THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
S U M M A R Y
DIARY: February 1, 2007 08:00 AM Thursday;
Millie at UCSF 1st cycle Cetuximab and Carboplatin for IBC relapse.
2...Tape Recording SDS Record Accurate Comprehensive New Way of Working
3...Case Management Referral Coordination Plan Collaboration UCSF Kaiser
4...Clinic Examination Orientation Starting Treatment Cetuximab
5...Breast Examination Shows Improvement IBC Rash
6...6 Patients Participating UCSF Cetuximab Carboplatin Clinical Study
7...Photographs Establish Baseline to Measure Progression of Disease
8...Measureable Disease Photographs IBC Rash Improving
9...IBC Rash Improved Measurable Disease Photographs Tape Measure
10...Side Effects Medicated After Weekly Examinations
11...Randomized Cetuximab Increases Treatment Options
12...Blood Tests 4 Week Cycle Cetuximab Performed at UCSF Saves Time Cost
13...INR 1.6 Low Pulmonary Embolism Needs Increase Coumadin Treatment
14...Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 1.6
15...Biopsies Not Medically Relevant Too High Risk for Coumadin Patient
16...Infusion Clinic for Cetuximab Treatent 1st Cycle 1st Treatment
18...Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
19...Schedule Weekly Treatments Continue on Thursdays
20...Blood Counts Good Dose Cetuximab Normal
....Anticoagulattion Therapy INR Low 1.6 PT Patient High 16.3
21...ANC 1760 Well Above 1500 Criteria for Blood Counts Approve Treatment
22...CA 15-3 68 Rise from 56 Cancer Marker 2 Tests Pending
23...Preparation for Treatment Required One (1) Attempt to Connect Port
24...Blood Flow Port Catheter Very Slow Difficult
25...Blood Draws 10 Vials for Clinical Study Research
26...Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
27...Cetuximab Loading Dose 684 MG 1st Treatment 2 Hours
29...Vitals Show Patient Stable
30...Energy Normal Stable After Treatment Taxotere Support Drugs
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1...There may be some mechanics to work out so that Kaiser's records are
Case Management Communication SDS Record Accurate Meeting UCSF 07013
7503 - ..
7504 - Summary/Objective
750501 - Follow up ref SDS B6 0000. ref SDS B4 0000.
750503 - Treatment today went smoothly. Brigid did another exam and asked more
750504 - questions about patient history, ref SDS 0 FO6H, with Jackie assisting
750505 - to take pictures for evaluating measurable disease on the cetuximab
750506 - drug trial. ref SDS 0 6T6M Millie was randomized to get only
750507 - cetuximab, which works out well, because it provides another "bite at
750508 - the apple," if disease progresses. Fortunately, at this time IBC
750509 - seems less severe than over the past few months, so starting with
750510 - minimum treatment is good strategy. ref SDS 0 XR3M Another advantage
750511 - is that cetuximab requires blood tests only every 4 weeks, which helps
750512 - reduce medical costs. UCSF can further save time for blood draws, by
750513 - performing the procedure on site an hour before starting treatment,
750514 - rather than Millie taking time off work to get blood drawn at Kaiser
750515 - the day before treatment. ref SDS 0 XR40 An action item is to clarify
750516 - how the Kaiser Coagulation Treatment Clinic will get notice of INR
750517 - results, and, also, clarify payment authority for blood tests
750518 - performed at UCSF. ref SDS 0 G55H Catherine in the Infusion Clinic on
750519 - the 5th floor was terrific. There was a small problem getting all 10
750520 - vials of blood drawn for the cetuximab study. This may relate to
750521 - Millie's blood draw the day before on 070131. ref SDS 0 H79H
750522 - Cetuximab treatment today was given over 2 hours to observe any
750523 - adverse reactions. Thankfully, there were none. Work was efficient
750524 - and professional in all respects. ref SDS 0 4N5M After treatment
750525 - Millie was more energetic than normal, possibly due to decadron.
750526 - ref SDS 0 F54N
750528 - [On 070204 UCSF notified no initial side effects of treatment,
750529 - and energy has increased; planning for CT test to evaluate
750530 - pulmonary embolism. ref SDS D2 JJ7O
750532 - ..
750533 - [On 080313 Millie begins 16th cycle on clinical study; and 1st
750534 - cycle 1st treatment with cetuximab and carboplatin together
750535 - treating 4th relapse of IBC. ref SDS F7 TZ8I
750539 - ..
7508 - Progress
750901 - Tape Recording SDS Record Accurate Comprehensive New Way of Working
750902 - Case Management Referral Coordination Plan Collaboration UCSF Kaiser
750904 - Follow up ref SDS B6 407N, ref SDS B4 407N.
750906 - Jackie said she received Millie's letter sent yesterday on 070131,
750907 - ref SDS C8 2P5M, transmitting the SDS record meeting with Doctor Rugo
750908 - and the medical team at UCSF the day before on 070130. ref SDS C7 0001
750909 - She forwarded a copy to Brigid, but did not forward to Doctor Rugo,
750910 - because the doctor depends on staff for accurate communications.
750912 - ..
750913 - Brigid said she has never seen reports on details of discussion in
750914 - meetings, shown in the SDS record for the meeting at UCSF on 070130.
750915 - ref SDS C7 1000 She did not realize Millie's patient history is so
750916 - complex. ref SDS C7 LU3J Brigid only had time to glance through the
750917 - record. Nothing jumped out inconsistent with her memory of the
750918 - meeting and medical examination on Tuesday, 070130. ref SDS C7 1000
750919 - She checked a few things that were a little hazy, and found alignment
750920 - with her notes in the medical chart. She added a few comments from
750921 - the SDS record that were not in the medical chart, but seemed possibly
750922 - important. Jackie said she read through the record last night just to
750923 - make sure everything is coordinated, and that Millie is getting
750924 - started on the "right foot" understanding treatment, and UCSF
750925 - procedures. She made a joke asking if Millie tape recorded the
750926 - meeting, because the narrative and background seems thorough and
750927 - accurate from her memory of the meeting.
750929 - ..
750930 - Brigid said that it is not necessary for patients to send this much
750931 - detail on meetings with the doctor for verification, because she is
750932 - very diligent making thorough notes in Millie's medical chart at UCSF.
750934 - ..
750935 - Millie asked for a copy of the medical chart to compare with patient
750936 - records.
750938 - ..
750939 - Brigid advised that UCSF never gives out the medical chart to
750940 - patients. She said it would take a lot of time, and there are a lot
750941 - of partial notes in short-hand that mean something to her, but not to
750942 - anyone else.
750944 - ..
750945 - Millie asked how the medical chart is checked for accuracy and
750946 - thorough reporting to provide comprehensive care which UCSF promises
750947 - in advertising for patients. This is shown outside on the wall of the
750948 - building.
750950 - ..
750951 - Brigid said UCSF does periodic audit reviews to verify everything is
750952 - in the medical chart.
750954 - ..
750955 - How does the auditor figure out notes that mean something to only one
750956 - person? What if something is missing? The doctor forgot to write it
750957 - down? What if something is entered incorrectly? How would the
750958 - auditor know?
750960 - ..
750961 - Brigid explained that sometimes things fall through the cracks, but
750962 - she is very careful writing everything down so the patient doesn't
750963 - have to worry.
750965 - ..
750966 - Discussed case management standards in Kaiser's Healthwise handbook
750967 - calling for "ping pong" practice of feedback for the doctor to verify
750968 - accuracy of communication with patients, reviewed on 990625.
750969 - ref SDS 4 3960 Kaiser's case management requires a well ordered
750970 - record to understand cause and effect in complex medical history.
750971 - Requirements for a well ordered record were reviewed on 890523.
750972 - ref SDS 1 TP8O Millie asked how the referral coordination plan for
750973 - Millie's treatment at UCSF applies Kaiser's case management practices?
750975 - ..
750976 - Brigid feels strongly there isn't enough time to perform Kaiser's
750977 - "ping pong" case management practice to verify verbal communications,
750978 - and to correlate alignment with the written reports, policy,
750979 - procedures, research, protocols, and correspondence, as shown in the
750980 - record meeting with Doctor Rugo on 070130. ref SDS C7 0001
750982 - ..
750983 - Jackie said it seemed strange reading understandings in the SDS record
750984 - of what she said, and did in the prior meeting on 070130, and further
750985 - how everything aligns with prior events. ref SDS C7 M882 Jackie noted
750986 - that busy people are not always aware of collateral effects, when
750987 - doing things in the moment, so placing everything in context is a
750988 - totally new experience.
750990 - [On 090206 Doctor Stritter reported that Millie has survived
750991 - very aggressive cancer for a long time by performing complex
750992 - clinical, logistical, and financal case management. ref SDS G3
750993 - 7Q7J
750995 - ..
750996 - [On 090213 1140 primary care physician at Kaiser credits SDS
750997 - well ordered record for case management extends Millie's
750998 - survival much longer than expected for disease trajectory.
750999 - ref SDS G4 NY7L
751001 - ..
751002 - Jackie agreed with Brigid that there is not enough time for staff to
751003 - check accuracy of communications in the detail supported by SDS
751004 - records. She indicated that details on patient medical history are
751005 - critical to have available, because when there is a lot going on
751006 - people suffer memory lapse or get confused. That happens all the
751007 - time, because it is impossible to remember everything. But, she cited
751008 - a big dilemma. If people spend time writing everything down, and then
751009 - checking for accuracy, there is no time left to do any work. This
751010 - aligns with Ross' analysis on 890809. ref SDS 2 3S6H Jackie feels
751011 - that Doctor Rugo cannot invest time to provide feedback that refines
751012 - accuracy on just one patient. Doctor Rugo likes short letters which
751013 - go quickly to the point of what is needed, without context and links
751014 - presented in SDS records.
751016 - ..
751017 - On 061011 1746 Kaiser notified UCSF reduced their bill $200 because
751018 - Kaiser documents on doctor's progress notes, labs and radiology tests
751019 - submitted for 2nd opinion were organized by the patient into a well
751020 - ordered record that reduced time and expense for understanding patient
751021 - history. ref SDS A9 Z39O This shows benefits of doctor/patient
751022 - partnership leveraging medical training and experience with patient's
751023 - time to provide a well ordered record that saves lives, time and
751024 - money.
751026 - ..
751027 - There was brief discussion that Brigid's assurance patients don't have
751028 - to worry because she write's everything down, ref SDS 0 S571,
751029 - conflicts with Brigid's report there isn't enough time to correlate
751030 - daily work with the record. Seems like patient's with lots of time
751031 - should be helping doctor's and staff with limited time.
751033 - ..
751034 - [On 080403 0900 Doctor Rugo requested assistance using SDS
751035 - records of patient history to coordinate UCSF and Kaiser
751036 - medical services for Millie's care. ref SDS F8 4U9O
751038 - ..
751039 - [On 081017 0021 Doctor Rugo thanked Millie for coordinating a
751040 - very complex work plan involving shared responsibilities at
751041 - UCSF and Kaiser to start Millie's next treatment. ref SDS G0
751042 - RI6I
751044 - ..
751045 - [On 090121 1017 Glenna called and said Doctor Rugo requested
751046 - help finding chemotherapy agents and protocols discussed for
751047 - Millie's next systemic treatment, using the SDS well ordered
751048 - record of patient history, ref SDS G1 Y67L, and cited the "work
751049 - plan" on 081016 that guided complex work in progress to start
751050 - Millie's previous treatment. ref SDS F3 J36R
751052 - ..
751053 - [On 090203 1206 Doctor Al-Bussam advised that Millie's well
751054 - ordered record of complex medical history, ref SDS G1 NU5H,
751055 - enabled efficient review ref SDS G2 8488; and, that accurate
751056 - understanding enabled determining Millie can get treatment for
751057 - cancer in time to be effective. ref SDS G2 OE4F
751060 - ..
751061 - Jackie advised that...
751063 - Clinic phone... 415 353 7070
751065 - ...is the primary contact between patients and UCSF for all issues
751066 - related to the study and requirements or medical questions, including
751067 - emergencies from complications and side effects of treatment.
751069 - ..
751070 - Case study on collaboration between UCSF and Kaiser during December
751071 - and January indicates need for coordination plan to facilitate
751072 - delivery of health care with multiple providers and divided
751073 - responsibilities. ref SDS C7 RM4G
751075 - [On 070202 meeting at Kaiser with primary care physician cites
751076 - requirement for written coordination plan between Kaiser and
751077 - UCSF with respect to mediciation prescriptions and emergencies.
751078 - ref SDS D1 2O5H
751080 - ..
751081 - [On 070215 Millie notifies Kaiser of confusing whirl
751082 - coordinating between multiple providers. ref SDS D5 VW6U
751084 - ..
751085 - [On 070216 Jackie confirms patient should call UCSF for
751086 - emergencies. ref SDS D6 AM4N
751088 - ..
751089 - [On 070217 Millie requests clarification of coordination
751090 - planning on emergency treatment; notes that patient history
751091 - shows treatment at Kaiser Emergency does not require calling a
751092 - number, just show up; notes that driving to San Francisco for
751093 - emergency treatment at UCSF might enocunter fatal traffic
751094 - delays. ref SDS D7 4Q8O
751096 - ..
751097 - Jackie submitted the form for handicap parking signed by the doctor,
751098 - planned on 070130, and cited in the letter to UCSF yesterday on
751099 - 070131. ref SDS C8 FT6Q
751101 - [...below, on 070201 0800 at 1705 on the way home, stopped at
751102 - DMV and obtained handicap parking permit. ref SDS 0 4R9I
751104 - ..
751105 - [On 110420 1538 received from DMV handicap parking permit
751106 - until June 2013. ref SDS G5 BZ5H
Examination Treatment Cetuximab 1st Treatment 1st Cycle Chemotherapy
Case Management Communication SDS Record Accurate Meeting 070130 at
780501 - ..
780502 - Clinic Examination Orientation Starting Treatment Cetuximab
780504 - Follow up ref SDS B6 407N, ref SDS B4 407N.
780506 - Brigid made an examination.
780508 - ..
780509 - Doctor Rugo did not meet with Millie this morning. She was in the
780510 - hallway and waved good luck after the meeting when Millie was leaving
780511 - the clinic enroute with Jackie's escort for treatment on the 5th
780512 - floor. Jackie left the room to consult with the doctor on several
780513 - occassions during the course of the meeting with Brigid, and later
780514 - when starting treatment by the Infusion Clinic, reflecting plans on
780515 - 070130 for scheduling treatment today. ref SDS C7 M882
780517 - ..
780518 - On subsequent treatments, Millie will only be examined every 2nd
780519 - treatment, i.e., the 1st and 3rd treatments. Doctor Rugo will
780520 - normally meet with Millie once a month to make an examination and
780521 - assess progress to start each new cycle.
780523 - [On 070412 examination for 3rd treatment moved to 4th treatment,
780524 - and Doctor Rugo's examination moved back a week to accomodate
780525 - traveling schedules. ref SDS E3 FO6H
Breast Examination Shows Improvement IBC Rash Left Right Breast Stom
810401 - ..
810402 - Breast Examination Shows Improvement IBC Rash
810404 - Follow up ref SDS C7 025H, ref SDS C1 025H.
810406 - Brigid did another examination, following up the work by Doctor Rugo
810407 - on 070130, and made similar findings. Millie noted that the rash
810408 - seems less intense today than on 070130. ref SDS C7 M68J
810410 - ..
810411 - Brigid described presentation of IBC on left and right breast areas
810412 - similar to Doctor Rugo on 070130. ref SDS C7 M69K
810414 - ..
810415 - Brigid asked quetions about patient history, presented previously
810416 - during the meeting at UCSF on 070130, ref SDS C7 LC49, and listed in
810417 - case study on 060722 tracking progression of disease with 3rd relapse
810418 - IBC. ref SDS 94 JD5K
810420 - ..
810421 - Questions on fatigue, shortness of breath and other symptoms of
810422 - pulmonary embolism were referred to the meeting with Doctor Rugo on
810423 - 070130, ref SDS C7 CV5L, and citing patient history listed on 060722.
810424 - ref SDS 93 ZV41
810426 - ..
810427 - Millie qualified for clinical study on cetuximab drug trial because
810428 - she has had only 3 treatments, as discussed in correspondence between
810429 - Doctor Rugo and the primary care physician on 061230. ref SDS B9 PN5X
810430 - The doctor got approval from study management to waive Millie's
810431 - treatment with Taxol and bevecizumab (Avastin), because Millie was
810432 - removed from treatment due to PE and not because the treatment became
810433 - ineffective.
6 Patients Currently UCSF Cetuximab Carboplatin 100 Patients Clinica
890401 - ..
890402 - 6 Patients Participating UCSF Cetuximab Carboplatin Clinical Study
890404 - There are six (6) patients on the Cextuximab Carboplatin clinical
890405 - study at UCSF, clarifying Consent documentation that says there are 20
890406 - patients on study at UCSF. ref SDS C3 1H3O The small number of
890407 - patients being studied reflects limited availability of patients who
890408 - meet protocol requirements for triple negative and with fewer than 4
890409 - treatments, discussed between Doctor Rugo and the primary care
890410 - physician at Kaiser on 061230. ref SDS B9 PN5X
Measureable Disease IBC Rash Photographs Tape Measure Evaluate Progr
930401 - ..
930402 - Photographs Establish Baseline to Measure Progression of Disease
930403 - Measureable Disease Photographs IBC Rash Improving
930404 - IBC Rash Improved Measurable Disease Photographs Tape Measure
930406 - Follow up ref SDS C7 M652, ref SDS C0 4Q6K.
930408 - Jackie used a camera to take several pictures of infected tissue for
930409 - measurable disease.
930411 - ..
930412 - Brigid placed small round bandage-type identification stickers on the
930413 - skin and held a cloth-like tape measure in several directions so that
930414 - the photographs of skin infected with IBC can be disucssed in the
930415 - record with reference to specific locations and rash dimensions, as
930416 - developed by Doctor Rugo during the meeting on 070130. ref SDS C7 M652
930418 - [On 080207 snafu caused loss of baseline photographs taken today;
930419 - may be able to use pictures from 070301. ref SDS F5 GH5H
Cetuximab Side Effects Face Rash Acne-like Mild Fatigue Weakness Sho
960401 - ..
960402 - Side Effects Medicated After Weekly Examinations
960404 - Follow up ref SDS C7 TQ6L, ref SDS C3 7Y4H.
960406 - Side effects discussed during examination at UCSF on 070130 seem
960407 - similar to symptoms of pulmonary embolism. ref SDS C7 TQ6L
960409 - ..
960410 - Millie will be examined by Brigid before treatment next Thursday on
960411 - 070208 to evaluate side effects. At that time, UCSF will decide on
960412 - providing medication for acne-like rash, if it occurs, as discussed by
960413 - Doctor Rugo on 070130, ref SDS C7 IJ5L, and reviewed previously with
960414 - Jackie during the call on 070117. ref SDS C4 QM7I
960416 - [On 070208 Millie requested treatment for the rash on her face
960417 - that is a side effect of cetuximab chemotherapy; this was deferred
960418 - for 2 weeks to the start of the next cycle on 070301. ref SDS D3
960419 - FO66
Randomized Cetuximab Drug Trial Cetuximab Carboplatin Clinical Study
990401 - ..
990402 - Randomized Cetuximab Increases Treatment Options
990404 - Jackie advised that Millie was randomized to get Cetuximab without
990405 - Carboplatin.
990407 - ..
990408 - This aligns with Millie's prior good luck getting randomized for
990409 - treatment with both Taxotere and bevacizumab (Avastin), reported on
990410 - 040416. ref SDS 18 8R6M Since there is a 50% chance in randomizing,
990411 - Millie was due this time to get only Cetuximab. Since IBC rash seems
990412 - to be improving, shown by examination the past few days, noted above,
990413 - ref SDS 0 FO6H, and since CA 15-3 seems relatively controlled,
990414 - reported on 070123, ref SDS C5 GK5B, then if the 2 tests now pending,
990415 - including yesterday, ref SDS C9 P56K, remain below 80, Millie seems to
990416 - have a good chance of improving with a single agent treatment at this
990417 - time. This preserves Carboplatin for additional treatment later, if
990418 - disease again progresses, as discussed with Doctor Rugo on 070130.
990419 - ref SDS C7 NI6K
990421 - [On 070202 Millie notified Gloria at the Kaiser Coagulation
990422 - Treatment Clinic on scope of new treatment. ref SDS D0 PY6U
990424 - ..
990425 - [On 070202 primary care physician at Kaiser indicated starting
990426 - treatment with cetuximab gives Millie another treatment option in
990427 - the event that disease progresses. ref SDS D1 QO6O
990429 - ..
990430 - [On 070202 primary care physician notices new rash on upper left
990431 - arm, which is a symptom of cellulitis, ref SDS D1 JP6F but may
990432 - progression of IBC. ref SDS D1 JP6L
990434 - ..
990435 - [On 070222 examination at UCSF indicates new rash likely
990436 - progression of IBC. ref SDS D8 B64F
990438 - ..
990439 - [On 070419 IBC subsiding; Millie fortunate responding to treatment
990440 - with cetuximab alone, clinical study changes protocol eliminating
990441 - this option because not enough patients getting favorable response
990442 - with cetuximab alone. ref SDS E4 Q665
Blood Tests Cetuximab Monthly Clinical Study Drug Trial Performed at
A20401 - ..
A20402 - Blood Tests 4 Week Cycle Cetuximab Performed at UCSF Saves Time Cost
A20404 - Brigid advised that Millie needs blood draws prior to examinations for
A20405 - approving chemotherapy with cetuximab only every 4 treatments, i.e.,
A20406 - once a month, rather than weekly, called out by the clinical study
A20407 - protocol, reviewed on 070116. ref SDS C3 5U7Z This change results
A20408 - from Millie being randomized in the study to get treatment only with
A20409 - cetuximab and not with Carboplatin. Since Cetuximab is designed to
A20410 - treat only cancer cells, there is less impact on the immune system
A20411 - than adding Carboplatin, which is a general chemotherapy drug more
A20412 - like capecitiabine and Taxotere that attack healthy cells along with
A20413 - cancer.
A20415 - [On 080306 Infusion Clinic medical chart shows incorrectly that
A20416 - Millie gets blood tests on 6-week cycle; causing confusion and
A20417 - delay despite excellent support by Infusion Clinic staff.
A20418 - ref SDS F6 NK5L
A20420 - ..
A20421 - On 030606 the primary care physician explained chemotherapy is a
A20422 - "poisen" that attacks everything, which reduces blood counts. This
A20423 - weakens the immune system, increasing risks of life threatening
A20424 - infection, e.g., pneumonia. Normal cancer care therefore requires
A20425 - blood tests to verify the immune system is strong enough for the
A20426 - patient to receive cheomtherapy. ref SDS 12 JP7G
A20428 - ..
A20429 - Previously, Kaiser would do blood tests the day before treatment to
A20430 - verify Millie could safely receive chemotherapy. If counts were too
A20431 - low, they would retest when Millie came in the day of treatment, and
A20432 - if counts had not increased enough, treatment would be delayed. For
A20433 - example, on 060810 Kaiser delayed Millie's treatment a week because
A20434 - blood counts were too low. ref SDS A0 5K4F Case study on patient
A20435 - history shows that sometimes, rather than delay treatment, Kaiser did
A20436 - another test the day of treatment to see if blood counts were at least
A20437 - rising, as effects of previous chemotherapy diminish. Treatment was
A20438 - often approved with blood counts below the target level, based on the
A20439 - doctor's judgement at the time of the patient's immediate condition
A20440 - shown by current blood work. ref SDS A0 HV45
A20442 - [On 070301 Doctor Rugo ordered an extra blood test because ANC was
A20443 - too low for treatment. ref SDS D9 H93H
A20445 - ..
A20446 - Jackie coordinated with Catherine on scheduling blood draws in the
A20447 - Infusion Clinic.
A20449 - ..
A20450 - Jackie will schedule Millie to get blood drawn at UCSF the same day as
A20451 - treatment, per below. ref SDS 0 QK6L Catherine said it takes about an
A20452 - hour to get results, so Millie can come in at 0800 to have blood
A20453 - drawn. During that hour, Doctor Rugo can do the monthly examination
A20454 - to start each new cycle.
A20456 - ..
A20457 - This solves blood draw problems discussed in the record on 070130.
A20458 - ref SDS C7 2Q4L Millie will not have to take time off the day before
A20459 - on Wednesdays to have blood drawn at Kaiser in Walnut Creek. She can
A20460 - have INR checked at the same time. If retesting is required to check
A20461 - ANC blood counts for safe treatment, this can done immediately without
A20462 - having to go back to Kaiser and delay treatment.
A20464 - [On 070301 testing at UCSF eliminates busy people having to
A20465 - account for differences in units of measures and standards
A20466 - between Kaiser and UCSF labs. ref SDS E0 HI6O
A20468 - ..
A20469 - CA 15-3 blood test is a diagnostic of measurable disease for IBC
A20470 - patients, since typically IBC does not register very well in image
A20471 - tests like PET and CT tests. The CA 15-3 cancer marker measures
A20472 - progression of disease, noted by the primary care physician in a
A20473 - letter to UCSF on 061230. ref SDS B9 PO3V CA 15-3 was initially
A20474 - reported to UCSF as the measurement of rising disease that required
A20475 - switching treatment in 2002, set out in Kaiser's letter to UCSF on
A20476 - 061228. ref SDS B8 D79P
A20478 - [On 070511 Millie ordered CA 15-3 at Kaiser to prepare for
A20479 - meeting with primary care physician scheduled on 070525, and to
A20480 - cross-check remarkable results reported by the UCSF Lab.
A20481 - ref SDS E5 B64J
A20483 - ..
A20484 - [On 070516 Kaiser reports CA 15-3 56 and describes this result
A20485 - as "stable," ref SDS E6 QN6M, which significantly conflicts
A20486 - with testing at UCSF. ref SDS E6 WV6L
A20488 - ..
A20489 - [On 070516 Millie asks Kaiser to verify accuracy of CA 15-3
A20490 - test on 070511, and to notify UCSF to be prepared for meeting
A20491 - with the patient on 070524. ref SDS E6 ZJ9N
A20493 - ..
A20494 - [On 070517 Kaiser advised that UCSF uses a different
A20495 - calibration method for CA 15-3 that cannot be compared to the
A20496 - Kaiser test results, like comparing apples and oranges.
A20497 - ref SDS D9 NT3O
A20499 - ..
A20500 - [On 070517 Nurse's Notes show nurse practitioner ordered
A20501 - another blood test to verify elevated CA 15-3 56 reported in
A20502 - Kaiser's test on 070511; but did not perform the test, and
A20503 - decided to wait another week to address the issue. ref SDS E7
A20504 - FG6H
A20506 - ..
A20507 - [On 070517 Brigid discloses that coordinating divided
A20508 - responsibilities on referral projects is difficult; and that
A20509 - UCSF recommends limiting laboratory work rather than empowering
A20510 - labs to cross-check tests for accuracy. ref SDS E8 466H
A20512 - ..
A20513 - [On 071017 problems ordering blood tests at Kaiser the day
A20514 - before treatment at UCSF - Jackie faxes request for blood draw
A20515 - to Arlette at Kaiser in Walnut Creek, Millie's main treatment
A20516 - location. ref SDS F0 Q45F Arlette is at lunch, delay finding
A20517 - out where to get blood drawn. ref SDS F0 4Q5M Arlette advises
A20518 - UCSF blood draw request was ordered by the doctor; tells
A20519 - customer to coordinate with Kaiser to schedule blood draws.
A20520 - ref SDS F0 4Q7G Kaiser in Walnut Creek cannot do blood draw
A20521 - until next week, ref SDS F0 YE9G; Millie goes to Kaiser in
A20522 - Martinez for the blood draw; finds the order is not entered in
A20523 - the computer, ref SDS F0 OS3F; blood draw performed using order
A20524 - found in the computer for prior blood draw from last January.
A20525 - ref SDS F0 OS5K
A20527 - ..
A20528 - [On 071018 blood test results were not available for review
A20529 - during examination, ref SDS F1 HL7O, treatment at UCSF was
A20530 - delayed for an hour or so until Kaiser submitted blood test
A20531 - results via fax. ref SDS F1 6N9F
A20533 - ..
A20534 - [On 071019 UCSF clinical trial staff confuses Neutrophils in
A20535 - Kaiser's blood test report on 071017, for NEUTS used by UCSF to
A20536 - assess patient safety for treatment. ref SDS F2 EU5U
A20538 - ..
A20539 - [On 071024 letter to UCSF proposes returning to performing
A20540 - blood tests at UCSF in order to avoid problems of confusion and
A20541 - delay, provided UCSF demonstrates there are no extra charges in
A20542 - billings. ref SDS F3 EP5W
A20544 - ..
A20545 - There may be some mechanics to work out so that Kaiser's records are
A20546 - maintained on patient history getting test reports from UCSF computers
A20547 - into Kaiser computers so that everybody is on the same page,
A20548 - especially managing Coumadin treatments based on INR reporting.
A20550 - ..
A20551 - Doing blood tests at UCSF will reduce costs to Kaiser from continual
A20552 - rework to correct mistakes. There were 3 blood tests and several CT
A20553 - tests at Kaiser before Millie got configured for treatment at UCSF.
A20558 - ..
A20559 - INR 1.6 Low Pulmonary Embolism Needs Increase Coumadin Treatment
A20560 - Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 1.6
A20562 - Millie's INR is low again today, at 1.6, for the blood test yesterday.
A20563 - ref SDS C9 P56K, and as shown below. ref SDS 0 SE6N This will require
A20564 - increasing Coumadin. May reflect that Millie is no longer being
A20565 - treated with capecitabine. On 061020 Ross in the Kaiser Pharmacy said
A20566 - that capecitabine compounds effects of Coumadin. ref SDS B1 T650 This
A20567 - was supported by discussion with Kaiser Coagulation Treatment clinic
A20568 - on 061024. ref SDS B2 TZ4I
A20570 - ..
A20571 - Adjusting Coumadin has previously required continuing blood draws,
A20572 - sometimes for months with weekly blood draws. UCSF plans to perform
A20573 - blood tests on site the day of treatments provides an efficient
A20574 - procedure, per above. ref SDS 0 G59O
Biopsies Cetuximab Clinical Study Not Medically Relevant Too High Ri
A90401 - ..
A90402 - Biopsies Not Medically Relevant Too High Risk for Coumadin Patient
A90404 - Follow up ref SDS C7 KT7J, ref SDS C3 0348.
A90406 - Biopsies were discussed today in relation to UCSF letter yesterday,
A90407 - reported on 070131. ref SDS C9 YA6X
A90409 - ..
A90410 - Apparently biopsies for the study do not provide medically relevant
A90411 - pathology to assess, for example, IBC or status change, which would
A90412 - benefit the patient, reviewed in the record on 070130. ref SDS C7 KT7J
A90413 - Since there is no medical benefit for the patient to incur risk of
A90414 - bleeding, the study biopsies pose an unreasonable risk, as reported in
A90415 - Jackie's letter yesterday. ref SDS C9 YA6X
A90417 - ..
A90418 - In this case, Millie's negative "status" is an asset that qualifies
A90419 - for a powerful new treatment. Jackie clarified the study targets
A90420 - patients like Millie who are HER2, ER, PR (triple negative), reported
A90421 - on 020321. ref SDS 8 LA7O This aligns with the consent form received
A90422 - on 070116, but clarifies the meaning of "triple negative." ref SDS C3
A90423 - 0Q7I
A90425 - ..
A90426 - Jackie also noted that while status change does occur. She believes
A90427 - this is a rare event, maybe less than 1%?? Veronica made a similar
A90428 - point recommending investigation for status change in a 2nd opinion
A90429 - received on 050907, ref SDS 78 AE6P
Cetuximab 1st Cycle 1st Treatment Chemotherapy 8th Cycle IBC 3rd Rel
AC04 - 0850
AC0501 - ..
AC0502 - Infusion Clinic for Cetuximab Treatent 1st Cycle 1st Treatment
AC0504 - Follow up ref SDS B6 407N.
AC0506 - Jackie accompanied Millie into the Infusion Clinic.
AC0508 - ..
AC0509 - Received treatment to begin 1st cycle with Cetuximab, and the 8th
AC0510 - treatment for 3rd relapse of IBC.
AC0512 - [On 080313 Millie begins 16th cycle on clinical study; and
AC0513 - 1st cycle 1st treatment with cetuximab and carboplatin
AC0514 - together treating 4th relapse of IBC. ref SDS F7 TZ8I
AC0516 - 1. Cycle 09 and 01 for relapse........ 060721, ref SDS 92 407N
AC0517 - 2. Cycle 10 and 02 for relapse........ 060814, ref SDS A1 LY6O
AC0518 - 3. Cycle 11 and 03 for relapse........ 060908, ref SDS A4 407N
AC0519 - 4. Cycle 12 and 04 for relapse........ 060929, ref SDS A6 407N
AC0520 - 5. Cycle 13 and 05 for relapse........ 061020, ref SDS B1 407N
AC0521 - 6. Cycle 14 and 06 for relapse........ 061110, ref SDS B4 407N
AC0522 - 7. Cycle 15 and 07 for relapse........ 061201, ref SDS B6 407N
AC0524 - ..
AC0525 - 8. Cycle 01 and 08 for relapse........ 070201, ref SDS 0 407N
AC0527 - ..
AC0528 - Nurses Notes...
AC0538 - [On 070301 visit number changed after 4 meetings.
AC0539 - ref SDS E0 QW4K
AC0541 - ..
AC0542 - UCSF Log Time...
AC0544 - In....... 0945
AC0545 - Out...... 1330
AC0546 - Visit.... 3.75 Hours
AC0548 - ..
AC0549 - Pain Assessment...
AC0551 - x
AC0552 - 0123456789 10
AC0554 - ..
AC0555 - Administration Site: Right Port Catheter
AC0556 - Needle Size: 20 G 1"
AC0557 - Blood Return Good: Yes
AC0559 - ..
AC0560 - Remind patient to call MD if temp > 101 F, Shaking Chills
AC0562 - This protocol differs from Kaiser requirements, reported on
AC0563 - 041202. ref SDS 52 IX9N
AC0565 - ..
AC0566 - Jackie brought 10 blood vials for the clinical study research.
AC0568 - ..
AC0569 - Jackie also brought authorization documents for Millie to get
AC0570 - treatment on the study.
AC0572 - ..
AC0573 - The receptionist asked Millie for insurance or other payment card.
AC0575 - ..
AC0576 - Upon discussion, Millie gave her Medicare account card.
AC0578 - ..
AC0579 - Catherine is the nurse today.
AC0581 - ..
AC0582 - Millie had a blood draw yesterday afternoon, Wednesday, 070131.
AC0583 - ref SDS C9 P56K
Side Effects Infusion Clinic UCSF Consultation Starting New Treatmen
AL04 - 0911
AL0501 - ..
AL0502 - Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
AL0504 - Follow up ref SDS B6 QU8K, ref SDS B4 QU8K.
AL0506 - ..
AL0507 - Need a new account for side effects beginning today on Cetuximab
AL0508 - clincial trial.
AL0510 - ..
AL0511 - Catherine asked Millie about past side effects for orientation of
AL0512 - future side effects on the new regimen.
AL0514 - ..
AL0515 - Side effects of treatment with Taxotere and capecitabine (Xeloda) are
AL0516 - listed in the record on 060724. ref SDS 95 QX8K
AL0518 - ..
AL0519 - Tired, fatigued - pulmonary emoblism...
AL0521 - Millie's energy seems improved the past few weeks, as
AL0522 - reported to the doctor on 070130. ref SDS C7 RT6I
AL0524 - ..
AL0525 - Heavy chest - shortness of breathing
AL0527 - This condition remains seems improved, as reported to
AL0528 - the doctor on 070130. ref SDS C7 RT6I
AL0530 - ..
AL0531 - Cough - clearing throat
AL0533 - This condition remains seems improved, as reported to
AL0534 - the doctor on 070130. ref SDS C7 RT6I
AL0537 - ..
AL0538 - Dry hands and feet...
AL0540 - This condition seems much improved since ending
AL0541 - treatment with Taxotere and capecitiabine on 061201.
AL0544 - ..
AL0545 - Eyes tearing
AL0547 - This seems improved since ending treatment with Taxoter
AL0548 - and capecitabine on 061201.
AL0551 - ..
AL0552 - Nausea
AL0554 - Problem previously resolved, as reported on 061110.
AL0555 - ref SDS B4 D19M
AL0558 - ..
AL0559 - Sores in mouth
AL0561 - None yet, cleaning mouth carefully to avoid problem.
Schedule Treatment Weekly Thursday 0800 4 Week Cycles Clinical Study
AP0401 - ..
AP0402 - Schedule Weekly Treatments Continue on Thursdays
AP0404 - Follow up ref SDS B6 QK6L, ref SDS B4 QK6L.
AP0406 - ..
AP0407 - Jackie advised that Millie's next treatment is scheduled for 070208
AP0408 - 0800.
AP0410 - ..
AP0411 - The next blood draw will be in 4 weeks. Jackie coordinated blood
AP0412 - draws for Millie at UCSF in the Infusion Clinic an hour before meeting
AP0413 - with Doctor Rugo to start each new cycle, discussed with Brigid and
AP0414 - Catherine, reported above. ref SDS 0 XR40
Blood Counts Good Test 070131 Enables Full Dose Treatment Cetuximab
AS0401 - ..
AS0402 - Blood Counts Good Dose Cetuximab Normal
AS0404 - Follow up ref SDS B6 Q659, ref SDS B4 Q659.
AS0406 - ..
AS0407 - Catherine submitted the report on the blood test yesterday on 070131
AS0408 - showing...
AS0410 - Patient Provider Category View FR Date To Date
AS0416 - ..
AS0417 - Procedure Results Reference Range
AS0423 - ** Marina Way South **
AS0425 - ..
AS0426 - Test Name Value Unit <-------- RANGE-------->
AS0427 - @CBC
AS0428 - WBC x 10-3 4.0 K/uL 3.5 - 12.5
AS0429 - RBC x 10-6 3.82 M/uL 3.60 - 5.70
AS0430 - Hemoglobin 12.6 g/dL 11.5 - 15.0
AS0431 - Hematocrit 36.6 % 34.0 - 46.0
AS0432 - MCV 96 fL 80.0 - 100.0
AS0433 - RDW H 14.5 % 11.9 - 14.3
AS0434 - Plt x10-3 236 K/uL 140 - 400
AS0435 - ..
AS0436 - Neutrophils 44 % 50 - 70
AS0437 - Lymphocytes 39 % 20 - 50
AS0438 - Monocyte 9 % 0 - 11
AS0439 - Eosinophils H 8 % 1 - 5
AS0440 - Basophil 1 % 0 - 2
AS0441 - Bands No Report % 0 - 5
AS0443 - ..
AS0444 - CA 15-3 No Report U/mL -< - 39
AS0446 - ..
AS0447 - Alkaline Phos 54 U/L 38 - 126
AS0449 - ..
AS0450 - Sodium 139 mEq/L 137 - 145
AS0451 - Potassium 4.5 mEq/L 3.5 - 5.3
AS0452 - BUN 13 ng/dL 7 - 17
AS0454 - ..
AS0455 - Creatinine 0.76 mg/dL 0.6 - 1.2
AS0456 - Calcium 9.5 mg/dL 8.4 - 10.2
AS0457 - Phosphorus 4.4 mg/dL 2.5 - 4.5
AS0458 - Magnesium 1.9 mg/dL 1.6 - 2.3
AS0459 - Protein, Total 7.1 g/dL 6.3 - 8.2
AS0460 - Albumin 4.3 g/dL 3.4 - 4.8
AS0462 - ..
AS0463 - Bili, Tot Adult 0.4 mg/dL 0.2 - 1.3
AS0464 - Bili, Unconj 0.6 mg/dL 0.1 - 1.1
AS0465 - Bili, Kunj 0.0 mg/dL 0.0 - 0.3
AS0466 - Bili, Direct 0.0 mg/dL 0.0 - 0.4
AS0467 - Bili, Direct 0.0 mg/dL 0.0 - 0.4
AS0469 - ..
AS0470 - ALT (SGPT) 37 U/L 11 - 66
AS0471 - AST (SGOT) 40 U/L
AS0473 - ..
AS0474 - RBC Morphology No Report
AS0475 - Poikilocytosis * No Report
AS0476 - Anisocytosis * No Report
AS0477 - Schistocytes * No Report
AS0478 - PLT Estimate No Report
AS0479 - PLT Morphology No Report
Anticoagulation Therapy Pulmonary Emboli INR Low 1.6 PT Patient High
AV0401 - ..
AV0402 - Anticoagulattion Therapy INR Low 1.6 PT Patient High 16.3
AV0404 - Follow up ref SDS B6 SE6N, ref SDS B4 SE6N.
AV0406 - PT, patient H 16.3 sec 8.9 - 11.1
AV0407 - PT INR L 1.6 sec 2 - 3
AV0409 - ..
AV0410 - Low INR may reflect that treatment with capecitabine (Xeloda) stopped
AV0411 - on 061201, and so compounding effect with Coumadin needs to be
AV0412 - reflected by adjusting level of Coumadin treatments, based on Gloria's
AV0413 - comments reported on 061024, ref SDS B2 TZ4I, and as further reported
AV0414 - above discussing blood draws at UCSF. ref SDS 0 6U5J
AV0416 - ..
AV0417 - Gloria called Millie at work and left a message to skip Coumadin on
AV0418 - Sunday in order to reduce INR to below 3.
AV0420 - [On 070202 Millie called and left a message for Gloria, that
AV0421 - she got Gloria's message today on changing Coumadin protocol,
AV0422 - Millie notified Gloria that treatment with cetuximab was
AV0423 - delayed again from 070131 and actually started on 070201, and
AV0424 - further explained that her work schedule has changed, so she is
AV0425 - no longer at work on Thursday, since this is her new day for
AV0426 - treatments, ref SDS D0 PY5Q; Millie submitted a letter to
AV0427 - Kaiser confirming these understandings. ref SDS D0 428G
AV0429 - ..
AV0430 - [On 070202 Millie asked Kaiser to submit prescription
AV0431 - instructions in writing via email. ref SDS D0 PZ3T
Absolute Neutrophils Count ANC 1760 Well Above 1500 Required for Tre
AY0401 - ..
AY0402 - ANC 1760 Well Above 1500 Criteria for Blood Counts Approve Treatment
AY0404 - Follow up ref SDS B6 P560, ref SDS B4 P560.
AY0406 - Millie has been worried lately that blood counts would not be high
AY0407 - enough for treatment, based on side effects reported to Kaiser this
AY0408 - afternoon, per above. ref SDS B6 SK9O Experience since 2002 has shown
AY0409 - a strong correlation between feeling tired, reported today,
AY0410 - ref SDS B4 FG3N, and having low blood counts.
AY0412 - ..
AY0413 - ANC seems to be dropping consistently, shown by reports...
AY0415 - 6972................................ 060814, ref SDS A1 P560
AY0416 - 6390................................ 060908, ref SDS A4 P560
AY0417 - 5200................................ 060929, ref SDS A6 P560
AY0418 - 3869................................ 061020, ref SDS B1 P560
AY0419 - 2880................................ 061110, ref SDS B4 P560
AY0420 - 2888................................ 061201, ref SDS B6 P560
AY0421 - 1760................................ 070201, ref SDS 0 P560
AY0423 - ..
AY0424 - Formula for ANC, from record on 050128. ref SDS 55 TZ3N
AY0426 - ..
AY0427 - Calculation from 060908 yielded 6390. ref SDS A4 P560
AY0429 - ..
AY0430 - Note that bands are added to neutrophils, but both neutrophils and
AY0431 - bands have no report today.
AY0433 - WBC = 4.0
AY0435 - Neutrophils = .44
AY0436 - Bands = no report
AY0438 - ..
AY0439 - ANC = 4.0 x 1000 x .44 = 1760
AY0441 - ..
AY0442 - ANC calculation was not submitted by the nurse today.
CA 15-3 68 Rise from 56 Cancer Marker Current Blood Test Erratic For
B10401 - ..
B10402 - CA 15-3 68 Rise from 56 Cancer Marker 2 Tests Pending
B10404 - Follow up ref SDS B6 2N5J, ref SDS B4 2N5J.
B10406 - The test on 070118 was received from Kaiser on 070123 showing 68,
B10407 - which increased 12 points after dropping nearly 20 points to 56
B10408 - reported on 070110. ref SDS C2 087J
B10410 - ..
B10411 - CA 15-3 for blood test yesterday was not available in the report
B10412 - today; there are two tests pending. Millie had CA 15-3 tested on
B10413 - 070123, ref SDS C5 AS6M, and again yesterday on 070113. ref SDS C9
B10414 - L96G
B10416 - [On 070202 CA 15-3 dropped to 52 and rose to 56 in next 2
B10417 - tests. ref SDS D1 087J
Port Catheter IV Connection Prepare for Drip Treatment 1 Try Require
BA04 - 0907
BA0501 - ..
BA0502 - Preparation for Treatment Required One (1) Attempt to Connect Port
BA0504 - Follow up ref SDS B6 EB7J, ref SDS B4 EB7J.
BA0506 - ..
BA0507 - UCSF did not follow Kaiser practice of using another nurse to assist
BA0508 - Catherine with verification that Millie is the correct patient, and is
BA0509 - getting the correct medication.
BA0511 - ..
BA0512 - Cetuximab does not require the patient to take Decadron for preparing
BA0513 - to get chemotherapy treatment, per instructions for Taxotere and
BA0514 - capecitabine reported on 050415, ref SDS 62 8U4O, and modified on
BA0515 - 050506. ref SDS 65 OW5G Decadron is given with IV after Benadryl.
BA0517 - ..
BA0518 - Catherine connected the IV tubes to the port....
BA0520 - ..
BA0521 - Interlink System Vented Paclitaxel set
BA0524 - ..
BA0525 - Blood Flow Port Catheter Very Slow Difficult
BA0527 - There was some initial problems getting blood to flow from the port
BA0528 - for the blood sample research vials. Catherine took several remedial
BA0529 - measures to eventually achieve sufficient flow to draw blood for the
BA0530 - the seven (7) vials required for the clinical study.
BA0532 - ..
BA0533 - This might have suggested the port was not well enough maintained.
BA0534 - When getting regular treatments, weekly, which will be the case for
BA0535 - Cetuximab, or every 3 weeks with Taxotere and capecitabine, there is
BA0536 - normally not a problem with maintenance of the port. Millie's last
BA0537 - treatment was 2 months ago on 061201. ref SDS B6 0001 Kaiser has a
BA0538 - port maintenance program to flush the port once a month, reported in
BA0539 - the record on 051121. ref SDS 85 SH5N This was done about a month
BA0540 - ago, so Millie is now borderline for needing the port flushed again.
BA0542 - [On 070208 no initial problems getting blood to flow from the
BA0543 - port. ref SDS D3 DC5W
BA0545 - ..
BA0546 - [On 070222 sluggish blood removal from port again; reported to
BA0547 - doctor. ref SDS D8 DC5W
BA0549 - ..
BA0550 - [On 070301 problem experienced on 070222 did not occur drawing
BA0551 - blood from the port catheter. ref SDS E0 DC5W
BA0553 - ..
BA0554 - [On 070531 problem of no blood return on initial access
BA0555 - occurred again. ref SDS E9 DC5W
BA0557 - ..
BA0558 - Kaiser has not scheduled to have the port flushed, which may be an
BA0559 - error, since no one knew when treatment would wind up being started,
BA0560 - illustrated by the record on 070129. ref SDS C6 YF8U
BA0562 - ..
BA0563 - Catherine flushed the port with saline.
Blood Draws 10 Vials Clinical Study Research Cetuximab Drug Trial Bl
BE0401 - ..
BE0402 - Blood Draws 10 Vials for Clinical Study Research
BE0404 - Catherine drew 10 vials of blood for the study, delivered by Jackie,
BE0405 - per above. ref SDS 0 1N46
BE0407 - ..
BE0408 - The first few vials were filled normally, then the rate of blood flow
BE0409 - dropped. Each successive vial took longer to fill. The last 2 blood
BE0410 - vials took much longer to fill. There was a joke about Millie
BE0411 - dropping for 10 push ups to pump up the heart rate and speed things
BE0412 - along.
BE0414 - [On 070208 blood removal flowed normally. ref SDS D3 O56V
BE0416 - ..
BE0417 - [On 070222 blood removal sluggish again using port catheter.
BE0418 - ref SDS D8 DC5W
BE0420 - ..
BE0421 - [On 070301 problem experienced on 070222 did not occur the
BE0422 - following week. ref SDS E0 DC5W
BE0424 - ..
BE0425 - Possibly the blood draw yesterday for treatment today, may,
BE0426 - ref SDS C9 L96G, have contributed to slow blood supply today.
BE0428 - ..
BE0429 - When the blood vials were filled, Jackie took them to the Research
BE0430 - department.
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A
BG04 - 0945
BG0501 - ..
BG0502 - Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
BG0504 - Follow up ref SDS B6 DC7J, ref SDS B4 DC7J.
BG0506 - Benadryl (diphenhydramine) started. 50 MG....... ref SDS 0 IJ41
BG0508 - ..
BG0509 - Purpose reported on 060721. ref SDS 92 DC7J
BG0511 - ..
BG0512 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
BG0513 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 0
BG0514 - IJ41
BG0518 - ..
BG08 - 0955
BG0901 - Benedryl completed equipment beeps.
BG0904 - ..
BG12 - 1000
BG1301 - Decadron (Dexamethasone) IV treatment started. 20 MG. ref SDS 0 FM4M
BG1303 - Purpose reported on 060721. ref SDS 92 8G9G
BG1306 - ..
BG16 - 1010
BG1701 - Decadron completed.
Cetuximab 1st Cycle 1st Treatment Clinical Study Drug Trial Treatmen
BI04 - 1015
BI0501 - ..
BI0502 - Cetuximab Loading Dose 684 MG 1st Treatment 2 Hours
BI0504 - Follow up ref SDS B6 4N5M, ref SDS B4 4N5M.
BI0506 - Cetuximab started....
BI0508 - 684 MG loading dose. ref SDS 0 5555
BI0510 - ..
BI0511 - Study supply
BI0514 - ..
BI0515 - This first treatment is given slowly over 2 hours. Subsequent weekly
BI0516 - treatments will take only 1 hour.
BI0518 - ..
BI0519 - Chemotherapy Orders...
BI0521 - [On 080313 new chemotherapy order begins adding Carboplatin
BI0522 - chemotherapy to treatment with cetuximab. ref SDS F7 4E9N
BI0529 - Auth# Stor BCC LOC
BI0530 - Visit: 12575738 DOS 20070201
BI0532 - ..
BI0533 - Date: 20070201
BI0535 - ..
BI0536 - Study Order for CC#05752: Phase II Trial of Cetuximab alone and
BI0537 - in combination with Carboplatin in ER-negative, PR-negative,
BI0538 - HER2-negative Nonoverexpressing Metastatic Breast Cancers
BI0540 - ..
BI0541 - Dates to be given: 070201
BI0542 - Arm 1:Cetuximab alone
BI0544 - ..
BI0545 - Diagnosis: breast cancer
BI0547 - ..
BI0548 - ICD-9 codes: 174.9
BI0549 - Allergies NKDA
BI0551 - ..
BI0552 - Pre-medications 30 - 60 minutes prior to cetuximab infusion
BI0554 - ..
BI0555 - x Diphenhydramine 50 mg IV or [illegible writing]
BI0557 - Benadryl............... ref SDS 0 DC7J
BI0559 - [On 070329 Brigid changed the Chemotherapy Order reducing
BI0560 - Diphenhydramine (Benadryl) from 50 mg to 25 mg in order to
BI0561 - reduce side effects of "restless legs." ref SDS E2 IJ44
BI0563 - ..
BI0564 - x Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
BI0566 - Further premed TBD [barely legible handwriting??]
BI0568 - ..
BI0569 - Medication: (plan to give weekly ********STUDY SUPPLY**********
BI0571 - ..
BI0572 - x Cetuximab (Erbitux) (loading dose)
BI0574 - 400 mg/m [squared] = 684 mg IV over 120 minutes for
BI0575 - first dose x 1
BI0577 - dose on date 20070201 Maximum infusion rate is 5 ml/minute
BI0578 - (concentration 2 mg/ml)
BI0580 - ..
BI0581 - x Cetuximab (Erbitux) (maintenance dose)
BI0583 - 250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
BI0584 - ____mg) IV over 60 or ____ minutes.
BI0586 - Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
BI0587 - Infuse once weekly for 8 weeks. First dose to be given on date
BI0588 - 20070201.
BI0590 - ..
BI0591 - Cetuximab is administered undiluted through a low protien
BI0592 - binding 0.22 micro in-line filter. Use NS solution to flush the
BI0593 - line at the end of the infusion.
BI0595 - ..
BI0596 - ARM 2: Administer carboplatin if vital signs are unremarkable
BI0597 - one hour after cetuximab infusion.
BI0599 - ..
BI0600 - Vital signs at baseline, upon cetuximab completion and one hour
BI0601 - after cetuximab.
BI0603 - ****please note start and stop times****
BI0605 - ..
BI0606 - Laboratory work:
BI0608 - See carboplatin orders
BI0610 - ..
BI0611 - x Notify MD for dose modifications if patient has severe
BI0612 - acne in form of rash
BI0614 - CBC with differential and platletes every 4 weeks
BI0615 - Creatinine and magnesium every 4 weeks
BI0616 - BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
BI0617 - weeks. If levels are outside of normal laboratory values
BI0618 - notify Brigid NP (MD/RN) at 415 443 4730
BI0620 - ..
BI0621 - [On 080110 Magnesium not included in labs to start new 4
BI0622 - week cycle. ref SDS F4 HH5I
BI0624 - ..
BI0625 - [On 080313 order for 2nd arm of clinical study that
BI0626 - includes both cetuximab and Carboplatin specifies the same
BI0627 - laboratory blood testing scope. ref SDS F7 M866
BI0629 - ..
BI0630 - x Physician has discussed risks/benefits of therapy with the
BI0631 - patient. Signed consent obtained.
BI0634 - Yes No O2 by nasal cannula at 2 liters/min prn for chest
BI0635 - pain or SOB
BI0637 - ..
BI0638 - Yes No Diphenhydramine 50 mg IV prn x1 for urticaria
BI0639 - [barely legible], pruritis SOB
BI0641 - ..
BI0642 - Yes No Hydrocortizone 100 mg IV prn x1 for urticaria
BI0643 - [barely legible], pruritis SOB
BI0645 - ..
BI0646 - Yes No Albuterol inhaler 2-4 puffs prn SOB or chest
BI0647 - tightness
BI0649 - ..
BI0650 - Yes No Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
BI0651 - anaphylaxis
BI0653 - ..
BI0654 - Breast CC05752 Cetuximab doc 20061024
BI0655 - Approved 20060615
BI0667 - ..
BI09 - 1215
BI1001 - Cetuximab treatment completed.
BI1003 - Millie had a 1 hour rest and observation period.
BI1007 - ..
BI13 - 1320
BI1401 - Line Flushing...
BI1403 - Saline: 10 cc
BI1405 - ..
BI1406 - Catherine disconnected the IV tubes.
BI1408 - ..
BI1409 - She inserted Herceptin to flush the port.
BI1411 - U100 Heparin 5 cc
BI1413 - ..
BI1414 - She then removed the needle from the port, and swabbed the needle
BI1415 - wound, and placed a temporary bandage.
BI1417 - ..
BI1418 - Port Access Removed........ Yes
BI1419 - Site Clear................. Yes
BI1420 - Infusion well tolerated.... Yes
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme
BL04 - 1310
BL0501 - ..
BL0502 - Vitals Show Patient Stable
BL0504 - Follow up ref SDS B6 AW4L, ref SDS B4 AW4L.
BL0506 - Catherine took vitals after starting Taxotere drip treatment...
BL0508 - Blood
BL0509 - Date Time Pressure Pulse Temprtr Weight So2
BL0511 - ..
BL0512 - 070201 1330..... 136 74 66 148 94
BL0513 - 070201 1220..... 110 65 62 36.3c 148 96
BL0514 - 070201 1000..... 132 80 65 36.9c 148 99
BL0515 - 061201 1534..... 123 76 76 97.5 150
BL0516 - 061110 1534..... 136 83 73 97.0 150 98
BL0517 - 061020 1534..... 140 79 67 99.8 151 97
BL0518 - 060929 1452..... 141 78 66 98.3 149
BL0519 - 060908 1335..... 139 79 73 98.1 149
BL0520 - 060814 1610..... 139 80 59 98.2 151
BL0521 - 060722 1440..... 142 74 67 98.1 149
BL0522 - 060711.......... 172 87 54 97.5 147
BL0523 - 060623.......... 141 87 71 98.0 147
BL0524 - 060428.......... 129 73 80 99.4 149
BL0525 - 060217.......... 153 81 61 98.6 150
BL0526 - 050916.......... 120 80 80 98.5
Energy Normal Stable Alert Drive Home After Treatment IBC 3rd Relaps
BO04 - 1705
BO0501 - ..
BO0502 - Energy Normal Stable After Treatment Taxotere Support Drugs
BO0504 - Follow up ref SDS B6 F54N, ref SDS B4 F54N.
BO0506 - ..
BO0507 - On 060724 diary side effects for 2nd phase taking Taxotere and
BO0508 - capecitabine (Xeloda). ref SDS 95 YP4I
BO0510 - ..
BO0511 - Millie was alert after treatment today, and not wobbly nor
BO0512 - disoriented.
BO0514 - ..
BO0515 - She was able to drive home from San Francisco to Concord without
BO0516 - difficulty. Performed several tasks, including stopping at DMV to get
BO0517 - handicap parking permit by submitting the form received from Jacki
BO0518 - this morning, per above, ref SDS 0 YY3F, and which was approved by
BO0519 - Doctor Rugo at UCSF in the meeting on Tuesday, reported on 070130
BO0520 - 1300. ref SDS C7 JK4G
BO0522 - [On 110420 1538 received from DMV handicap parking permit
BO0523 - until June 2013. ref SDS G5 BZ5H
BO0525 - ..
BO0526 - She went to the store.
BO0528 - ..
BO0529 - Millie had trouble sleeping last night. She was up about every hour.
BO0531 - ..
BO0532 - Her energy level the next day was normal to elevated.
BO0534 - ..
BO0535 - So far, no acne-like rash or other evident side effects.