CONTACTS 

SUBJECTS
Treatment Cancer and Trial on New Cancer Treatment Double Blind Test
Avastin Meeting with Rosalie for Briefing on Trial Protocol Receive
Double Blind Test Placebo Not Protocol for Avastin Uses Randomized S
Cancer Treatment Delayed Cellulitus Diagnosed Treated with Antibioti
Meeting Rosalie Sign Documents Consent to Participate in Av

1107 -
1107 -    ..
1108 - Summary/Objective
1109 -
110901 - Follow up ref SDS 10 0000. ref SDS 9 0000.
110902 -
110903 - Rosalie did a great job going over recent changes to the consent form,
110904 - ref SDS 0 BK8M, and explaining side effects beyond normal reactions to
110905 - chemotherapy are generally minimal, e.g., slight nose bleeds.
110906 - ref SDS 0 V77O  The primary change to the protocol is that limitations
110907 - on maximum treatment cycles has been eliminated; patients can continue
110908 - receiving treatment as long as favorable results are reported.
110909 - ref SDS 0 JP89  Based on Rosalie's presentation and assurances about
110910 - side effects which will be monitored with monthly examinations and
110911 - quarterly CT scan testing, ref SDS 0 HS45, the consent was signed to
110912 - participate in the trial of Avastin. ref SDS 0 966M  Rosalie concurred
110913 - with the plan to start the trial by taking sick leave for the first 6
110914 - weeks to assess tolerance for treatments. ref SDS 0 HS87  After
110915 - getting clearance from the doctor on other health issues, Rosalie
110916 - enrolled Millie in the Avastin program, ref SDS 0 9739, and scheduled
110917 - preliminary tests, ref SDS 0 HS45, including inserting a port for
110918 - administering intravenous drugs. ref SDS 0 V750  Kaiser needs to
110919 - comment on possible advantage to install "dual" ports so there is one
110920 - for backup in the event of malfunction. ref SDS 0 6C6I
110921 -
110922 -    [...in another meeting, the doctor cleared Millie for treatments.
110923 -    ref SDS 11 0001
110924 -
110930 -
110931 -
110933 -  ..
1110 -
1111 -
1112 - Progress
1113 -
111301 - Avastin Meeting with Rosalie for Briefing on Trial Protocol
111302 - Consent Form Changed for Avastin Cancer Treatments Trial Protocol
111303 -
111304 - Follow up ref SDS 10 BK8M.
111305 -
111306 - Rosalie presented a revised consent for the Avastin cancer treatment
111307 - trial, which she said has major changes from the 10-page document
111308 - submitted by Kaiser to the patient on 040318. ref SDS 10 TG4M  The new
111309 - version now has 11 pages.
111311 -  ..
111312 - Rosalie pointed to changes in the new consent document typed in red
111313 - that facilitate understanding what has been changed.
111314 -
111315 -     [On 040420 Rosalie reviewed additional information that she
111316 -     indicated summarizes what has been presented previously, rather
111317 -     than adding new information. ref SDS 18 TK5G
111318 -
111337 -
111339 -  ..
111340 - Changes to Protocol Consent Documents
111341 -
111342 - Rosalie did an excellent job applying Kaiser's policy.  She used an
111343 - ink pen and marked in the margins, on the form distributed to the
111344 - patient, location of additions and deletions to facilitate customers
111345 - in typing in changes...
111347 -         ..
111348 -    1.  Page 2 of 11....
111349 -
111350 -        Previously read in pertinent part...
111352 -         ..
111353 -        Group A:
111354 -
111355 -            You will receive paclitaxel as an infusion in the vein
111356 -            every week for three weeks followed by one week rest
111357 -            period.  You will not receive any treatment during the one
111358 -            week rest period.  In addition you will receive bevcizumab
111359 -            as an infusion in the vein once every two weeks.  Each
111360 -            4-week period will be considered one cycle.  All treatment
111361 -            will done in a clinic or doctor's office. You may a receive
111362 -            a maximum of 18 cycles (72 weeks) of treatment. ref OF 1
111363 -            C630
111364 -
111365 -               Note -- "bevcizumab" is spelled "bevacizumab" in the
111366 -               document header, ref OF 1 QR4J, and in other locations.
111368 -         ..
111369 -        New version now reads...
111371 -         ..
111372 -        Group A:
111373 -
111374 -            You will receive paclitaxel as an infusion in the vein
111375 -            every week for three weeks followed by one week rest
111376 -            period.  You will not receive any treatment during the one
111377 -            week rest period.  In addition you will receive bevcizumab
111378 -            as an infusion in the vein once every two weeks.  Each
111379 -            4-week period will be considered one cycle.  All treatment
111380 -            will done in a clinic or doctor's office. You may continue
111381 -            treatment as long as your disease is improving or remaining
111382 -            stable and you are not having side effects from the
111383 -            treatment. ref OF 2 C630
111384 -
111385 -               Note -- "bevcizumab" is spelled "bevacizumab" in the
111386 -               document header, ref OF 1 QR4J, and in other locations.
111388 -         ..
111389 -        Critical change is the last sentence that now says...
111390 -
111391 -            You may continue treatment as long as your disease is
111392 -            improving or remaining stable and you are not having side
111393 -            effects from the treatment, ref OF 2 C630, rather than for
111394 -            only 18 months, under the prior protocol. ref OF 1 C630
111396 -             ..
111397 -            Note... length of participation has been changed to align
111398 -            with this change to treatment plan. ref SDS 0 5Q6F
111399 -
111401 -         ..
111402 -    2.  Page 2 of 11....
111403 -
111404 -        Previously read in pertinent part...
111406 -         ..
111407 -        Group B:
111408 -
111409 -            You will receive paclitaxel as an infusion in the vein
111410 -            every week for three weeks followed by one week rest
111411 -            period.  You will not receive any treatment during the one
111412 -            week rest period. Each 4-week period will be considered one
111413 -            cycle.  All treatment will done in a clinic or doctor's
111414 -            office. You may a receive a maximum of 18 cycles (72 weeks)
111415 -            of treatment. ref OF 1 C638
111417 -         ..
111418 -        New version now reads...
111420 -         ..
111421 -        Group B:
111422 -
111423 -            You will receive paclitaxel as an infusion in the vein
111424 -            every week for three weeks followed by one week rest
111425 -            period.  You will not receive any treatment during the one
111426 -            week rest period. Each 4-week period will be considered one
111427 -            cycle.  All treatment will done in a clinic or doctor's
111428 -            office.  You may continue treatment as long as your disease
111429 -            is improving or remaining stable and you are not having
111430 -            side effects from the treatment. ref OF 2 C638
111432 -         ..
111433 -        Critical change is the last sentence that now says...
111434 -
111435 -            You may continue treatment as long as your disease is
111436 -            improving or remaining stable and you are not having side
111437 -            effects from the treatment, ref OF 2 C630, rather than for
111438 -            only 18 months, under the prior protocol. ref OF 1 C630
111440 -         ..
111441 -    3.  Page 2 of 11....
111442 -
111443 -        Previously read in pertinent part...
111445 -         ..
111446 -        LENGTH OF PARTICIPATION
111447 -
111448 -            You will be in the study for a maximum of 72 weeks or until
111449 -            your disease progresses or side effects of therapy would
111450 -            make it unsafe for you to continue. You medical condition
111451 -            will be tracked for five years from the time you begin
111452 -            treatment on this study to look at the long-term effects of
111453 -            the treatment. Your doctor may decide to take you off this
111454 -            study if your disease does not improve or if side effects
111455 -            of treatment would make it unsafe to continue. ref OF 1
111456 -            UK54
111458 -         ..
111459 -        New version now reads...
111461 -         ..
111462 -        LENGTH OF PARTICIPATION
111463 -
111464 -            You will be in the study until your disease progresses or
111465 -            side effects of therapy would make it unsafe for you to
111466 -            continue. Your medical condition will be tracked for five
111467 -            years from the time you begin treatment on this study to
111468 -            look at the long-term effects of the treatment. Your doctor
111469 -            may decide to take you off this study if your disease does
111470 -            not improve or if side effects of treatment would make it
111471 -            unsafe to continue. ref OF 2 UK54
111473 -         ..
111474 -        Critical change is the first sentence that now says...
111475 -
111476 -            You will be in the study until your disease progresses or
111477 -            side effects of therapy would make it unsafe for you to
111478 -            continue, ref OF 2 UK54; rather than for a maximum of 72
111479 -            weeks under the prior protocol. ref OF 1 UK54
111481 -             ..
111482 -            This change aligns "Length of Participation" with the new
111483 -            explanation of Group A and Group B treatments plans.
111484 -
111486 -         ..
111487 -    4.  Page 11...
111488 -
111489 -        This is a new page to provide a diagrammatic scheme showing the
111490 -        randomized study plan, ref OF 2 D58I, for treatment of Group A
111491 -        patients, as revised, per above, ref SDS 0 0132, and for Group
111492 -        B patients, also, as revised above. ref SDS 0 OR97
111494 -         ..
111495 -        Critical change provides a summary of the study plan...
111496 -
111497 -            The diagram summarizes Group A and Group B (shown as "Arm
111498 -            A" and "Arm B" in the diagram) treatments, and so provides
111499 -            added clarity of a diagram.
111500 -
111501 -
111502 -
111503 -
111504 -
1116 -

SUBJECTS
Accuracy Patient History Critical for Drug Trial Protocols Kaiser Wi
Accuracy Critical Case History for Drug Trial Protocols
Accuracy Bumbling Guess Treatment Options Not Enough Time Doctor Can

2205 -
220601 -  ..
220602 - Proactive Medical Management Timely Treatment of Emerging Problems
220603 - Accuracy Critical Case History for Drug Trial Protocols
220604 - Kaiser Policy Withholds Computer File Increase Burden on Patients
220605 - Case History Requires Extra Time Kaiser Withholds File for Accuracy
220606 -
220607 - Rosalie said that Kaiser will not make the computer file on the
220608 - Avastin/Taxol trial available to patients for efficient case
220609 - management that strengthens accuracy.  She was unsure about why, or
220610 - what harm Kaiser might suffer from saving time and trauma for the
220611 - patient in developing an accurate record of the work, per above.
220612 - ref SDS 0 JP6M
220614 -  ..
220615 - Rosalie explained the importance of accurate medical records to manage
220616 - patient care.  Cancer patients require higher precision on diagnosing,
220617 - treating, and monitoring changes in status, because chemotherapy
220618 - lowers natural immunity.  A wide range of minor maladies that the body
220619 - normally cures naturally can quickly cascade out of control, if not
220620 - closely monitored and treated promptly.  Vital signs, blood tests, and
220621 - image testing with PET and CT scans support the doctor's training and
220622 - experience for proactive management to assess small, emerging changes
220623 - in body chemestry that compound into major problems, if not treated
220624 - with the correct protocol, reflecting common requirements for good
220625 - management cited on 921127. ref SDS 1 0674
220626 -
220627 -        [On 060821 conversation to get the gist of the story for
220628 -        complex patient history supports written 2nd opinion without
220629 -        review of written chronology. ref SDS 38 YK6N
220631 -  ..
220632 - The 50 or so side effects of the Avastin (Bevacizumab) trial, which
220633 - Rosalie reviewed below, ref SDS 0 V77O, present complex requirements
220634 - to prevent cancer treatments from making the patient worse instead of
220635 - better,
220637 -  ..
220638 - Rosalie advised that Kaiser's records are audited for compliance with
220639 - protocols.  Keeping records and auditing for accuracy fosters thorough
220640 - work ups for diagnosis, timely treatment, and careful monitoring of
220641 - progress.  Rosalie feels that monthly examinations and quarterly CT
220642 - tests on the Avastin trial, also, discussed below, ref SDS 0 HS45,
220643 - provide precision medical practice that prevents side effects from
220644 - cascading out of control.
220645 -
220646 -        [On 040416 case study illustrates advantages of audits to
220647 -        support vigilence avoiding errors and omissions in health care
220648 -        and medical practice. ref SDS 16 GN7J
220650 -         ..
220651 -        [On 041021 errors in chemotherapy treatment by the Infusion
220652 -        Clinic illustrate requirement for high degree of precision
220653 -        following protocols. ref SDS 30 NG7B
220655 -         ..
220656 -        [On 041104 Millie diagnosed with pulmonary emboli after 6
220657 -        months of symptoms, and 2 CT tests; problem discovered on 3rd
220658 -        CT test. ref SDS 31 4Y9G
220660 -         ..
220661 -        [On 060722 case study shows that protocol for monthly
220662 -        examinations and quarterly CT scans were not sufficient to
220663 -        discover pulmonary emboli in Millie's case. ref SDS 37 6G6O
220665 -  ..
220666 - Kaiser's practice to audit accuracy of medical records aligns with ISO
220667 - requirements for an audit trail showing traceability to original
220668 - sources that maintains alignment with patient history, objectives,
220669 - requirements, and commitments, reviewed on 950721. ref SDS 2 1740  On
220670 - 951026 organizations certified ISO compliant report difficulty
220671 - complying with good management practice. ref SDS 3 3245  Accordingly,
220672 - Kaiser's understanding about the importance of accuracy, shows the
220673 - right attitude, and aligns with the Healthwise Handbook, calling for
220674 - investing time to ensure accurate communications for effective care,
220675 - reviewed on 990625. ref SDS 4 0806
220677 -  ..
220678 - Did Kaiser's audit process discover problems with CT test on 031031
220679 - that ignored expanding lymphadenopathy cited in prior tests, as shown
220680 - in the record on 031205? ref SDS 8 GJ69
220681 -
220682 -        [On 040416 errors and omissions in diagnosis, treatment, and
220683 -        monitoring were reviewed in a case study of Millie's patient
220684 -        history. ref SDS 16 GN7J
220686 -         ..
220687 -        [On 040517 Millie diagnosed with IBC based on biopsy of red
220688 -        rash, ref SDS 19 6T5G; research revealed symptoms of IBC, which
220689 -        were prevously reported in Kaiser's testing beginning on
220690 -        021218. ref SDS 19 N23J
220692 -         ..
220693 -        [On 040812 primary care physician reports that medical practice
220694 -        in oncology requires less precision treating patients than
220695 -        needed for engineering to verify accuracy of tests. ref SDS 24
220696 -        TQ62
220698 -         ..
220699 -        [On 041018 Doctor Benz read from patient's letter to verify the
220700 -        scope and agenda for a 2nd opinion, ref SDS 27 LX3U, the doctor
220701 -        further requested written verification of CA 15-3 cancer
220702 -        marker, even though he also said that UCSF does not rely on
220703 -        this criteria, ref SDS 27 L16Q, all demonstrating importance of
220704 -        accuracy in medical practice illustrated by Rosalie's
220705 -        explanation of drug trial protocols, ref SDS 0 6E4K, however,
220706 -        the doctor then relied on asking questions to obtain patient's
220707 -        personal memory of events over 3 years to prepare a hurried,
220708 -        cursory, and erroneous chronology of patient history that
220709 -        ignored the written record submitted to UCSF. ref SDS 27 EN63
220711 -         ..
220712 -        [On 041019 in offering a 2nd opinion, Doctor Guardino asked an
220713 -        aide to authenticate conversation during a meeting at Stanford
220714 -        Medical Center by leaving the room to check the written record
220715 -        showing a pathology report that discovered IBC was dated
220716 -        040419, rather than three (3) days earlier on 040416.
220717 -        ref SDS 29 BV92
220719 -         ..
220720 -        [On 041130 discussion at Kaiser on getting a written work
220721 -        plan and review by Tumor Board on treating the patient,
220722 -        ref SDS 33 YR8F, after major change in status due to
220723 -        pulmonary emboli ended participation in the Avasting Taxol
220724 -        trial. ref SDS 33 WL9M
220726 -         ..
220727 -        [On 041230 primary care physician asked patient for reasons
220728 -        chemotherapy regimine was changed to another drug, illustrating
220729 -        importance of timely, accurate records. ref SDS 36 XQ84
220730 -
220731 -
220732 -
220733 -
220734 -
220735 -
220736 -
2208 -

SUBJECTS
Sign Documents Consent to Participate in Avastin Trial Drug Chemothe

2403 -
240401 -  ..
240402 - Avastin Trial Consent Signed to Participate
240403 - Consent Signed to Participate in Trial for Avastin Cancer Treatments
240404 -
240405 - Rosalie was very thorough reviewing the consent for participation in
240406 - the trial, per above, ref SDS 0 JP82, and offered clear explanations
240407 - of side effects that reassured Millie about risks from participating
240408 - in a trial, per below. ref SDS 0 V77O
240410 -  ..
240411 - Millie initialed each page, and signed in the 3 or 4 places that
240412 - required full signature. ref OF 2 7H5O  Rosalie then took the
240413 - documents and had them signed by other hospital officials, including
240414 - the primary care physician.
240416 -     ..
240417 -    [On 040517 Millie reports severe coughing and heaviness in chest
240418 -    causing difficult breathing for several hours, cited as side effect
240419 -    of Avastin, ref OF 2 CE45, diagnosed as reaction to allergy; no
240420 -    treatment prescribed. ref SDS 21 RZ4I
240422 -     ..
240423 -    [On 040812 Genentec, manufacturer of Avastin announces increased
240424 -    risk for pulminary emboli (blood clots); Millie reports family
240425 -    history of blood clot issues, and asks about report in connection
240426 -    with symptoms of coughing, difficult breathing, heaviness in chest;
240427 -    doctor interprets increased risk on Avastin trial related to
240428 -    personal history of blood clots, and so no change in treatment was
240429 -    prescribed. ref SDS 24 RZ4I
240431 -     ..
240432 -    [On 041104 coughing and heaviness in chest diagnosed due to blood
240433 -    clot, pulminary emboli, which is a side effect of Avastin,
240434 -    ref OF 2 CE39, found in CT test. ref SDS 31 N43I
240436 -     ..
240437 -    [On 041104 coughing and heaviness in chest diagnosed due to blood
240438 -    clot (pulminary emboli) reported in CT test, and which is a side
240439 -    effect of Avastin (Bevacizumab) listed in the record on 040517,
240440 -    ref SDS 19 ML8J; Millie removed from Avastin trial; all cancer
240441 -    treatments suspended. ref SDS 31 N43I
240443 -  ..
240444 - After visiting with Rosalie, the primary care physician examined
240445 - Millie, as called out in the protocol consent, discussed with Rosalie
240446 - on 040318. ref SDS 10 UO3H
240448 -  ..
240449 - Millie thanked Rosalie again for thorough and professional
240450 - presentation on the protocol.
240451 -
240452 -    [...during the meeting with the primary care physician later in the
240453 -    afternoon, he indicated that Rosalie would schedule follow up
240454 -    meetings, which suggests Rosalie will be prime contact for
240455 -    communications going forward. ref SDS 11 9M6O
240456 -
240457 -
240458 -
240459 -
240460 -
2405 -

SUBJECTS
Scheduled Treatment Commence Immediately Cleared by Primary Care Phy

2703 -
270401 -  ..
270402 - Schedule Treatment Commence Immediately Cleared by Doctor
270403 - Treatment Scheduled to Commence Immediately Cleared by Doctor
270404 -
270405 - During the meeting with the primary care physician, reported in
270406 - another record, ref SDS 11 0001, Rosalie continued to interact with
270407 - Millie and the primary care physician, coming into and leaving the
270408 - examination room to discuss arrangements for Millie to start
270409 - treatments.
270411 -  ..
270412 - Based on the doctor's determination that diagnosis of the red rash on
270413 - the left breast is not cellulitus, nor some other condition that
270414 - requires recovery prior to participating in the Avastin trial
270415 - protocol, ref SDS 11 IM6J, Rosalie will now schedule treatments to
270416 - begin without further delay, as occurred on 040318. ref SDS 10 DK5N
270417 -
270418 -     [On 040407 Rosalie called and scheduled treatments to begin on
270419 -     040420. ref SDS 13 3S6L
270420 -
270421 -
270422 -
270423 -
2705 -

SUBJECTS
Avastin Consent Form Treatments 18 Month Trial Extended to Duration
Change Consent Form Avastin Treatments 18 Month Trial Extended to Du

3004 -
300501 -  ..
300502 - 18 Month Trial Extended to Duration of Patient Requirements
300503 -
300504 - A major change in the terms of patient consent is that the 18 cycle
300505 - (which is 18 months) limitation in the prior version, ref OF 1 C630,
300506 - has been eliminated.  Rosalie seemed to indicate that the new protocol
300507 - permits patients to continue with treatment as long as there is
300508 - evidence of favorable results, which she said means there is no
300509 - progression of disease nor emergence of harmful side effects.
300510 - ref SDS 0 5Q6F
300512 -  ..
300513 - This appears to reflect the circumstance of metastatic cancer patients
300514 - require continuing treatment going forward in their lives.
300515 -
300516 -
300517 -
300518 -
300519 -
3006 -

SUBJECTS
Side Effects 50 Avastin Bevacizumab Explained by Kaiser Severity Exe

3403 -
340401 -  ..
340402 - Side Effects Severity Exemplified by Slight Nose Bleeds
340403 - Severity Likely Side Effects Discussed Exemplified by Nose Bleeds
340404 - Bevacizumab Side Effects Severity Exemplified by Slight Nose Bleeds
340405 -
340406 - Millie asked about side effects?
340408 -  ..
340409 - Rosalie said that the most common side effects of Avastin is a slight
340410 - nose bleed in some patients. ref OF 2 CE59  She described this as not
340411 - a typical nose bleed where blood flows freely, but more like a
340412 - condition where in wiping the nose with tissue, there might be be some
340413 - blood stains.
340415 -  ..
340416 - This was reassuring.
340417 -
340418 -        [On 040812 Millie reported continuing nose bleeds, cough, heavy
340419 -        chest. ref SDS 24 RZ4I
340420 -
340421 -        [On 041005 Millie reported continuing nose bleeds, cough, heavy
340422 -        chest. ref SDS 26 RZ4I
340424 -         ..
340425 -        [On 041210 nose bleed side effects subside after ending
340426 -        treatment with bevacizumab. ref SDS 35 FL8G
340428 -  ..
340429 - Rosalie discussed all of the 50 for so side effects, ref OF 2 UK66,
340430 - from treatment with both taxol, ref OF 2 UK88, and Bevacizumab (rhuMab
340431 - VEGF), commonly called Avastin. ref OF 2 CE39  She indicated again
340432 - that slight nose bleeds exemplify severity of the most likely side
340433 - effects, and that severe problems have been very rare for the Avastin
340434 - drug trials.  Rosalie advised that monthly examinations prior to
340435 - starting a new cycle of treatment, and quarterly CT scans (discussed
340436 - below, ref SDS 0 HS45) help avoid serious side effects with early
340437 - detection and treatment, including ending treatment with Avastin.
340438 -
340439 -        [On 041104 pulmonary emboli (blood clots in the lungs)
340440 -        diagnosed with CT test, after 2 prior CT tests failed to make
340441 -        findings to account for rising symptoms past 6 months;
340442 -        Millie'streatment with becizaumb (Avastin) was ended.
340443 -        ref SDS 31 RZ4I
340445 -         ..
340446 -        [On 060722 wicked problems commonly occur in medical
340447 -        practice, illustrated by Millie's patient history.
340448 -        ref SDS 37 346F
340450 -         ..
340451 -        [On 061002 Millie diagnosed with recurrence pulmonary emboli by
340452 -        CT test on 060930 after prior CT test failed to make findings.
340453 -        ref SDS 39 JK7J
340455 -         ..
340456 -        [On 061020 primary care physician advised that CT tests for
340457 -        pulmonary embolism are different from CT tests for cancer, and
340458 -        so have to be expressly requested with the order for the test.
340459 -        ref SDS 40 S56G
340461 -  ..
340462 - Taxol and Avastin cause patients to feel increasingly tired, weak and
340463 - fatigued, causing shortness of breath, and heavy chest due to loss of
340464 - fitness with normal exertion, as part of chemotherapy treatment.
340465 - Millie experienced these symptoms during treatment with AC and then
340466 - Taxotere in 2002.  On 030606 the doctor explained side effects of
340467 - chemotherapy accumulate to make treatment increasingly less tolerable,
340468 - ref SDS 7 ED8H, but then dissipate, if patients get better and can
340469 - end treatment, at least for awhile. ref SDS 7 435J
340471 -  ..
340472 - There were no examples presented of "severe" side effects, and no
340473 - discussion of correlations with family history nor descriptions of
340474 - symptoms that signify occurrance of severe side effects from
340475 - treatment with Avastin.
340476 -
340477 -        [On 040517 Millie reports coughing, shortness of breath, and
340478 -        heavy chest, ref SDS 19 RZ4I, which are symptoms of side
340479 -        effects for Avastin. ref OF 2 CE47
340481 -         ..
340482 -        [On 040525 Millie reported slight breakhout on her forehead
340483 -        that looks like acne; Rosalie indicated this is a "rash,"
340484 -        ref SDS 20 BG41, listed as a side effect of Avastin.
340485 -        ref OF 2 CE7T
340487 -         ..
340488 -        [On 040614 side effects coughing, difficult breathing, heavy
340489 -        chest more severe, ref SDS 22 RZ4I; cough medicine prescribed
340490 -        to relieve sore throat. ref SDS 22 RH3N
340492 -         ..
340493 -        [On 040713 side effects cough, shortness of breath, low energy
340494 -        continue; cough medicine helps sore throat from coughing.
340495 -        ref SDS 23 RZ4I
340497 -         ..
340498 -        [On 040812 side effects increase, Millie asks about ending
340499 -        treatment with Avastin/Taxol trial. ref SDS 24 RZ4I
340501 -         ..
340502 -        [On 040812 Genentec manufacturer of Avastin (bevacizumab)
340503 -        reports deaths from side effect pulmonary emboli, ref SDS 24
340504 -        MG4G; which is another side effect of Avastin. ref OF 2 CE3U
340505 -        Millie reports family history of mother dying at age 40 about
340506 -        50 years ago from blood clot related issues, and more recently,
340507 -        last year Millie's son now age 49, was hospitalized for
340508 -        pulmonary emboli, ref SDS 24 MG5K; doctor explains that since
340509 -        Millie has not yet been diagnosed with pulmonary emboli, the
340510 -        Genentec warning does not require change in her treatment.
340511 -        ref SDS 24 W35K
340513 -         ..
340514 -        [On 040909 side effects cough about the same, heavy chest
340515 -        problem increases, e.g., cannot walk up a flight of stairs,
340516 -        ref SDS 25 RZ4I; doctor describes delimma that CT tests do not
340517 -        show cause of cough and breathing problems, patient has serious
340518 -        symptoms and there is no explanation. ref SDS 25 TN7F  Patient
340519 -        plans to get 2nd opinion to assist Kaiser. ref SDS 25 M14J
340521 -         ..
340522 -        [On 041005 side effects worsen, without explanation nor relief;
340523 -        patient seeking 2nd opinion. ref SDS 26 RZ4I
340525 -         ..
340526 -        [On 041018 meeting at UCSF for 2nd opinion report problems of
340527 -        persistant cough, shortness of breath, difficult breathing for
340528 -        5 months; Doctor Benz indicates problem could be cancer in the
340529 -        lungs. ref SDS 27 LX96
340531 -         ..
340532 -        [On 041019 meeting at Stanford for 2nd opinion report problems
340533 -        of persistant cough, shortness of breath, difficult breathing
340534 -        for 5 months. ref SDS 28 4G9H
340536 -         ..
340537 -        [On 041104 pulmonary emboli (blood clots in the lungs) side
340538 -        effect of Avastin chemotherapy drug trial, ref OF 2 CE3U,
340539 -        diagnosed by CT scan, as cause of persistant cough, heavy
340540 -        chest, difficult breathing, Millie removed from cancer
340541 -        treatment on Avastin trial to reduce risk of death, ref SDS 31
340542 -        RZ4I; Kaiser policy requires cancer patients diagnosed with
340543 -        pulmonary emboli get treatment for life, ref SDS 31 4Y9G,
340544 -        Coumadin increased from 1 mg to 4 mg, and preceeded with
340545 -        Lovenox treatments. ref SDS 31 N455
340547 -         ..
340548 -        [On 041117 UCSF 2nd opinion cites patient cough and heavy
340549 -        chest, and shortness of breath; offers no ideas for resolution;
340550 -        does not propose investigation for lung cancer; but says matter
340551 -        is under investigation without specifying by whom or in what
340552 -        manner. ref SDS 32 OT5Q
340554 -         ..
340555 -        [On 041117 UCSF 2nd opinion recommends continuing
340556 -        Avasting/Taxol drug trial. ref SDS 32 OU5P
340558 -         ..
340559 -        [On 041209 Stanford 2nd opinion cites patient cough and
340560 -        shortness of breath. ref SDS 34 O18R
340562 -         ..
340563 -        [On 060722 case study pulmonary emboli. ref SDS 37 6G6O
340564 -
340565 -
340566 -
340567 -
340568 -
340569 -
340570 -
3406 -

SUBJECTS
Sick Leave 6 Weeks to Evaluate and Adjust to Weekly Chemotherapy

3703 -
370401 -  ..
370402 - Sick Leave 6 Weeks to Evaluate and Adjust to Weekly Chemotherapy
370403 - Kaiser Approves 6 Weeks Leave Evaluate Adjust to Weekly Chemotherapy
370404 -
370405 - Rosalie was pleased to hear that Millie will be taking a 6-week sick
370406 - leave from her job at N&P, and then will assess returning to work
370407 - based on the record of energy and recovery from treatments, which will
370408 - be once a week for 3 weeks, then a week of rest.
370410 -  ..
370411 - Millie has notified her management at work about pending treatment
370412 - requirements for taking sick leave.
370414 -  ..
370415 - Does Kaiser need to generate documentation that supports arrangements
370416 - for sick leave, perhaps for insurance purposes?
370418 -  ..
370419 - Rosalie said that the treatment regimen can be adjusted to accommodate
370420 - the vacation Millie has planned for July to visit an Arizona spa and
370421 - resort with her daughter in July.
370422 -
370423 -
370424 -
370425 -
370426 -
3705 -

SUBJECTS
PET Scan Findings Show Previous Metastatic Lymphadenopathy No Longer
Metastasis New Nonspecific May be Post Treatment Trauma Inflammatory
CT Scan Performed for Comparison with PET Scan to Evaluate New Metas
CT Scan Findings Show Previous Metastatic Lymphadenopathy No Longer
CT Scan Findings Show 2 New 1 CM Masses in Area of Prior Surgery for
Distant Metastasis Not Reported in CT Test on 030508
CT Scan Findings Show 1 CM Masses Increased to 1.5 CM 50% Growth
CT Scan Test Ordered Instead of PET Scan Test and Compare with Origi
CT Scan Test Shows No Evidence Progression Distant Metastasis Stable
CT Scan Test Shows Evidence of Cancer Recurrence Localized in Neck O

5012 -
501301 -  ..
501302 - CT Tests Scheduled to Prepare for Starting Avastin Treatment Trial
501303 -
501304 - Follow up ref SDS 10 LK5L, ref SDS 8 LK5L.
501305 -
501306 - Rosalie explained that patients will be closely monitored during
501307 - treatment.  In addition to monthly examinations by the doctor,
501308 - discussed previously on 040318, ref SDS 10 UO3H, Kaiser will perform CT
501309 - tests and take fluids for diagnostic review every 3 months.
501310 -
501311 -     [On 041104 followed up. ref SDS 31 SW4F
501313 -  ..
501314 - Millie needs another CT test, because the last one a few weeks ago,
501315 - and reviewed by the doctor on 040318, ref SDS 10 LK5L, is a day or so
501316 - beyond the requirements of the protocol for a CT test within 30 days
501317 - of starting actual treatments.
501319 -  ..
501320 - CT testing will cover the full body, including the head, and will be
501321 - performed every 3 months on all patients in the test group.
501323 -  ..
501324 - Rosalie advised that Millie will be notified by Kaiser when to come in
501325 - for the CT test next week.  She requested that Millie call her, if
501326 - Kaiser does not call by next Tuesday, 040406, to schedule the CT test.
501327 -
501328 -     [On 040406 received call from Kaiser scheduling CT test for
501329 -     040410. ref SDS 12 0001
501330 -
501331 -
501332 -
501333 -
5014 -

SUBJECTS
Blood Serum Urine Fluid Tests Schedule and Performed Today

5303 -
530401 -  ..
530402 - Blood and Fluid Tests Schedule and Performed Today
530403 -
530404 - As part of preparation to begin treatments, Rosalie prepared documents
530405 - for Millie to have blood and other fluid tests to evaluate patient
530406 - recovery, ref OF 2 UJ44, and to provide data for scientific studies
530407 - that will be performed by CTSU, ref OF 2 CH39, and others for research
530408 - called out in the consent signed today. ref OF 2 CH40
530410 -  ..
530411 - Following the meetings today, we went to the lab in the hospital and
530412 - Millie provided the fluids called out in the order.
530413 -
530414 -
530415 -
530416 -
530417 -
530418 -
5305 -

SUBJECTS
Port Surgery Installation Scheduled by Rosalie
Port Will Provide Partial Relief from Excessive Needle Insertions in

5704 -
570501 -  ..
570502 - Port Catheter to Relieve Injury from Needle Penetrations
570503 - Surgery Port Catheter Implant Scheduled Avoid Injury to Right Arm
570504 -
570505 - Rosalie showed the diagram on the wall in the examination room that
570506 - illustrates positioning and scope of port catheter implantation.
570508 -  ..
570509 - Millie asked about risks of this surgery and whether it will solve
570510 - the problem by avoiding needle penetrations?
570512 -  ..
570513 - Rosalie said that implanting a port catheter as shown in the diagram
570514 - on the wall in the examination room is "outpatient" minor surgery.  It
570515 - takes about 20 minutes with local anesthetic.  The patient is then
570516 - released to go home.  She advised that many cancer patients have this
570517 - surgery.  Rosalie feels this experience shows that risks of this
570518 - surgery are much less than the two surgeries Millie had in 2002, the
570519 - first on 020312, ref SDS 5 0001, and follow up on 020327 to get clear
570520 - margins. ref SDS 6 0001
570522 -  ..
570523 - Rosalie advised that implanting a port catheter will solve problems
570524 - Millie has experienced by eliminating the pain and discomfort from
570525 - needle penetrations that Millie reported to the doctor during the
570526 - meeting on 040318. ref SDS 10 RX9O
570528 -  ..
570529 - Millie agreed to have the surgery.
570531 -  ..
570532 - Rosalie will arrange for Millie to have surgery to implant a port
570533 - catheter for blood draws and providing intravenous chemotherapy
570534 - treatments, including the bevacizumab, (rhuMab VEGF), ref OF 1 C594,
570535 - more commonly called Avastin.
570536 -
570537 -     [On 040407 Rosalie called and advised surgery will likely not
570538 -     occur prior to start of treatments on 040420, but there was a
570539 -     feeling it would occur by the end of the month. ref SDS 13 3S6L
570541 -      ..
570542 -     [On 040409 Millie wrote to Rosalie confirming understandings on
570543 -     schedule for surgery to install a port. ref SDS 14 NE52
570545 -      ..
570546 -     [On 040414 Kaiser scheduled surgery to install the port on 040419,
570547 -     ref SDS 15 194J, a day before treatments are scheduled to begin on
570548 -     040420. ref SDS 14 K175
570550 -      ..
570551 -     [On 040419 port catheter installed at Kaiser in Martinez CA;
570552 -     reported a success, expecting to relieve trauma from needle
570553 -     punctures and penetrations for blood draws and IV infusion
570554 -     treatments for chemotherapy. ref SDS 17 PPSW
570556 -      ..
570557 -     [On 080501 Brigid explained concerns at UCSF that risks of
570558 -     outpatient minor surgery to remove the current port and replace
570559 -     with a Power Port that is safer for CT contrast medium injections
570560 -     is greater risk than injury to the arm from excessive needle
570561 -     penetrations. ref SDS 41 R59F
570563 -  ..
570564 - Dual "port" installation needs consideration based on reports that
570565 - blood clots can clog these mechanisms, which prevents or delays
570566 - treatment, or requires using a vein, contrary to objectives of the
570567 - port.
570569 -  ..
570570 - A dual port will further reduce excessive exposure to needle problems
570571 - caused from drawing blood and administering treatments intravenously.
570572 -
570573 -     [On 040407 Rosalie called and explained that Kaiser does not use a
570574 -     "dual" port procedure to reduce risks of blood clots causing ports
570575 -     to get clogged. ref SDS 13 3S6L
570577 -      ..
570578 -     [On 040409 Millie wrote to Rosalie confirming understandings that
570579 -     Kaiser does not support a dual port system. ref SDS 14 NE99
570581 -      ..
570582 -     [On 040414 Kaiser scheduled surgery to install the port on 040419,
570583 -     ref SDS 15 194J, a day before treatments are scheduled to begin on
570584 -     040420. ref SDS 14 K175
570586 -      ..
570587 -     [On 040601 minor bleeding from port after treatment explained as
570588 -     helping to avoid clogging problems. ref SDS 20 9V5G
570589 -
570590 -
570591 -
570592 -
570593 -
570594 -
570595 -
570596 -
570597 -
570598 -
5706 -