CONTACTS 

SUBJECTS
Cetuximab 5th Cycle 1st Treatment 17th Total Treatment Chemotherapy

0903 -
0903 -    ..
0904 - Summary/Objective
0905 -
090501 - Follow up ref SDS 78 0000. ref SDS 75 0000.
090502 -
090503 - After examination and approval this morning by the medical team in the
090504 - Breast Care Clinic, ref SDS 0 1M6H, Millie received the 1st treatment
090505 - starting the 5th cycle, making 17 total treatments with cetuximab
090506 - chemotherapy on clinical study at UCSF. ref SDS 0 7T3H  Side effects
090507 - remain mild, ref SDS 0 QU8K; slight recurrent dizziness, not
090508 - clinically significant testing pulse standing and sitting. ref SDS 0
090509 - Y14O  CA 15-3 36 was not available to the medical team, until a few
090510 - days after the meeting today, due a lag in reporting on this test.  A
090511 - week later on 070531, UCSF reported significant increase from 29 to
090512 - 37, which aligns with testing at Kaiser, ref SDS 0 2N5J, and raises
090513 - concern about relapse and changing the treatment.  Rising CA 15-3
090514 - appears in conflict with CT test results that report no metastatic
090515 - disease, and with visual examination showing IBC rash continues to
090516 - subside. ref SDS 0 EU6O  ANC (NEUTS) blood counts increased to the
090517 - level for safe treatment, correcting prior conditions. ref SDS 0 P560
090518 - INR remains steady within range for continuing current Coumadin
090519 - regimen to treat pulmonary embolism. ref SDS 0 SE6N
090520 -
090521 -
090522 -
090524 -  ..
0906 -
0907 -
0908 - Progress
0909 -
090901 - Infusion Clinic for Cetuximab Treatent
090902 -
090903 - Follow up ref SDS 78 1M6H, ref SDS 75 1M6H.
090904 -
090905 - Millie met with the medical team in the Breast Care Clinic on the 2nd
090906 - floor.  Doctor noted continuing improvement and stability of Millie's
090907 - IBC condition, and so approved another cycle of treatment with
090908 - cetuximab alone.  After meeting with medical team, Millie went to the
090909 - Infusion Clinic on the 5th floor for treatment.
090911 -  ..
090912 - Agenda...
090913 -
090914 -    1.  Side effects.............................. ref SDS 0 QU8K
090915 -    2.  Blood tests............................... ref SDS 0 R54J
090916 -    3.  INR Coagulation Management................ ref SDS 0 SE6N
090917 -    4.  NEUTS immune system safe for treatment.... ref SDS 0 P560
090918 -    5.  CA 15-3 response to treatment............. ref SDS 0 2N5J
090919 -    6.  Treatment cetuximab....................... ref SDS 0 4N5M
090920 -    7.  Vitals.................................... ref SDS 0 AW4L
090921 -    8.  Energy after treatment.................... ref SDS 0 F54N
090923 -  ..
090924 - Millie received 17th overall and 1st treatment of 5th cycle with
090925 - cetuximab, starting from 070201, ref SDS 37 G68I, and the 24th
090926 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 16 407N
090928 -  ..
090929 - Catherine was the nurse today.
090931 -           ..
090932 -          Taxotere Capecitabine
090933 -
090934 -          Follow up ref SDS 78 PR8Q, ref SDS 75 PR8Q.
090935 -
090936 -                   Relapse Treatments
090937 -
090938 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 16 407N
090939 -      2.  Cycle 10 and 02 ................... 060814, ref SDS 20 LY6O
090940 -      3.  Cycle 11 and 03 ................... 060908, ref SDS 21 407N
090941 -      4.  Cycle 12 and 04 ................... 060929, ref SDS 22 407N
090942 -      5.  Cycle 13 and 05 ................... 061020, ref SDS 28 407N
090943 -      6.  Cycle 14 and 06 ................... 061110, ref SDS 30 407N
090944 -      7.  Cycle 15 and 07 ................... 061201, ref SDS 31 407N
090946 -           ..
090947 -          Cetuxiab Clinical Study
090948 -
090949 -          Follow up ref SDS 78 7T3H, ref SDS 75 7T3H.
090950 -
090951 -                   Total    Cetuximab
090952 -      8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 37 SG8I
090953 -      9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 39 SG8I
090954 -     10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 40 SG8I
090955 -     11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 43 SG8I
090956 -     12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 48 SG8I
090957 -     13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 51 7T3H
090958 -     14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 56 7T3H
090959 -     15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 57 7T3H
090960 -     16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 61 7T3H
090961 -     17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 64 7T3H
090962 -     18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 66 7T3H
090963 -     19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 68 7T3H
090964 -     20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 71 7T3H
090965 -     21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 73 7T3H
090966 -     22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 75 7T3H
090967 -     23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 78 7T3H
090968 -     24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 0 7T3H
090970 -  ..
090971 - Nurses Notes...
090982 -  ..
090983 - Why is the visit number constant in Nurse's Notes, and yet seems to
090984 - vary in the schedule received from Nola on 070315? ref SDS 56 159O
090986 -     ..
090987 -    UCSF Log Time...
090988 -
090989 -                   Blood
090990 -                    Test   Infusion
090991 -
090992 -          In.......          0930
090993 -          Out......          1235
090994 -          Visit....      Min  3.0  Hours  Total 2.5 Hours reported
090996 -      ..
090997 -     Pain Assessment...
090998 -
090999 -          x
091000 -          0123456789 10
091001 -
091002 -     <923k
091003 -     Administration Site:  Right Port Catheter
091004 -     Needle Size:          20 G 1"
091005 -     Blood Return Good:    Yes
091007 -      ..
091008 -     Remind patient to call MD if temp > 101 F, Shaking Chills
091009 -
091010 -            This protocol differs from Kaiser requirements, reported on
091011 -            041202. ref SDS 10 IX9N
091012 -
091013 -
091014 -
091015 -
0911 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

3303 -
3304 - 0940
330501 -  ..
330502 - Side Effects Minimal...
330503 -
330504 - Follow up ref SDS 78 QU8K, ref SDS 75 QU8K.
330506 -  ..
330507 - Nurse's notes report side effects...
330509 -             ..
330510 -        1.  Rash acne-like
330511 -
330512 -            Follow up ref SDS 78 958F, ref SDS 75 958F.
330513 -
330514 -            Very mild facial rash continues about the same from 070208
330515 -            around the nose and chin. ref SDS 39 QU8K  Antibiotic
330516 -            treatment effective prescribed on 070222. ref SDS 43 FO66
330517 -
330519 -             ..
330520 -        2.  Dry skin face, chest arm
330521 -
330522 -            Follow up ref SDS 78 JS6M, ref SDS 75 JS6M.
330523 -
330524 -            Background reported on 070503. ref SDS 68 JS6M  Condition
330525 -            continues controlled with Curel treatment prescribe on
330526 -            070301, ref SDS 45 5V73, and later Aquaphor on 070322.
330527 -            ref SDS 57 JS6M
330528 -
330530 -             ..
330531 -        3.  Dizziness Symptoms Enlarged Right Ventricle Cor Pulmonale
330532 -
330533 -            Recurrance of slight dizziness getting out of bed was
330534 -            reported during examination by the medical team to approve
330535 -            starting another treatment cycle today. ref SDS 80 PT4K
330536 -            Dizziness is a symptom of Cor Pulmonale, which Kaiser
330537 -            diagnosed in Millie's case in a CT test report on 060930,
330538 -            and reviewed on 061012. ref SDS 26 LG9L  Millie reported
330539 -            mild dizziness beginning on 060217, continuing until
330540 -            symptoms dissipated on 060812, also, reported on 061012.
330541 -            ref SDS 26 GH4M
330542 -
330543 -               [On 070525 dizziness recurrence presented to primary
330544 -               care physician at Kaiser. ref SDS 81 PT4K
330546 -             ..
330547 -            Catherine asked Flora to take Millie's pulse standing
330548 -            today, as well as sitting.  The report shows a difference
330549 -            of sitting 56 and standing 67. ref SDS 0 AW4L  Catherine
330550 -            seemed to indicate this aligns with normal conditions.
330551 -            Discussed taking more time to change positions getting out
330552 -            of bed.
330553 -
330555 -             ..
330556 -        4.  Inflammation Port Catheter Tender Red
330557 -
330558 -            Follow up ref SDS 78 UD4K, ref SDS 73 RQ4O.
330559 -
330560 -            Nurses Notes makes no report port catheter site red and
330561 -            tender again today, per below. ref SDS 0 UJ4M  This is a
330562 -            change from last week on 070517, ref SDS 78 UD4K, and
330563 -            aligns with 2 weeks ago. ref SDS 73 RQ4O
330564 -
330566 -             ..
330567 -        5.  Lymphedema Cellulitis Complications
330568 -            Inflammation Erratic Upper Left Arm Side Effects Cetuximab
330569 -
330570 -            Follow up ref SDS 78 SU6L, ref SDS 75 SU6L.
330571 -
330572 -            Lymphedema continues relatively controlled with major
330573 -            swelling in the left arm reduced this morning to 10.75,
330574 -            cited in the study on 060509. ref SDS 13 HO7F  There is no
330575 -            evident association with cetuximab treatments.
330577 -             ..
330578 -            There are no evident signs of Cellulitis.
330580 -             ..
330581 -            Changing intensity of rash on the upper left arm seems
330582 -            reduced in recent weeks, reported on 070503, ref SDS 73
330583 -            8B8I, and previously by the medical team on 070426,
330584 -            ref SDS 70 115F, and following the report at Kaiser on
330585 -            070330. ref SDS 63 N19J  Causes of erratic inflammation,
330586 -            including side effects of cetuximab treatments are listed
330587 -            in the record for treatment on 070426. ref SDS 71 8B8Y
330588 -
330590 -             ..
330591 -        6.  Tired, fatigued - pulmonary emoblism
330592 -
330593 -            Follow up ref SDS 78 FG3N, ref SDS 75 FG3N.
330594 -
330595 -            Fatigue, shortness of breath and other symptoms of
330596 -            pulmonary embolism were presented during meeting on 070130,
330597 -            ref SDS 35 CV5L, citing case study listed on 060722.
330598 -            ref SDS 17 ZV41  These are also side effects of cetuximab
330599 -            treatments, reported on 070116. ref SDS 34 O64M  Planning
330600 -            was discussed this morning with the medical team for thin
330601 -            slice spiral CT test to assess pulmonary embolism and Cor
330602 -            Pulmonale (enlarged right ventricle), per above.
330603 -            ref SDS 75 VP4H
330605 -             ..
330606 -            Energy and exercise remain active, reported on 070503.
330607 -            ref SDS 73 CA4K
330609 -             ..
330610 -            Naps continue 2 - 3 hours after treatments, since beginning
330611 -            on 070405. ref SDS 64 BB7G  May indicate accumulating
330612 -            effects of cetuximab that make patients tired, listed as
330613 -            side effect in Consent documents reviewed on 070116.
330614 -            ref SDS 34 O64M
330615 -
330617 -             ..
330618 -        7.  Heavy chest - shortness of breathing
330619 -
330620 -            Follow up ref SDS 78 UL6L, ref SDS 75 UL6L.
330621 -
330622 -            Patient history was reported to UCSF on 070130. ref SDS 35
330623 -            RT6I
330625 -             ..
330626 -            Condition seems improved, tracking continuing higher
330627 -            energy, per above. ref SDS 75 CA4K
330628 -
330630 -             ..
330631 -        8.  Cough - clearing throat
330632 -
330633 -            Follow up ref SDS 78 8N4G, ref SDS 75 8N4G.
330634 -
330635 -            Condition seems less evident lately.
330636 -
330637 -
330638 -
330639 -
3307 -

SUBJECTS
Schedule Treatment Weekly Thursday 0830 4 Week Cycles Clinical Study

4103 -
410401 -  ..
410402 - Schedule Weekly Treatments Continue on Thursdays
410403 -
410404 - Follow up ref SDS 78 QK6L, ref SDS 75 QK6L.
410405 -
410406 - Millie's next treatment is scheduled for 070531 0830, reported by Nola
410407 - on 070510, ref SDS 75 3E8L, updating schedule issued previously on
410408 - 070315. ref SDS 55 159O
410409 -
410410 -
410411 -
410412 -
410413 -
4105 -

SUBJECTS
Blood Tests Counts High Immune System Safe Cetuximab Treatment 1st T

4903 -
4904 - 0850
490501 -  ..
490502 - Blood Test Counts Normal Full Dose Cetuximab Ordered
490503 -
490504 - Follow up ref SDS 71 R54J, ref SDS 61 Q659.
490505 -
490506 - Millie had a test this morning prior to treatment, so that results
490507 - were available in time to determine that blood counts show Millie's
490508 - immune system is strong enough to safely get chemothrapy treatment in
490509 - the Infusion Clinic today, and during the next cycle, as planned on
490510 - 070201. ref SDS 36 XR40  Blood tests prior to treatment aligns with
490511 - work on 070503, ref SDS 73 R54J, applying prior practice that was
490512 - effective, reported on 070329, ref SDS 61 Q659, and corrects problems
490513 - reported on 070426. ref SDS 71 953O
490514 -
490515 -
490517 -  ..
4906 -
4907 -
4908 - 1020
4909 -
490901 - During treatment, Catherine submitted results of the test.
490903 -     ..
490917 -     ..
490918 -    Log#:                   070524 08:50
490919 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
490920 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
490922 -     ..
490923 -    CBC with DIFF & PLT CT                                     CBCD
490924 -     ..
490925 -    WBC COUNT               4.2    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
490926 -    RBC COUNT               4.79   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
490927 -    HEMOGLOBIN             14.8    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
490928 -    HEMATOCRIT             44.3    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
490929 -    MCV                    92      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
490930 -    MCH                    30.9    pg           26  -   34     MCH
490931 -    MCHC                   33.7    g/dL         31  -   36     MCHC
490932 -    PLATELETS             237      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
490933 -    ..
490934 -       (posted 070531, ref SDS 82 NQ6K)
490935 -    CA 15-3      H*        37      U/mL             <  31    CA15-3  CA 15-3                        <  39
490936 -
490937 -         Note new reference range and change in methodology.  Performed
490938 -         using the Roche Elecsys 2010 ECLIA method.  Performed at UCSF
490939 -         China Basin Lab, 185 Berry, San Francisco, CA  94107.
490940 -    ..
490941 -     (NEUTS x 1000 = ANC for Kaiser)
490942 -    NEUTS                   1.84   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
490943 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
490945 -     ..
490946 -    LYMPHS                  1.77   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
490947 -    MONOS                   0.37   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
490948 -    EOS                     0.17   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
490949 -    BASOS                   0.08   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
490950 -                                                                                                 0  -  5
490951 -     ..
490952 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
490953 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
490954 -     ..
490955 -    PT              H      25.5    S          12.5  - 16.0     PT    PT, patient       sec     8.9  -  11.1
490956 -    INL NRM Ratio   H       2.2                0.9  -  1.2     INR   PT INR            sec     2.0  -  3.0
490957 -    PARTIAL
490958 -     THROMBOPLASTIN  Not Reported  S          22.4  - 33.3     PTT
490960 -     ..
490961 -    ELECTROLYTE PANEL                                          LYTE
490962 -    SODIUM                140      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
490963 -    POTASSIUM               4.5    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
490964 -    CHLORIDE              104      mmol/L       98  -  107     CL
490965 -    CARBON DIOX TOTAL      29      mmol/L       23  -  32      CO2
490966 -    ANION GAP               7                    3  -  14      ANGA
490968 -     ..
490969 -    UREA NITROGEN          10      mg/dL         8  -  23      BUN   BUN               mg/dL     7  -  17
490970 -    CALCIUM                 9.6    mg/dL       8.7  -  10.1    CA    Calcium           mg/dL   8.4  -  10.2
490971 -    MAGNESIUM               2.0    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
490973 -     ..
490974 -    CREATININE              0.7    mg/dL       0.6  -  1.2     CR    Creatinine        mg/dL   0.6  -  1.2
490975 -    GLUCOSE                81      mg/dL        70  -  199     GLU   Glucose           mg/dL     ?  -   ?
490976 -    AST                    38      U/L          16  -  41      AST   AST (SGOT)        U/L      14  -  36
490977 -    ALT                    24      U/L          11  -  54      ALT   ALT (SGPT)        U/L      11  -  66
490978 -    BILIRUBIN TOTAL         0.9    mg/dL       0.3  -  1.3     BILT  Bili Total        mg/dL   0.2  -  1.3
490979 -    ALKALINE PHOSPHATASE   65      U/L          29  -  111     ALKP  Alkaline Ph       U/L      38  -  126
490980 -    PROTEIN TOTAL           6.5    g/dL        5.8  -  8.0     TP    Protein, Total    g/dL    6.3  -  8.2
490981 -    ALBUMIN                 4.4    g/dL        3.4  -  4.7     ALB   Albumin           g/dL    3.4  -  4.8
490982 -
490983 -
490984 -
490985 -
490986 -
490987 -
4910 -

SUBJECTS
INR 2.2 Coagulation Control Coumadin Treatment Pulmonary Embolism PT

5903 -
590401 -  ..
590402 - Coagulation Control INR 2.2 Normal Stable PT 25.5 High
590403 -
590404 - Follow up ref SDS 71 SE6N, ref SDS 61 SE6N.
590405 -
590406 - The test today shows PT 25.5 and INR 2.2, per above. ref SDS 0 PU7Y
590407 -
590408 - This has been stable for several months indicating the current regimen
590409 - is effective, and so supports continuing blood test regimen once a
590410 - month, per review on 070329, ref SDS 61 IL6G, citing planning on
590411 - 070308, ref SDS 52 CS6J, and communication with Gloria the day before
590412 - on 070307. ref SDS 49 IY6I
590413 -
590414 -
590415 -
5905 -

SUBJECTS
Absolute Neutrophils Count ANC 1840 Above 1800 Safe Level UCSF Requi

6803 -
680401 -  ..
680402 - ANC 1840 Below 1800 Criteria for Blood Counts to Approve Treatment
680403 -
680404 - Follow up ref SDS 73 P560, ref SDS 71 P560.
680405 -
680406 - Background on differences representing ANC in Kaiser and UCSF blood
680407 - testing is reported on 070301. ref SDS 47 U37I
680409 -  ..
680410 - Background on testing prior to treatment to verify immune system is
680411 - strong enough for safe treatment is reported on 070426. ref SDS 71
680412 - 4J4O
680414 -  ..
680415 - ANC is shown as "NUETS" in the UCSF system, which reported 1.84 for
680416 - the blood test today, per above. ref SDS 0 QY6H  This is equivalent to
680417 - 1840 in Kaiser's scheme.  Catherine noted NEUTS 1.84 is above UCSF
680418 - criteria of 1800 and so signals safe treatment based on strength of
680419 - the immune system.  Other authorities list 1.50 (ANC 1500) as a common
680420 - level for safe treatments, including cetuximab.  This is a significant
680421 - increase from the previous test showing 1.54 on 070503.
680423 -  ..
680424 - ANC suddenly falls...
680425 -
680426 -        6972................................ 060814, ref SDS 19 P560
680427 -        6390................................ 060908, ref SDS 20 P560
680428 -        5200................................ 060929, ref SDS 21 P560
680429 -        3869................................ 061020, ref SDS 47 P560
680430 -        2880................................ 061110, ref SDS 29 P560
680431 -        2888................................ 061201, ref SDS 30 P560
680432 -        1760................................ 070201, ref SDS 36 P560
680433 -        1230................................ 070301, ref SDS 47 P560
680434 -        1510................................ 070308, ref SDS 46 P560
680435 -        1810................................ 070329, ref SDS 61 P560
680436 -        1870................................ 070419, ref SDS 68 P560
680437 -        1470................................ 070426, ref SDS 71 P560
680438 -        1540................................ 070503, ref SDS 73 P560
680439 -        1840................................ 070524, ref SDS 0 P560
680440 -
680441 -
680442 -
6805 -

SUBJECTS
CA 15-3 37 Blood Tests 070524 Cancer Marker Reverses Begins Rising P

7803 -
780401 -  ..
780402 - CA 15-3 36 Rises Above Target Aligns Kaiser Rise Signals Relapse
780403 -
780404 - Follow up ref SDS 78 2N5J, ref SDS 71 2N5J.
780406 -  ..
780407 - UCSF testing today with the Roche Elecsys 2010 ECLIA calibration
780408 - method yielded CA 15-3 37, ref SDS 0 A16M, increasing 30% compared to
780409 - CA 15-3 29 reported by UCSF a few weeks ago on 070426. ref SDS 70 087J
780410 - Rising cancer marker aligns with concerns raised by Kaiser's test on
780411 - 070511, showing CA 15-3 56 using a different methodology, and reported
780412 - by Kaiser on 070516. ref SDS 77 RH9H
780413 -
780414 -        [...in another record today, UCSF medical team reviewed CA 15-3
780415 -        diagnostic issues. ref SDS 80 087J
780417 -  ..
780418 - At that time, on 070516 Kaiser was asked to verify test data and
780419 - coordinate findings with UCSF on rising CA 15-3 in relation to patient
780420 - history showing CA 15-3 declined substantially during the prior
780421 - period. ref SDS 77 ZJ9N  The next day, Kaiser reported using a
780422 - different calibration method from UCSF, which accounts for the large
780423 - disparity in test results, ref SDS 79 NT3O, but does not address the
780424 - change in direction from falling to rising cancer marker diagnostics,
780425 - ref SDS 79 H38K, and noted in Millie's letter to Kaiser the next day
780426 - on 070517. ref SDS 79 IV9S
780428 -  ..
780429 - There is no record that Kaiser verified test data or coordinated to
780430 - support UCSF referral work.
780431 -
780432 -        [On 070610 Kaiser reported the right channels of communication
780433 -        are now open with UCSF. ref SDS 83 OG7F
780435 -  ..
780436 - On 070517 UCSF responded to notice from Millie of rising CA 15-3 56 on
780437 - 070516, ref SDS 77 J55T, and proposed avoiding cross checks to verify
780438 - accuracy of laboratory work. ref SDS 79 466H  UCSF indicated Kaiser's
780439 - findings do not raise concerns about progression of Millie's cancer
780440 - and treatment. ref SDS 79 6E4G
780441 -
780442 -        [On 070531 UCSF not concerned results of blood test today show
780443 -        CA 15-3 37 rising 30% from the prior report on 070426, because
780444 -        CT scans show no metastatic cancer, and IBC inflammation
780445 -        appears to be subsiding. ref SDS 82 NQ6K
780447 -  ..
780448 - Nurses Notes on treatment in the Infusion Clinic on 070517 show UCSF
780449 - considered testing CA 15-3 again, ref SDS 79 JU5F, in response to
780450 - notice in Millie's letter on 070516 transmitting Kaiser's report on CA
780451 - 15-3 56. ref SDS 77 J55T
780453 -  ..
780454 - Testing today aligns with considerations on 070517 that CA 15-3 cancer
780455 - marker has stopped falling, and begun to rise again, signalling
780456 - possible relapse under the current treatment.  Rising CA 15-3 reported
780457 - by Kaiser and UCSF seems conflicting with CT testing, most recently on
780458 - 070520.  Review during the examination today shows no findings of
780459 - metastatic disease that might cause CA 15-3 to rise.  Examination
780460 - today shows IBC rash at all sites continues to subside.  Implication
780461 - is that cancer is expanding broadly at a microscopic level that
780462 - registers in the CA 15-3 cancer marker test, but is too small for
780463 - identification with CT image testing and visual observation IBC rash
780464 - on the patient's skin.
780465 -
780466 -
780467 -
780468 -
7805 -

SUBJECTS
Port Catheter IV Connection Prepare for Drip Treatment 1 Try Require

8703 -
8704 - 0845
870501 -  ..
870502 - Preparation for Treatment Required One (1) Attempt to Connect Port
870503 -
870504 - Follow up ref SDS 78 EB7J, ref SDS 75 EB7J.
870506 -  ..
870507 - The nurse connected the IV tubes to the port....
870509 -       ..
870510 -      Interlink System Vented Paclitaxel set
870512 -  ..
870513 - Like last week and earlier on 070301, there were no problems getting
870514 - blood to flow from the port, ref SDS 48 EB7J, as occurred on 070222,
870515 - ref SDS 42 DC5W, and earlier on 070201. ref SDS 37 DC5W
870517 -  ..
870518 - The nurse flushed the port with saline.
870520 -  ..
870521 - Prior inflammation above and at the port catheter penetration reported
870522 - on 070419, ref SDS 68 UJ4M, and again last week on 070517, ref SDS 78
870523 - UD4K, was not observed to be problematic today, per review of side
870524 - effects above. ref SDS 0 UD4K
870525 -
870526 -
870527 -
870528 -
870529 -
8706 -

SUBJECTS
Blood Draws 7 Vials Clinical Study Research Cetuximab Drug Trial Blo

9603 -
960401 -  ..
960402 - Blood Draws 7 Vials for Clinical Study Research
960403 -
960404 - Follow up ref SDS 71 O56V, ref SDS 68 O56V.
960405 -
960406 - The nurse drew seven (7) vials of blood today for research on the
960407 - cetuximab clincial trial, and required to start each cycle.  Today is
960408 - the 1st treatment for the 5th cycle. ref SDS 0 7T3H
960409 -
960410 -
960411 -
960412 -
960413 -
9605 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

A403 -
A404 - 1015
A40501 -  ..
A40502 - Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
A40503 -
A40504 - Follow up ref SDS 78 DC7J, ref SDS 75 DC7J.
A40505 -
A40506 - Benadryl (diphenhydramine) started.   25 MG....... ref SDS 71 IJ44
A40507 -
A40508 -        Purpose reported on 060721. ref SDS 15 DC7J
A40510 -  ..
A40511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
A40512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 75
A40513 - IJ41
A40514 -
A40515 -
A40517 -  ..
A406 -
A407 -
A408 - 1035
A409 -
A40901 - Benedryl completed equipment beeps.
A40902 -
A40903 -
A40904 -
A40906 -  ..
A410 -
A411 -
A412 -
A413 -
A41301 - Decadron (dexamethasone) IV pre-treatment........ ref SDS 57 FM4M
A41302 -
A41303 - On 070208 Decadron was not given because Millie did not experience
A41304 - side effects of nausea and vomitting after treatment with cetuximab on
A41305 - 070201. ref SDS 39 G57I  Since this favorable condition continues, per
A41306 - above, ref SDS 57 D19M, Decadron was not given again today.
A41307 -
A41309 -  ..
A414 -
A415 -
A416 -
A41601 - Decadron completed -- not reported.
A41602 -
A41603 -
A41604 -
A41605 -
A417 -

SUBJECTS
Cetuximab 5th Cycle 1st Treatment Blood Counts Safe Levels Clinical

AF03 -
AF04 - 1040
AF0501 -  ..
AF0502 - Cetuximab Full Dose Blood Counts Below Targets Treatment 1 Hour
AF0503 -
AF0504 - Follow up ref SDS 78 4N5M, ref SDS 75 4N5M.
AF0506 -  ..
AF0507 - Cetuximab started.
AF0508 -
AF0509 -           Verify chemotherapy order for 070208.
AF0511 -  ..
AF0512 - Chemotherapy order calls for cetuximab to start 30 - 60 minutes after
AF0513 - Beyadryl pre-tretment. ref SDS 0 IJ41
AF0515 -  ..
AF0516 - Chemotherapy Orders...
AF0517 -
AF0523 -    Auth#                                     Stor BCC LOC
AF0524 -    Visit:  12575738             DOS 20070201
AF0526 -     ..
AF0527 -    Date:  20070201
AF0529 -     ..
AF0530 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
AF0531 -    in combination with Carboplatin in ER-negative, PR-negative,
AF0532 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers
AF0534 -     ..
AF0535 -    Dates to be given:  070201
AF0536 -    Arm 1:Cetuximab alone
AF0538 -     ..
AF0539 -    Diagnosis:  breast cancer
AF0541 -     ..
AF0542 -    ICD-9 codes: 174.9
AF0543 -    Allergies  NKDA
AF0545 -     ..
AF0546 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
AF0548 -     ..
AF0549 -    4. Diphenhydramine 25 mg IV or  [illegible writing]
AF0550 -
AF0551 -       Benadryl........... ref SDS 57 DC7J
AF0552 -
AF0553 -       On 070329 Brigid changed the Chemotherapy Order reducing
AF0554 -       Diphenhydramine (Benadryl) from 50 mg to 25 mg in order to
AF0555 -       reduce side effects of "restless legs." ref SDS 61 IJ44
AF0557 -        ..
AF0558 -       This was effective, reported above. ref SDS 61 7R6H
AF0560 -     ..
AF0561 -    5. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
AF0562 -
AF0563 -       Further premed TBD [barely legible handwriting??]
AF0565 -     ..
AF0566 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
AF0568 -     ..
AF0569 -    6. Cetuximab (Erbitux) (loading dose)
AF0570 -
AF0571 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
AF0572 -              first dose x 1
AF0573 -
AF0574 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
AF0575 -       (concentration 2 mg/ml)
AF0577 -     ..
AF0578 -    7. Cetuximab (Erbitux) (maintenance dose)
AF0579 -
AF0580 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
AF0581 -              ____mg) IV over 60 or ____ minutes.
AF0582 -
AF0583 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
AF0584 -       Infuse once weekly for 8 weeks.  First dose to be given on date
AF0585 -       20070201.
AF0587 -        ..
AF0588 -       Cetuximab is administered undiluted through a low protien
AF0589 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
AF0590 -       line at the end of the infusion.
AF0592 -        ..
AF0593 -       ARM 2:  Administer carboplatin of vital signs are unremarkable
AF0594 -       one hour after cetuximab infusion.
AF0596 -        ..
AF0597 -       Vital signs at baseline, upon cetuximab completion and one hour
AF0598 -       after cetuximab.
AF0599 -
AF0600 -       ****please note start and stop times****
AF0602 -        ..
AF0603 -       Laboratory work:
AF0604 -
AF0605 -          See carboplatin orders
AF0607 -        ..
AF0608 -       x  Notify MD for dose modifications if patient has severe
AF0609 -          acne in form rash
AF0610 -
AF0611 -          CBC with differential and platletes every 4 weeks
AF0612 -          Creatinine and magnesium every 4 weeks
AF0613 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
AF0614 -          weeks.  If levels are outside of normal laboratory values
AF0615 -          notify Brigid NP  (MD/RN) at 415 443 4730
AF0617 -        ..
AF0618 -       x  Physician has discussed risks/benefits of therapy with the
AF0619 -          patient.  Signed consent obtained.
AF0620 -
AF0621 -
AF0622 -          Yes   5.  O2 by nasal cannula at 2 liters/min prn for chest
AF0623 -          pain or SOB
AF0625 -           ..
AF0626 -          Yes   6.  Diphenhydramine 50 mg IV prn x1 for urticaria
AF0627 -          [barely legible], pruritis SOB
AF0629 -           ..
AF0630 -          Yes   7.  Hydrocortizone 100 mg IV prn x1 for urticaria
AF0631 -          [barely legible], pruritis SOB
AF0633 -           ..
AF0634 -          Yes   8.  Albuterol inhaler 2-4 puffs prn SOB or chest
AF0635 -          tightness
AF0637 -           ..
AF0638 -          Yes   9.  Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
AF0639 -          anaphylaxis
AF0641 -           ..
AF0642 -          Breast CC05752 Cetuximab doc 20061024
AF0643 -          Approved 20060615
AF0645 -           ..
AF0646 -          Physician signature [Hope Rugo]
AF0648 -           ..
AF0649 -          Provider#  35313
AF0651 -           ..
AF0652 -          Date:  20010131
AF0653 -
AF0655 -  ..
AF07 -
AF08 -
AF09 - 1145
AF10 -
AF1001 - Cetuximab treatment completed.
AF1002 -
AF1003 - Millie had a 1 hour rest and observation period, required by the
AF1004 - protocol. ref SDS 75 G679
AF1005 -
AF1006 -
AF1007 -
AF1009 -  ..
AF11 -
AF12 -
AF13 - 1235
AF14 -
AF1401 - Nurse disconnected the IV tubes.
AF1403 -  ..
AF1404 - She inserted Herceptin to flush the port.
AF1406 -  ..
AF1407 - She then removed the needle from the port, and swabbed the needle
AF1408 - wound, and placed a temporary bandage.
AF1409 -
AF1410 -
AF1411 -
AF1412 -
AF1413 -
AF15 -

SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme

AN03 -
AN04 - 0945
AN0501 -  ..
AN0502 - Vitals Show Patient Stable
AN0503 -
AN0504 - Follow up ref SDS 78 AW4L, ref SDS 75 AW4L.
AN0505 -
AN0506 -     Conversion Celsius to Farhenheit...
AN0507 -
AN0508 -              http://www.wbuf.noaa.gov/tempfc.htm
AN0509 -
AN0510 -                     Blood
AN0511 -    Date   Time   Pressure  Pulse  Temperture  Weight So2
AN0512 -    .
AN0513 -    070524 1235..... 134  75     61   36.6c  97.88          99
AN0514 -    070524 1145..... 119  69     58   37.1c  98.78          98
AN0515 -    070524   standing..........  67 ................
AN0516 -    070524 0945..... 132  80     56   37.0c  98.60          98
AN0517 -    070517 1120..... 126  72     56   36.7c  98.06         100
AN0518 -    070517 1020..... 140  75     54   36.6c  97.88          98
AN0519 -    070517 0940..... 140  75     54   36.1c  96.98          99
AN0520 -    070510 1145..... 145  86     54   35.9c  96.62         100
AN0521 -    070510 1045..... 149  82     69   37.0c  98.60          97
AN0522 -    070510 0900..... 132  75     62   36.8c  98.24          99
AN0523 -    070503 1150..... 113  67     59   36.8c  98.24          98
AN0524 -    070503 1055..... 125  72     54   36.1c  96.98         100
AN0525 -    070503 0915..... 127  70     60   36.9c  98.42          99
AN0526 -    070426 1130..... 119  70     57   36.3c  97.34          96
AN0527 -    070426 1030..... 141  73     67   36.4c  97.52          99
AN0528 -    070426 0900..... 130  78     52   36.5c  97.7           97
AN0529 -
AN0530 -
AN0531 -
AN0532 -
AN06 -

SUBJECTS
Energy Normal Stable Alert Drive Home After Treatment Tired Sleep 2

B203 -
B204 - 1235
B20501 -  ..
B20502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
B20503 -
B20504 - Follow up ref SDS 78 F54N, ref SDS 75 F54N.
B20506 -  ..
B20507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
B20508 - clinical study drug trial. ref SDS 17 YP4I
B20510 -  ..
B20511 - Millie was alert after treatment again today, and not wobbly nor
B20512 - disoriented.  She was able to drive home without side effects of
B20513 - treatment.
B20515 -  ..
B20516 - After arriving home about 1330, Millie took a nap from about 1410
B20517 - until about 1600.  Could relate to side effects from cetuximab
B20518 - treatments that cause fatigue, reported on 070116. ref SDS 34 O64M
B20519 -
B20520 -
B20521 -
B20522 -
B20523 -
B20524 -
B20525 -
B206 -