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: July 31, 2008 08:00 AM Thursday; Rod Welch

Millie 2nd treatment 6th cycle cetuximab Carboplatin 4th relapse IBC.

1...Summary/Objective
...Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
...Cetuxiab Alone Clinical Study
...Cetuxiab with Carboplatin Clinical Study 2nd Arm
2...Labs Blood Test
3...NEUTS Decrease Neupogen Continue 2 Treatments Per Week New Cycle
4...Side Effects May Limit Neupogen Treatments Could Limit Chemotherapy
5...Cancer Marker CA 15-3 Results for Test 080724


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

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

0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS C7 0000. ref SDS C3 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040507 -
040509 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Background on Millie's treatment in the clinical study is reported on
040902 - 080508. ref SDS 93 TZ8I
040904 -    ..
040905 -   Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
040906 -
040907 -   Follow up ref SDS C7 X33O, ref SDS C3 X33O.
040908 -
040909 -   Millie had left mastectomy on 051021.  Biopsy at that time reported
040910 -   no findings of cancer.  Approximately 8 months later on 060707 the
040911 -   doctor diagnosed IBC relapse and prescribed treatment. ref SDS 3
040912 -   PF3O
040913 -
040914 -    1.  Cycle 09 and 01 ................... 060721, ref SDS 4 407N
040915 -    2.  Cycle 10 and 02 ................... 060814, ref SDS 6 LY6O
040916 -    3.  Cycle 11 and 03 ................... 060908, ref SDS 6 407N
040917 -    4.  Cycle 12 and 04 ................... 060929, ref SDS 6 407N
040918 -    5.  Cycle 13 and 05 ................... 061020, ref SDS 7 407N
040919 -    6.  Cycle 14 and 06 ................... 061110, ref SDS 8 407N
040920 -    7.  Cycle 15 and 07 ................... 061201, ref SDS 9 407N
040922 -    ..
040923 -   Cetuxiab Alone Clinical Study
040924 -
040925 -   Follow up ref SDS C7 356I, ref SDS C3 356I.
040926 -
040927 -                   Total    Cetuximab
040928 -    8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 11 SG8I
040929 -    9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 12 SG8I
040930 -   10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 13 SG8I
040931 -   11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 14 SG8I
040932 -   12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 15 SG8I
040933 -   13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 17 7T3H
040934 -   14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 18 7T3H
040935 -   15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 19 7T3H
040936 -   16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 20 7T3H
040937 -   17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 21 7T3H
040938 -   18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 22 7T3H
040939 -   19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 23 7T3H
040940 -   20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 24 7T3H
040941 -   21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 25 7T3H
040942 -   22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 26 7T3H
040943 -   23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 27 7T3H
040944 -   24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 28 7T3H
040945 -   25.  Cycle 05 and 12 and 02 18.......... 070531, ref SDS 29 7T3H
040946 -   26.  Cycle 05 and 12 and 03 19.......... 070607, ref SDS 30 7T3H
040947 -   27.  Cycle 05 and 12 and 04 20.......... 070614, ref SDS 31 0001
040948 -   28.  Cycle 06 and 13 and 01 21.......... 070621, ref SDS 32 0001
040949 -   29.  Cycle 06 and 13 and 02 22.......... 070628, ref SDS 33 0001
040950 -   30.  Cycle 06 and 13 and 03 23.......... 070705, ref SDS 34 0001
040951 -   31.  Cycle 06 and 13 and 04 24.......... 070712, ref SDS 34 0001
040952 -   32.  Cycle 07 and 14 and 01 25.......... 070719, ref SDS 35 0001
040953 -   33.  Cycle 07 and 14 and 02 26.......... 070726, ref SDS 33 0001
040954 -   34.  Cycle 07 and 14 and 03 27.......... 070802, ref SDS 34 0001
040955 -   35.  Cycle 07 and 14 and 04 28.......... 070809, ref SDS 36 0001
040956 -   36.  Cycle 08 and 15 and 01 29.......... 070816, ref SDS 37 0001
040957 -   37.  Cycle 08 and 15 and 02 30.......... 070823, ref SDS 38 0001
040958 -   38.  Cycle 08 and 15 and 03 31.......... 070830, ref SDS 38 0001
040959 -   39.  Cycle 08 and 15 and 04 32.......... 070906, ref SDS 39 0001
040960 -   40.  Cycle 09 and 16 and 01 33.......... 070920, ref SDS 40 0001
040961 -   41.  Cycle 09 and 16 and 02 34.......... 070927, ref SDS 41 0001
040962 -   42.  Cycle 09 and 16 and 03 35.......... 071004, ref SDS 42 0001
040963 -   43.  Cycle 09 and 16 and 04 36.......... 071011, ref SDS 43 0001
040964 -   44.  Cycle 10 and 17 and 01 37.......... 071018, ref SDS 44 0001
040965 -   45.  Cycle 10 and 17 and 02 38.......... 071025, ref SDS 45 0001
040966 -   46.  Cycle 10 and 17 and 03 39.......... 071101, ref SDS 31 0001
040967 -   47.  Cycle 10 and 17 and 04 40.......... 071108, ref SDS 46 0001
040968 -   48.  Cycle 11 and 18 and 01 41.......... 071115, ref SDS 47 0001
040969 -   49.  Cycle 11 and 18 and 02 42.......... 071122, ref SDS 33 0001
040970 -   50.  Cycle 11 and 18 and 03 43.......... 071129, ref SDS 49 0001
040971 -   51.  Cycle 11 and 18 and 04 44.......... 071206, ref SDS 50 0001
040972 -   52.  Cycle 12 and 19 and 01 45.......... 071213, ref SDS 53 0001
040973 -   53.  Cycle 12 and 19 and 02 46.......... 071220, ref SDS 56 0001
040974 -   54.  Cycle 12 and 19 and 03 47.......... 071227, ref SDS 57 0001
040975 -   55.  Cycle 12 and 19 and 04 48.......... 080103, ref SDS 58 0001
040976 -   56.  Cycle 13 and 20 and 01 49.......... 080110, ref SDS 61 0001
040977 -   57.  Cycle 13 and 20 and 02 50.......... 080117, ref SDS 62 0001
040978 -   58.  Cycle 13 and 20 and 03 51.......... 080124, ref SDS 63 0001
040979 -   59.  Cycle 13 and 20 and 04 52.......... 080131, ref SDS 65 0001
040980 -   60.  Cycle 14 and 21 and 01 53.......... 080207, ref SDS 69 0001
040981 -   61.  Cycle 14 and 21 and 02 54.......... 080214, ref SDS 70 0001
040982 -   62.  Cycle 14 and 21 and 03 55.......... 080221, ref SDS 34 0001
040983 -   63.  Cycle 14 and 21 and 04 56.......... 080228, ref SDS 75 0001
040984 -   64.  Cycle 15 and 22 and 01 57 01  00... 080306, ref SDS 78 TZ8I
040986 -    ..
040987 -   Cetuxiab with Carboplatin Clinical Study 2nd Arm
040988 -
040989 -   Follow up ref SDS C7 5B6J, ref SDS C3 5B6J.
040990 -
040991 -   On 080207 doctor reports IBC may be spreading. ref SDS 68 GH5H
040992 -   Follow up examination on 080219 Doctor Rugo diagnosed progression of
040993 -   disease. ref SDS 88 3J4I  Photographs show spread of IBC rash,
040994 -
040995 -             2nd
040996 -             Arm              Cetuximab Carboplatin
040997 -   65.  Cycle 01 15 and 22 and 02 58 02  01... 080313, ref SDS 79 TZ8I
040998 -   66.  Cycle 01 15 and 22 and 03 59 03  01... 080320, ref SDS 80 TZ8I
040999 -   67.  Cycle 01 15 and 22 and 04 60 04  01... 080327, ref SDS 81 TZ8I
041000 -   68.  Cycle 02 16 and 23 and 01 61 05  02... 080403, ref SDS 82 TZ8I
041001 -   69.  Cycle 02 16 and 23 and 02 62 06  03... 080410, ref SDS 85 TZ8I
041002 -   70.  Cycle 02 16 and 23 and 03 63 07  03... 080417, ref SDS 87 TZ8I
041003 -   71.  Cycle 02 16 and 23 and 04 64 08  03... 080424, ref SDS 89 TZ8I
041004 -   72.  Cycle 03 17 and 24 and 01 65 09  04... 080501, ref SDS 91 5B6J
041005 -   73.  Cycle 03 17 and 24 and 02 66 10  05... 080508, ref SDS 93 5B6J
041006 -   74.  Cycle 03 17 and 24 and 03 67 11  05... 080515, ref SDS 94 5B6J
041007 -   75.  Cycle 03 17 and 24 and 04 68 12  05... 080522, ref SDS 95 5B6J
041008 -   76.  Cycle 04 18 and 25 and 01 69 13  06... 080529, ref SDS 98 5B6J
041009 -   77.  Cycle 04 18 and 25 and 02 70 14  07... 080605, ref SDS 99 5B6J
041010 -   78.  Cycle 04 18 and 25 and 03 71 15  08... 080612, ref SDS A2 5B6J
041011 -   79.  Cycle 04 18 and 25 and 04 72 16  08... 080619, ref SDS A5 5B6J
041012 -   80.  Cycle 05 19 and 26 and 01 73 17  09... 080626, ref SDS B0 5B6J
041013 -   81.  Cycle 05 19 and 26 and 02 74 18  10... 080703, ref SDS B4 5B6J
041014 -   82.  Cycle 05 19 and 26 and 03 75 19  11... 080710, ref SDS B7 5B6J
041015 -   83.  Cycle 05 19 and 26 and 04 76 20  11... 080717, ref SDS C3 5B6J
041016 -   84.  Cycle 06 20 and 27 and 01 77 21  12... 080724, ref SDS C7 5B6J
041017 -   85.  Cycle 06 20 and 27 and 02 78 22  13... 080731, ref SDS 0 5B6J
041019 -  ..
041020 - Today is the 2nd treatment of the 6th cycle with cetuximab and
041021 - Carboplatin together.  This is the 22nd treatment overall with
041022 - cetuximab on the 2nd arm of the clinical study, but is only the 13th
041023 - treatment with Carboplatin due to low blood counts.
041025 -  ..
041026 - Diane is the nurse today.  Catherine is on vacation until 080821.
041028 -  ..
041029 - Diane just returned from vacation in Oregon.  Had a great time, living
041030 - in a remote location that was 30 miles from the nearest store.
041031 - Caught Trout from the deck of their cabin.  Lots of hiking, great
041032 - trails.
041034 -  ..
041035 - Diane submitted today the copy of the Huber needle specification,
041036 - which Catherine made last week and left in the medical chart for
041037 - Millie, after Millie left UCSF following treatment, and in accordance
041038 - with Catherine's letter to Millie on 080724. ref SDS C7 MB3V  This
041039 - actually duplicated a copy made and submitted to Millie Thursday
041040 - morning on 080724. ref SDS C7 MV7Y
041041 -
041042 -        [On 080821 a nurse had difficulty getting blood to flow through
041043 -        the Power Port with Huber needle technology, ref SDS D1 LO5F;
041044 -        Diane completed the blood draw, ref SDS D1 A66O; Diane seemed
041045 -        to advise that UCSF has standardized on all departments using
041046 -        the same Huber needle used for high powered injections of
041047 -        contrast medium for CT tests, so that mistakes do not occur
041048 -        substituting a less rigorous needle. ref SDS D1 N96I
041050 -         ..
041051 -        [On 080904 Catherine seemed say that nurses must select
041052 -        from a range of different Huber needles available for
041053 -        treatment in the Infusion Clinic, per Angiodynamics
041054 -        manufacturer's Lifeguard Safety needles listed on 080724,
041055 -        ref SDS C7 N79U; Catherine plans to use the needle specified
041056 -        for high pressure injections to treat Millie at UCSF on the
041057 -        day when the same needle will be used later in the same day
041058 -        at Kaiser for a CT test. ref SDS D2 V64G
041059 -
041060 -
041061 -
041062 -
041063 -
0411 -

SUBJECTS
Default Null Subject Account for Blank Record

0503 -
0504 - 0800
050501 -  ..
050502 - Labs Blood Test
050503 -
050504 - Follow up ref SDS C7 FW5N, ref SDS C3 FW5N.
050505 -
050506 - Adding Carboplatin to the treatment protocol now requires weekly blood
050507 - tests to determine if the immune system is strong enough for safe
050508 - chemotherapy treatment, reported on 070201, ref SDS 11 XR40, and citing
050509 - the clinical study protocol received from UCSF on 070116. ref SDS 10
050510 - 5U7Z
050512 -  ..
050513 - During treatment, Diane submitted results of the test.
050514 -
050529 -     ..
050530 -    Log#:                   080731 08:15
050531 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
050532 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
050533 -     ..
050534 -    CBC with DIFF & PLT CT                                     CBCD
050535 -     ..
050536 -    WBC COUNT               4.5    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
050537 -    RBC COUNT      L        3.77   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
050538 -    HEMOGLOBIN             12.9    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
050539 -    HEMATOCRIT             37.3    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
050540 -    MCV                    99      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
050541 -    MCH            H       34.1    pg           26  -   34     MCH
050542 -    MCHC                   34.5    g/dL         31  -   36     MCHC
050543 -    PLATELETS             226      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
050544 -
050545 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
050546 -        Francisco, CA  94115
050547 -    ..
050548 -     (NEUTS x 1000 = ANC for Kaiser)
050549 -    NEUTS         L         1.92   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
050550 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
050552 -     ..
050553 -    LYMPHS                  1.79   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
050554 -    MONOS                   0.50   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
050555 -    EOS                     0.23   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
050556 -    BASOS                   0.07   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
050557 -
050559 -     ..
050560 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
050561 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
050563 -     ..
050564 -    CREAT with eGFR
050565 -    CREATININE              0.46   mg/dL      0.42  - 1.06     CR    Creatinine        mg/dL   0.6  -  1.2
050566 -
050567 -      Note: Creatinine assay changed to IDMS standardization on
050568 -      February 4, 2008 causing decrease in results of approximately
050569 -      0.09 mg/dL
050571 -     ..
050572 -    eGFR if Caucasian     >60      mL/min                      GFRC
050573 -    eGFR if African Amer  >60      mL/min                      GFRA
050574 -
050575 -      eGFR corrected for 1.73 sq meters of body surface area
050576 -      Note:  eGFR is only an estimation. Please see online Lab Manual
050577 -      for potential limitations.
050578 -      Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
050579 -      CA  94115
050580 -
050582 -  ..
050583 - NEUTS Decrease Neupogen Continue 2 Treatments Per Week New Cycle
050584 - Side Effects May Limit Neupogen Treatments Could Limit Chemotherapy
050585 -
050586 - Follow up ref SDS C7 PU6K, ref SDS C3 PU6K.
050587 -
050588 - Blood counts decreased again this week, shown by the Lab report today
050589 - with NEUTS 1.92, ref SDS 0 QY6H, compared with NEUTS 2.32 last week on
050590 - 080724, ref SDS C7 QY6H  This is still well above the minimum of 1.5
050591 - for Millie to safely get chemotherapy treatment today.  Slight drop in
050592 - blood counts aligns with getting chemotherapy treatment last week with
050593 - Carboplatin, and suggests 2 Neupogen treatments per week may be on a
050594 - declining path of effectiveness, that eventually requires adding a 3rd
050595 - Neupogen treatment for each weekly cycle.
050596 -
050597 -        [On 080807 rising blood counts with same 2 treatments per week
050598 -        of Neupogen, may signal better prospects for maintaining blood
050599 -        counts that enable Millie to continue getting care in the
050600 -        clinical study. ref SDS D0 PU6K
050602 -  ..
050603 - Side effects of Neupogen reported on...
050604 -
050605 -               080726................, ref SDS C9 9W9I
050606 -               080721................, ref SDS C6 9W9I
050607 -               080713................, ref SDS C0 RM94
050608 -               080629................, ref SDS B3 6Q5J
050609 -               080628................, ref SDS B1 6Q5J
050610 -
050611 - ...show lessening effects, suggesting increased ability to tolerate 2
050612 - Neupogen treatments per week.  Hopefully, this indicates ability to
050613 - tolerate adding another weekly Neupogen treatment, increasing the dose
050614 - to 3 per week, if that becomes necessary in another few cycles for
050615 - Millie to continue getting the Carboplatin chemotherapy required by
050616 - the clinical study protcol, and which has been effective preventing
050617 - her cancer to worsen.
050618 -
050619 -
050621 -  ..
050622 - Cancer Marker CA 15-3 Results for Test 080724
050623 -
050624 - Follow up ref SDS C7 TR4K. ref SDS B0 PW7I.
050625 -
050626 - CA 15-3 71 was flat again last week; actually slightly down, shown by
050627 - the blood test for 080724 received from Diane today. ref SDS C7 A16M
050629 -  ..
050630 - This provided a big relief today from concerns a few weeks ago, when
050631 - it appeared the cancer maker had significantly escalated, reported in
050632 - the record on 080724. ref SDS C7 KE6G
050634 -  ..
050635 - The cancer marker was an issue last week on 080725 when Millie
050636 - notified NP of plans to return to work. ref SDS C8 MH7L
050637 -
050638 -
050639 -
050640 -
050641 -
050642 -
050643 -
050644 -
050645 -
0507 -