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 3, 2007 08:30 AM Thursday; Rod Welch

Millie at UCSF 2nd treatment 4th cycle cetuximab for 3rd relapse IBC.

1...Summary/Objective
2...Clinic Examination Orientation Starting Treatment Cetuximab
3...Breast Examination IBC Intensity Declines
4...Emotional Roller Coaster Endemic Cancer Treatment and Coordination
5...Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing
6...Prognosis Disease May Subside 10 Months or More Before Progression
7...Progresssion of Disease May be Delayed for 10 Months or More
8...Measureable Disease Photographs IBC Rash Improving
9...IBC Rash Improved Measurable Disease Photographs Tape Measure
10...Side Effects Medicated After Weekly Examinations
11...Infusion Clinic for Cetuximab Treatent
..........Taxotere Capecitabine
..........Cetuxiab Clinical Study
12...Nurses Notes...
13...Side Effects Minimal...
........1...Rash acne-like
........2...Dry skin face, chest arm
........3...Inflammation Port Catheter Resolved
........4...Inflammation rash right chest
........5...Rash right arm
........6...Sleeping difficulty subsided
........7...Lymphedema Cellulitis Complications
............Inflammation Erratic Upper Left Arm Side Effects Cetuximab
........8...Tired, fatigued - pulmonary emoblism
........9...Heavy chest - shortness of breathing
.......10...Cough - clearing throat
.......11...Dry hands and feet
.......12...Eyes tearing
.......13...Nausea and vomitting
.......14...Sores in mouth
14...Schedule Weekly Treatments Continue on Thursdays
15...Blood Test Counts Low Full Dose Cetuximab Approved after Testing
16...ANC 1540 Below 1800 Criteria for Blood Counts to Approve Treatment
17...Preparation for Treatment Required One (1) Attempt to Connect Port
18...Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
19...Cetuximab Full Dose Blood Counts Below Targets Treatment 1 Hour
20...Vitals Show Patient Stable
21...Energy Normal Stable After Treatment Cetuximab Support Drugs


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

SUBJECTS
Treatment Cetuximab 2nd Treatment 4th Cycle Chemotherapy 11th Cycle

1103 -
1103 -    ..
1104 - Summary/Objective
1105 -
110501 - Follow up ref SDS 49 0000. ref SDS 46 0000.
110502 -
110503 - Millie received 2nd treatment starting the 4th cycle of cetuximab
110504 - treatment on clinical study at UCSF. ref SDS 0 7T3H  Testing today
110505 - showed blood counts increased slightly, below safe levels for
110506 - treatment. ref SDS 0 P560  Catherine notified the medical team for
110507 - authorization of treatment, ref SDS 0 ME4H, which aligns with patient
110508 - history. ref SDS 0 V75F  Treatment was performed today after getting
110509 - results of blood tests, required by standard of care. ref SDS 0 EY7H
110510 -
110511 -
110512 -
110514 -  ..
1106 -
1107 -
1108 - Progress
1109 -
110901 - Clinic Examination Orientation Starting Treatment Cetuximab
110902 -
110903 - Follow up ref SDS 49 407N, ref SDS 46 407N.
110905 -  ..
110906 - Agenda...
110907 -
110908 -    1.  Breast examination........................ ref SDS 0 FO6H
110909 -    2.  Infusion Clinic........................... ref SDS 0 1M6H
110910 -    3.  Side effects.............................. ref SDS 0 QU8K
110911 -
110912 -
110913 -
110914 -
1110 -

SUBJECTS
Breast Examination Not Performed 2nd Treatment in Cycle Prior to Tre

1903 -
190401 -  ..
190402 - Breast Examination IBC Intensity Declines
190403 -
190404 - Follow up ref SDS 49 FO6H, ref SDS 46 FO6H.
190405 -
190406 - Breast examination not scheduled for 2nd treatment in cycle.
190407 -
190408 -
190409 -
1905 -

SUBJECTS
Emotional Health No Examination 2nd Treatment of Cycle in Breast Car

2603 -
260401 -  ..
260402 - Emotional Roller Coaster Endemic Cancer Treatment and Coordination
260403 -
260404 - Follow up ref SDS 49 6A7J, ref SDS 46 6A7J.
260405 -
260406 - Emotional health review not scheduled for 2nd treatment in cycle.
260407 -
260408 -
260409 -
2605 -

SUBJECTS
Prognosis Not Reviewed Breast Care Clinic Prior to 2nd Treatment of

3203 -
320401 -  ..
320402 - Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing
320403 - Prognosis Disease May Subside 10 Months or More Before Progression
320404 - Progresssion of Disease May be Delayed for 10 Months or More
320405 -
320406 - Follow up ref SDS 49 6A9H, ref SDS 46 6A9H.
320407 -
320408 - Prognosis examination not scheduled for 2nd treatment in the cycle.
320409 -
320410 -
320411 -
3205 -

SUBJECTS
Measurable Disease Not Reviewed 2nd Treatment Cycle Examination Brea

3803 -
380401 -  ..
380402 - Measureable Disease Photographs IBC Rash Improving
380403 - IBC Rash Improved Measurable Disease Photographs Tape Measure
380404 -
380405 - Follow up ref SDS 49 6T6M, ref SDS 46 6T6M.
380406 -
380407 - Measurable disease not discussed with medical team during 2nd
380408 - treatment of the cycle.
380409 -
380410 -
380411 -
380412 -
380413 -
3805 -

SUBJECTS
Side Effects Not Reviewed in Breast Care Clinic Prior to 2nd Treatme

4403 -
440401 -  ..
440402 - Side Effects Medicated After Weekly Examinations
440403 -
440404 - Follow up ref SDS 49 FO66, ref SDS 46 FO66.
440405 -
440406 - Side Effects reviewed by Catherine in the Infusion Clinic, reported
440407 - below. ref SDS 0 QU8K
440408 -
440409 -
440410 -
440411 -
4405 -

SUBJECTS
Cetuximab 4th Cycle 2nd Treatment 14th Total Treatment Chemotherapy

5003 -
5004 - 0845
500501 -  ..
500502 - Infusion Clinic for Cetuximab Treatent
500503 -
500504 - Follow up ref SDS 49 1M6H, ref SDS 46 1M6H.
500506 -  ..
500507 - Millie received 14th overall and 2nd treatment of 4th cycle with
500508 - cetuximab, starting from 070201, ref SDS 19 G68I, and the 21th
500509 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 7 407N
500511 -  ..
500512 - Catherine was the nurse today.
500514 -           ..
500515 -          Taxotere Capecitabine
500516 -
500517 -          Follow up ref SDS 49 PR8Q, ref SDS 46 PR8Q.
500518 -
500519 -                   Relapse Treatments
500520 -
500521 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 7 407N
500522 -      2.  Cycle 10 and 02 ................... 060814, ref SDS 11 LY6O
500523 -      3.  Cycle 11 and 03 ................... 060908, ref SDS 12 407N
500524 -      4.  Cycle 12 and 04 ................... 060929, ref SDS 13 407N
500525 -      5.  Cycle 13 and 05 ................... 061020, ref SDS 14 407N
500526 -      6.  Cycle 14 and 06 ................... 061110, ref SDS 15 407N
500527 -      7.  Cycle 15 and 07 ................... 061201, ref SDS 16 407N
500529 -           ..
500530 -          Cetuxiab Clinical Study
500531 -
500532 -          Follow up ref SDS 49 7T3H, ref SDS 46 7T3H.
500533 -
500534 -                   Total    Cetuximab
500535 -      8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 19 SG8I
500536 -      9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 21 SG8I
500537 -     10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 22 SG8I
500538 -     11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 25 SG8I
500539 -     12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 28 SG8I
500540 -     13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 31 7T3H
500541 -     14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 33 7T3H
500542 -     15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 34 7T3H
500543 -     16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 39 7T3H
500544 -     17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 42 7T3H
500545 -     18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 44 7T3H
500546 -     19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 46 7T3H
500547 -     20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 49 7T3H
500548 -     21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 0 7T3H
500550 -  ..
500551 - Nurses Notes...
500562 -  ..
500563 - Why is the visit number constant in Nurse's Notes, and yet seems to
500564 - vary in the schedule received from Nola last week? ref SDS 33 159O
500566 -     ..
500567 -    UCSF Log Time...
500568 -
500569 -                   Blood
500570 -                    Test   Infusion
500571 -
500572 -          In.......          0830
500573 -          Out......          1130
500574 -          Visit....      Min  3.0  Hours  Total 3 Hours
500576 -      ..
500577 -     Pain Assessment...
500578 -
500579 -          x
500580 -          0123456789 10
500581 -
500582 -     <923k
500583 -     Administration Site:  Right Port Catheter
500584 -     Needle Size:          20 G 1"
500585 -     Blood Return Good:    Yes
500587 -      ..
500588 -     Remind patient to call MD if temp > 101 F, Shaking Chills
500589 -
500590 -            This protocol differs from Kaiser requirements, reported on
500591 -            041202. ref SDS 3 IX9N
500592 -
500593 -
500594 -
500595 -
5006 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

6803 -
6804 - 0840
680501 -  ..
680502 - Side Effects Minimal...
680503 -
680504 - Follow up ref SDS 49 QU8K, ref SDS 46 QU8K.
680506 -  ..
680507 - Nurse's notes report side effects...
680509 -             ..
680510 -        1.  Rash acne-like
680511 -
680512 -            Follow up ref SDS 46 SK9O, ref SDS 49 958F.
680513 -
680514 -            Very mild facial rash continues from 070208 around the nose
680515 -            and chin. ref SDS 21 QU8K  Treatment effective prescribed
680516 -            on 070222. ref SDS 25 FO66
680517 -
680519 -             ..
680520 -        2.  Dry skin face, chest arm
680521 -
680522 -            Follow up ref SDS 46 JS6M, ref SDS 49 JS6M.
680523 -
680524 -            Background on notice and treatments prescribed reported on
680525 -            070322. ref SDS 34 JS6M  Medical team commented during
680526 -            examination on 070329, how well Millie looks. ref SDS 37
680527 -            N49K  The next day on 070330, the primary care physician at
680528 -            Kaiser commented similarly, during follow up examination.
680529 -            ref SDS 41 N49K  This indicates UCSF examinations by
680530 -            Catherine in the Infusion Clinic, and by Brigid in the
680531 -            Breast Care Center has been timely, thorough, and effective
680532 -            prescribing Curel on 070301, ref SDS 27 5V73, and later
680533 -            Aquaphor on 070322. ref SDS 34 JS6M
680534 -
680536 -             ..
680537 -        3.  Inflammation Port Catheter Resolved
680538 -
680539 -            Follow up ref SDS 46 RQ4O, ref SDS 49 RQ4O.
680540 -
680541 -            Nurses Notes report port catheter site much less red today
680542 -            and no tenderness.
680544 -                   ..
680545 -                  [On 070517 port catheter site red and tender again.
680546 -                  ref SDS 53 UD4K
680548 -             ..
680549 -        4.  Inflammation rash right chest
680550 -
680551 -            Follow up ref SDS 46 KU3L, ref SDS 49 KU3L.
680552 -
680553 -            Examination of right chest observes various blemishes.
680554 -            Patient reports no interim recurrent rash at this location.
680555 -            Aligns with declining CA 15-3 cancer marker from blood test
680556 -            last week on 070426, ref SDS 49 2N5J, and reviewed in the
680557 -            record meeting with the medical team at that time.
680558 -            ref SDS 48 GJ5M
680559 -
680560 -
680562 -             ..
680563 -        5.  Rash right arm
680564 -
680565 -            Follow up ref SDS 46 LI4M
680566 -
680567 -            Catherine does not comment on this issue in Nurse's Notes
680568 -            today.  Examination by the medical team on 070329 found no
680569 -            evidence of disease in the right arm. ref SDS 37 H15M
680570 -
680572 -             ..
680573 -        6.  Sleeping difficulty subsided
680574 -
680575 -            Follow up ref SDS 46 NG3I
680576 -
680577 -            This problem has subsided as worry and doubt have been
680578 -            reduced by continuing favorable reports showing response to
680579 -            treatment, discussed with the medical team during
680580 -            examination on 070426. ref SDS 48 Y642
680581 -
680583 -             ..
680584 -        7.  Lymphedema Cellulitis Complications
680585 -            Inflammation Erratic Upper Left Arm Side Effects Cetuximab
680586 -
680587 -            Follow up ref SDS 49 SU6L, ref SDS 46 SU6L.
680588 -
680589 -            Lymphedema continues relatively controlled with major
680590 -            swelling in the left reduced this morning to 11.25, cited
680591 -            in the study on 060509. ref SDS 5 HO7F  There is no evident
680592 -            association with cetuximab treatments.
680594 -             ..
680595 -            Intensity of rash on the upper left arm continues to rise
680596 -            and fall since the report at Kaiser on 070330. ref SDS 41
680597 -            N19J Causes of erratic inflammation are listed in the
680598 -            record for treatment last week on 070426. ref SDS 49 8B8Y
680600 -             ..
680601 -            Today, there is no evidence of increased inflammation on
680602 -            the upper left arm, continuing favorable report for
680603 -            examination by the medical team last week on 070426 in the
680604 -            Breast Care Center. ref SDS 48 115F
680605 -
680606 -
680608 -             ..
680609 -        8.  Tired, fatigued - pulmonary emoblism
680610 -
680611 -            Follow up ref SDS 49 FG3N, ref SDS 46 FG3N.
680612 -
680613 -            Fatigue, shortness of breath and other symptoms of
680614 -            pulmonary embolism were presented during meeting on 070130,
680615 -            ref SDS 18 CV5L, citing case study listed on 060722.
680616 -            ref SDS 8 ZV41  These are also side effects of cetuximab
680617 -            treatments, reported on 070116. ref SDS 17 O64M
680619 -             ..
680620 -            Energy has continued to rise back to normal despite effects
680621 -            of cetuximab, as reported last week on 070426. ref SDS 46
680622 -            FG3N
680624 -             ..
680625 -            Millie continues working out in the gym, and hiking trails
680626 -            of 3 - 5 miles several times a week, as reported to the
680627 -            medical team during examination on 070329. ref SDS 37 E44L
680628 -            Increased strength and stamina are shown by improved vitals
680629 -            reported today, per below. ref SDS 0 AW4L  Benefits of
680630 -            exercise to strengthen fitness builds the immune system
680631 -            that resists cancer and other diseases, presented during a
680632 -            meeting at Kaiser on 030606. ref SDS 1 JP7G  Published
680633 -            guidance emphasizes benefits of exercise, reviewed on
680634 -            050609. ref SDS 4 F88M
680636 -             ..
680637 -            Millie has been taking naps 2 - 3 hours after treatments
680638 -            the past month, beginning on 070405. ref SDS 42 BB7G  May
680639 -            indicate accumulating effects of cetuximab that make
680640 -            patients tired, listed as side effect in Consent documents
680641 -            reviewed on 070116. ref SDS 17 O64M
680642 -
680644 -             ..
680645 -        9.  Heavy chest - shortness of breathing
680646 -
680647 -            Follow up ref SDS 46 UL6L
680648 -
680649 -            Patient history was reported to UCSF on 070130. ref SDS 18
680650 -            RT6I
680652 -             ..
680653 -            Condition seems improved, tracking continuing higher
680654 -            energy, per above. ref SDS 0 CA4K
680655 -
680657 -             ..
680658 -       10.  Cough - clearing throat
680659 -
680660 -            Follow up ref SDS 46 8N4G
680661 -
680662 -            This condition occassionally increases noticably with
680663 -            episodes of mild, contined cough and clearing throat, as
680664 -            reported to the doctor on 070130. ref SDS 18 RT6I
680665 -
680667 -             ..
680668 -       11.  Dry hands and feet
680669 -
680670 -            Follow up ref SDS 46 UM32
680672 -             ..
680673 -            Dry hands and feet seem much improved since ending
680674 -            treatment with Taxotere and capecitiabine on 061201.
680675 -
680677 -             ..
680678 -       12.  Eyes tearing
680679 -
680680 -            Follow up ref SDS 46 HM9G
680681 -
680682 -            This seems improved since ending treatment with Taxoter
680683 -            and capecitabine on 061201.
680684 -
680686 -             ..
680687 -       13.  Nausea and vomitting
680688 -
680689 -            Follow up ref SDS 46 D19M
680691 -             ..
680692 -            Problems with Taxotere and capecitabine reported on 061110,
680693 -            ref SDS 15 D19M, did not occur this past week after
680694 -            treatment with cetuximab.  As a result, there was no
680695 -            pre-treatment with Decadron today, per below. ref SDS 34
680696 -            G57I
680698 -             ..
680699 -       14.  Sores in mouth
680700 -
680701 -            Follow up ref SDS 46 KW4R
680702 -
680703 -            None yet, cleaning mouth carefully to avoid problem.
680704 -
680705 -
680706 -
680707 -
6808 -

SUBJECTS
Schedule Treatment Weekly Thursday 0800 4 Week Cycles Clinical Study

7603 -
760401 -  ..
760402 - Schedule Weekly Treatments Continue on Thursdays
760403 -
760404 - Follow up ref SDS 49 QK6L, ref SDS 46 QK6L.
760406 -  ..
760407 - Millie's next treatment is scheduled for 070510 0830, reported by Nola
760408 - on 070315. ref SDS 33 159O
760409 -
760410 -
760411 -
760412 -
7605 -

SUBJECTS
Blood Tests Counts Low Received Before Treatment Evaluate Cetuximab

8303 -
8304 - 0830
830501 -  ..
830502 - Blood Test Counts Low Full Dose Cetuximab Approved after Testing
830503 -
830504 - Follow up ref SDS 49 R54J, ref SDS 46 R54J.
830505 -
830506 - Millie had another blood draw this morning to test safety for getting
830507 - treatment in light of sudden drop in blood counts from 1.87 on 070329
830508 - down to 1.47, below the target level of 1.80, reported last week
830509 - ref SDS 49 QY6H
830511 -  ..
830512 - Testing this morning prior to treatment corrects the problem last week
830513 - when test results did not arrive until after treatment and showed
830514 - blood counts too low for safe treatment. ref SDS 49 953O
830516 -  ..
830517 - Results showed blood counts starting to rise again, so treatment was
830518 - approved, per below. ref SDS 0 P560
830519 -
830521 -  ..
8306 -
8307 -
8308 - 1117
8309 -
830901 - During treatment, Catherine submitted results of the test.
830903 -     ..
830917 -     ..
830918 -    Log#:                   070503 09:20
830919 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
830920 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
830922 -     ..
830923 -    CBC with DIFF & PLT CT                                     CBCD
830924 -     ..
830925 -    WBC COUNT               4.3    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
830926 -    RBC COUNT               4.40   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
830927 -    HEMOGLOBIN             13.7    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
830928 -    HEMATOCRIT             40.3    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
830929 -    MCV                    92      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
830930 -    MCH                    31.2    pg           26  -   34     MCH
830931 -    MCHC                   34.1    g/dL         31  -   36     MCHC
830932 -    PLATELETS             199      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
830934 -     ..
830935 -    CA 15-3        Not performed   U/mL             <  31    CA15-3  CA 15-3                        <  39
830936 -    ..
830937 -     (NEUTS x 1000 = ANC for Kaiser)
830938 -    NEUTS         L         1.54   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
830939 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
830941 -     ..
830942 -    LYMPHS                  2.16   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
830943 -    MONOS                   0.35   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
830944 -    EOS                     0.21   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
830945 -    BASOS                   0.07   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
830946 -                                                                                                 0  -  5
830947 -
830948 -
8310 -

SUBJECTS
Absolute Neutrophils Count ANC 1540 Below 1800 Safe Level UCSF Requi

9103 -
910401 -  ..
910402 - ANC 1540 Below 1800 Criteria for Blood Counts to Approve Treatment
910403 -
910404 - Follow up ref SDS 49 P560, ref SDS 46 P560.
910405 -
910406 - Background on differences representing ANC in Kaiser and UCSF blood
910407 - testing is reported on 070301. ref SDS 28 U37I
910409 -  ..
910410 - ANC shown as "NUETS" in the UCSF blood test reported 1.54 for the test
910411 - today, per above. ref SDS 0 QY6H  This is equivalent to 1540 in
910412 - Kaiser's scheme.  Catherine noted NEUTS 1.54 is still well below UCSF
910413 - criteria of 1800 for safe treatment based on strength of the immune
910414 - system, but is going in the "right direction," i.e., rising, compared
910415 - to significant decline last week on 070426. ref SDS 49 GV7L  Other
910416 - authorities list 1.50 (ANC 1500) as a common level for safe
910417 - treatments, including cetuximab.
910418 -
910419 -     [On 070509 Millie's letter asks UCSF about follow up testing blood
910420 -     counts for safe treatment. ref SDS 51 3N5P
910422 -      ..
910423 -     [On 070510 UCSF does not order follow up test. ref SDS 52
910424 -     MZ3N
910426 -  ..
910427 - Nurse's Notes report treatment was performed today after getting blood
910428 - test results, and consulting with the medical team, per below.
910429 - ref SDS 0 EY7H
910431 -  ..
910432 - Millie's patient history supports approving treatment with low blood
910433 - counts.  The study on 060810 shows she has often been treated when
910434 - blood counts are too low, ref SDS 10 HV45, and so far there have been
910435 - no adverse consequences, which testing is designed to prevent.
910437 -  ..
910438 - ANC rises slightly...
910439 -
910440 -        6972................................ 060814, ref SDS 11 P560
910441 -        6390................................ 060908, ref SDS 12 P560
910442 -        5200................................ 060929, ref SDS 13 P560
910443 -        3869................................ 061020, ref SDS 14 P560
910444 -        2880................................ 061110, ref SDS 15 P560
910445 -        2888................................ 061201, ref SDS 16 P560
910446 -        1760................................ 070201, ref SDS 19 P560
910447 -        1230................................ 070301, ref SDS 28 P560
910448 -        1510................................ 070308, ref SDS 27 P560
910449 -        1810................................ 070329, ref SDS 39 P560
910450 -        1870................................ 070419, ref SDS 46 P560
910451 -        1470................................ 070426, ref SDS 49 P560
910452 -        1540................................ 070503, ref SDS 0 P560
910453 -
910454 -
910455 -
910456 -
9105 -

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

9903 -
9904 - 0845
990501 -  ..
990502 - Preparation for Treatment Required One (1) Attempt to Connect Port
990503 -
990504 - Follow up ref SDS 49 EB7J, ref SDS 46 EB7J.
990506 -  ..
990507 - The nurse connected the IV tubes to the port....
990509 -       ..
990510 -      Interlink System Vented Paclitaxel set
990512 -  ..
990513 - Like last week and earlier on 070301, there were no problems getting
990514 - blood to flow from the port, ref SDS 28 EB7J, as occurred on 070222,
990515 - ref SDS 24 DC5W, and earlier on 070201. ref SDS 19 DC5W
990517 -  ..
990518 - The nurse flushed the port with saline.
990520 -  ..
990521 - Prior inflammation above and at the port catheter penetration reported
990522 - on 070419, ref SDS 46 UJ4M, has improved, reported above. ref SDS 0
990523 - RQ4O
990524 -
990525 -
9906 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

A603 -
A604 - 0920
A60501 -  ..
A60502 - Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
A60503 -
A60504 - Follow up ref SDS 49 DC7J, ref SDS 46 DC7J.
A60505 -
A60506 - Benadryl (diphenhydramine) started.   25 MG....... ref SDS 49 IJ44
A60507 -
A60508 -        Purpose reported on 060721. ref SDS 6 DC7J
A60510 -  ..
A60511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
A60512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 49
A60513 - IJ41
A60515 -  ..
A60516 - UCSF waited today until results of the blood test were received at
A60517 - 0920, ref SDS 0 075H, and reviewed with the medical team prior to
A60518 - beginning Millie's infusion treatment today at 0920, per above.
A60519 - ref SDS 0 GV7L  This corrected problem last week discovering blood
A60520 - counts were too low for treatment after treatment was already given.
A60521 - ref SDS 49 MN6M
A60522 -
A60523 -
A60524 -
A60525 -
A60527 -  ..
A606 -
A607 -
A608 - 0940
A609 -
A60901 - Benedryl completed equipment beeps.
A60902 -
A60903 -
A60904 -
A60906 -  ..
A610 -
A611 -
A612 -
A613 -
A61301 - Decadron (dexamethasone) IV pre-treatment........ ref SDS 34 FM4M
A61302 -
A61303 - On 070208 Decadron was not given because Millie did not experience
A61304 - side effects of nausea and vomitting after treatment with cetuximab on
A61305 - 070201. ref SDS 21 G57I  Since this favorable condition continues, per
A61306 - above, ref SDS 34 D19M, Decadron was not given again today.
A61307 -
A61309 -  ..
A614 -
A615 -
A616 -
A61601 - Decadron completed -- not reported.
A61602 -
A61603 -
A61604 -
A61605 -
A617 -

SUBJECTS
Cetuximab 4th Cycle 2nd Treatment Blood Counts Below Safe Levels Cli

AG03 -
AG04 - 0950
AG0501 -  ..
AG0502 - Cetuximab Full Dose Blood Counts Below Targets Treatment 1 Hour
AG0503 -
AG0504 - Follow up ref SDS 49 4N5M, ref SDS 46 4N5M.
AG0506 -  ..
AG0507 - Cetuximab started.
AG0508 -
AG0509 -           Verify chemotherapy order for 070208.
AG0511 -  ..
AG0512 - Chemotherapy order calls for cetuximab to start 30 - 60 minutes after
AG0513 - Beyadryl pre-tretment. ref SDS 49 IJ41
AG0515 -  ..
AG0516 - Millie received a full dose of cetuximab treatment, even though blood
AG0517 - counts from the test today were below the level for safe treatment,
AG0518 - discussed above, ref SDS 0 P560, citing the record showing Millie has
AG0519 - often has treatments with low blood counts. ref SDS 0 V75F
AG0521 -  ..
AG0522 - Chemotherapy Orders...
AG0523 -
AG0529 -    Auth#                                     Stor BCC LOC
AG0530 -    Visit:  12575738             DOS 20070201
AG0532 -     ..
AG0533 -    Date:  20070201
AG0535 -     ..
AG0536 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
AG0537 -    in combination with Carboplatin in ER-negative, PR-negative,
AG0538 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers
AG0540 -     ..
AG0541 -    Dates to be given:  070201
AG0542 -    Arm 1:Cetuximab alone
AG0544 -     ..
AG0545 -    Diagnosis:  breast cancer
AG0547 -     ..
AG0548 -    ICD-9 codes: 174.9
AG0549 -    Allergies  NKDA
AG0551 -     ..
AG0552 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
AG0554 -     ..
AG0555 -    4. Diphenhydramine 25 mg IV or  [illegible writing]
AG0556 -
AG0557 -       Benadryl........... ref SDS 34 DC7J
AG0558 -
AG0559 -       On 070329 Brigid changed the Chemotherapy Order reducing
AG0560 -       Diphenhydramine (Benadryl) from 50 mg to 25 mg in order to
AG0561 -       reduce side effects of "restless legs." ref SDS 39 IJ44
AG0563 -        ..
AG0564 -       This was effective, reported above. ref SDS 39 7R6H
AG0566 -     ..
AG0567 -    5. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
AG0568 -
AG0569 -       Further premed TBD [barely legible handwriting??]
AG0571 -     ..
AG0572 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
AG0574 -     ..
AG0575 -    6. Cetuximab (Erbitux) (loading dose)
AG0576 -
AG0577 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
AG0578 -              first dose x 1
AG0579 -
AG0580 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
AG0581 -       (concentration 2 mg/ml)
AG0583 -     ..
AG0584 -    7. Cetuximab (Erbitux) (maintenance dose)
AG0585 -
AG0586 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
AG0587 -              ____mg) IV over 60 or ____ minutes.
AG0588 -
AG0589 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
AG0590 -       Infuse once weekly for 8 weeks.  First dose to be given on date
AG0591 -       20070201.
AG0593 -        ..
AG0594 -       Cetuximab is administered undiluted through a low protien
AG0595 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
AG0596 -       line at the end of the infusion.
AG0598 -        ..
AG0599 -       ARM 2:  Administer carboplatin of vital signs are unremarkable
AG0600 -       one hour after cetuximab infusion.
AG0602 -        ..
AG0603 -       Vital signs at baseline, upon cetuximab completion and one hour
AG0604 -       after cetuximab.
AG0605 -
AG0606 -       ****please note start and stop times****
AG0608 -        ..
AG0609 -       Laboratory work:
AG0610 -
AG0611 -          See carboplatin orders
AG0613 -        ..
AG0614 -       x  Notify MD for dose modifications if patient has severe
AG0615 -          acne in form rash
AG0616 -
AG0617 -          CBC with differential and platletes every 4 weeks
AG0618 -          Creatinine and magnesium every 4 weeks
AG0619 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
AG0620 -          weeks.  If levels are outside of normal laboratory values
AG0621 -          notify Brigid NP  (MD/RN) at 415 443 4730
AG0623 -        ..
AG0624 -       x  Physician has discussed risks/benefits of therapy with the
AG0625 -          patient.  Signed consent obtained.
AG0626 -
AG0627 -
AG0628 -          Yes   5.  O2 by nasal cannula at 2 liters/min prn for chest
AG0629 -          pain or SOB
AG0631 -           ..
AG0632 -          Yes   6.  Diphenhydramine 50 mg IV prn x1 for urticaria
AG0633 -          [barely legible], pruritis SOB
AG0635 -           ..
AG0636 -          Yes   7.  Hydrocortizone 100 mg IV prn x1 for urticaria
AG0637 -          [barely legible], pruritis SOB
AG0639 -           ..
AG0640 -          Yes   8.  Albuterol inhaler 2-4 puffs prn SOB or chest
AG0641 -          tightness
AG0643 -           ..
AG0644 -          Yes   9.  Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
AG0645 -          anaphylaxis
AG0647 -           ..
AG0648 -          Breast CC05752 Cetuximab doc 20061024
AG0649 -          Approved 20060615
AG0651 -           ..
AG0652 -          Physician signature [Hope Rugo]
AG0654 -           ..
AG0655 -          Provider#  35313
AG0657 -           ..
AG0658 -          Date:  20010131
AG0659 -
AG0661 -  ..
AG07 -
AG08 -
AG09 - 1050
AG10 -
AG1001 - Cetuximab treatment completed.
AG1002 -
AG1003 - Millie had a 1 hour rest and observation period, required by the
AG1004 - protocol. ref SDS 34 G679
AG1005 -
AG1006 -
AG1007 -
AG1009 -  ..
AG11 -
AG12 -
AG13 - 1150
AG14 -
AG1401 - Nurse disconnected the IV tubes.
AG1403 -  ..
AG1404 - She inserted Herceptin to flush the port.
AG1406 -  ..
AG1407 - She then removed the needle from the port, and swabbed the needle
AG1408 - wound, and placed a temporary bandage.
AG1409 -
AG1410 -
AG1411 -
AG1412 -
AG1413 -
AG15 -

SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme

AN03 -
AN04 - 0900
AN0501 -  ..
AN0502 - Vitals Show Patient Stable
AN0503 -
AN0504 - Follow up ref SDS 49 AW4L, ref SDS 46 AW4L.
AN0505 -
AN0506 -                    Blood
AN0507 -    Date   Time     Pressure   Pulse  Temprtr  Weight   So2
AN0508 -    .
AN0509 -    070503 1150..... 113  67     59     36.8c            98
AN0510 -    070503 1055..... 125  72     54     36.1c           100
AN0511 -    070503 0915..... 127  70     60     36.9c            99
AN0512 -    070426 1130..... 119  70     57     36.3c            96
AN0513 -    070426 1030..... 141  73     67     36.4c            99
AN0514 -    070426 0900..... 130  78     52     36.5c            97
AN0515 -    070419 1230..... 133  79     57     36.3c            98
AN0516 -    070419 1130..... 141  78     56     37.6c **1        99
AN0517 -    070419 0930..... 153  80     53     36.1c           100
AN0518 -    070412 1120..... 114  65     53     36.6c            96
AN0519 -    070412 1020..... 130  66     57     36.8c            99
AN0520 -    070412 0900..... 116  69     65     36.8c            97
AN0521 -    070405 1130..... 133  75     55     36.2c            97
AN0522 -
AN0523 -            Consistently low pulse, does it reflect low blood pressure
AN0524 -            side effect of cetuximab, or improved fitness from working
AN0525 -            out that benefits emotional stress and immune system?
AN0527 -     ..
AN0528 -    070405 1030..... 114  69     57     36.4c            99
AN0529 -    070405 0900..... 128  78     54     36.5c           100
AN0530 -    070329 1140..... 125  74     53     36.8c            98
AN0531 -    070329 1045..... 125  72     53         c           100
AN0532 -    070329 0900..... 141  76     60     36.6c            99
AN0533 -    070322 1055..... 118  71     55     37.0c            97
AN0534 -    070322 1015..... 120  69     57     37.1c            98
AN0535 -    070322 0900..... 130  70     56     36.0c            98
AN0536 -    070315 1300..... 119  75     58     36.2c            98
AN0537 -    070315 1150..... 137  73     52     36.5c            99
AN0538 -    070315 0945..... 143  85     60     36.4c            97
AN0539 -    070308 1100..... 144  87     70     36.0c            98
AN0540 -    070301 1645..... 125  62     90 *   36.4c
AN0541 -    070301 1505..... 112  69     86 *   36.6c            98
AN0542 -    070222 1145..... 115  73     58     36.3c   147      98
AN0543 -    070222 1045..... 100  60     56     36.6c   147      98
AN0544 -    070222 0930..... 117  63     68     36.2c   147      97
AN0545 -    070215 1200..... 106  66     61     37.0c   147      97
AN0546 -    070215 1055.....  96  61     64     37.0c   147      94
AN0547 -    070215 0930..... 100  64     66     36.7c   147      98
AN0548 -    070208 0920..... 143  70     59     36.5c   147      98
AN0549 -    070201 1330..... 136  74     66             148      94
AN0550 -    070201 1220..... 110  65     62     36.3c   148      96
AN0551 -    070201 1000..... 132  80     65     36.9c   148      99
AN0552 -    061201 1534..... 123  76     76     97.5    150
AN0553 -    061110 1534..... 136  83     73     97.0    150      98
AN0554 -    061020 1534..... 140  79     67     99.8    151      97
AN0555 -    060929 1452..... 141  78     66     98.3    149
AN0556 -    060908 1335..... 139  79     73     98.1    149
AN0557 -    060814 1610..... 139  80     59     98.2    151
AN0558 -    060722 1440..... 142  74     67     98.1    149
AN0559 -    060711.......... 172  87     54     97.5    147
AN0560 -    060623.......... 141  87     71     98.0    147
AN0561 -    060428.......... 129  73     80     99.4    149
AN0562 -    060217.......... 153  81     61     98.6    150
AN0563 -    050916.......... 120  80     80     98.5
AN0564 -
AN0565 -  *    Need vitals taken twice to verify atypical diagnostics.
AN0566 -  **1  Nurses Notes seem to show 97.6 which is cellcius scale.
AN0567 -
AN0568 -
AN0569 -
AN06 -

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

B103 -
B104 - 1130
B10501 -  ..
B10502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
B10503 -
B10504 - Follow up ref SDS 49 F54N, ref SDS 46 F54N.
B10506 -  ..
B10507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
B10508 - clinical study drug trial. ref SDS 9 YP4I
B10510 -  ..
B10511 - Millie was alert after treatment again today, and not wobbly nor
B10512 - disoriented.  She was able to drive home without side effects of
B10513 - treatment.
B10515 -  ..
B10516 - Today, we experimented and drove through Oakland following signs for
B10517 - the detour because the bridge from the San Francisco - Oakland Bay
B10518 - bridge to get to Highway 24 on the way to Walnut Creek was exploded by
B10519 - a truck accident a few days ago.  This made the trip home about 50
B10520 - minutes instead of 40 minutes.
B10522 -  ..
B10523 - After arriving home about 1320, Millie took a nap from about 1320
B10524 - until about 1600.  Could relate to side effects from cetuximab
B10525 - treatments that cause fatigue, reported on 070116. ref SDS 17 O64M
B10526 -
B10527 -
B10528 -
B10529 -
B10530 -
B10531 -
B10532 -
B106 -