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: May 1, 2008 09:30 AM Thursday; Rod Welch

Millie 1st treatment 3rd cycle cetuximab Carboplatin 4th relapse IBC.

1...Summary/Objective
...Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
...Cetuxiab Alone Clinical Study
...Cetuxiab with Carboplatin Clinical Study 2nd Arm
2...Labs Blood Test
3...CA 15-3 59 Cancer Marker Shows Improvement Responding to Treatment
4...NEUTS Steady UCSF Prescribed 1 Neupogen Treatment Per Week
5...Coagulation Control INR 2.4 Normal Stable PT 26.1 High
6...Magnesium Not Report for Blood Test Today
7...Chemotherapy Orders for Cetuximab and Carboplatin
8...Cetuximab Chemotherapy Orders
....Medication: (plan to give weekly)
....Laboratory work:
9...Carboplatin Chemotherapy Orders
....Antimetics:
....Chemotherapy (plan to treat weekly for 3 out of 4 weeks).
....Carboplatin Reduced to 175 MG Aid Blood Counts Maintain Treatments
....Laboratory work:
....Neupogen Prescribed 2 Treatments

ACTION ITEMS.................. Click here to comment!

1...Note: Chemotherapy Orders for Carboplatin today seem to change the
2...There is nothing in the record showing this change was presented by

CONTACTS 

SUBJECTS
Cetuximab 12th Cycle 3rd Treatment 18th Total Treatment Chemotherapy

0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 96 0000. ref SDS 95 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040507 -
040509 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - The first treatment on the clinical study began on 070201 with
040902 - cetuximab alone, ref SDS 12 G68I, and continued for 14 cycles.  The
040903 - second arm of the clinical study adding Carboplatin chemotherapy to
040904 - cetuximab was ordered by the doctor on 080306. ref SDS 85 NW3N  The
040905 - first treatment with Carboplatin was delayed a week by the patient,
040906 - ref SDS 85 M18J, and so started on 080313. ref SDS 87 TZ8I
040907 -
040909 -    ..
040910 -   Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
040911 -
040912 -   Follow up ref SDS 96 DX3I. ref SDS 95 DX3I.
040913 -
040914 -   Millie had left mastectomy on 051021.  Biopsy at that time reported
040915 -   no findings of cancer.  Approximately 8 months later on 060707 the
040916 -   doctor diagnosed IBC relapse and prescribed treatment. ref SDS 2
040917 -   PF3O
040918 -
040919 -    1.  Cycle 09 and 01 ................... 060721, ref SDS 3 407N
040920 -    2.  Cycle 10 and 02 ................... 060814, ref SDS 5 LY6O
040921 -    3.  Cycle 11 and 03 ................... 060908, ref SDS 5 407N
040922 -    4.  Cycle 12 and 04 ................... 060929, ref SDS 5 407N
040923 -    5.  Cycle 13 and 05 ................... 061020, ref SDS 6 407N
040924 -    6.  Cycle 14 and 06 ................... 061110, ref SDS 7 407N
040925 -    7.  Cycle 15 and 07 ................... 061201, ref SDS 8 407N
040927 -    ..
040928 -   Cetuxiab Alone Clinical Study
040929 -
040930 -   Follow up ref SDS 96 N55I. ref SDS 95 N55I.
040931 -
040932 -   On 061208 the doctor diagnosed progression of disease, the 3rd
040933 -   relapse. ref SDS 9 025H  On 070105 the doctor prescribed treatment
040934 -   with clinical trial for cetuximab and Carboplatin. ref SDS 10 PK68
040935 -   Millie was randomized to start treatment with only cetuximab.  She
040936 -   began treatment with cetuximab alone on 070201...
040937 -
040938 -                   Total    Cetuximab
040939 -    8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 12 SG8I
040940 -    9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 13 SG8I
040941 -   10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 14 SG8I
040942 -   11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 15 SG8I
040943 -   12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 16 SG8I
040944 -   13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 18 7T3H
040945 -   14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 19 7T3H
040946 -   15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 20 7T3H
040947 -   16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 21 7T3H
040948 -   17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 22 7T3H
040949 -   18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 23 7T3H
040950 -   19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 24 7T3H
040951 -   20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 25 7T3H
040952 -   21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 26 7T3H
040953 -   22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 27 7T3H
040954 -   23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 28 7T3H
040955 -   24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 29 7T3H
040956 -   25.  Cycle 05 and 12 and 02 18.......... 070531, ref SDS 30 7T3H
040957 -   26.  Cycle 05 and 12 and 03 19.......... 070607, ref SDS 31 7T3H
040958 -   27.  Cycle 05 and 12 and 04 20.......... 070614, ref SDS 32 0001
040959 -   28.  Cycle 06 and 13 and 01 21.......... 070621, ref SDS 33 0001
040960 -   29.  Cycle 06 and 13 and 02 22.......... 070628, ref SDS 34 0001
040961 -   30.  Cycle 06 and 13 and 03 23.......... 070705, ref SDS 35 0001
040962 -   31.  Cycle 06 and 13 and 04 24.......... 070712, ref SDS 36 0001
040963 -   32.  Cycle 07 and 14 and 01 25.......... 070719, ref SDS 37 0001
040964 -   33.  Cycle 07 and 14 and 02 26.......... 070726, ref SDS 38 0001
040965 -   34.  Cycle 07 and 14 and 03 27.......... 070802, ref SDS 39 0001
040966 -   35.  Cycle 07 and 14 and 04 28.......... 070809, ref SDS 40 0001
040967 -   36.  Cycle 08 and 15 and 01 29.......... 070816, ref SDS 41 0001
040968 -   37.  Cycle 08 and 15 and 02 30.......... 070823, ref SDS 42 0001
040969 -   38.  Cycle 08 and 15 and 03 31.......... 070830, ref SDS 42 0001
040970 -   39.  Cycle 08 and 15 and 04 32.......... 070906, ref SDS 43 0001
040971 -   40.  Cycle 09 and 16 and 01 33.......... 070920, ref SDS 44 0001
040972 -   41.  Cycle 09 and 16 and 02 34.......... 070927, ref SDS 45 0001
040973 -   42.  Cycle 09 and 16 and 03 35.......... 071004, ref SDS 46 0001
040974 -   43.  Cycle 09 and 16 and 04 36.......... 071011, ref SDS 47 0001
040975 -   44.  Cycle 10 and 17 and 01 37.......... 071018, ref SDS 48 0001
040976 -   45.  Cycle 10 and 17 and 02 38.......... 071025, ref SDS 49 0001
040977 -   46.  Cycle 10 and 17 and 03 39.......... 071101, ref SDS 50 0001
040978 -   47.  Cycle 10 and 17 and 04 40.......... 071108, ref SDS 51 0001
040979 -   48.  Cycle 11 and 18 and 01 41.......... 071115, ref SDS 52 0001
040980 -   49.  Cycle 11 and 18 and 02 42.......... 071122, ref SDS 38 0001
040981 -   50.  Cycle 11 and 18 and 03 43.......... 071129, ref SDS 55 0001
040982 -   51.  Cycle 11 and 18 and 04 44.......... 071206, ref SDS 56 0001
040983 -   52.  Cycle 12 and 19 and 01 45.......... 071213, ref SDS 59 0001
040984 -   53.  Cycle 12 and 19 and 02 46.......... 071220, ref SDS 62 0001
040985 -   54.  Cycle 12 and 19 and 03 47.......... 071227, ref SDS 63 0001
040986 -   55.  Cycle 12 and 19 and 04 48.......... 080103, ref SDS 64 0001
040987 -   56.  Cycle 13 and 20 and 01 49.......... 080110, ref SDS 67 0001
040988 -   57.  Cycle 13 and 20 and 02 50.......... 080117, ref SDS 68 0001
040989 -   58.  Cycle 13 and 20 and 03 51.......... 080124, ref SDS 69 0001
040990 -   59.  Cycle 13 and 20 and 04 52.......... 080131, ref SDS 71 0001
040991 -   60.  Cycle 14 and 21 and 01 53.......... 080207, ref SDS 75 0001
040992 -   61.  Cycle 14 and 21 and 02 54.......... 080214, ref SDS 76 0001
040993 -   62.  Cycle 14 and 21 and 03 55.......... 080221, ref SDS 39 0001
040994 -   63.  Cycle 14 and 21 and 04 56.......... 080228, ref SDS 83 0001
040995 -   64.  Cycle 15 and 22 and 01 57 01  00... 080306, ref SDS 86 TZ8I
040997 -    ..
040998 -   Cetuxiab with Carboplatin Clinical Study 2nd Arm
040999 -
041000 -   Follow up ref SDS 96 FE5G. ref SDS 95 FE5G.
041001 -
041002 -   On 080207 doctor reports IBC may be spreading. ref SDS 74 GH5H
041003 -   Follow up examination on 080219 Doctor Rugo diagnosed progression of
041004 -   disease. ref SDS 79 3J4I  Photographs show spread of IBC rash,
041005 -
041006 -             2nd
041007 -             Arm           Cetuximab Carboplatin
041008 -   65.  Cycle 01 15 and 22 and 02 58 02  01... 080313, ref SDS 87 TZ8I
041009 -   66.  Cycle 01 15 and 22 and 03 59 03  01... 080320, ref SDS 88 TZ8I
041010 -   67.  Cycle 01 15 and 22 and 04 60 04  01... 080327, ref SDS 89 TZ8I
041011 -   68.  Cycle 02 16 and 23 and 01 61 05  02... 080403, ref SDS 90 TZ8I
041012 -   69.  Cycle 02 16 and 23 and 02 62 06  03... 080410, ref SDS 93 TZ8I
041013 -   70.  Cycle 02 16 and 23 and 03 63 07  03... 080417, ref SDS 95 TZ8I
041014 -   71.  Cycle 02 16 and 23 and 04 64 08  03... 080424, ref SDS 96 TZ8I
041015 -   72.  Cycle 03 17 and 24 and 01 65 09  04... 080501, ref SDS 0 5B6J
041017 -  ..
041018 - Today is the 1st treatment of the 3rd cycle with cetuximab and
041019 - Carboplatin together.  This is the 9th treatment overall with
041020 - cetuximab on the 2nd arm of the clinical study, but is only the 4th
041021 - treatment with Carboplatin.
041023 -  ..
041024 - Catherine is out today.
041026 -  ..
041027 - Diane drew Millie's blood this morning at 0800 for labs needed to
041028 - support meeting with the medical team on the 2nd floor at 0830.
041030 -  ..
041031 - Diane asked Millie about severe bruising on her right arm?
041032 - Previously, bruising occurred from a fall, reported in Nurses Notes on
041033 - 080202. ref SDS 71 CX9O
041035 -  ..
041036 - Millie explained problems last week.  Kaiser could not find a vein for
041037 - a needle puncture to inject contrast medium for a CT test, similar to
041038 - the report on 080214. ref SDS 76 1D9I  This time it took 4 tries over
041039 - several hours, a big mess reported on 080425. ref SDS 97 FP6F
041040 -
041041 -
041042 -
041043 -
041044 -
0411 -

SUBJECTS
Default Null Subject Account for Blank Record

0503 -
050401 -  ..
050402 - Labs Blood Test
050403 -
050404 - Follow up ref SDS 96 FW5N. ref SDS 95 FW5N.
050405 -
050406 - Adding Carboplatin to the treatment protocol now requires weekly blood
050407 - tests to determine if the immune system is strong enough for safe
050408 - chemotherapy treatment, reported on 070201, ref SDS 12 XR40, and citing
050409 - the clinical study protocol received from UCSF on 070116. ref SDS 11
050410 - 5U7Z
050412 -  ..
050413 - During treatment, Diane submitted results of the test.
050414 -
050429 -     ..
050430 -    Log#:                   080501 08:10
050431 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
050432 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
050433 -     ..
050434 -    CBC with DIFF & PLT CT                                     CBCD
050435 -     ..
050436 -    WBC COUNT               3.4    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
050437 -    RBC COUNT               4.07   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
050438 -    HEMOGLOBIN             12.9    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
050439 -    HEMATOCRIT             39.5    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
050440 -    MCV                    97      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
050441 -    MCH                    31.8    pg           26  -   34     MCH
050442 -    MCHC                   32.8    g/dL         31  -   36     MCHC
050443 -    PLATELETS             172      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
050444 -    ..
050445 -       (posted 080508, ref SDS A1 GM8H)
050446 -    CA 15-3      H*        59      U/mL             <  33     CA153  CA 15-3                        <  39
050447 -
050448 -         Note new reference range [<33 changed from <31] and change in
050449 -         methodology effective March 1, 2008.  Performed using the
050450 -         Siemens Centaur Chemiluminesence method.  CA 15-3 result using
050451 -         the Roche Elecsys assay is 75 U/mL.  Ref range <31 U/mL.  This
050452 -         rebaseline value provided at no additional charge.
050454 -          ..
050455 -         This new note updates explanation of tests prior to 080301,
050456 -         e.g., on 080207. ref SDS 75 A16M
050457 -    ..
050458 -     (NEUTS x 1000 = ANC for Kaiser)
050459 -    NEUTS         L         1.34   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
050460 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
050461 -
050462 -         [On 080529 blood counts improve, ref SDS A3 4F38, medical team
050463 -         prescribes 1 treatment with Neupogen starting the 4th cycle.
050464 -         ref SDS A3 4F42; during treatment in the Infusion Clinic after
050465 -         meeting with medical team, nurse confirms guidance for 1
050466 -         treatment with Neupogen. ref SDS A4 TE6N
050468 -     ..
050469 -    LYMPHS                  1.45   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
050470 -    MONOS                   0.25   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
050471 -    EOS                     0.13   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
050472 -    BASOS                   0.05   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
050473 -    LUC/ATYP LYMPHS         0.13   x10E9/L       0  -  0.2     LALA
050474 -                                                                                                 0  -  5
050475 -     ..
050476 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
050477 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
050478 -    PT            H        26.1    s          12.0  -  14.1    PT    PT, patient       sec     8.9  -  11.1
050479 -    INL NRM Ratio H         2.4                0.9  -  1.1     INR   INR                       2.0  -  3.0
050481 -     ..
050482 -    ELECTROLYTE PANEL                                          LYTE
050483 -    SODIUM        L       133      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
050484 -    POTASSIUM               3.8    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
050485 -    CHLORIDE               98      mmol/L       98  -  107     CL
050486 -    CARBON DIOX TOTAL  L   22      mmol/L       23  -  32      CO2
050487 -    ANION GAP              13                    3  -  14      ANGA
050488 -     ..
050489 -    UREA NITROGEN          10      mg/dL         8  -  23      BUN   BUN               mg/dL     7  -  17
050490 -    GLUCOSE               124      mg/dL        70  -  199     GLU   Glucose           mg/dL     ?  -   ?
050491 -    AST              H     48      U/L          16  -  41      AST   AST (SGOT)        U/L      14  -  36
050492 -    ALT                    25      U/L          11  -  54      ALT   ALT (SGPT)        U/L      11  -  66
050493 -    BILIRUBIN, TOTAL        1.0    mg/dL       0.3  - 1.3      BILT  Bili Total        mg/dL   0.2  - 1.3
050494 -    ALKALINE PHOSPHATASE   64      U/L          29  - 111      ALKP  Alkaline Ph       U/L      38  - 126
050495 -    PROTEIN, TOTAL          6.5    g/dL        5.8  - 8.0      TP    Protine Total     g/dL    6.3  - 8.2
050496 -    ALBUMIN                 3.9    g/dL        3.4  - 4.7      ALB   Albumin           g/dL    3.4  - 4.8
050497 -    CALCIUM                 8.7    mg/dL       8.7  - 10.1     CA    Calcium           mg/dL   8.4  - 10.2
050498 -     ..
050499 -    MAGNESIUM      L        1.6    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
050500 -
050501 -        Note:  there was no report for Magnesium in the test today,
050502 -        however the next day on 080404 Brigid called and advised that
050503 -        Jackie added Magnesium to the test specification and this was
050504 -        performed on the blood draw today, with the result that the
050505 -        complete test results include Magnesium. ref SDS 91 O059
050507 -     ..
050508 -    CREAT with eGFR
050509 -    CREATININE              0.55   mg/dL      0.42  - 1.06     CR    Creatinine        mg/dL   0.6  -  1.2
050510 -
050511 -      Note: Creatinine assay changed to IDMS standardization on
050512 -      February 4, 2008 causing decrease in results of approximately
050513 -      0.09 mg/dL
050515 -     ..
050516 -    eGFR if Caucasian     >60      mL/min                      GFRC
050517 -    eGFR if African Amer  >60      mL/min                      GFRA
050518 -
050519 -      eGFR corrected for 1.73 sq meters of body surface area
050520 -      Note:  eGFR is only an estimation. Please see online Lab Manual
050521 -      for potential limitations.
050522 -      Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
050523 -      CA  94115
050524 -
050525 -
050527 -  ..
050528 - CA 15-3 59 Cancer Marker Shows Improvement Responding to Treatment
050529 -
050530 - Millie received results of lab today for CA 15-3 59, ref SDS 0 A16M,
050531 - cancer marker a week later on 080508, ref SDS A1 GM8H, and shows
050532 - improving condition with decrease for CA 15-3 66 from the previous
050533 - cycle on 080403. ref SDS 90 A16M
050534 -
050535 -
050537 -  ..
050538 - NEUTS Steady UCSF Prescribed 1 Neupogen Treatment Per Week
050539 -
050540 - Blood counts remain steady today NEUTS 1.34, ref SDS 0 QY6H, compared
050541 - with last week on 080424, ref SDS 96 QY6H, still below the level for
050542 - safe treatment, presents continued difficulties.
050544 -  ..
050545 - During the meeting with the medical team prior to treatment in the
050546 - Infusion Clinic, there was discussion of blood counts, Neupogen and
050547 - chemotherapy treatments. ref SDS 98 RH6K  The doctor approved
050548 - treatment with a full dose of Carboplatin chemotherapy and prescribed
050549 - 1 Neupogen treatment per week for the new cycle. ref SDS 98 CZ3N
050550 -
050551 -         [...in another record, after the meeting Millie sent a letter
050552 -         to the medical team confirming understandings the doctor
050553 -         ordered a full dose of Carboplatin chemotherapy, and ordered 1
050554 -         treatment of Neupogen to maintain blood counts. ref SDS A0
050555 -         MG3P
050557 -  ..
050558 - Megan came to the Infusion Clinic during Millie's treatment, and told
050559 - the nurse that Chemo Orders prescribe 2 weekly Neupogen treatments.
050560 - ref SDS 98 Z28H   UCSF did not submit the Chemotherapy Order for today
050561 - (shown below, ref SDS 0 4E9N) to Millie.
050562 -
050563 -         [On 080515 Millie received a copy of Chemotherapy Orders for
050564 -         today, starting the 3rd cycle. ref SDS A2 E43I
050566 -  ..
050567 - Later in the day, Brigid wrote a letter saying to ignore the Chemo
050568 - Orders and stick with the initial plan for 1 weekly Neupogen
050569 - treatment. ref SDS 98 M658
050570 -
050571 -         [On 080529 blood counts improve, ref SDS A3 4F38, medical team
050572 -         prescribes 1 treatment with Neupogen starting the 4th cycle.
050573 -         ref SDS A3 4F42; during treatment in the Infusion Clinic after
050574 -         meeting with medical team, nurse confirms guidance for 1
050575 -         treatment with Neupogen. ref SDS A4 TE6N
050576 -
050577 -
050578 -
050579 -
0506 -

SUBJECTS
Default Null Subject Account for Blank Record

1503 -
150401 -  ..
150402 - Coagulation Control INR 2.4 Normal Stable PT 26.1 High
150403 -
150404 - Follow up ref SDS 96 SE6N, ref SDS 95 SE6N.
150405 -
150406 - INR 2.4 performed with labs today falls within the range of 2.0 - 3.0
150407 - that shows Millie's treatment with Coumadin (Warfarin) for pulmonary
150408 - embolism seems to be effective.
150409 -
150410 -
150411 -
150412 -
150413 -
150414 -
1505 -

SUBJECTS
Default Null Subject Account for Blank Record

2403 -
240401 -  ..
240402 - Magnesium Not Report for Blood Test Today
240403 -
240404 - Follow up ref SDS 96 RW6F, ref SDS 95 RW6F.
240405 -
240406 - There was no report on Magnesium for the blood test this morning, per
240407 - above. ref SDS 90 CP6J
240409 -  ..
240410 - Previously, on 080110 Magnesium was not shown in the blood test
240411 - report. ref SDS 65 JH6F
240412 -
240413 -
240414 -
240415 -
240416 -
2405 -

SUBJECTS
Chemotherapy Orders 2nd Cycle 1st Treatment Clinical Study Drug Tria

3003 -
300401 -  ..
300402 - Chemotherapy Orders for Cetuximab and Carboplatin
300403 -
300404 - Follow up ref SDS 90 4E9N, ref SDS 87 4E9N.
300405 -
300406 - After meeting with the medical team on the 2nd floor, Megan did not
300407 - submit the Chemotherapy Orders and blood vials for Millie to take to
300408 - the Infusion Clinic on the 5th floor.  This changes practice for the
300409 - past 18 months on the project.  Today, while Millie was getting
300410 - treatment, Megan came into the Infusion Clinic and submitted the
300411 - Chemotherapy Order to the nurse for starting the 3rd cycle on the 2nd
300412 - arm of the clinical study, signed by the doctor, and prepared by
300413 - Brigid.
300415 -             ..
300416 -            [On 080515 Millie received a copy of Chemotherapy Orders
300417 -            for today, starting the 3rd cycle. ref SDS A2 E43I
300419 -             ..
300420 -            [On 080529 entered Chemotherapy Orders for today, 080501,
300421 -            which were received on 080515, and shown here in this part
300422 -            of the record. ref SDS A4 MM9I
300424 -             ..
300425 -            [On 080529 UCSF continued new pratice of separate delivery
300426 -            for Chemotherapy Orders and blood vials to the 5th floor
300427 -            Infusion Clinic. ref SDS A4 I66I
300429 -  ..
300430 - Another change is that today, UCSF prepared two (2) Chemotherapy
300431 - Orders...
300432 -
300433 -        1.  Chemotherapy Orders prescribes treatment with cetuximab
300434 -            updating original prescription on 070201. ref SDS 12 4N5M,
300435 -            and shown below. ref SDS 0 MM6N
300437 -             ..
300438 -        2.  Chemotherapy Orders prescribes treatment with Carboplatin
300439 -            updating prescription 4 weeks ago 080403. ref SDS 90 4E9N
300440 -            and shown below. ref SDS 0 I66I
300442 -  ..
300443 - This is the first time in patient history Millie has received 2
300444 - separate orders.  There was no evident discussion of this change in
300445 - practice during the meeting with the medical team.
300447 -  ..
300448 - Note:  Chemotherapy Orders for Carboplatin today seem to change the
300449 - amount of treatment. ref SDS 0 PVUQ
300450 -
300451 -            [On 080529 review of Chemotherapy Orders for today, 080501,
300452 -            which were received from UCSF on 080515, ref SDS A2 E43I,
300453 -            and shown in this part of the record, ref SDS A4 MM9I,
300454 -            discovered UCSF evidently reduced the dose of Carboplatin
300455 -            and prescribed 2 weekly Neupogen treatments, per below,
300456 -            ref SDS 0 PVUQ, contrary to understandings with the medical
300457 -            team today, 080501, that Millie would get full dose of
300458 -            Carboplatin with 1 weekly Neupogen tratment this cycle.
300459 -            ref SDS 98 CZ3N
300461 -             ..
300462 -            [On 080529 Chemotherapy Orders for Carboplatin show same
300463 -            dose 175 mg as today, ref SDS A4 PVUQ, but there is a
300464 -            handwritten mark that says "error," dated 080529 with
300465 -            initials mg. ref SDS A4 F55F
300466 -
300468 -  ..
300469 - Cetuximab Chemotherapy Orders
300470 -
300471 -
300477 -    Auth#                                     Stor BCC LOC
300478 -    Visit:  14264581             DOS 20080501
300479 -
300480 -            [On 080529 Millie received only 1 Chemotherapy Order for
300481 -            Carboplatin, and did not receive a Chemotherapy Order for
300482 -            cetuximab, as received today. ref SDS A4 MM6N
300484 -             ..
300485 -            [On 080626 Millie again received a Chemotherapy Order for
300486 -            cetuximab, like today, and another document for the
300487 -            Chemotherapy Order for Carboplatin. ref SDS A7 MM6N
300489 -             ..
300490 -            [On 080724 Millie received only 1 Chemotherapy Order for
300491 -            Carboplatin, and did not receive a Chemotherapy Order for
300492 -            cetuximab, as received today. ref SDS A9 MM6N
300494 -     ..
300495 -    Date:  20080501
300497 -     ..
300498 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
300499 -    in combination with Carboplatin in ER-negative, PR-negative,
300500 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers.
300502 -     ..
300503 -    Arm:  2 - Cetuximab + Carboplatin
300505 -     ..
300506 -    Dates to be given: 20080501
300508 -     ..
300509 -    Allergies:  NKDA
300511 -     ..
300512 -    Height:  62 inches
300514 -     ..
300515 -    Weight:  141 pounds
300517 -     ..
300518 -    Diagnosis:  Breast Cancer (IBC)
300520 -     ..
300521 -    ICD-9 codes: 174.4/198.2
300523 -  ..
300524 -
300525 -        [On 080626 Chemotherapy Order for cetuximab shows ICD-9 codes
300526 -        174.9 and 198.2 rather than 174.4 and 198.2 shown in the orders
300527 -        today. ref SDS A7 VU7K
300529 -  ..
300530 - Chemotherapy Order for Cetuximab continues...
300531 -
300532 -    Cycle:  3
300534 -     ..
300535 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
300537 -     ..
300538 -    x  Diphenhydramine 50 mg IV
300539 -
300540 -       Benadryl............... explained on 070201. ref SDS 12 DC7J
300542 -     ..
300543 -    Medication:  (plan to give weekly)
300544 -
300545 -    x  Cetuximab - Erbitux - (study supply) (maintenance)
300546 -
300547 -       250 mg/m*m = 428 mg
300549 -     ..
300550 -    Maximum infusion rate is 5 ml/minute. (concentration 2 mg/ml)
300552 -     ..
300553 -    Infuse once weekly for 8 weeks.  First dose is to be given on date
300554 -    080501
300556 -     ..
300557 -    Cetuximab is administered undiluted through a low protein binding
300558 -    0.22 micro in-line filter.  Use NS soution to flush the line at
300559 -    the end of the Infusion.
300561 -     ..
300562 -    Arm 2:  Administer carboplatin if vital signs are unremarkable one
300563 -    hour after cetuximab infusion.
300565 -     ..
300566 -    Vital signs at baseline, upon cetuximab completion and one hour
300567 -    after cetuximab.
300568 -
300569 -    **** please not start and stop times ****
300570 -
300572 -     ..
300573 -    Laboratory work:
300574 -
300575 -    x  See carboplatin orders.
300576 -    x  Notify MD for dose modifications if patient has severe acne
300577 -       form rash
300578 -    x  CBC with differential and plateletes every 4 weeks
300579 -    x  Creatinine and magnesium every 4 weeks
300580 -    x  BUN, AST, Alk Phos, ALT, total bilrubin, electrolytes every
300581 -       8 weeks
300583 -     ..
300584 -    If levels are outside of normal laboratory values notify
300585 -
300588 -  ..
300589 - Chemotherapy Orders continue...
300591 -     ..
300592 -    x  Physician has discussed risks/benefits of chemotherapy with the
300593 -       patient.  Consent, form obtained.
300594 -
300595 -       x  Yes  O2 [oxygyn] by nasal cannula at 2 liters/min prn for chest pain or SOB
300597 -           ..
300598 -       x  Yes  Diphenhydramine 50 mg IV prn x 1 unticaria pruntis, SOB
300599 -               (this is Benadryl)
300601 -        ..
300602 -       x  Yes  Hydrocrotisone 100 mg IV prn x 1 unticaria pruntis, SOB
300604 -        ..
300605 -       x  Yes  Aubterol inhaler 2 - 4 puffs prn SOB or chest tightness
300607 -        ..
300608 -       x  Yes  Epnephnna nhaler 2 - 4 puffs prn SOB or chest tightness
300610 -        ..
300611 -       Physician Signature
300612 -
300615 -                Date:  080429
300617 -        ..
300618 -       Nurse Signature:
300619 -
300622 -                Date:  080313
300624 -  ..
300625 - No nurses signature is shown in the copy received from UCSF; may have
300626 - been entered and filed in UCSF records later.
300627 -
300628 -
300630 -  ..
300631 - Carboplatin Chemotherapy Orders
300632 -
300633 - Follow up ref SDS 90 4E9N, ref SDS 87 4E9N.
300634 -
300635 - Only major difference between chemotherapy orders today and for last
300636 - month on 080403 is that Carboplatin was decreased today from 250 mg on
300637 - 080403, ref SDS 90 4F56, to 175 mg today. ref SDS 0 PVUY
300639 -  ..
300640 - This change was not noticed until the following cycle starting on
300641 - 080529, because the Chemotherapy Orders were not received until
300642 - several weeks later on 080515. ref SDS A2 E43I  At that time, no
300643 - review was made.
300645 -             ..
300646 -            [On 080529 reviewed Chemotherapy Orders for today, 080501,
300647 -            received from UCSF on 080515, ref SDS A2 E43I, and shown in
300648 -            this part of the record, ref SDS A4 MM9I, discovered UCSF
300649 -            evidently reduced the dose of Carboplatin and prescribed 2
300650 -            weekly Neupogen treatments, per below, ref SDS 99 PVUQ,
300651 -            contrary to understandings with the medical team today,
300652 -            080501, that Millie would get full dose of Carboplatin with
300653 -            1 weekly Neupogen tratment this cycle. ref SDS 98 CZ3N
300655 -             ..
300656 -            [On 080529 Chemotherapy Orders for Carboplatin show same
300657 -            dose 175 mg as today, ref SDS A4 PVUQ; there is a
300658 -            handwritten mark that says "error," dated 080529 with
300659 -            initials mg. ref SDS A4 F55F
300661 -     ..
300667 -    Auth#                                     Stor BCC LOC
300668 -    Visit:  14264561             DOS 20080501
300670 -     ..
300671 -    Date:  20080501
300673 -     ..
300674 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
300675 -    in combination with Carboplatin in ER-negative, PR-negative,
300676 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers.
300678 -     ..
300679 -    Arm:  2 - Cetuximab + Carboplatin
300681 -     ..
300682 -    Dates to be given: 20080501
300684 -     ..
300685 -    Allergies:  NKDA
300687 -     ..
300688 -    Height:  62 inches
300690 -     ..
300691 -    Weight:  141 pounds
300693 -     ..
300694 -    Diagnosis:  Metastatic breast cancer (IBC)
300696 -     ..
300697 -    ICD-9 codes: 174.4/198.2
300699 -  ..
300700 - This seems different from Chemotherapy Order for Carboplatin on 080403
300701 - that shows 174.9/198.2/174.??. ref SDS 90 IJ37
300702 -
300703 -            [On 080529 codes assigned to Chemotherapy Order for the
300704 -            next cycle are much different from codes assigned today.
300705 -            ref SDS A4 PVSS
300707 -  ..
300708 - Chemotherapy Order for Carboplatin continues...
300709 -
300710 -    Cycle:  3
300712 -     ..
300713 -    Days:  1, 8, 15  (arm 2)
300714 -
300716 -     ..
300717 -    Antimetics:
300718 -
300719 -    Follow up ref SDS 90 2N43, ref SDS 87 2N43.
300720 -
300721 -    x  Dexamethasone    10 mg   IV     (Decadron)
300722 -    x  Ondansetron  8 mg   IV          (Zofran)
300723 -
300725 -     ..
300726 -    Chemotherapy (plan to treat weekly for 3 out of 4 weeks).
300727 -    Carboplatin Reduced to 175 MG Aid Blood Counts Maintain Treatments
300728 -
300729 -    Follow up ref SDS 90 2N4N, ref SDS 87 2N4N.
300730 -
300731 -    May administer Carboplatin if vital signs are unremarkable one
300732 -    hour after cetuximab infusion..
300733 -
300734 -    ** Please note start and stop times **
300736 -     ..
300737 -    Carboplatin (commercial supply) AUC 1.5 = 175 mg in D5W 250 ml
300739 -  ..
300740 - Chemo orders for previous cycle started on 080403 seems to show
300741 - Carboplatin 250 mg. ref SDS 90 4F56
300743 -  ..
300744 - There is nothing in the record showing this change was presented by
300745 - the medical team today.  Reducing potency in the Chemotherapy Orders
300746 - seems conflicting with understandings during the meeting this morning
300747 - that Millie wants to maintain potency to increase chances of recovery
300748 - from IBC, ref SDS 98 W84O, noted as favorable so far with initial
300749 - potency, shown during examination by the medical team earlier today.
300750 - ref SDS 98 JJ3N
300751 -
300752 -            [On 080529 reviewed Chemotherapy Orders for today, 080501,
300753 -            received from UCSF on 080515, ref SDS A2 E43I, and shown in
300754 -            this part of the record, ref SDS A4 MM9I, discovered UCSF
300755 -            evidently reduced the dose of Carboplatin and prescribed 2
300756 -            weekly Neupogen treatments, per below, ref SDS 0 PVUQ,
300757 -            contrary to understandings with the medical team today,
300758 -            080501, that Millie would get full dose of Carboplatin with
300759 -            1 weekly Neupogen tratment this cycle. ref SDS 98 CZ3N
300761 -             ..
300762 -            [On 080529 Chemotherapy Orders for Carboplatin show same
300763 -            dose 175 mg as today, ref SDS A4 PVUQ, but there is a
300764 -            handwritten mark that says "error," dated 080529 with
300765 -            initials mg. ref SDS A4 F55F
300767 -             ..
300768 -            [On 080625 Millie asks medical team about error in
300769 -            Chemotherapy Orders disclosed today by UCSF. ref SDS A6
300770 -            PQWV
300772 -             ..
300773 -            [On 080716 Millie's letter to Kaiser asks about meeting to
300774 -            discuss CA 15-3 141 and progression of disease before
300775 -            scheduled meeting on 080829. ref SDS A8 VG7L
300777 -  ..
300778 - Chemotherapy Order for Carboplatin continues...
300779 -
300780 -    IV over 30 minutes weekly x 3 doses followed by 1 week rest.
300782 -  ..
300783 - [hand writting...]
300784 -
300785 -               Carbo dose to remain the same unless CR >= 1.3
300787 -  ..
300788 - [...where CR = "Creatinine"]
300789 -
300790 -            Carboplatin dose in mg = (desired AUC)(GFR+25)
300791 -
300792 -        GFR (estimated) =
300793 -
300794 -               (140-age in years)(weight in kg)(for females x 0.85)
300795 -               ----------------------------------------------------
300796 -                         (Cr in mg/dL)(72)
300798 -  ..
300799 - Unlike previous Chemotherapy Orders issued on 080403 which showed
300800 - handwritten values in the dosage formula, ref SDS 90 NV9H, there is
300801 - no similar handwriting on the Chemotherapy Orders received today from
300802 - UCSF.
300804 -  ..
300805 - Chemotherapy Orders continues...
300807 -     ..
300808 -    Laboratory work:
300809 -
300810 -    Follow up ref SDS 90 2N6N, ref SDS 87 2N6N.
300811 -
300812 -    x  CBC with differential and platelets
300813 -    x  Creatinine, magnesium every 4 weeks
300814 -    x  BUN, AST, Alk phos, Alt, Total bilirubin, eletrolytes every 8 weeks
300816 -  ..
300817 - On 070201 chemotherapy order for cetuximab alone appears identical to
300818 - requirements for laboratory blood tests. ref SDS 11 5594
300819 -
300820 -            [On 080529 Chemotherapy Orders omit specifiying laboratory
300821 -            blood work required to support treatment. ref SDS A4 PWPW
300823 -  ..
300824 - Chemotherapy Orders continues...
300825 -
300826 -    If ANC >= 1.5 x 1000/L, platelets >= 75 x 1000/L give 100% of dose
300828 -     ..
300829 -    If ANC <  1.5 x 1000/L, platelets <  75 x 1000/L....
300830 -
300834 -        ..
300835 -       See cetuximab orders. [received on 080501. ref SDS 0 MM6N]
300837 -  ..
300838 - For some reason this instruction is not selected, which conflicts with
300839 - the record on 080313 for the initial order, ref SDS 87 4F92, and
300840 - further conflicts with the record today showing UCSF issued new
300841 - Chemotherapy Orders for cetuximab, per above. ref SDS 0 MM6N
300842 -
300843 -            [On 080529 Chemotherapy Orders for Carboplatin show same
300844 -            omission of reference to cetuximab orders. ref SDS A4 PWSR
300846 -  ..
300847 - Chemotherapy Orders continue...
300849 -     ..
300850 -    Neupogen Prescribed 2 Treatments
300851 -
300852 -
300853 - Handwriting says at this point near bottom of the form...
300854 -
300855 -        Neupogen 480 mcg SQ on D2 + 3
300857 -  ..
300858 - This appears to prescribe 2 Neupogen treatments for each weekly
300859 - treatment of Carboplatin during the cycle.  It conflicts with the
300860 - report on planning during the meeting with the medical team, which
300861 - prescribed 1 Neupogen treatment per week in order to continue getting
300862 - the full dose of Carboplatin. ref SDS 98 4G7G  Millie's letter today
300863 - sent to the medical team after meeting on the 2nd floor confirmed
300864 - these understandings. ref SDS A0 MG3P
300866 -  ..
300867 - Later in the day, Millie received a letter from UCSF submitted by
300868 - Brigid and which changed the prescription from 2 treatments to only 1
300869 - Neupogen treatment per week this cycle. ref SDS 98 M658
300870 -
300871 -           [On 080529 Chemotherapy Orders again prescribe 2 Neupogen
300872 -           treatments, ref SDS A4 PWSY, Millie was told to take only 1
300873 -           Neupogen treatment. ref SDS A4 JU4H
300875 -  ..
300876 - Chemotherapy Orders continue...
300878 -     ..
300879 -    x  Physician has discussed risks/benefits of chemotherapy with the
300880 -       patient.  Consent, form obtained.
300881 -
300882 -       x  Yes  O2 [oxygyn] by nasal cannula at 2 liters/min prn for chest pain or SOB
300884 -           ..
300885 -       x  Yes  Diphenhydramine 50 mg IV prn x 1 unticaria pruntis, SOB
300886 -               (this is Benadryl)
300888 -        ..
300889 -       x  Yes  Hydrocrotisone 100 mg IV prn x 1 unticaria pruntis, SOB
300891 -        ..
300892 -       x  Yes  Aubterol inhaler 2 - 4 puffs prn SOB or chest tightness
300894 -        ..
300895 -       x  Yes  Epnephnna nhaler 2 - 4 puffs prn SOB or chest tightness
300897 -        ..
300898 -       Physician Signature
300899 -
300902 -                Date:  080306
300904 -        ..
300905 -       Nurse Signature:
300906 -
300909 -                Date:  080313
300911 -  ..
300912 - No nurses signature is shown in the copy received from UCSF; may have
300913 - been entered and filed in UCSF records later.
300914 -
300915 -
300916 -
300917 -
300918 -
300919 -
300920 -
300921 -
300922 -
300923 -
300924 -
3010 -