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: April 19, 2007 09:15 AM Thursday; Rod Welch

Millie at UCSF 3rd cycle 4th treatment Cetuximab for IBC relapse.

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 Possible Infection Port Catheter
........4...Inflammation rash right chest
........5...Rash right arm
........6...Restless legs side effect Benedryl Resolved
........7...Sleeping difficulty subsided
........8...Lymphedema Cellulitis Complications
............Inflammation Erratic Upper Left Arm
........9...Tired, fatigued - pulmonary emoblism
.......10...Heavy chest - shortness of breathing
.......11...Cough - clearing throat
.......12...Dry hands and feet
.......13...Eyes tearing
.......14...Nausea and vomitting
.......15...Sores in mouth
14...Schedule Weekly Treatments Continue on Thursdays
15...Blood Test Counts Normal Full Dose Cetuximab Ordered
16...ANC 1870 Above 1800 Criteria for Blood Counts to Approve Treatment
17...Preparation for Treatment Required One (1) Attempt to Connect Port
18...Blood Draws 7 Vials for Clinical Study Research
19...Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
20...Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
21...Vitals Show Patient Stable
22...Energy Normal Stable After Treatment Cetuximab Support Drugs

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

1...Consistently low pulse, does it reflect low blood pressure

CONTACTS 

SUBJECTS
Treatment Cetuximab 4th Treatment 3rd Cycle Chemotherapy 10th Cycle

1103 -
1103 -    ..
1104 - Summary/Objective
1105 -
110501 - Follow up ref SDS 40 0000. ref SDS 38 0000.
110502 -
110503 - Millie received the 4th treatment in the 3rd cycle of the cetuximab
110504 - clinical study.  A blood test was done out of sequence to perform a
110505 - culture testing for infection on the port catheter.  Energy continues
110506 - to recover well after treatment.  Fatigue also may reflect
110507 - accumulating side effects of cetuximab shown by sleeping for several
110508 - hours following treatment. ref SDS 0 D48I
110509 -
110510 -
110511 -
110512 -
110514 -  ..
1106 -
1107 -
1108 - Progress
1109 -
110901 - Clinic Examination Orientation Starting Treatment Cetuximab
110902 -
110903 - Follow up ref SDS 40 407N, ref SDS 38 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 Performed in Breast Care Clinic Prior to Treatmen

1903 -
190401 -  ..
190402 - Breast Examination IBC Intensity Declines
190403 -
190404 - Follow up ref SDS 40 FO6H, ref SDS 38 FO6H.
190405 -
190406 - Breast examination performed in Breast Care clinic. ref SDS 41 025H
190407 -
190408 -
190409 -
1905 -

SUBJECTS
Emotional Health Not Reviewed Examination Breast Care Clinic Prior t

2603 -
260401 -  ..
260402 - Emotional Roller Coaster Endemic Cancer Treatment and Coordination
260403 -
260404 - Follow up ref SDS 40 6A7J, ref SDS 38 6A7J.
260405 -
260406 - Emotional health reviewed during examination performed in Breast Care
260407 - clinic. ref SDS 41 Y642
260408 -
260409 -
260410 -
2605 -

SUBJECTS
Prognosis Reviewed Examination Breast Care Clinic Prior to Treatment

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 40 6A9H, ref SDS 38 6A9H.
320407 -
320408 - Prognosis reviewed with medical team during examination in the Breast
320409 - Care Clinic. ref SDS 41 M645
320410 -
320411 -
320412 -
3205 -

SUBJECTS
Measurable Disease Not Reviewed No Examination Breast Care Clinic Pr

3803 -
380401 -  ..
380402 - Measureable Disease Photographs IBC Rash Improving
380403 - IBC Rash Improved Measurable Disease Photographs Tape Measure
380404 -
380405 - Follow up ref SDS 40 6T6M, ref SDS 38 6T6M.
380406 -
380407 - Measurable disease will be reviewed with medical team during
380408 - examination in the Breast Care Clinic that will start the next
380409 - treatment cycle on 070426.
380410 -
380411 -
380412 -
380413 -
380414 -
3805 -

SUBJECTS
Side Effects Reviewed Examination in Breast Care Clinic Prior to Tre

4403 -
440401 -  ..
440402 - Side Effects Medicated After Weekly Examinations
440403 -
440404 - Follow up ref SDS 40 FO66, ref SDS 38 FO66.
440405 -
440406 - Side Effects reviewed with medical team during examination in the
440407 - Breast Care Clinic. ref SDS 41 TQ6L
440408 -
440409 -
440410 -
440411 -
4405 -

SUBJECTS
Cetuximab 3rd Cycle 4th Treatment 12th Total Treatment Chemotherapy

5003 -
5004 - 0845
500501 -  ..
500502 - Infusion Clinic for Cetuximab Treatent
500503 -
500504 - Follow up ref SDS 40 1M6H, ref SDS 38 1M6H.
500506 -  ..
500507 - Millie received 12th overall and 4th treatment of 3rd cycle with
500508 - Cetuximab, starting from 070201, ref SDS 15 G68I, and the 19th
500509 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 4 407N
500511 -  ..
500512 - Catherine was the nurse today.
500514 -           ..
500515 -          Taxotere Capecitabine
500516 -
500517 -          Follow up ref SDS 40 PR8Q, ref SDS 38 PR8Q.
500518 -
500519 -                   Relapse Treatments
500520 -
500521 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 4 407N
500522 -      2.  Cycle 10 and 02 ................... 060814, ref SDS 7 LY6O
500523 -      3.  Cycle 11 and 03 ................... 060908, ref SDS 8 407N
500524 -      4.  Cycle 12 and 04 ................... 060929, ref SDS 9 407N
500525 -      5.  Cycle 13 and 05 ................... 061020, ref SDS 10 407N
500526 -      6.  Cycle 14 and 06 ................... 061110, ref SDS 11 407N
500527 -      7.  Cycle 15 and 07 ................... 061201, ref SDS 12 407N
500529 -           ..
500530 -          Cetuxiab Clinical Study
500531 -
500532 -          Follow up ref SDS 40 7T3H, ref SDS 38 7T3H.
500533 -
500534 -                   Total    Cetuximab
500535 -      8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 15 SG8I
500536 -      9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 17 SG8I
500537 -     10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 18 SG8I
500538 -     11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 21 SG8I
500539 -     12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 24 SG8I
500540 -     13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 27 7T3H
500541 -     14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 29 7T3H
500542 -     15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 30 7T3H
500543 -     16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 35 7T3H
500544 -     17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 38 7T3H
500545 -     18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 40 7T3H
500546 -     19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 0 7T3H
500548 -  ..
500549 - Nurses Notes...
500560 -  ..
500561 - Why is the visit number constant in Nurse's Notes, and yet seems to
500562 - vary in the schedule received from Nola last week? ref SDS 29 159O
500564 -     ..
500565 -    UCSF Log Time...
500566 -
500567 -                   Blood
500568 -                    Test   Infusion
500569 -
500570 -          In.......          0930
500571 -          Out......          1230
500572 -          Visit....      Min  3.0  Hours  Total 3 Hours
500574 -      ..
500575 -     Pain Assessment...
500576 -
500577 -          x
500578 -          0123456789 10
500579 -
500580 -     <923k
500581 -     Administration Site:  Right Port Catheter
500582 -     Needle Size:          20 G 1"
500583 -     Blood Return Good:    Yes
500585 -      ..
500586 -     Remind patient to call MD if temp > 101 F, Shaking Chills
500587 -
500588 -            This protocol differs from Kaiser requirements, reported on
500589 -            041202. ref SDS 1 IX9N
500590 -
500591 -
500592 -
500593 -
5006 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

6703 -
6704 - 0840
670501 -  ..
670502 - Side Effects Minimal...
670503 -
670504 - Follow up ref SDS 40 QU8K, ref SDS 38 QU8K.
670506 -  ..
670507 - Nurse's notes report side effects...
670509 -             ..
670510 -        1.  Rash acne-like
670511 -
670512 -            Follow up ref SDS 40 SK9O
670513 -
670514 -            Minimal facial rash continues from 070208 around the nose
670515 -            and chin. ref SDS 17 QU8K  Millie reported slight increased
670516 -            rash on the chin, which is not noticable today, except by
670517 -            careful examination.  Treatment very effective with
670518 -            medication prescribed on 070222. ref SDS 21 FO66
670519 -
670521 -             ..
670522 -        2.  Dry skin face, chest arm
670523 -
670524 -            Follow up ref SDS 40 JS6M
670525 -
670526 -            Background on notice and treatments prescribed reported on
670527 -            070322. ref SDS 30 JS6M  Medical team commented during
670528 -            examination on 070329, how well Millie looks. ref SDS 33
670529 -            N49K  The next day on 070330, the primary care physician at
670530 -            Kaiser commented similarly, during follow up examination.
670531 -            ref SDS 37 N49K  This indicates UCSF examinations by
670532 -            Catherine in the Infusion Clinic, and by Brigid in the
670533 -            Breast Care Center has been timely, thorough, and effective
670534 -            prescribing Curel on 070301, ref SDS 23 5V73, and later
670535 -            Aquaphor on 070322. ref SDS 30 JS6M
670536 -
670538 -             ..
670539 -        3.  Inflammation Possible Infection Port Catheter
670540 -
670541 -            Doctor Rugo noticed this morning during examination in the
670542 -            Breast Care Center that there is a slight inflammation at
670543 -            the needle penetration for the port catheter.  There is
670544 -            also a large blemish, perhaps .5" diameter about .75" above
670545 -            the port catheter. ref SDS 41 S640
670547 -             ..
670548 -            The doctor ordered a culture with a blood test this
670549 -            morning, per below, ref SDS 0 R54J, to evaluate these new
670550 -            conditions, which may be side effects of cetuximab.
670551 -
670553 -             ..
670554 -        4.  Inflammation rash right chest
670555 -
670556 -            Follow up ref SDS 40 KU3L
670557 -
670558 -            Examination of right chest observes various blemishes.
670559 -            Nurses's Notes report no rash above the port, continuing
670560 -            observations the last several weeks reported on 070329.
670561 -            ref SDS 35 KU3L  Patient reports no interim recurrent rash
670562 -            at this location.
670563 -
670565 -             ..
670566 -        5.  Rash right arm
670567 -
670568 -            Follow up ref SDS 40 LI4M
670569 -
670570 -            Catherine does not comment on this issue in Nurse's Notes
670571 -            today.  Examination by the medical team on 070329 found no
670572 -            evidence of disease in the right arm. ref SDS 33 H15M
670573 -
670575 -             ..
670576 -        6.  Restless legs side effect Benedryl Resolved
670577 -
670578 -            Follow up ref SDS 40 F77K
670579 -
670580 -            This was resolved on 070329 by Brigid changing the
670581 -            chemotherapy order to reduce the dose of Benadryl
670582 -            pre-treatment. ref SDS 33 MF4N
670583 -
670585 -             ..
670586 -        7.  Sleeping difficulty subsided
670587 -
670588 -            Follow up ref SDS 40 NG3I
670589 -
670590 -            This problem has subsided as worry and doubt have been
670591 -            reduced by continuing favorable reports showing response to
670592 -            treatment, discussed with the medical team during
670593 -            examination on 070329. ref SDS 33 Y642
670594 -
670596 -             ..
670597 -        8.  Lymphedema Cellulitis Complications
670598 -            Inflammation Erratic Upper Left Arm
670599 -
670600 -            Follow up ref SDS 40 SU6L
670601 -
670602 -            Lymphedema continues relatively controlled with major
670603 -            swelling in the left arm measured this morning at 11.5, and
670604 -            shown by the study on 060509. ref SDS 2 HO7F  There is no
670605 -            evident association with cetuximab treatments.  Proximate
670606 -            cause was left breast mastectomy with removal of lymph
670607 -            nodes in the left axillary, complicated by exercise to
670608 -            strengthen the immune system for resisting cancer, and by
670609 -            cat bites that flow from engaging pets for qualify of life,
670610 -            reported in the case study on 070130. ref SDS 14 VX6F
670612 -             ..
670613 -            Increased intensity of rash on the upper left arm was
670614 -            reported on 070330 during examination at Kaiser by primary
670615 -            care physician. ref SDS 37 N19J
670617 -             ..
670618 -            These changes were diagnosed without biopsy as
670619 -            complications of lymphedema causing Cellulitis with
670620 -            elevated temperature, and possibly triggered by patient's
670621 -            increased exercise that overtaxed the system. ref SDS 37
670622 -            7C7F  Keflex antibiotics was prescribed, ref SDS 37 474O;
670623 -            about 3 hours later self-examination showed increased
670624 -            inflammation had subsided, and so Keflex treatment was not
670625 -            performed. ref SDS 37 KZ6L
670627 -             ..
670628 -            Today, there is no evidence of increased inflammation rash
670629 -            intensity of the upper left arm, as seen during examination
670630 -            by the medical team in the Breast Care Center on the 2nd
670631 -            floor prior to treatment.
670633 -             ..
670634 -            Causes of erratic inflammation were considered during
670635 -            examination in the Breast Care Center, ref SDS 41 S57H,
670636 -            to assess possibilities...
670637 -
670638 -              1.  IBC progression...................... ref SDS 41 527G
670639 -              2.  Cellulitis complications lymphedema.. ref SDS 41 4Y93
670640 -              3.  Cetuximab side effects inflammation.. ref SDS 41 F57K
670641 -              4.  Cat bite............................. ref SDS 41 P67J
670642 -
670644 -             ..
670645 -        9.  Tired, fatigued - pulmonary emoblism
670646 -
670647 -            Follow up ref SDS 40 FG3N
670648 -
670649 -            Fatigue, shortness of breath and other symptoms of
670650 -            pulmonary embolism were presented during meeting on 070130,
670651 -            ref SDS 14 CV5L, citing case study listed on 060722.
670652 -            ref SDS 5 ZV41
670654 -             ..
670655 -            Energy that seemed to be declining leading up to treatment
670656 -            on 070301, ref SDS 24 CA4K, has continued to rise back to
670657 -            normal, as reported last week on 070322. ref SDS 30 CA4K
670658 -            Millie continues working out in the gym, and has started
670659 -            hiking the trail at Lafayette Reservoir again, as reported
670660 -            to the medical team during examination on 070329.
670661 -            ref SDS 33 E44L  An active life that brings strength and
670662 -            stamina is reflected in Millie's improved vitals, shown
670663 -            today, per below. ref SDS 0 AW4L  Increased exercise in
670664 -            the morning on 070330 may have triggered symptoms of
670665 -            Cellulitis diagnosed during examination later in the
670666 -            afternoon on 070330. ref SDS 37 7C7F
670668 -             ..
670669 -            Millie has been taking naps 2 - 3 hours after treatments
670670 -            the past month, beginning on 070405. ref SDS 38 BB7G  May
670671 -            indicate accumulating effects of cetuximab that make
670672 -            patients tired, listed as side effect in Consent documents
670673 -            reviewed on 070116. ref SDS 13 O64M
670674 -
670676 -             ..
670677 -       10.  Heavy chest - shortness of breathing
670678 -
670679 -            Follow up ref SDS 40 UL6L
670680 -
670681 -            Patient history was reported to UCSF on 070130. ref SDS 14
670682 -            RT6I
670684 -             ..
670685 -            Condition seems improved, tracking continuing higher
670686 -            energy, per above. ref SDS 38 CA4K
670687 -
670689 -             ..
670690 -       11.  Cough - clearing throat
670691 -
670692 -            Follow up ref SDS 40 8N4G
670693 -
670694 -            This condition occassionally increases noticably with
670695 -            episodes of mild, contined cough and clearing throat, as
670696 -            reported to the doctor on 070130. ref SDS 14 RT6I
670697 -
670699 -             ..
670700 -       12.  Dry hands and feet
670701 -
670702 -            Follow up ref SDS 40 UM32
670704 -             ..
670705 -            Dry hands and feet seem much improved since ending
670706 -            treatment with Taxotere and capecitiabine on 061201.
670707 -
670709 -             ..
670710 -       13.  Eyes tearing
670711 -
670712 -            Follow up ref SDS 40 HM9G
670713 -
670714 -            This seems improved since ending treatment with Taxoter
670715 -            and capecitabine on 061201.
670716 -
670718 -             ..
670719 -       14.  Nausea and vomitting
670720 -
670721 -            Follow up ref SDS 40 D19M
670723 -             ..
670724 -            Problems with Taxotere and capecitabine reported on 061110,
670725 -            ref SDS 11 D19M, did not occur this past week after
670726 -            treatment with cetuximab.  As a result, there was no
670727 -            pre-treatment with Decadron today, per below. ref SDS 30
670728 -            G57I
670730 -             ..
670731 -       15.  Sores in mouth
670732 -
670733 -            Follow up ref SDS 40 KW4R
670734 -
670735 -            None yet, cleaning mouth carefully to avoid problem.
670736 -
670737 -
670738 -
670739 -
6708 -

SUBJECTS
Schedule Treatment Weekly Thursday 0800 4 Week Cycles Clinical Study

7303 -
730401 -  ..
730402 - Schedule Weekly Treatments Continue on Thursdays
730403 -
730404 - Follow up ref SDS 40 QK6L, ref SDS 38 QK6L.
730406 -  ..
730407 - Millie's next treatment is scheduled for 070426 0830, reported by Nola
730408 - on 070315. ref SDS 29 159O
730410 -  ..
730411 - The schedule was modifed by the medical team last week on 070412,
730412 - switching Millie's meeting with the doctor from next week to today.
730413 - ref SDS 40 FO6H  This change does not affect the schedule for
730414 - treatment next week.
730415 -
730416 -
730417 -
730418 -
7305 -

SUBJECTS
Blood Tests Culture Evaluate Infection Port Catheter Counts Normal C

7903 -
7904 - 0922
790501 -  ..
790502 - Blood Test Counts Normal Full Dose Cetuximab Ordered
790503 -
790504 - Follow up ref SDS 35 Q659, ref SDS 27 Q659.
790505 -
790506 - Millie had a blood draw this morning in the Infusion Clinic after
790507 - meeting with the medical team for examination.  The test was ordered
790508 - by the doctor to perform a blood culture for assessing a prominent
790509 - blemish near and above the port catheter, as reported earlier this
790510 - morning. ref SDS 41 L55J
790512 -  ..
790513 - This was a limited test CBC with DIFF & PLT CT only.
790514 -
790516 -  ..
7906 -
7907 -
7908 - 1117
7909 -
790901 - During treatment, Catherine submitted results of the test.
790903 -     ..
790917 -     ..
790918 -    Log#:                   070419 09:30
790919 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
790920 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
790922 -     ..
790923 -    CBC with DIFF & PLT CT                                     CBCD
790924 -     ..
790925 -    WBC COUNT               4.6    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
790926 -    RBC COUNT               4.33   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
790927 -    HEMOGLOBIN             13.6    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
790928 -    HEMATOCRIT             39.5    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
790929 -    MCV                    91      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
790930 -    MCH                    31.5    pg           26  -   34     MCH
790931 -    MCHC                   34.5    g/dL         31  -   36     MCHC
790932 -    PLATELETS             204      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
790933 -    ..
790934 -     (NEUTS x 1000 = ANC for Kaiser)
790935 -    NEUTS                   1.87   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
790936 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
790938 -     ..
790939 -    LYMPHS                  2.07   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
790940 -    MONOS                   0.40   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
790941 -    EOS                     0.17   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
790942 -    BASOS                   0.07   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
790943 -                                                                                                 0  -  5
790944 -
790945 -
7910 -

SUBJECTS
Absolute Neutrophils Count ANC 1870 Above 1800 UCSF Requirement for

8603 -
860401 -  ..
860402 - ANC 1870 Above 1800 Criteria for Blood Counts to Approve Treatment
860403 -
860404 - Follow up ref SDS 35 P560, ref SDS 24 P560.
860405 -
860406 - Background on differences representing ANC in Kaiser and UCSF blood
860407 - testing is reported on 070301. ref SDS 24 U37I
860409 -  ..
860410 - ANC reported as "NUETS" in the UCSF blood test reported as 1.87, per
860411 - above. ref SDS 0 QY6H  This is equivalent to 1810 in Kaiser's scheme.
860413 -  ..
860414 - ANC continues rising...
860415 -
860416 -        6972................................ 060814, ref SDS 7 P560
860417 -        6390................................ 060908, ref SDS 8 P560
860418 -        5200................................ 060929, ref SDS 9 P560
860419 -        3869................................ 061020, ref SDS 10 P560
860420 -        2880................................ 061110, ref SDS 11 P560
860421 -        2888................................ 061201, ref SDS 12 P560
860422 -        1760................................ 070201, ref SDS 15 P560
860423 -        1230................................ 070301, ref SDS 24 P560
860424 -        1510................................ 070308, ref SDS 23 P560
860425 -        1810................................ 070329, ref SDS 35 P560
860426 -        1870................................ 070419, ref SDS 0 P560
860428 -  ..
860429 - Blood counts for ANC rising shows strengthening immune system that
860430 - reverses prior trend over the past 6 months, which threatened to delay
860431 - or impede schedule of weekly treatments, especially if the doctor
860432 - added carboplatin to increase effectiveness of treatments, as reported
860433 - last month on 070301. ref SDS 24 AZ4G  ANC rising over the past 2
860434 - months validates UCSF treatment plan.
860435 -
860436 -
860437 -
860438 -
860439 -
8605 -

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

9303 -
9304 - 0926
930501 -  ..
930502 - Preparation for Treatment Required One (1) Attempt to Connect Port
930503 -
930504 - Follow up ref SDS 40 EB7J, ref SDS 38 EB7J.
930506 -  ..
930507 - The nurse connected the IV tubes to the port....
930509 -       ..
930510 -      Interlink System Vented Paclitaxel set
930512 -  ..
930513 - Like last week and earlier on 070301, there were no problems getting
930514 - blood to flow from the port, ref SDS 24 EB7J, as occurred on 070222,
930515 - ref SDS 20 DC5W, and earlier on 070201. ref SDS 15 DC5W
930517 -  ..
930518 - The nurse flushed the port with saline.
930520 -  ..
930521 - As noted, during examination in the Breast Care Center the doctor
930522 - noticed inflammation at the port catheter penetration, and another
930523 - slightly above. ref SDS 41 S640  The doctor ordered a blood test for a
930524 - culture to investigate infection, per above. ref SDS 0 R54J
930525 -
930526 -
930527 -
930528 -
930529 -
9306 -

SUBJECTS
Blood Draws None Today 7 Vials Clinical Study Research Cetuximab Dru

A003 -
A00401 -  ..
A00402 - Blood Draws 7 Vials for Clinical Study Research
A00403 -
A00404 - Follow up ref SDS 40 O56V, ref SDS 38 O56V.
A00405 -
A00406 - Blood draws for the clinical study occur only to start a new cycle; so
A00407 - there were no blood draws today during the 2nd treatment of cycle 3.
A00408 -
A00409 -
A00410 -
A00411 -
A00412 -
A005 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

A603 -
A604 - 0930
A60501 -  ..
A60502 - Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
A60503 -
A60504 - Follow up ref SDS 40 DC7J, ref SDS 38 DC7J.
A60505 -
A60506 - Benadryl (diphenhydramine) started.   50 MG....... ref SDS 30 IJ41
A60507 -
A60508 -        Purpose reported on 060721. ref SDS 3 DC7J
A60510 -  ..
A60511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
A60512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 38
A60513 - IJ41
A60515 -  ..
A60516 - Nurse Notes report NS back up flush 250 cc.
A60517 -
A60518 -
A60520 -  ..
A606 -
A607 -
A608 - 0950
A609 -
A60901 - Benedryl completed equipment beeps.
A60903 -  ..
A60904 - Millie reported that decreasing the dose of Benadryl pre-treatment to
A60905 - 25 mg completely eliminated previous problems of "restless legs," per
A60906 - above. ref SDS 35 F77K
A60907 -
A60908 -
A60910 -  ..
A610 -
A611 -
A612 -
A613 -
A61301 - Decadron (dexamethasone) IV pre-treatment........ ref SDS 30 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 17 G57I  Since this favorable condition continues, per
A61306 - above, ref SDS 30 D19M, Decadron was not given again today.
A61307 -
A61309 -  ..
A614 -
A615 -
A616 -
A61601 - Decadron completed -- not reported.
A61602 -
A61603 -
A61604 -
A61605 -
A617 -

SUBJECTS
Cetuximab 3rd Cycle 4th Treeatment Clinical Study Drug Trial Treatme

AF03 -
AF04 - 1000
AF0501 -  ..
AF0502 - Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
AF0503 -
AF0504 - Follow up ref SDS 40 4N5M, ref SDS 38 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 30 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 30 DC7J
AF0552 -
AF0553 -       Earlier this morning, Brigid changed the Chemotherapy Order
AF0554 -       reducing Diphenhydramine (Benadryl) from 50 mg to 25 mg in order
AF0555 -       to reduce side effects of "restless legs," per above.
AF0556 -       ref SDS 35 F77K
AF0558 -        ..
AF0559 -       This was effective, reported above. ref SDS 35 7R6H
AF0561 -     ..
AF0562 -    5. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
AF0563 -
AF0564 -       Further premed TBD [barely legible handwriting??]
AF0566 -     ..
AF0567 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
AF0569 -     ..
AF0570 -    6. Cetuximab (Erbitux) (loading dose)
AF0571 -
AF0572 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
AF0573 -              first dose x 1
AF0574 -
AF0575 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
AF0576 -       (concentration 2 mg/ml)
AF0578 -     ..
AF0579 -    7. Cetuximab (Erbitux) (maintenance dose)
AF0580 -
AF0581 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
AF0582 -              ____mg) IV over 60 or ____ minutes.
AF0583 -
AF0584 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
AF0585 -       Infuse once weekly for 8 weeks.  First dose to be given on date
AF0586 -       20070201.
AF0588 -        ..
AF0589 -       Cetuximab is administered undiluted through a low protien
AF0590 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
AF0591 -       line at the end of the infusion.
AF0593 -        ..
AF0594 -       ARM 2:  Administer carboplatin of vital signs are unremarkable
AF0595 -       one hour after cetuximab infusion.
AF0597 -        ..
AF0598 -       Vital signs at baseline, upon cetuximab completion and one hour
AF0599 -       after cetuximab.
AF0600 -
AF0601 -       ****please note start and stop times****
AF0603 -        ..
AF0604 -       Laboratory work:
AF0605 -
AF0606 -          See carboplatin orders
AF0608 -        ..
AF0609 -       x  Notify MD for dose modifications if patient has severe
AF0610 -          acne in form rash
AF0611 -
AF0612 -          CBC with differential and platletes every 4 weeks
AF0613 -          Creatinine and magnesium every 4 weeks
AF0614 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
AF0615 -          weeks.  If levels are outside of normal laboratory values
AF0616 -          notify Brigid NP  (MD/RN) at 415 443 4730
AF0618 -        ..
AF0619 -       x  Physician has discussed risks/benefits of therapy with the
AF0620 -          patient.  Signed consent obtained.
AF0621 -
AF0622 -
AF0623 -          Yes   5.  O2 by nasal cannula at 2 liters/min prn for chest
AF0624 -          pain or SOB
AF0626 -           ..
AF0627 -          Yes   6.  Diphenhydramine 50 mg IV prn x1 for urticaria
AF0628 -          [barely legible], pruritis SOB
AF0630 -           ..
AF0631 -          Yes   7.  Hydrocortizone 100 mg IV prn x1 for urticaria
AF0632 -          [barely legible], pruritis SOB
AF0634 -           ..
AF0635 -          Yes   8.  Albuterol inhaler 2-4 puffs prn SOB or chest
AF0636 -          tightness
AF0638 -           ..
AF0639 -          Yes   9.  Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
AF0640 -          anaphylaxis
AF0642 -           ..
AF0643 -          Breast CC05752 Cetuximab doc 20061024
AF0644 -          Approved 20060615
AF0646 -           ..
AF0647 -          Physician signature [Hope Rugo]
AF0649 -           ..
AF0650 -          Provider#  35313
AF0652 -           ..
AF0653 -          Date:  20010131
AF0654 -
AF0656 -  ..
AF07 -
AF08 -
AF09 - 1115
AF10 -
AF1001 - Cetuximab treatment completed.
AF1002 -
AF1003 - Millie had a 1 hour rest and observation period, required by the
AF1004 - protocol. ref SDS 30 G679
AF1005 -
AF1006 -
AF1007 -
AF1009 -  ..
AF11 -
AF12 -
AF13 - 1225
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

AL03 -
AL04 - 0930
AL0501 -  ..
AL0502 - Vitals Show Patient Stable
AL0503 -
AL0504 - Follow up ref SDS 40 AW4L, ref SDS 38 AW4L.
AL0505 -
AL0506 -                    Blood
AL0507 -    Date   Time     Pressure   Pulse  Temprtr  Weight   So2
AL0509 -     ..
AL0510 -    070419 1230..... 133  79     57     36.3c            98
AL0511 -    070419 1130..... 141  78     56     37.6c **1        99
AL0512 -    070419 0930..... 153  80     53     36.1c           100
AL0513 -    070412 1120..... 114  65     53     36.6c            96
AL0514 -    070412 1020..... 130  66     57     36.8c            99
AL0515 -    070412 0900..... 116  69     65     36.8c            97
AL0516 -    070405 1130..... 133  75     55     36.2c            97
AL0517 -
AL0518 -            Consistently low pulse, does it reflect low blood pressure
AL0519 -            side effect of cetuximab, or improved fitness from working
AL0520 -            out that benefits emotional stress and immune system?
AL0522 -     ..
AL0523 -    070405 1030..... 114  69     57     36.4c            99
AL0524 -    070405 0900..... 128  78     54     36.5c           100
AL0525 -    070329 1140..... 125  74     53     36.8c            98
AL0526 -    070329 1045..... 125  72     53         c           100
AL0527 -    070329 0900..... 141  76     60     36.6c            99
AL0528 -    070322 1055..... 118  71     55     37.0c            97
AL0529 -    070322 1015..... 120  69     57     37.1c            98
AL0530 -    070322 0900..... 130  70     56     36.0c            98
AL0531 -    070315 1300..... 119  75     58     36.2c            98
AL0532 -    070315 1150..... 137  73     52     36.5c            99
AL0533 -    070315 0945..... 143  85     60     36.4c            97
AL0534 -    070308 1100..... 144  87     70     36.0c            98
AL0535 -    070301 1645..... 125  62     90 *   36.4c
AL0536 -    070301 1505..... 112  69     86 *   36.6c            98
AL0537 -    070222 1145..... 115  73     58     36.3c   147      98
AL0538 -    070222 1045..... 100  60     56     36.6c   147      98
AL0539 -    070222 0930..... 117  63     68     36.2c   147      97
AL0540 -    070215 1200..... 106  66     61     37.0c   147      97
AL0541 -    070215 1055.....  96  61     64     37.0c   147      94
AL0542 -    070215 0930..... 100  64     66     36.7c   147      98
AL0543 -    070208 0920..... 143  70     59     36.5c   147      98
AL0544 -    070201 1330..... 136  74     66             148      94
AL0545 -    070201 1220..... 110  65     62     36.3c   148      96
AL0546 -    070201 1000..... 132  80     65     36.9c   148      99
AL0547 -    061201 1534..... 123  76     76     97.5    150
AL0548 -    061110 1534..... 136  83     73     97.0    150      98
AL0549 -    061020 1534..... 140  79     67     99.8    151      97
AL0550 -    060929 1452..... 141  78     66     98.3    149
AL0551 -    060908 1335..... 139  79     73     98.1    149
AL0552 -    060814 1610..... 139  80     59     98.2    151
AL0553 -    060722 1440..... 142  74     67     98.1    149
AL0554 -    060711.......... 172  87     54     97.5    147
AL0555 -    060623.......... 141  87     71     98.0    147
AL0556 -    060428.......... 129  73     80     99.4    149
AL0557 -    060217.......... 153  81     61     98.6    150
AL0558 -    050916.......... 120  80     80     98.5
AL0559 -
AL0560 -  *    Need vitals taken twice to verify atypical diagnostics.
AL0561 -  **1  Nurses Notes seem to show 97.6 which is impossible, so.....
AL0562 -
AL0563 -
AL0564 -
AL06 -

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

AY03 -
AY04 - 1120
AY0501 -  ..
AY0502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
AY0503 -
AY0504 - Follow up ref SDS 40 F54N, ref SDS 38 F54N.
AY0506 -  ..
AY0507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
AY0508 - clinical study drug trial. ref SDS 6 YP4I
AY0510 -  ..
AY0511 - Millie was alert after treatment again today, and not wobbly nor
AY0512 - disoriented.  She was able to drive home without side effects of
AY0513 - treatment.
AY0515 -  ..
AY0516 - After arriving home about 1320, Millie took a nap from about 1320
AY0517 - until about 1600.  Could relate to side effects from cetuximab
AY0518 - treatments that cause fatigue, reported on 070116. ref SDS 13 O64M
AY0519 -
AY0520 -
AY0521 -
AY0522 -
AY0523 -
AY0524 -
AY0525 -
AY06 -