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 10, 2008 08:00 AM Thursday; Rod Welch

Millie 3rd treatment 5th 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 New Power Port Huber Needle Configured Kaiser
3...Power Port Huber Needle Configured Kaiser Surgeon Effective at UCSF
4...Missing Blood Tests Previous Lab on 080526
5...NEUTS Improve UCSF Prescribed Neupogen Treatment on Sunday
6...Xray Needed for Power Port UCSF Coordinates with Kaiser
7...Power Port Surgery Certification Required Kaiser Submit to UCSF


..............
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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 B4 0000. ref SDS B0 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040508 -  ..
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 B4 X33O, ref SDS B0 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 B4 356I, ref SDS B0 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
040985 -
040987 -    ..
040988 -   Cetuxiab with Carboplatin Clinical Study 2nd Arm
040989 -
040990 -   Follow up ref SDS B4 5B6J, ref SDS B0 5B6J.
040991 -
040992 -   On 080207 doctor reports IBC may be spreading. ref SDS 68 GH5H
040993 -   Follow up examination on 080219 Doctor Rugo diagnosed progression of
040994 -   disease. ref SDS 88 3J4I  Photographs show spread of IBC rash,
040995 -
040996 -             2nd
040997 -             Arm              Cetuximab Carboplatin
040998 -   65.  Cycle 01 15 and 22 and 02 58 02  01... 080313, ref SDS 79 TZ8I
040999 -   66.  Cycle 01 15 and 22 and 03 59 03  01... 080320, ref SDS 80 TZ8I
041000 -   67.  Cycle 01 15 and 22 and 04 60 04  01... 080327, ref SDS 81 TZ8I
041001 -   68.  Cycle 02 16 and 23 and 01 61 05  02... 080403, ref SDS 82 TZ8I
041002 -   69.  Cycle 02 16 and 23 and 02 62 06  03... 080410, ref SDS 85 TZ8I
041003 -   70.  Cycle 02 16 and 23 and 03 63 07  03... 080417, ref SDS 87 TZ8I
041004 -   71.  Cycle 02 16 and 23 and 04 64 08  03... 080424, ref SDS 89 TZ8I
041005 -   72.  Cycle 03 17 and 24 and 01 65 09  04... 080501, ref SDS 91 5B6J
041006 -   73.  Cycle 03 17 and 24 and 02 66 10  05... 080508, ref SDS 93 5B6J
041007 -   74.  Cycle 03 17 and 24 and 03 67 11  05... 080515, ref SDS 94 5B6J
041008 -   75.  Cycle 03 17 and 24 and 04 68 12  05... 080522, ref SDS 95 5B6J
041009 -   76.  Cycle 04 18 and 25 and 01 69 13  06... 080529, ref SDS 98 5B6J
041010 -   77.  Cycle 04 18 and 25 and 02 70 14  07... 080605, ref SDS 99 5B6J
041011 -   78.  Cycle 04 18 and 25 and 03 71 15  08... 080612, ref SDS A2 5B6J
041012 -   79.  Cycle 04 18 and 25 and 04 72 16  08... 080619, ref SDS A5 5B6J
041013 -   80.  Cycle 05 19 and 26 and 01 73 17  09... 080626, ref SDS B0 5B6J
041014 -   81.  Cycle 05 19 and 26 and 02 74 18  10... 080703, ref SDS B4 5B6J
041015 -   82.  Cycle 05 19 and 26 and 03 75 19  11... 080710, ref SDS 0 5B6J
041017 -  ..
041018 - Today is the 3rd treatment of the 5th cycle with cetuximab and
041019 - Carboplatin together.  This is the 19th treatment overall with
041020 - cetuximab on the 2nd arm of the clinical study, but is only the 11th
041021 - treatment with Carboplatin due to low blood counts.
041022 -
041023 -
041024 -
041025 -
041026 -
0411 -

SUBJECTS
Default Null Subject Account for Blank Record

0503 -
0504 - 0800
050501 -  ..
050502 - Labs Blood Test New Power Port Huber Needle Configured Kaiser
050503 - Power Port Huber Needle Configured Kaiser Surgeon Effective at UCSF
050504 -
050505 - Follow up ref SDS B4 FW5N, ref SDS B0 FW5N.
050506 -
050507 - Adding Carboplatin to the treatment protocol now requires weekly blood
050508 - tests to determine if the immune system is strong enough for safe
050509 - chemotherapy treatment, reported on 070201, ref SDS 11 XR40, and citing
050510 - the clinical study protocol received from UCSF on 070116. ref SDS 10
050511 - 5U7Z
050513 -  ..
050514 - Catherine was Millie's nurse today.
050516 -  ..
050517 - Catherine received Millie's letter, ref DIP 1 0001, sent yesterday on
050518 - 080709, ref SDS B6 FK6F, reporting surgery the day before on Tuesday,
050519 - to replace the port catheter with a new Power Port. ref SDS B5 0001
050521 -  ..
050522 - Catherine used the Huber needle pre-configured with stitches by Doctor
050523 - Riley-Paull during surgery.  The port worked perfectly today,
050524 - reflecting testing at Kaiser on Tuesday, 080708. ref SDS B5 6F4I
050525 - Blood flowed generously, with no problems.  Catherine will coordinate
050526 - with the medical staff on removing stitches after Millie's treatment
050527 - today, as planned by the surgeon at Kaiser. ref SDS B5 LI5K
050529 -             ..
050530 -            [...below, UCSF receives Kaiser certificate explaining
050531 -            Power Port was tested ready for use. ref SDS 0 MZ8G
050533 -             ..
050534 -            [On 080717 Millie letter to Kaiser commending the surgeon
050535 -            on successful Power Port surgery and accessing the Power
050536 -            Port for Millie's treatment at UCSF 2 days later,
050537 -            ref SDS B9 EF5I; and requesting name of anesthesiologist
050538 -            who did great work. ref SDS B9 623X
050540 -             ..
050541 -            [On 080911 UCSF used similar procedure to configure Huber
050542 -            needle accessing Power Port for Millie's treatment to be
050543 -            used later at Kaiser for a CT test. ref SDS C1 OY4J
050544 -
050545 -
050547 -  ..
050548 - During treatment, Catherine submitted results of the test.
050549 -
050564 -     ..
050565 -    Log#:                   080710 08:10
050566 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
050567 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
050568 -     ..
050569 -    CBC with DIFF & PLT CT                                     CBCD
050570 -     ..
050571 -    WBC COUNT               7.4    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
050572 -    RBC COUNT      L        3.74   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
050573 -    HEMOGLOBIN             12.7    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
050574 -    HEMATOCRIT             36.8    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
050575 -    MCV                    98      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
050576 -    MCH                    34.0    pg           26  -   34     MCH
050577 -    MCHC                   34.6    g/dL         31  -   36     MCHC
050578 -    PLATELETS             173      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
050579 -
050580 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
050581 -        Francisco, CA  94115
050582 -    ..
050583 -     (NEUTS x 1000 = ANC for Kaiser)
050584 -    NEUTS         L         5.12   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
050585 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
050587 -     ..
050588 -    LYMPHS                  1.52   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
050589 -    MONOS                   0.37   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
050590 -    EOS                     0.32   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
050591 -    BASOS                   0.05   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
050592 -
050594 -  ..
050595 - Missing Blood Tests Previous Lab on 080526
050596 -
050597 - Follow up ref SDS B4 TW3O.
050598 -
050599 - Catherine reviewed labs on 080626 reporting tests were omitted
050600 - compared to prior tests, ref SDS B0 HS7I, following up review last
050601 - week on 080703. ref SDS B4 TW3O
050603 -  ..
050604 - She feels the test on 080626 correctly applies Chemotherapy Orders
050605 - issued on 080626. ref SDS B0 PWPW  Previous labs may have included
050606 - tests that were ordered my mistake.  Catherine advised that Brigid and
050607 - Doctor Rugo are both out of the office today.  She proposed discussing
050608 - scope of labs with the medical team in 2 weeks when we meet to start
050609 - the next cycle.
050610 -
050611 -
050613 -  ..
050614 - NEUTS Improve UCSF Prescribed Neupogen Treatment on Sunday
050615 -
050616 - Follow up ref SDS B4 PU6K, ref SDS B0 PU6K.
050617 -
050618 - Blood counts increased significantly again for the 3rd consecutive
050619 - week shown by the Lab report today with NEUTS 5.12, ref SDS 0 QY6H,
050620 - compared with NEUTS 2.90 last week on 080703, ref SDS B4 QY6H
050621 - Significant rise in blood counts with weekly Carboplatin chemotherapy
050622 - treatments, reflects getting 2 treatments with Neupogen last week at
050623 - the Kaiser Infusion Clinic, and aligns with Brigid's instructions
050624 - during the meeting at UCSF on 080626, ref SDS A9 QJ4H, even though
050625 - Chemotherapy Orders to do not prescribe Neupogen. ref SDS B0 PWSY
050627 -  ..
050628 - Catherine advised that Doctor Rugo and Brigid are both out of the
050629 - office today.  She feels Millie's 3 successive weeks of rising blood
050630 - counts to far above the save level for treatment could support cost
050631 - containment and avoiding side effects, reported on 080629, ref SDS B3
050632 - 6Q5J, by avoiding one or both Neupogen treatments this week.  Since
050633 - there is no medical professional to consult on Millie's case,
050634 - Catherine recommended continuing with 2 Neupogen treatments this week,
050635 - i.e., tomororw and Saturday, following the prescription during the
050636 - meeting on 080626. ref SDS A9 QJ4H
050638 -  ..
050639 - Side effects of Neupogen reported on 080628, ref SDS B1 6Q5J, and
050640 - again on 080629, ref SDS B3 6Q5J, have been less severe the past week
050641 - even though Neupogen treatments have continued at 2 per week.
050642 -
050643 -     [On 080713 Millie reported recurrence of Neupogen side effects.
050644 -     ref SDS B7 RM99
050645 -
050646 -
050647 -
050648 -
0507 -

SUBJECTS
Default Null Subject Account for Blank Record

0603 -
060401 -  ..
060402 - Xray Needed for Power Port UCSF Coordinates with Kaiser
060403 - Power Port Surgery Certification Required Kaiser Submit to UCSF
060404 -
060405 - Follow up ref SDS B4 MZ8G, ref SDS B0 MZ8G.
060406 -
060407 - Surgery at Kaiser this past Tuesday on 080708 replaced the port
060408 - catheter with a Power Port. ref SDS B5 0001
060410 -  ..
060411 - Millie submitted the certificate from Kaiser reporting that the Power
060412 - Port implanted on 080708 was tested successfully, ref SDS B5 BF4K, as
060413 - requested by UCSF on 080626. ref SDS B0 MZ9L
060415 -  ..
060416 - On 080627 Millie coordinated with the primary care physician at Kaiser
060417 - notifying that UCSF needs a "certificate" from the surgeon.  The
060418 - primary care physician in the Oncology Department at Kaiser notified
060419 - the surgeon to prepare a "certificate" stating Power Port has been
060420 - tested and found suitable for use at UCSF.  On 080708 surgery was
060421 - performed for the Power Port; the surgeon was reminded to submit a
060422 - "certificate" on suitability for use at UCSF.  The surgoen was
060423 - annoyed, noting there is no medical documentation for "certificates."
060424 - ref SDS B5 O65F
060426 -  ..
060427 - Catherine clarified today that UCSF needs the xray report showing
060428 - placement of the Power Port. ref SDS B5 O67N  UCSF management called
060429 - Kaiser during Millie's treatment today.  The Kaiser Surgery department
060430 - coordinated submission of the xray report via fax to the Infusion
060431 - Clinic at UCSF. ref SDS B5 UY3I  Catherine filed the Kaiser xray
060432 - report in Millie's medical chart at UCSF.  The certificate was
060433 - evidently not needed.
060435 -  ..
060436 - Millie reviewed documentation on the Power Port with instructions for
060437 - use, received from Kaiser on 080708. ref SDS B5 DZ5O
060439 -  ..
060440 - Catherine assisted Millie in filling out the Power Port identification
060441 - card received in the packet on 080708. ref SDS B5 PPRR
060443 -  ..
060444 - Catherine made copies of instructions for use, including guidance on
060445 - the back of the ID card showing flushing volumes to maintain the Power
060446 - Port for optimal flow, as shown in the record on 080708. ref SDS B5
060447 - EM3L
060448 -
060450 -  ..
0605 -
0606 -
0607 - 1245
0608 -
060801 - Millie's treatment was stretched out today due to heavy volume of
060802 - patients.  Another nurse assisted to disconnect the treatment IV for
060803 - Carboplatin and flush the port, per Bard protocol, reported on 080708,
060804 - ref SDS B5 XJ6S, while Catherine was tending other patients.
060806 -  ..
060807 - Catherine advised that she got approval to remove stitches holding the
060808 - Huber needle in the Power Port.
060810 -  ..
060811 - Catherine removed the several bandages to expose the Huber needle, and
060812 - the stitches.  She used a specially sealed set of scissors and
060813 - tweesers to carefully remove the stitches.  They came looses easily
060814 - and without discomfort to Millie, in the manner explained by the
060815 - surgeon at Kaiser on 080708. ref SDS B5 LI5K
060817 -  ..
060818 - Catherine remarked on excellent work by the surgeon.  She said
060819 - sometimes an incision of this kind is longer than needed, or there
060820 - might be 2 incisions where only one is needed, and this extends
060821 - discomfort from recovery and healing time for the patient.  Catherine
060822 - noted only a single small incision, and that the new Power Port seems
060823 - to have been slid into place an inch or so from the site of the port
060824 - catheter that was removed.
060826 -  ..
060827 - Millie asked about removing the surgical tape covering the incision
060828 - wound for implanting the Power Port during surgery on Tuesday, 080708.
060829 - ref SDS B5 436J
060831 -  ..
060832 - Catherine explained the tape may fall off over the next week, and if
060833 - not, she will inspect the incision wound and decide about removing the
060834 - tape at that time.
060835 -
060836 -     [On 080717 Catherine examined the wound and noted good progress
060837 -     healing; decided to leave the surgical tape in place another week.
060838 -     ref SDS B8 IL3L
060840 -      ..
060841 -     [On 080719 as a result of complications from CT test on 080718
060842 -     causing bleeding throught surgical wound, Julie in Kaiser Infusion
060843 -     Clinic removed the original surgical tape from the Power Port
060844 -     incision wound; inspection shows healing, but possible compromise
060845 -     with slight gap from the bleeding; fresh surgical tape was placed
060846 -     to dress the wound. ref SDS C0 LD87
060848 -  ..
060849 - Catherine placed a large square bandage over the area, including the
060850 - adhesion tape over the incison wound.  She seemed to say Millie can
060851 - remove the large bandage in a day or so, but should leave the tape in
060852 - place that was placed by the surgeon until next week.  She said this
060853 - tape is designed to wear off naturally, and so may begin to curl in a
060854 - few days, but leave it in place until treatment next Thursday.
060855 - Catherine will remove it at that time.
060856 -
060857 -
060858 -
060859 -
060860 -
060861 -
060862 -
060863 -
060864 -
060865 -
060866 -
060867 -
0609 -