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: March 1, 2007 03:00 PM Thursday; Rod Welch

Millie at UCSF 2nd cycle 1st treatment Cetuximab for IBC relapse.

1...Summary/Objective
2...Clinic Examination Orientation Starting Treatment Cetuximab
3...Breast Examination Likely IBC Progression Spreading Upper Left Arm
4...Measureable Disease Photographs IBC Rash Improving
5...IBC Rash Improved Measurable Disease Photographs Tape Measure
6...Side Effects Medicated After Weekly Examinations
7...Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
8...INR 2.5 Low Pulmonary Embolism Needs Increase Coumadin Treatment
9...Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 2.5
10...Infusion Clinic for Cetuximab Treatent
..........Taxotere Capecitabine
..........Cetuxiab Clinical Study
11...Nurses Notes...
12...Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
13...Schedule Weekly Treatments Continue on Thursdays
14...Blood Counts Low Full Dose Cetuximab Ordered
....Coagulation Control INR High 2.5 PT 28 High
15...ANC 1230 Well Below 1800 Criteria for Blood Counts to Approve Treatment
16...CA 15-3 36 Tests 2 From Kaiser 1 from UCSF Pending Submission
17...Preparation for Treatment Required One (1. Attempt to Connect Port
18...Blood Draws 7 Vials for Clinical Study Research
19...Benedryl 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...Case study indicates many differences from Kaiser's blood testing
2...ISO may have a standard for converting multiple providers to a common
3...UCSF and Kaiser appear to calculate INR much differently. In Kaiser's
4...However, if INR reported by UCSF in the test today is actually high,

CONTACTS 

SUBJECTS
Treatment Cetuximab 1st Treatment 2nd Cycle Chemotherapy 10th Cycle

0603 -
0603 -    ..
0604 - Summary/Objective
0605 -
060501 - Follow up ref SDS D8 0000. ref SDS D2 0000.
060502 -
060503 - Started 2nd cycle cetuximab treatment for IBC on clinical study.
060504 - Looks like problem reported last week drawing blood for study protocol
060505 - did not occur today.
060506 -
060507 -
060508 -
060510 -  ..
0606 -
0607 -
0608 - Progress
0609 -
060901 - Clinic Examination Orientation Starting Treatment Cetuximab
060902 -
060903 - Follow up ref SDS D8 407N, ref SDS D2 407N.
060904 -
060905 - Agenda...
060906 -
060907 -    1.  Side effects.............................. ref SDS 0 QU8K
060908 -    2.  Infusion Clinic........................... ref SDS 0 1M6H
060909 -
060910 -
060911 -
0610 -

SUBJECTS
Breast Examination Shows Improvement IBC Rash Left Right Breast Stom

1003 -
100401 -  ..
100402 - Breast Examination Likely IBC Progression Spreading Upper Left Arm
100403 -
100404 - Follow up ref SDS D8 FO6H, ref SDS D2 FO6H.
100405 -
100406 - Examination was performed prior to treatment in the Oncology Clinic
100407 - under supervision of Doctor Rugo.
100408 -
100409 -
100410 -
1005 -

SUBJECTS
Measureable Disease IBC Rash Photographs Tape Measure Evaluate Progr

1303 -
130401 -  ..
130402 - Measureable Disease Photographs IBC Rash Improving
130403 - IBC Rash Improved Measurable Disease Photographs Tape Measure
130404 -
130405 - Follow up ref SDS D8 6T6M, ref SDS D2 6T6M.
130406 -
130407 -
130408 -
130409 -
1305 -

SUBJECTS
Cetuximab Side Effects Mild Face Rash Acne-like Medication Prescript

1903 -
190401 -  ..
190402 - Side Effects Medicated After Weekly Examinations
190403 -
190404 - Follow up ref SDS D8 FO66, ref SDS D2 FO66.
190405 -
190406 -
190407 -
190408 -
1905 -

SUBJECTS
Blood Tests Cetuximab Monthly Clinical Study Drug Trial Performed at

2203 -
220401 -  ..
220402 - Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
220403 -
220404 - Follow up ref SDS D8 XR40, ref SDS D2 XR40.
220405 -
220406 - Blood test today, results reported below. ref SDS 0 Q659
220407 -
220409 -  ..
220410 - INR 2.5 Low Pulmonary Embolism Needs Increase Coumadin Treatment
220411 - Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 2.5
220412 -
220413 - Follow up ref SDS D8 6U5J, ref SDS D2 6U5J.
220414 -
220415 -
220416 -
220417 -
220418 -
2205 -

SUBJECTS
Cetuximab 2nd Cycle 1st Treatment Chemotherapy 8th Cycle IBC 3rd Rel

2503 -
2504 - 1500
250501 -  ..
250502 - Infusion Clinic for Cetuximab Treatent
250503 -
250504 - Follow up ref SDS D8 1M6H, ref SDS D2 1M6H.
250505 -
250506 - Treatment was given after meeting with Doctor Rugo in the Oncology
250507 - Clinic, which was delayed from 1330 until OA 1415. ref SDS E0 0001
250509 -  ..
250510 - Catherine is the nurse today.  She had a family matter, and so some of
250511 - the work was performed by a trainee, Carrie (??), who was assisted by
250512 - an experienced infusion treatment nurse, Pauline Cassidy.
250514 -  ..
250515 - Millie feels after treatment today that Carrie deserves credit for
250516 - being a fast learner, and Pauline was very helpful supporting the work
250517 - on short notice, similar to last week on 070222. ref SDS D7 GZ5I
250518 - Millie further noted that Catherine's knowledge of patient history
250519 - strengthens work operations.
250521 -  ..
250522 - Millie received 5th overall and 1st treatment of 2nd cycle with
250523 - Cetuximab, starting from 070201, ref SDS C6 G68I, and the 12th
250524 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 89 407N
250526 -           ..
250527 -          Taxotere Capecitabine
250528 -
250529 -          Follow up ref SDS D8 PR8Q, ref SDS D2 PR8Q.
250530 -
250531 -                   Relapse Treatments
250532 -
250533 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 89 407N
250534 -      2.  Cycle 10 and 02 ................... 060814, ref SDS 98 LY6O
250535 -      3.  Cycle 11 and 03 ................... 060908, ref SDS A1 407N
250536 -      4.  Cycle 12 and 04 ................... 060929, ref SDS A3 407N
250537 -      5.  Cycle 13 and 05 ................... 061020, ref SDS A8 407N
250538 -      6.  Cycle 14 and 06 ................... 061110, ref SDS B2 407N
250539 -      7.  Cycle 15 and 07 ................... 061201, ref SDS B4 407N
250541 -           ..
250542 -          Cetuxiab Clinical Study
250543 -
250544 -          Follow up ref SDS D8 7T3H, ref SDS D2 7T3H.
250545 -
250546 -                   Total    Cetuximab
250547 -      8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS C6 SG8I
250548 -      9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS C9 SG8I
250549 -     10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS D2 SG8I
250550 -     11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS D8 SG8I
250551 -     12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 0 SG8I
250553 -  ..
250554 - Nurses Notes...
250565 -  ..
250566 - This is the first change in the "Visit" number since the meeting on
250567 - 070201. ref SDS C6 R35G
250569 -     ..
250570 -    UCSF Log Time...
250571 -
250572 -          In....... 1500
250573 -          Out...... 1730
250574 -          Visit.... 2.5  Hours
250576 -      ..
250577 -     Pain Assessment...
250578 -
250579 -          x
250580 -          0123456789 10
250581 -
250582 -     <923k
250583 -     Administration Site:  Right Port Catheter
250584 -     Needle Size:          20 G 1"
250585 -     Blood Return Good:    Yes
250587 -      ..
250588 -     Remind patient to call MD if temp > 101 F, Shaking Chills
250589 -
250590 -            This protocol differs from Kaiser requirements, reported on
250591 -            041202. ref SDS 49 IX9N
250592 -
250593 -
250594 -
250595 -
2506 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

3503 -
3504 - 0910
350501 -  ..
350502 - Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
350503 -
350504 - Follow up ref SDS D8 QU8K, ref SDS D2 QU8K.
350506 -  ..
350507 - Catherine asked Millie about side effects...
350508 -
350509 -            Rash like acne
350510 -
350511 -               Mild condition continues from 070208 around the nose,
350512 -               ref SDS C9 QU8K; treatment effective with medication
350513 -               prescribed on 070222. ref SDS D8 FO66
350515 -             ..
350516 -            Face very dry...
350517 -
350518 -               Millie notified UCSF in a letter on 070228 of sudden
350519 -               extremely dry fact, a new side effect of cetuximab; and
350520 -               requested treatment. ref SDS D9 LR4S  Brigid prescribed
350521 -               a face cream.
350522 -
350524 -             ..
350525 -            Lymphedema Cellulitis Complications
350526 -
350527 -               Treatment for cellulitis begun on 070217, ref SDS D6
350528 -               N069, was completed on 070228; rash diagnosed on 070222
350529 -               as IBC, ref SDS D8 FO66, and discussed again with
350530 -               Doctor Rugo during cyclical examination today.
350531 -
350533 -             ..
350534 -            Tired, fatigued - pulmonary emoblism...
350535 -
350536 -               Fatigue, shortness of breath and other symptoms of
350537 -               pulmonary embolism were presented during meeting on
350538 -               070130, ref SDS C4 CV5L, citing case study listed on
350539 -               060722. ref SDS 90 ZV41
350541 -                ..
350542 -               On 070218 Millie notified the primary care physician and
350543 -               UCSF that energy continues to recover; she played tennis
350544 -               and pulse reached 144. ref SDS D6 N05H
350546 -                ..
350547 -               Energy has begun to decline with increasing treatments
350548 -               of cetuximab, ref SDS 0 7T3H, but sill elevated compared
350549 -               to condition on ending 6 months of treatment with
350550 -               Taxotere and capecitabine, and after suffering pulmonary
350551 -               embolism, ref SDS A6 M36G, and enlarged right ventricle,
350552 -               reported on 061012. ref SDS A6 7E5L
350553 -
350554 -                   [On 070308 energy seems to be rising again back to
350555 -                   normal. ref SDS E7 CA4K
350556 -
350558 -             ..
350559 -            Heavy chest - shortness of breathing
350560 -
350561 -               Patient history was reported to UCSF on 070130.
350562 -               ref SDS C4 RT6I
350563 -
350564 -               Condition seems improved, as reported on 070204.
350565 -               ref SDS C8 JJ7O  No noticable increase, aligns with
350566 -               continuing higher energy. ref SDS D8 CA4K
350567 -
350569 -             ..
350570 -            Cough - clearing throat
350571 -
350572 -               This condition seems improved, as reported to the doctor
350573 -               on 070130. ref SDS C4 RT6I
350574 -
350576 -             ..
350577 -            Dry hands and feet...
350578 -
350579 -               Dry hands and feet seem much improved since ending
350580 -               treatment with Taxotere and capecitiabine on 061201.
350581 -
350583 -             ..
350584 -            Eyes tearing
350585 -
350586 -               This seems improved since ending treatment with Taxoter
350587 -               and capecitabine on 061201.
350588 -
350590 -             ..
350591 -            Nausea and vomitting
350592 -
350593 -               Problems with Taxotere and capecitabine reported on
350594 -               061110, ref SDS B2 D19M, did not occur this past week
350595 -               after treatment with cetuximab.  As a result, there was
350596 -               no pre-treatment with Decadron today, per below.
350597 -               ref SDS 0 G57I
350599 -             ..
350600 -            Sores in mouth
350601 -
350602 -               None yet, cleaning mouth carefully to avoid problem.
350603 -
350604 -
350605 -
350606 -
3507 -

SUBJECTS
Schedule Treatment Weekly Thursday 0800 4 Week Cycles Clinical Study

3803 -
380401 -  ..
380402 - Schedule Weekly Treatments Continue on Thursdays
380403 -
380404 - Follow up ref SDS D8 QK6L, ref SDS D2 QK6L.
380406 -  ..
380407 - Millie's next treatment is scheduled for 070308 0900.
380409 -  ..
380410 - Blood draw will be needed next week on 070308 0800 to check ANC,
380411 - because the ANC diagnositc is low today, 1230, ordered by Doctor Rugo
380412 - during the meeting today.
380413 -
380414 -
380415 -
380416 -
3805 -

SUBJECTS
Blood Counts Low Test 070301 Blood Removal Port Catheter Okay Correc

7503 -
7504 - 1200
750501 -  ..
750502 - Blood Counts Low Full Dose Cetuximab Ordered
750503 -
750504 - Follow up ref SDS D8 Q659, ref SDS D2 Q659.
750505 -
750506 - Millie had a blood test today at 1200 (noon) in the UCSF Infusion
750507 - Clinic; previous test was on 070301, and reported in the record on
750508 - 070201. ref SDS C6 Q659
750510 -  ..
750511 - Catherine submitted the report on the blood test, shown below.
750512 - ref SDS 0 075H
750514 -  ..
750515 - Over the next few days, there was time to correlate UCSF blood test
750516 - standards, with Kaiser, based on patient history.
750518 -  ..
750519 - Case study indicates many differences from Kaiser's blood testing
750520 - diagnotics with respect to scope, units and ranges, further suggesting
750521 - substantive differences in test measurement protocols that effect
750522 - application to diagnosis and treatment, e.g, INR. ref SDS 0 SE6N
750523 -
750524 -        [On 070305 Millie discovered differences between the way UCSF
750525 -        and Kaiser set the normal range for INR, ref SDS E3 K14H; she
750526 -        wrote a letter to Jackie at UCSF with a copy to Arlette and to
750527 -        Gloria, and asking for clarification from UCSF to facilitate
750528 -        Gloria's work managing Millie's Coumadin treatments for
750529 -        pulmonary embolism. ref SDS E3 3A4Y
750531 -         ..
750532 -        [On 090420 1451 case study shows labs enable effective care
750533 -        when performed locally because blood counts are dynamic in
750534 -        realtime with treatment decisions. ref SDS F3 HT9K
750536 -  ..
750537 - This presents significant risk of mistakes distinguishing differences
750538 - large and small interpreting blood test results for diagnosis and
750539 - treatment decisions, e.g., INR, discussed below. ref SDS 0 SE6N
750541 -  ..
750542 - ISO may have a standard for converting multiple providers to a common
750543 - standard to avoid mistakes.
750545 -  ..
750546 - Case studies for managing patient history are listed on 061018.
750547 - ref SDS A7 0001
750549 -  ..
750550 - Millie's letter on 070228 to UCSF with copy to Kaiser requested review
750551 - today of a draft coordination plan to manage blood test reporting.
750552 - ref SDS D9 LQ6W
750553 -
750554 -            [On 070330 coordination failing, medical chart at Kaiser
750555 -            shows lab at UCSF, rather than entering the blood test
750556 -            report to aid patient care. ref SDS E8 128S
750558 -     ..
750572 -     ..
750573 -    Log#:                   070301 12:00
750574 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
750575 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
750577 -     ..
750578 -    PARN CBC with DIFF & PLT CT                               CBCD
750579 -     ..
750580 -    WBC COUNT               4.1    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
750581 -    RBC COUNT               4.23   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
750582 -    HEMOGLOBIN             13.8    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
750583 -    HEMATOCRIT             39.8    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
750584 -    MCV                    94      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
750585 -                                                                     RDW              %       11.9  -  14.3
750586 -    MCH                    32.6    pg           26  -   34     MCH
750587 -    MCHC                   34.7    g/dL         31  -   36     MCHC
750588 -    PLATELETS             230      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
750589 -    ..
750590 -       (posted 070307)
750591 -    CA 15-3                36      U/mL             <  31    CA15-3  CA 15-3                        <  39
750593 -     ..
750594 -    NEUTS           L       1.23   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
750595 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
750597 -     ..
750598 -    LYMPHS                  2.10   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
750599 -    MONOS                   0.36   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
750600 -    EOS                     0.30   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
750601 -    BASOS                   0.08   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
750602 -                                                                     Bands             %         0  -  5
750604 -     ..
750605 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
750606 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
750608 -     ..
750609 -    PT              H      28.0    S          12.5  - 16.0     PT    PT, patient       sec     8.9  -  11.1
750610 -    INL Nrm Ratio   H       2.5                0.9  -  1.2     INR   PT INR            sec     2.0  -  3.0
750611 -    PARTIAL
750612 -     THROMBOPLASTIN        31.7    S          22.4  - 33.3     PTT
750614 -     ..
750615 -    ELECTROLYTE PANEL                                          LYTE
750616 -    SODIUM                140      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
750617 -    POTASSIUM               4.0    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
750618 -    CHLORIDE              105      mmol/L       98  -  107     CL
750619 -    CARBON DIOX TOTAL      27      mmol/L       23  -  32      CO2
750620 -    ANION GAP               8                    3  -  14      ANGA
750622 -     ..
750623 -    UREA NITROGEN          12      mg/dL         8  -  23      BUN   BUN               mg/dL     7  -  17
750624 -    CALCIUM                 9.4    mg/dL       8.7  -  10.1    CA    Calcium           mg/dL   8.4  -  10.2
750625 -    MAGNESIUM               2.0    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
750627 -     ..
750628 -    CREATININE              0.7    mg/dL       0.6  -  1.2     CR    Creatinine        mg/dL   0.6  -  1.2
750629 -    AST                    36      U/L          16  -  41      AST   AST (SGOT)        U/L      14  -  36
750630 -    ALT                    24      U/L          11  -  54      ALT   ALT (SGPT)        U/L      11  -  66
750631 -    BILIRUBIN TOTAL         0.7    mg/dL       0.3  -  1.3     BILT  Bili Total        mg/dL   0.2  -  1.3
750632 -    ALKALINE PHOSPHATASE   53      U/L          29  -  111     ALKP  Alkaline Ph       U/L      38  -  126
750633 -    PROTEIN TOTAL           6.2    g/dL        5.8  -  8.0     TP    Protein, Total    g/dL    6.3  -  8.2
750634 -    ALBUMIN                 4.0    g/dL        3.4  -  4.7     ALB   Albumin           g/dL    3.4  -  4.8
750635 -
750636 -
750637 -
750638 -
7507 -

SUBJECTS
Coagulation Control Coumadin Treatment Pulmonary Embolism INR 2.5 PT

9603 -
960401 -     ..
960402 -    Coagulation Control INR High 2.5 PT 28 High
960403 -
960404 -    Follow up ref SDS D8 SE6N, ref SDS D2 SE6N.
960405 -
960406 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
960407 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
960409 -     ..
960410 -    PT              H      28.0    S          12.5  - 16.0     PT    PT, patient       sec     8.9  -  11.1
960411 -    INL Nrm Ratio   H       2.5                0.9  -  1.2     INR   PT INR            sec     2.0  -  3.0
960412 -    PARTIAL
960413 -     THROMBOPLASTIN        31.7    S          22.4  - 33.3     PTT
960415 -  ..
960416 - UCSF and Kaiser appear to calculate INR much differently.  In Kaiser's
960417 - scheme, 2.5 is a perfect result in the middle of the target range 2.0
960418 - - 3.0; yet 2.5 is high in UCSF diagnostics that use a normative scale
960419 - of 0.9 - 1.2 (see comparative blood test report above, ref SDS 0 PU7Y,
960420 - and therefore would require adjusting Coumadin treatments for
960421 - pulmonary embolism.
960423 -  ..
960424 - Since 2.5 is more than double the high range of 1.2 on the UCSF scale,
960425 - it therefore seems to correlate to more than INR 6 in the Kaiser
960426 - scheme.  On 061214, Gloria, at Kaiser's Coagulation Control Clinic in
960427 - Martinez, CA, notified Millie that a conflict overlooked in prescribed
960428 - medications caused INR to jump to 6.4.  This required ending
960429 - conflicting treatment, and further required immediate change in the
960430 - Coumadin protocol to reduce risk of hemorraging. ref SDS B7 0001
960432 -  ..
960433 - Differences in blood test standards presents a very high risk for
960434 - error, cited above. ref SDS 0 HI6O  When busy people look at a blood
960435 - test report, or ask someone for a diagnostic, or remember a diagnostic
960436 - from a telephone call, meeting, etc., and are told or observe or
960437 - simply recall that INR is 2.5, there will be a very great tendency to
960438 - overlook if this is a Kaiser test or UCSF test.
960440 -  ..
960441 - Millie skipped getting blood tested on 070222 for INR, per planning on
960442 - 070215 for evaluating Coumadin to control pulmonary embolism.
960443 - ref SDS D2 6U5J  This saves time, money, and avoids needle
960444 - penetrations that cause trauma to the right arm, reported on 040318,
960445 - ref SDS 11 CO3G, because getting blood drawn through the port, other
960446 - than on treatment days, has proven difficult to coordinate.
960448 -  ..
960449 - Planning on 070215 was to test for INR with UCSF blood tests for
960450 - cancer treatment. ref SDS D2 IC9O
960452 -  ..
960453 - However, if INR reported by UCSF in the test today is actually high,
960454 - as shown in the report, ref SDS 0 SE6N, then Gloria will want to
960455 - consider adjusting Coumadin treatments this week.
960457 -  ..
960458 - The difference between being perfect and being 100% too high requires
960459 - investigation.  On 070222 Jackie talked about developing a
960460 - coordination plan to facilitate collaboration between Kaiser and UCSF
960461 - in Millie's care. ref SDS D7 VK5N  Differences in blood test
960462 - diagnostics should be normalized, ref SDS D7 WY6J, with particular
960463 - attention to INR assessment, cited in Millie's letter to UCSF on
960464 - 070228. ref SDS D9 LQ6W
960465 -
960466 -        [On 070302 Gloria at the Kaiser Coagulation Control Clinic
960467 -        in Martinez, CA called and left a message saying that since
960468 -        Kaiser did not receive results of the blood test at UCSF
960469 -        the day before on 070301, Millie should get a blood test
960470 -        for INR the following week on 070308 to evaluate Coumadin
960471 -        treatments for pulmonary embolism. ref SDS E2 U24Y
960473 -         ..
960474 -        [On 070302 Millie called back and left a message for Gloria at
960475 -        the Kaiser Coagulation Control Clinic in Martinez, CA, and
960476 -        Millie sent a letter to Arlette in the doctor's office at
960477 -        Kaiser's oncology clinic in Walnut Creek; copies were sent to
960478 -        Gloria, and to Jackie, the Clinical Research Coordinator at
960479 -        UCSF confirming the telephone message to Gloria that reported
960480 -        the blood test on 070301 shows INR 2.5, ref SDS E2 K14H, and so
960481 -        testing for INR would occur with the next blood test on 070329
960482 -        for the next cycle of cetuximab treatment for IBC. ref SDS E2
960483 -        X84G
960485 -         ..
960486 -        [On 070305 entering results of the blood test on 070301 showed
960487 -        a big difference in the way UCSF and Kaiser set the "normal"
960488 -        range for INR, ref SDS E1 SE6N, Millie wrote a letter notifying
960489 -        Jackie at UCSF with copies to Arlette and Gloria at Kaiser,
960490 -        ref SDS E3 XG5H; and asking UCSF for clarification to
960491 -        facilitate managing Millie's Coumadin treatments for pulmonary
960492 -        embolism. ref SDS E3 3A4Y
960494 -         ..
960495 -        [On 070305 Millie requested that Gloria coordinate directly
960496 -        with UCSF on interpreting the UCSF blood test report for
960497 -        prescribing Coumadin to treat pulmonary embolism, and
960498 -        reminded that UCSF has ordered another blood test on
960499 -        070308, so that INR can be tested again if needed.
960500 -        ref SDS E3 3A6S
960502 -         ..
960503 -        [On 070305 Brigid advised INR 2 - 3 is the correct range for
960504 -        prescribing Coumadin to treat Millie for pulmonary embolism,
960505 -        despite being 100% over the normal range in the report for the
960506 -        UCSF blood test on 070301. ref SDS E3 SN5O
960508 -         ..
960509 -        [On 070305 UCSF did not make distribution to coorindate
960510 -        communciations with Kaiser; Millie sent a letter thanking
960511 -        Brigid for timely response to INR question, and sent copies
960512 -        thanking Jackie for timely coordination, and also copies to
960513 -        Arlette at Kaiser in Walnut Creek, and to Gloria in
960514 -        Kaiser's Coagulation Control Clinic in Martinez, CA for
960515 -        managing Coumadin that treats Millie's pulmonary embolism.
960516 -        ref SDS E3 B18H
960518 -         ..
960519 -        [On 070306 Millie requests feedback from Gloria to verify
960520 -        accuracy of understandings that Kaiser is satisfied with
960521 -        UCSF blood test on INR for prescribing Coumadin to treat
960522 -        pulmonary embolism, and advises current regimen will
960523 -        continue until further notice. ref SDS E4 FJ9K
960525 -         ..
960526 -        [On 070307 Gloria confirmed Millie's current Coumadin
960527 -        treatment should be continued based on UCSF blood test
960528 -        reporting, ref SDS E6 UH4M, and advised there is not enough
960529 -        time to confirm with written instructions that verify
960530 -        accuracy. ref SDS E6 UH6L
960531 -
960532 -
960533 -
960534 -
9606 -

SUBJECTS
Absolute Neutrophils Count ANC 1230 Well Below 1800 Required for Tre

AB03 -
AB0401 -  ..
AB0402 - ANC 1230 Well Below 1800 Criteria for Blood Counts to Approve Treatment
AB0403 -
AB0404 - Follow up ref SDS D8 P560, ref SDS D2 P560.
AB0405 -
AB0406 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
AB0407 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
AB0409 -     ..
AB0410 -    NEUTS           L       1.23   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
AB0411 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
AB0413 -  ..
AB0414 - During the meeting with Doctor Rugo this afternoon prior to treatment,
AB0415 - Brigid explained today that NEUTS = 1.23 listed in the UCSF blood test
AB0416 - report today, per above, ref SDS 0 QY6H, corresponds to ANC listed in
AB0417 - Kaiser's report. ref SDS E0 VF5M  This reflects Nurses's Notes for
AB0418 - treatment today showing ANC 1.23.
AB0420 -  ..
AB0421 - Additionally, UCSF does not multiply the calculation by 1000, as
AB0422 - Kaiser does, reported on 060810. ref SDS 97 GL4M, so the number 1.23
AB0423 - correspondes to ANC 1230 in Kaiser's scheme.  UCSF may calculate ANC
AB0424 - differently, because Kaiser uses 1500 for the low check point, also,
AB0425 - reported on 060810, ref SDS 97 5K4F, rather than 1800 (1.8), indicated
AB0426 - in UCSF test report. ref SDS 0 QY6H
AB0428 -  ..
AB0429 - ANC continues falling...
AB0430 -
AB0431 -        6972................................ 060814, ref SDS 98 P560
AB0432 -        6390................................ 060908, ref SDS A1 P560
AB0433 -        5200................................ 060929, ref SDS A3 P560
AB0434 -        3869................................ 061020, ref SDS A8 P560
AB0435 -        2880................................ 061110, ref SDS B2 P560
AB0436 -        2888................................ 061201, ref SDS B4 P560
AB0437 -        1760................................ 070201, ref SDS C6 P560
AB0438 -        1230................................ 070301, ref SDS 0 P560
AB0440 -  ..
AB0441 - Since the calculation at UCSF for ANC seems different from Kaiser,
AB0442 - direct comparisons in the above table may be misleading.
AB0443 -
AB0444 -            [On 070301 research on low blood counts indicates so far
AB0445 -            Millie has "mild" neutropenia. ref SDS E0 R13I
AB0447 -  ..
AB0448 - Doctor Rugo approved treatment today with low ANC.  This aligns with
AB0449 - patient history for treatment with ANC in range today, reported in
AB0450 - case study on 060810, ref SDS 97 5V7M, citing work at Kaiser on
AB0451 - 050916. ref SDS 78 4N5M
AB0452 -
AB0453 -            [On 070308 ANC increased to 1.51 within the normal range
AB0454 -            for cetuximab treatments. ref SDS E7 P560
AB0455 -
AB0456 -
AB0457 -
AB0458 -
AB0459 -
AB05 -

SUBJECTS
CA 15-3 Test 070208 and 070215 Results Still Pending Submission by K

AF03 -
AF0401 -  ..
AF0402 - CA 15-3 36 Tests 2 From Kaiser 1 from UCSF Pending Submission
AF0403 -
AF0404 - Follow up ref SDS D8 2N5J, ref SDS D2 2N5J.
AF0406 -  ..
AF0407 - CA 15-3 for the blood test this morning was not provided with results
AF0408 - reported today.  Subsequently, on 070307 Catherine called and advised
AF0409 - the result for the test today is 36. ref SDS E6 U85L   Later on 070307
AF0410 - Arlette at Kaiser reported CA 15-3 was 55 on 070208, and a week later
AF0411 - dropped again to 52 on 070315.  This record of consistently falling
AF0412 - cancer marker since starting treatment with cetuximab on 070201 seems
AF0413 - to indicate response to treatment. ref SDS 0 A16M
AF0415 -  ..
AF0416 - CA 15-3 36 is the best cancer marker condition for Millie in over a
AF0417 - year, shown in the record meeting with the doctor today. ref SDS E0
AF0418 - 087J
AF0420 -  ..
AF0421 - CA 15-3 presents a diagnostic of measurable disease in Millie's case,
AF0422 - noted in the record for the meeting at UCSF on 070130. ref SDS C4 M652
AF0423 -
AF0424 -      [On 070302 letter to Kaiser requests results of CA 15-3 tests on
AF0425 -      070208 and 070215. ref SDS E2 EY5W
AF0426 -
AF0427 -      [On 070306 Millie asks Kaiser for CA 15-3 test results for
AF0428 -      blood work on 070208 and 070215. ref SDS E5 MI7J
AF0430 -       ..
AF0431 -      [On 070511 Millie ordered CA 15-3 at Kaiser to prepare for
AF0432 -      meeting with primary care physician scheduled on 070525, and to
AF0433 -      cross-check remarkable results reported by the UCSF Lab.
AF0434 -      ref SDS E9 B64J
AF0436 -       ..
AF0437 -      [On 070516 Kaiser reports CA 15-3 56 and describes this result as
AF0438 -      "stable," ref SDS F0 QN6M, which significantly conflicts with
AF0439 -      testing at UCSF. ref SDS F0 WV6L
AF0441 -       ..
AF0442 -      [On 070516 Millie asks Kaiser to verify accuracy of CA 15-3 test
AF0443 -      on 070511, and to notify UCSF to be prepared for meeting with the
AF0444 -      patient on 070524. ref SDS F0 ZJ9N
AF0446 -       ..
AF0447 -      [On 070517 Kaiser advised that UCSF uses a different calibration
AF0448 -      method for CA 15-3 that cannot be compared to the Kaiser test
AF0449 -      results, like comparing apples and oranges. ref SDS E0 NT3O
AF0451 -       ..
AF0452 -      [On 070517 Nurse's Notes show nurse practitioner ordered another
AF0453 -      blood test to verify elevated CA 15-3 56 reported in Kaiser's
AF0454 -      test on 070511; but did not perform the test, and decided to wait
AF0455 -      another week to address the issue. ref SDS F1 FG6H
AF0457 -       ..
AF0458 -      [On 070517 Brigid discloses that coordinating divided
AF0459 -      responsibilities on referral projects is difficult; and that UCSF
AF0460 -      recommends limiting laboratory work rather than empowering labs
AF0461 -      to cross-check tests for accuracy. ref SDS F2 466H
AF0462 -
AF0463 -
AF0464 -
AF0465 -
AF0466 -
AF05 -

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

AJ03 -
AJ04 - 1500
AJ0501 -  ..
AJ0502 - Preparation for Treatment Required One (1. Attempt to Connect Port
AJ0503 -
AJ0504 - Follow up ref SDS D8 EB7J, ref SDS D2 EB7J.
AJ0506 -  ..
AJ0507 - Catherine connected the IV tubes to the port....
AJ0509 -       ..
AJ0510 -      Interlink System Vented Paclitaxel set
AJ0512 -  ..
AJ0513 - There were no problems getting blood to flow from the port for the
AJ0514 - blood sample research vials, as occurred last week on 070222,
AJ0515 - ref SDS D7 DC5W, and earlier on 070201. ref SDS C6 DC5W
AJ0517 -  ..
AJ0518 - Pauline flushed the port with saline.
AJ0519 -
AJ0520 -
AJ0521 -
AJ0522 -
AJ06 -

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

AN03 -
AN0401 -  ..
AN0402 - Blood Draws 7 Vials for Clinical Study Research
AN0403 -
AN0404 - Follow up ref SDS D8 O56V, ref SDS D2 O56V.
AN0405 -
AN0406 - Blood draw for cetuximab clinical study research required today.
AN0407 - Seven (7) vials were drawn, adding to 10 vials on 070201, ref SDS C6
AN0408 - O56V, and another 7 vials drawn on 070208. ref SDS C9 O56V
AN0410 -  ..
AN0411 - Blood blood normally.  Problems reported drawing the last few vials on
AN0412 - 070201, ref SDS C6 O56V, did not occur today.
AN0413 -
AN0414 -
AN0415 -
AN0416 -
AN0417 -
AN0418 -
AN05 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

AP03 -
AP04 - 1530
AP0501 -  ..
AP0502 - Benedryl Reduce Side Effects Cetuximab Chemotherapy Treatment
AP0503 -
AP0504 - Follow up ref SDS D8 DC7J, ref SDS D2 DC7J.
AP0505 -
AP0506 - Benadryl (diphenhydramine) started.   50 MG....... ref SDS 0 IJ41
AP0507 -
AP0508 -        Purpose reported on 060721. ref SDS 89 DC7J
AP0510 -  ..
AP0511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
AP0512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 0
AP0513 - IJ41
AP0514 -
AP0516 -  ..
AP06 -
AP07 -
AP08 - 1540
AP09 -
AP0901 - Benedryl completed equipment beeps.
AP0902 -
AP0903 -
AP0905 -  ..
AP10 -
AP11 -
AP12 -
AP13 -
AP1301 - Decadron (dexamethasone) IV pre-treatment........ ref SDS 0 FM4M
AP1302 -
AP1303 - On 070208 Decadron was not given because Millie did not experience
AP1304 - side effects of nausea and vomitting after treatment with cetuximab on
AP1305 - 070201. ref SDS C9 G57I  Since this favorable condition continues, per
AP1306 - above, ref SDS 0 D19M, Decadron was not given again today.
AP1307 -
AP1308 -
AP1309 -
AP1310 -
AP1311 -
AP1313 -  ..
AP14 -
AP15 -
AP16 -
AP17 -
AP1701 - Decadron completed -- not reported.
AP1702 -
AP1703 -
AP1704 -
AP1705 -
AP18 -

SUBJECTS
Cetuximab 2nd Cycle 1st Treatment Clinical Study Drug Trial Treatmen

AR03 -
AR04 - 1545
AR0501 -  ..
AR0502 - Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
AR0503 -
AR0504 - Follow up ref SDS D8 4N5M, ref SDS D2 4N5M.
AR0505 -
AR0506 - Cetuximab started.
AR0507 -
AR0508 -           Verify chemotherapy order for 070208.
AR0510 -  ..
AR0511 - Chemotherapy Orders...
AR0512 -
AR0518 -    Auth#                                     Stor BCC LOC
AR0519 -    Visit:  12575738             DOS 20070201
AR0521 -     ..
AR0522 -    Date:  20070201
AR0524 -     ..
AR0525 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
AR0526 -    in combination with Carboplatin in ER-negative, PR-negative,
AR0527 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers
AR0529 -     ..
AR0530 -    Dates to be given:  070201
AR0531 -    Arm 1:Cetuximab alone
AR0533 -     ..
AR0534 -    Diagnosis:  breast cancer
AR0536 -     ..
AR0537 -    ICD-9 codes: 174.9
AR0538 -    Allergies  NKDA
AR0540 -     ..
AR0541 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
AR0543 -     ..
AR0544 -    3. Diphenhydramine 50 mg IV or  [illegible writing]
AR0546 -     ..
AR0547 -    4. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
AR0548 -
AR0549 -       Further premed TBD [barely legible handwriting??]
AR0551 -     ..
AR0552 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
AR0554 -     ..
AR0555 -    5. Cetuximab (Erbitux) (loading dose)
AR0556 -
AR0557 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
AR0558 -              first dose x 1
AR0559 -
AR0560 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
AR0561 -       (concentration 2 mg/ml)
AR0563 -     ..
AR0564 -    6. Cetuximab (Erbitux) (maintenance dose)
AR0565 -
AR0566 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
AR0567 -              ____mg) IV over 60 or ____ minutes.
AR0568 -
AR0569 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
AR0570 -       Infuse once weekly for 8 weeks.  First dose to be given on date
AR0571 -       20070201.
AR0573 -        ..
AR0574 -       Cetuximab is administered undiluted through a low protien
AR0575 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
AR0576 -       line at the end of the infusion.
AR0578 -        ..
AR0579 -       ARM 2:  Administer carboplatin of vital sighs are unremarkable
AR0580 -       one hour after cetuximab infusion.
AR0582 -        ..
AR0583 -       Vital signs at baseline, upon cetuximab completion and one hour
AR0584 -       after cetuximab.
AR0585 -
AR0586 -       ****please note start and stop times****
AR0588 -        ..
AR0589 -       Laboratory work:
AR0590 -
AR0591 -          See carboplatin orders
AR0593 -        ..
AR0594 -       x  Notify MD for dose modifications if patient has severe
AR0595 -          acneinform rash
AR0596 -
AR0597 -          CBC with differential and platletes every 4 weeks
AR0598 -          Creatinine and magnesium every 4 weeks
AR0599 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
AR0600 -          weeks.  If levels are outside of normal laboratory values
AR0601 -          notify Brigid NP  (MD/RN) at 415 443 4730
AR0603 -        ..
AR0604 -       x  Physician has discussed risks/benefits of therapy with the
AR0605 -          patient.  Signed consent obtained.
AR0606 -
AR0607 -
AR0608 -          Yes  No   O2 by nasal cannula at 2 liters/min prn for chest
AR0609 -          pain or SOB
AR0611 -           ..
AR0612 -          Yes  No   Diphenhydramine 50 mg IV prn x1 for urticaria
AR0613 -          [barely legible], pruritis SOB
AR0615 -           ..
AR0616 -          Yes  No   Hydrocortizone 100 mg IV prn x1 for urticaria
AR0617 -          [barely legible], pruritis SOB
AR0619 -           ..
AR0620 -          Yes  No   Albuterol inhaler 2-4 puffs prn SOB or chest
AR0621 -          tightness
AR0623 -           ..
AR0624 -          Yes  No   Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
AR0625 -          anaphylaxis
AR0627 -           ..
AR0628 -          Breast CC05752 Cetuximab doc 20061024
AR0629 -          Approved 20060615
AR0631 -           ..
AR0632 -          Physician signature [Hope Rugo]
AR0634 -           ..
AR0635 -          Provider#  35313
AR0637 -           ..
AR0638 -          Date:  20010131
AR0639 -
AR0641 -  ..
AR07 -
AR08 -
AR09 - 1645
AR10 -
AR1001 - Cetuximab treatment completed.
AR1002 -
AR1003 - Millie had a 1 hour rest and observation period.
AR1004 -
AR1005 -
AR1007 -  ..
AR11 -
AR12 -
AR13 - 1730
AR14 -
AR1401 - Pauline disconnected the IV tubes.
AR1403 -  ..
AR1404 - She inserted Herceptin to flush the port.
AR1406 -  ..
AR1407 - She then removed the needle from the port, and swabbed the needle
AR1408 - wound, and placed a temporary bandage.
AR1409 -
AR1410 -
AR1411 -
AR1412 -
AR1413 -
AR15 -

SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme

AU03 -
AU04 - 0930
AU0501 -  ..
AU0502 - Vitals Show Patient Stable
AU0503 -
AU0504 - Follow up ref SDS D8 AW4L, ref SDS D2 AW4L.
AU0505 -
AU0506 - Catherine took vitals after starting Taxotere drip treatment...
AU0507 -
AU0508 -                    Blood
AU0509 -    Date   Time     Pressure   Pulse  Temprtr  Weight   So2
AU0511 -     ..
AU0512 -    070301 1645..... 125  62     90 *   36.4c
AU0513 -    070301 1505..... 112  69     86 *   36.6c            98
AU0514 -    070222 1145..... 115  73     58     36.3c   147      98
AU0515 -    070222 1045..... 100  60     56     36.6c   147      98
AU0516 -    070222 0930..... 117  63     68     36.2c   147      97
AU0517 -    070215 1200..... 106  66     61     37.0c   147      97
AU0518 -    070215 1055.....  96  61     64     37.0c   147      94
AU0519 -    070215 0930..... 100  64     66     36.7c   147      98
AU0520 -    070208 0920..... 143  70     59     36.5c   147      98
AU0521 -    070201 1330..... 136  74     66             148      94
AU0522 -    070201 1220..... 110  65     62     36.3c   148      96
AU0523 -    070201 1000..... 132  80     65     36.9c   148      99
AU0524 -    061201 1534..... 123  76     76     97.5    150
AU0525 -    061110 1534..... 136  83     73     97.0    150      98
AU0526 -    061020 1534..... 140  79     67     99.8    151      97
AU0527 -    060929 1452..... 141  78     66     98.3    149
AU0528 -    060908 1335..... 139  79     73     98.1    149
AU0529 -    060814 1610..... 139  80     59     98.2    151
AU0530 -    060722 1440..... 142  74     67     98.1    149
AU0531 -    060711.......... 172  87     54     97.5    147
AU0532 -    060623.......... 141  87     71     98.0    147
AU0533 -    060428.......... 129  73     80     99.4    149
AU0534 -    060217.......... 153  81     61     98.6    150
AU0535 -    050916.......... 120  80     80     98.5
AU0536 -
AU0537 -  *  Need vitals taken twice to verify atypical diagnostics.
AU0538 -
AU0539 -
AU0540 -
AU0541 -
AU06 -

SUBJECTS
Energy Normal Stable Alert Drive Home After Treatment IBC 3rd Relaps

AX03 -
AX04 - 1730
AX0501 -  ..
AX0502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
AX0503 -
AX0504 - Follow up ref SDS D8 F54N, ref SDS D2 F54N.
AX0506 -  ..
AX0507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
AX0508 - clinical study drug trial. ref SDS 92 YP4I
AX0510 -  ..
AX0511 - Millie reported side effects today lower energy. ref SDS 0 FG3N
AX0513 -  ..
AX0514 - Millie was alert after treatment again today, and not wobbly nor
AX0515 - disoriented.  She was able to drive home without side effects of
AX0516 - treatment.
AX0517 -
AX0518 -
AX0519 -
AX0520 -
AX0521 -
AX0522 -
AX0523 -
AX0524 -
AX0525 -
AX06 -