day "1" is crossed out because Carboplatin was not approved
470506 - for treatment today due to low blood counts, per above. ref SDS 0 PU6K
470508 -  ..
470509 - This conflicts with "Dates to be given" section shown above.
470510 - ref SDS 0 PVQX
470512 -  ..
470513 - Chemotherapy Order Carboplatin continues...
470515 -     ..
470516 -    Antimetics:
470517 -
470518 -    Follow up ref SDS D8 PVTT, ref SDS B7 PVTT.
470519 -
470520 -    x  Dexamethasone    10 mg   IV     (Decadron)
470521 -    x  Ondansetron  8 mg   IV          (Zofran)
470522 -
470524 -     ..
470525 -    Chemotherapy (plan to treat weekly for 3 out of 4 weeks).
470526 -    Carboplatin Dose Reduced May Aid Blood Counts Maintain Treatments
470527 -
470528 -    Follow up ref SDS D8 PVUQ, ref SDS B7 PVUQ.
470529 -
470530 -    May administer Carboplatin if vital signs are unremarkable one
470531 -    hour after cetuximab infusion..
470532 -
470533 -    ** Please note start and stop times **
470535 -     ..
470536 -    Carboplatin (commercial supply) AUC 1.5 = 175 mg in D5W 250 ml
470538 -  ..
470539 - Chemo orders today seem to show the same dose specified for cycle 4
470540 - started on 080529 and marked "error," ref SDS A5 PVUQ, reviewed on
470541 - 080626. ref SDS B6 2X5L  At that time, the medical chart was
470542 - confusing, because Brigid could not find the Chemotherapy Order for
470543 - 080529 marked "error." ref SDS B6 RF4J  UCSF planned to investigate
470544 - the error in the Chemotherapy Order. ref SDS B6 RF53
470546 -  ..
470547 - Chemotherapy Orders continue...
470548 -
470549 -    IV over 30 minutes weekly x 3 doses followed by 1 week rest.
470551 -  ..
470552 - [hand writting...]
470553 -
470554 -               Carbo dose to remain the same unless CR > 1.3
470556 -  ..
470557 - [...where CR = "Creatinine"]
470558 -
470559 -            Carboplatin dose in mg = (desired AUC)(GFR+25)
470560 -
470561 -        GFR (estimated) =
470562 -
470563 -               (140-age in years)(weight in kg)(for females x 0.85)
470564 -               ----------------------------------------------------
470565 -                         (Cr in mg/dL)(72)
470567 -  ..
470568 - Unlike previous Chemotherapy Orders issued on 080403 which showed
470569 - handwritten values in the dosage formula, ref SDS 87 NV9H, there is
470570 - no similar handwriting on the Chemotherapy Orders received today from
470571 - UCSF.
470573 -  ..
470574 - Chemotherapy Orders continues...
470576 -     ..
470577 -    Laboratory Work:
470578 -
470579 -    Follow up ref SDS D8 PWPW, ref SDS B7 PWPW.
470580 -
470581 -    x  CBC with differential and platelets
470582 -    x  Creatinine, magnesium every 4 weeks
470583 -    x  BUN, AST, Alk phos, Alt, Total bilirubin, eletrolytes every 8 weeks
470585 -  ..
470586 - Before meeting with the medical team this morning, Millie got a blood
470587 - draw in the Infusion Clinic, per above, ref SDS 0 439L, as planned in
470588 - Millie's letter to UCSF this morning on the agenda for meeting with
470589 - the medical team. ref SDS F5 6Y5K
470591 -  ..
470592 - Chemotherapy Orders continues...
470593 -
470594 -    If ANC >= 1.5 x 1000/L, platelets >= 75 x 1000/L give 100% of dose
470596 -     ..
470597 -    If ANC <  1.5 x 1000/L, platelets <  75 x 1000/L....
470598 -
470601 -        ..
470602 -    x  See cetuximab orders.
470604 -  ..
470605 - The section checked to see cetuximab orders refers to the Chemotherapy
470606 - Order for cetuximab, per above. ref SDS 0 MM6N
470608 -  ..
470609 - Chemotherapy Orders continue...
470610 -
470611 -       Study tubes
470613 -  ..
470614 - The "Study tubes" section today is not checked and is blank; however,
470615 - this morning Heather reported that Jill, the new Clinical Study
470616 - Coordinator, delivered the 7 vials to the Infusion Clinic, per above,
470617 - ref SDS 0 LO4G, required for the trial protocol, and requested in
470618 - Millie's letter to the medical team this morning. ref SDS F5 6Y5K
470620 -  ..
470621 - Last month on 080724, the section on "Study tubes" was filled out, but
470622 - showed only three (3) study tubes were delivered. ref SDS D8 QD7H
470624 -  ..
470625 - Chemotherapy Orders continue...
470627 -     ..
470628 -    Neupogen Prescribed in Chemotherapy Orders
470629 -
470630 -    Follow up ref SDS B6 PWSY, ref SDS A4 PWTR.
470631 -
470632 - During the meeting with the medical team on the 2nd floor at 0800 this
470633 - morning, the doctor ordered continuing for the 7th cycle starting
470634 - today the same prescription issued for the 4th cycle shown in the
470635 - record on 080529, ref SDS A5 PWSY  The Chemotherapy Orders for today
470636 - shows in handwriting...
470637 -
470638 -        Neupogen 480 mcg SQ on D2 3 3 carbo
470640 -  ..
470641 - This duplicates the handwritten prescription in the Chemotherapy Order
470642 - for cetuximab received above. ref SDS 0 RU7O
470644 -  ..
470645 - This seems to reflect instructions that Neupogen is only given on the
470646 - 3 days in the cycle when Millie gets Carboplatin, and so is skipped
470647 - for the 4th treatment in the cycle when Millie gets only cetuximab.
470649 -  ..
470650 - On 080609 Zan in the Kaiser Oncology Pharmacy set up an account for
470651 - Millie to get Neupogen treatments in the Kaiser Infusion Clinic based
470652 - on Chemotherapy Orders showing the UCSF prescription.  At that time,
470653 - Zan used the Chemotherapy Orders for 080529 which show a prescritpion
470654 - for 2 Neupogen treatments per week. ref SDS A8 L16I
470656 -  ..
470657 - Chemotherapy Orders continue...
470659 -     ..
470660 -    x  Physician has discussed risks/benefits of chemotherapy with the
470661 -       patient.  Consent, form obtained.
470662 -
470663 -       x  Yes  O2 [oxygyn] by nasal cannula at 2 liters/min prn for chest pain or SOB
470665 -           ..
470666 -       x  Yes  Diphenhydramine 50 mg IV prn x 1 unticaria pruntis, SOB
470667 -               (this is Benadryl)
470669 -        ..
470670 -       x  Yes  Hydrocrotisone 100 mg IV prn x 1 unticaria pruntis, SOB
470672 -        ..
470673 -       x  Yes  Aubterol inhaler 2 - 4 puffs prn SOB or chest tightness
470675 -        ..
470676 -       x  Yes  Epnephnna nhaler 2 - 4 puffs prn SOB or chest tightness
470678 -        ..
470679 -       Physician Signature
470680 -
470683 -                Date:  080815
470685 -        ..
470686 -       Nurse Signature:
470687 -
470690 -                Date:  080724
470692 -  ..
470693 - No nurses signature is shown in the copy received from UCSF; may have
470694 - been entered and filed in UCSF records later.
470695 -
470696 -
470697 -
470698 -
470699 -
470700 -
470701 -
470702 -
4708 -