THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net


S U M M A R Y


DIARY: October 16, 2008 11:42 PM Thursday; Rod Welch

Letter to medical team on work plan for Millie starting new treatment.

1...Summary/Objective
............Study Title: A phase I/II study of sunitinib (SU11248) in
............combination with metronomic cyclophosphamide and
............methotrexate for patients with metastatic breast cancer.
2...Progression of Cancer 6th Relapse and 5th Relapse of IBC
........Case Study 6th Relapse Overall and 5th Relapse IBC
3...Work Plan Transition Treatment for Millie 5th Relapse IBC
4...Status Change Triple Negative Biopsy Evaluate Expand Treatments
5...5th Relapse IBC Work Plan Biopsy Check Triple Negative Status Change
6...Case Study Status Change Order Biopsy Obtain Pathology Findings


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

SUBJECTS
Meetings Results 081016 Examination UCSF Doctor Review Response Trea

3003 -
3003 -    ..
3004 - Summary/Objective
3005 -
300501 - Follow up ref SDS 38 0000.
300502 -
300503 -
300504 -
300505 -
300507 -  ..
3006 -
3007 -
3008 - Progress
3009 -
300901 - Submitted letter summarizing results of the meeting today at UCSF,
300902 - and discussion on starting a new treatment regimen...
300903 -
300904 -    1.  Subject: Work Plan Consider Change Treatment Sunitinib Clinical Study
300905 -        Date: Thu, 16 Oct 2008 23:57:24 -0700
300910 -         ..
300911 -    2.  Dear Doctor Rugo,
300913 -         ..
300914 -    3.  Initially, request comment from Gloria at Kaiser's Coagulation
300915 -        Control Clinic in Martinez on the blood test today at UCSF.
300916 -        ref SDS 39 K66J
300918 -  ..
300919 - Responds to Gloria's letter dated 081004 received yesterday on 081015
300920 - asking about blood test results. ref SDS 37 YG5H
300922 -  ..
300923 - Millie's letter to the medical team continues...
300924 -
300925 -    4.  As a precaution, I skipped Coumadin today pending guidance from
300926 -        Gloria on INR 4.2.  Brigid indicated that significantly
300927 -        elevated pulse for several hours above 180 reported on 081012,
300928 -        ref SDS 36 4I8M, does not raise concerns, but, at that time,
300929 -        the INR results were not yet reported.
300930 -
300931 -            [On 081019 Millie notified Gloria that Coumadin treatment
300932 -            was resumed the next day on Friday, 081017. ref SDS 46 TH7T
300934 -             ..
300935 -            [On 081024 Millie received a letter from Kaiser reporting
300936 -            receipt of notice in Millie's letter today that INR 4.2
300937 -            elevated above normal, ref SDS 59 RF5I, and further
300938 -            received a form letter that says to notify Kaiser about
300939 -            changes in health, and activity, which was done in the
300940 -            letter today without any evident awareness by Kaiser.
300941 -            ref SDS 59 B46J
300943 -             ..
300944 -            [On 081024 Millie notified Kaiser that INR 2.3 returned to
300945 -            normal range between 2.0 and 3.0 with another blood test a
300946 -            week later on 081023 at UCSF. ref SDS 60 6V5T
300948 -         ..
300949 -    5.  Today, during treatment, I received from Megan [actually
300950 -        Glenna] a consent to participate in a new study, ref SDS 39
300951 -        KV4O, and dated recently on 080820...
300953 -             ..
300954 -            Study Title:  A phase I/II study of sunitinib (SU11248) in
300955 -            combination with metronomic cyclophosphamide and
300956 -            methotrexate for patients with metastatic breast cancer.
300958 -         ..
300959 -    6.  This implements planning you discussed during the meeting today
300960 -        on the 2nd floor in the Breast Care Clinic.
300962 -  ..
300963 - UCSF proposal to consider sunitinib clinical study aligns with
300964 - Millie's request in the letter to the medical team yesterday to begin
300965 - review of options for future treatments. ref SDS 38 K45V
300967 -  ..
300968 - Treatment with cyclophosphmaide in the sunitinib trial, per above,
300969 - ref SDS 0 J38U, appears conflicting with patient history.
300970 - Cyclophosphamide is the generic name for Cytoxan, which Millie
300971 - received with Andriamycin (i.e., AC) twice previously.  Doctor Johnson
300972 - stopped AC after just 2 cycles in June 2002, because treatment was
300973 - ineffective, reported 020603. ref SDS 2 WO4O  AC was prescribed again
300974 - beginning on 050104 for the purpose of qualifying Millie for a
300975 - clinical trial.  However, after 4 cycles, AC was ended on 050329,
300976 - because the cancer marker went up with each treatment. ref SDS 11 T58M
300978 -  ..
300979 - Today, Doctor Rugo explained that there is discretion to waive some
300980 - criteria, since the main benefit expected for Millie is with the
300981 - "targeted" therapy sunitinib, similar to cetuximab.  The past 2 years,
300982 - Millie experienced high quality of life with cetuximab alone.  After
300983 - adding carboplatin chemotherapy, this treatment was not very
300984 - effective, because after many relapses Millie's cancer has mutated to
300985 - resist chemotherapies.
300987 -             ..
300988 -            [On 081017 entered Sunitinib clinical study consent
300989 -            document into the record for case management. ref SDS 42
300990 -            HF5H
300992 -             ..
300993 -            [On 081018 Doctor Stritter speaking at a Wellness Community
300994 -            event related her research showing promising potential for
300995 -            Millie's treatment with Sunitinib. ref SDS 44 PQ6X
300997 -             ..
300998 -            [On 081021 Millie submitted sunitinib consent document to
300999 -            primary care physician at Kaiser to prepare for meeting on
301000 -            081024 to consider approval for this line of treatment.
301001 -            ref SDS 50 W83I
301003 -             ..
301004 -            [On 081022 Millie hand carried a printed copy of Consent
301005 -            document to primary care physician at Kaiser in Walnut
301006 -            Creek to prepare for meeting to review sunitinib clinical
301007 -            study and consider approval for this treatment. ref SDS 51
301008 -            XK5H
301010 -             ..
301011 -            [On 081024 primary care phsyician prescribes treatment for
301012 -            Millie at UCSF with sunitinib metronomic and multi-agent
301013 -            protocol, ref SDS 63 XZ8W, because Millie's advancing
301014 -            cancer has become resistant to chemotherapy and so requires
301015 -            double agent drugs, and Kaiser only has single agent
301016 -            treatments which will be ineffective to treat Millie's 5th
301017 -            relapse of IBC, and further, becauser Kaiser's experience
301018 -            with sunitinib indicates this can be effective for Millie.
301019 -            ref SDS 63 ER4I
301021 -             ..
301022 -            [On 090514 0830 Doctor Rugo prescribes MPA clinical trial
301023 -            for Millie to recover from the 8th relapse of cancer, and
301024 -            assigns Millie to get MPA only in order to avoid side
301025 -            effects of cyclophosphamide that caused severe side effects
301026 -            for Millie on the sunitinib protocol. ref SDS A6 265I
301028 -             ..
301029 -            [On 090615 1418 Doctor Rugo exercised discretion to waive
301030 -            some criteria in order to expedite Millie starting
301031 -            treatment to recover from medical mistakes getting
301032 -            radiation medical services from UCSF on referral, and which
301033 -            missed treating cancer in the breastbone. ref SDS A7 RY7N
301035 -  ..
301036 - Millie's letter to the medical team continues...
301037 -
301038 -    7.  It would help me review and follow up to get the computer file
301039 -        for this document.  Jackie submitted the computer file for the
301040 -        cetuximab Carboplatin study, received on 070116. ref SDS 16 0Q7I
301042 -         ..
301043 -    8.  I could type it up from the paper, but it saves a lot of work
301044 -        to get the computer file.
301045 -
301046 -            [On 081017 the doctor will discuss with Pfizer giving a
301047 -            copy to the patient of the computer file for the consent
301048 -            document. ref SDS 41 MO3F
301050 -             ..
301051 -            [On 081017 entered Sunitinib clinical study consent
301052 -            document into the record for case management. ref SDS 42
301053 -            HF5H
301055 -             ..
301056 -            [On 081031 Glenna proposed sending via email the signature
301057 -            page of the Consent document in a computer file.
301058 -            ref SDS 75 CC3O
301060 -         ..
301061 -    9.  By copy to Doctor Johnson, I am letting him know about the UCSF
301062 -        proposal [per above, ref SDS 0 J38U], so he can investigate,
301063 -        and advise me during the meeting next Friday at Kaiser.  If
301064 -        there is a problem getting the computer file, I will submit the
301065 -        Sunitinib study papers received today, so Doctor Johnson can
301066 -        make a copy to review.
301068 -  ..
301069 - UCSF proposal to consider sunitinib clinical study, per above,
301070 - ref SDS 0 J38U, aligns with Millie's request in the letter to the
301071 - medical team yesterday to begin review of options for future
301072 - treatments, ref SDS 38 K45V, and implements Doctor Johnson's guidance
301073 - in the meeting 080829 for UCSF to begin planning for transition to a
301074 - new treatment, ref SDS 32 RP9R, required by finding of progression of
301075 - cancer reported by Lynn at UCSF on 080821, ref SDS 30 4C6O, and
301076 - concurred by Doctor Johnson's examination at Kaiser a week later on
301077 - 080829. ref SDS 32 RP8T
301079 -             ..
301080 -            [On 081019 Millie sent a letter to the primary care
301081 -            physician submitting Doctor Stritter's favorable comments
301082 -            on the sunitinib clinical trial for treatting Millie's 5th
301083 -            relapse of IBC. ref SDS 45 D13Q
301085 -             ..
301086 -            [On 081021 Consent document for Sunitinib clinical study
301087 -            sent to primary care physician to prepare for meeting on
301088 -            081024. ref SDS 47 7L5S
301090 -             ..
301091 -            [On 081023 agenda for meeting at Kaiser review questions on
301092 -            sunitinib clinical study. ref SDS 53 L45S
301094 -             ..
301095 -            [On 081022 Millie had FNA procedure at Kaiser in Walnut
301096 -            Creek. ref SDS 52 NZ5N
301098 -             ..
301099 -            [On 081023 Kaiser reports pathology on FNA biopsy was
301100 -            positive for breast cancer. ref SDS 54 4Q9Q
301102 -             ..
301103 -            [On 081023 Doctor Rugo advises that pathology report on FNA
301104 -            biopsy showing positive for breast cancer stops Millie
301105 -            treatment on cetuximab Carboplatin clinical study,
301106 -            ref SDS 55 D65G; doctor meeting with staff to schedule next
301107 -            steps. ref SDS 55 KY7Y
301109 -             ..
301110 -            [On 081023 Millie's letter to Doctor Rugo reviews work plan
301111 -            to begin sunitinib clinical study to maintain continunity
301112 -            of treatment for IBC. ref SDS 56 4T8W
301113 -
301115 -  ..
301116 - Progression of Cancer 6th Relapse and 5th Relapse of IBC
301117 -
301118 -
301119 -   10.  This proposal to change treatment reflects examination today
301120 -        showing rising IBC intensity on my left arm, and small nodules
301121 -        in the breast bone area.  IBC rash in the breast and abdomen
301122 -        areas remains light and scatterd suggestive of responding to
301123 -        treatment;  however, the left arm and new nodules seem very
301124 -        significant.
301126 -  ..
301127 - Rising systems of IBC on left arm, and nodules in breast bone area
301128 - seem conflicting with cancer marker CA 15-3 95 stable for 3 months.
301129 - Stable to reduced IBC rash at other sites aligns with stable cancer
301130 - marker, reported in the record for treatment at UCSF today.
301131 - ref SDS 39 VK6H
301132 -
301133 -            [On 081024 1150 Doctor Johnson's examination at Kaiser
301134 -            found substantial progression of IBC disease, ref SDS 62
301135 -            W19H, and so approved the UCSF work plan for transitioning
301136 -            to treatment with sunitinib protocol at UCSF, ref SDS 62
301137 -            Y85H, as shown in this record below. ref SDS 0 J36R
301139 -  ..
301140 - Millie's letter to the medical team continues...
301141 -
301142 -   11.  You further found the swelled node in the left supraclavicular,
301143 -        reported by Lynn on 080821. ref SDS 30 4C6O [and confirmed by
301144 -        Doctor Johnson a week later on 080829, ref SDS 31 1Z6O, and the
301145 -        medical team was notified later that day. ref SDS 32 RP8T]
301147 -         ..
301148 -        Case Study 6th Relapse Overall and 5th Relapse IBC
301149 -
301150 -        Follow up ref SDS 28 0T8H, ref SDS 15 H54F.
301151 -
301152 -        1.  Lymph node biopsy positive start
301153 -            bevacizumab Taxotere.............. 040318, ref SDS 5 8R6M
301154 -        2.  Cancer marker IBC increase end
301155 -            bevacizumab Taxotere due to
301156 -            pulmonary embolism................ 041210, ref SDS 9 025H
301157 -        3.  Cancer marker IBC recurs 9 months
301158 -            months after mastectomy........... 060711, ref SDS 14 025H
301159 -        4.  Cancer marker IBC worsens end
301160 -            capeticabine Taxotere............. 061201, ref SDS 15 RU6J
301161 -        5.  IBC progression with increased
301162 -            lymph nodes in axilla add
301163 -            Carboplatin to cetuximab.......... 080306, ref SDS 28 NW3N
301164 -        6.  IBC worsesn CT test swelled
301165 -            LN left supraclavicular; treatment
301166 -            cetuximab and Carboplatin end;
301167 -            begin work plan for sunitinib
301168 -            metronomic protocol............... 081016, ref SDS 0 J34U
301169 -
301170 -               [On 090122 2321 Doctor Rugo diagnoses 6th relapse of
301171 -               IBC, ends sunitinib treatment. ref SDS A3 J47F
301173 -  ..
301174 - Millie's letter to the medical team continues...
301175 -
301176 -   12.  Doctor Johnson concurred the following week, noted in the
301177 -        letter to the team on 080829. ref SDS 32 RP8T
301178 -
301179 -            [On 081023 Doctor Daamen reports pathology on swelled lymph
301180 -            node in left supraclavicular positive for breast cancer.
301181 -            ref SDS 54 4Q9Q
301183 -             ..
301184 -            [On 081023 Doctor Rugo ends Millie's treatment with
301185 -            cetuximab and Carboplatin because biopsy on 081022 was
301186 -            positive for cancer. ref SDS 55 D65G
301188 -             ..
301189 -            [On 081113 CT test neck finds swelled lymph node in left
301190 -            supraclavicular. ref SDS 86 5O6N
301192 -         ..
301193 -   13.  I was encouraged today by your remarks that this study aligns
301194 -        with Doctor Johnson's goals on 080829 for "targeted" treatment,
301195 -        ref SDS 32 RP9R, [that the most difficult side effect taking
301196 -        sunitinib is a dry mouth, or mouth sores causing saliva], and
301197 -        that UCSF has another study [scheduled to start in about 4
301198 -        months], which can treat my IBC, as well as non-study options.
301199 -
301200 -            [On 090121 Glenna asked for help from Millie's "well
301201 -            ordered record" of patient history in order to expedite
301202 -            finding treatments in time to be effective, which Doctor
301203 -            Rugo has proposed for treating Millie after sunitinib,
301204 -            ref SDS A2 Y67L; listed the report today that UCSF is
301205 -            starting another study, and that UCSF has other non-study
301206 -            options for Millie. ref SDS A2 QC4I
301208 -             ..
301209 -            [On on 090130 Millie's letter to the medical team reports
301210 -            that on 090129 Doctor Rugo prescribed treating Millie with
301211 -            hyperthermia in the Radiation Oncology Department at UCSF,
301212 -            and in order to establish local control of expanding IBC,
301213 -            following relapse during treatment with sunitinib study.
301214 -            ref SDS A4 AY9Q
301216 -             ..
301217 -            [On 090514 0830 Doctor Rugo prescribes MPA clinical trial
301218 -            of another "targeted" drug for Millie to recover from the
301219 -            8th relapse of cancer, and assigns Millie to get MPA only
301220 -            in order to avoid side effects of cyclophosphamide that
301221 -            caused severe side effects for Millie on the sunitinib
301222 -            protocol. ref SDS A6 265I
301224 -         ..
301225 -   14.  Discussion occurred so fast today that I cannot remember these
301226 -        details.  Recall I was in shock and emotional from the pace of
301227 -        events.  I deeply appreciate your manner today [Millie asked
301228 -        "What's going to happen to me?" -- if there are no more
301229 -        treatments for her difficult patient profile.  Doctor Rugo put
301230 -        her arm around Millie's shoulder and said "Don't worry.  We're
301231 -        not going to let anything happen to you!  We have more drugs
301232 -        lined up after sunitinib" - per Doctor Johnson's instructions,
301233 -        above. ref SDS 0 J35X], along with Brigid and Megan, helping me
301234 -        deal with transition.
301236 -  ..
301237 - UCSF report on having more treatments for Millie after sunitinib, per
301238 - above, ref SDS 0 J38U, aligns with Millie's request in the letter to
301239 - the medical team yesterday to present options for future treatments.
301240 - ref SDS 38 K45V  Millie's letter yesterday asked about meeting again
301241 - with Doctor Benz to get an updated list of additional treatments for
301242 - Millie's patient profile.  Doctor Rugo's remarks today may indicate
301243 - she consulted with Doctor Benz, so that continuity of care is
301244 - maintained without interruption.
301246 -  ..
301247 - During the meeting, Doctor Rugo said that UCSF will coordinate with
301248 - Kaiser to sort out payment issues for this next treatment, so that
301249 - Millie does not face problems of over-billings that occurred last
301250 - year, shown by the record on 070830. ref SDS 17 7X5G
301252 -  ..
301253 - Doctor Rugo commented on health care challenges of rising costs to
301254 - meet rising demand for medical services, while balancing requirements
301255 - for cost containment.  She seemed to indicate her son was hospitalized
301256 - briefly for a minor malady a few years ago while on vacation in Hawii.
301257 - She was shocked to get the bill, and wound up making equitable payment
301258 - for services her son received.  Yet, 2 years later, she still gets
301259 - demands for unjustified overcharges.
301261 -  ..
301262 - As a result, the doctor wants to ensure payment arrangements are
301263 - resolved for Millie on her next treatment, in order to prevent a
301264 - repeat of problems last year.
301265 -
301266 -            [On 081017 Millie thanks doctor again for assistance coping
301267 -            with transition. ref SDS 41 NR9P
301269 -             ..
301270 -            [On 081017 Sunitinib Consent document explains the clinical
301271 -            study offers "targeted" treatment for breast cancer.
301272 -            ref SDS 42 006S
301274 -             ..
301275 -            [On 081018 Doctor Stritter speaking at a Wellness Community
301276 -            event related her research showing promising potential for
301277 -            Millie's treatment with Sunitinib. ref SDS 44 PQ6X
301279 -             ..
301280 -            [On 081021 Consent document for Sunitinib clinical study
301281 -            sent to primary care physician to prepare for meeting on
301282 -            081024. ref SDS 47 7L5S
301284 -             ..
301285 -            [On 081023 agenda for meeting at Kaiser review questions on
301286 -            sunitinib clinical study. ref SDS 53 L45S
301288 -             ..
301289 -            [On 081024 1150 primary care physician related experience
301290 -            treating patients with sunitinib at Kaiser, other than for
301291 -            breast cancer, shows some patients suffer side effects of
301292 -            fatigue and neuropathy; the dose levels may different from
301293 -            what Millie will get at UCSF, and Millie's good physicial
301294 -            condition from vigorous exercise will help minimize these
301295 -            effects in Millie's case. ref SDS 62 O668
301297 -             ..
301298 -            [On 081219 1140 Doctor Johnson disappointed that treatment
301299 -            with sunitinib was delayed for months due to problems
301300 -            performing case management, ref SDS A1 KK3M; Kaiser asks
301301 -            Millie again to remind Doctor Rugo to identify more
301302 -            treatments at UCSF that can be provided in time to be
301303 -            effective recovering from future relapses. ref SDS A1 H85I
301305 -             ..
301306 -            [On 090121 Glenna asked for help from Millie's "well
301307 -            ordered record" of patient history in order to expedite
301308 -            finding treatments in time to be effective, which Doctor
301309 -            Rugo has proposed for treating Millie after sunitinib,
301310 -            ref SDS A2 Y67L; listed the report today that UCSF is
301311 -            starting another study, and that UCSF has other non-study
301312 -            options for Millie. ref SDS A2 QC4I
301314 -             ..
301315 -            [On 090223 0947 dentist billed $17,000 for son's
301316 -            examination in hospital Emergency Department for 3 hours
301317 -            and for which no treatment was required. ref SDS A5 K06O
301318 -
301319 -
301320 -
3014 -

SUBJECTS
Work Plan Treatment 5th Relapse IBC Biopsy FNA Fine Needle Aspiratio
Meetings Results 081016 Examination UCSF Doctor Review Response Trea

6504 -
650501 -  ..
650502 - Work Plan Transition Treatment for Millie 5th Relapse IBC
650503 - Status Change Triple Negative Biopsy Evaluate Expand Treatments
650504 - 5th Relapse IBC Work Plan Biopsy Check Triple Negative Status Change
650505 -
650507 -  ..
650508 - Millie's letter to the medical team continues...
650509 -
650510 -   15.  The work plan seems to be...
650511 -
650512 -               [On 081017 0021 Doctor Rugo thanks Millie for help on
650513 -               coordinating UCSF work plan for Kaiser to get Millie
650514 -               ready in time for treatment to be effective at UCSF.
650515 -               ref SDS 41 ZM3G
650517 -                ..
650518 -               [On 081029 work plan updated, ref SDS 72 LH4O; submitted
650519 -               to Glenna, study coordinator at UCSF. ref SDS 72 H96H
650520 -
650521 -        1.  Kaiser biopsy the node in the left supraclavicular to
650522 -            verify cancer.  I have the form Brigid prepared and signed
650523 -            today that says in part...
650525 -                    ..
650526 -                   FNA L SC node, ER PR HER2 neu status
650528 -             ..
650529 -            Ordering test for status change may indicate the sunitinib
650530 -            study targets triple negative, and if the node is positive
650531 -            for cancer, then status can be assessed.
650533 -  ..
650534 - This makes biopsy to evaluate progression and check for status change
650535 - critical for starting treatment as soon as possible to prevent cancer
650536 - on the 5th relapse of IBC from cascading out of control.  Aligns with
650537 - patient history in case study on 041230 showing primary care physician
650538 - at Kaiser describes timely treatment essential for oncology care.
650539 - ref SDS 10 P19O
650541 -  ..
650542 - On 040303 Millie had FNA biopsy of a node in the left supraclavicular
650543 - performed by Doctor Lau in the Head and Neck Department. ref SDS 3
650544 - Y171  Pathology was positive on 040309, ref SDS 4 0001, leading to
650545 - determination of recurrence, and metastatic cancer on 040318,
650546 - ref SDS 5 8R6M, treated with the Avastin clinical study.  Kaiser did
650547 - not test for status change with the FNA biopsy on 040303.
650549 -  ..
650550 - A month later on 040419 the surgeon performed a punch biopsy of the
650551 - left breast to assess recurrent rash, as an added procedure during
650552 - surgery to implant a port catheter. ref SDS 6 789F  On 040429 the
650553 - surgeon advised the biopsy was positive for cancer, but did not
650554 - disclose what kind of cancer. ref SDS 7 C155  On 040517 the pathology
650555 - report was submitted on the punch biopsy.  Review after the meeting
650556 - showed IBC, and there was no finding on status change. ref SDS 8 6T5G
650558 -  ..
650559 - On 050909 Doctor Shim at Kaiser Oncology in Oakland recommended that
650560 - Kaiser in Walnut Creek test for status change that can have a huge
650561 - impact on expanding treatments for Millie. ref SDS 13 JX9P
650563 -  ..
650564 - On 060711 Kaiser in Walnut Creek reported status change was tested
650565 - with the biopsy on 040419, despite there being no report in pathology
650566 - received on 040517, and remained triple negative, ref SDS 14 SW7O,
650567 - i.e., there was no change from original status on 020321. ref SDS 1
650568 - LA7O
650570 -  ..
650571 - On 071007 Millie attended a cancer support group seminar; the speaker
650572 - indicated criteria for HER2 negative may have dropped from 2 to 1.6;
650573 - asked Doctor Rugo at UCSF about propsects of expanding treatment to
650574 - use Herception available onlyt to HER2 positive patient status.
650575 - ref SDS 18 S68T  On 071009 Doctor Rugo advised that UCSF continues to
650576 - rely on HER2 negative standard at 2, i.e., there has been no change in
650577 - criteria. ref SDS 19 HH4W
650579 -  ..
650580 - On 080207 Doctor Rugo asked Millie to request the pathology report
650581 - from Kaiser on the biopsy for 040419 that was described on 060711 as
650582 - having tested for status change, ref SDS 20 6S6G; and in order to
650583 - assess current options for treating Millie's 4th relapse of IBC.
650584 - ref SDS 20 655G  On 080219 UCSF received report for biopsy on 040419
650585 - and determined there is no change in Millie's triple negative status
650586 - as of that time on 040419, which would increase treatment options.
650587 - ref SDS 26 VX6G
650588 -
650590 -  ..
650591 - Case Study Status Change Order Biopsy Obtain Pathology Findings
650592 -
650593 - Today, the order for biopsy to check status tries again to expand
650594 - Millie's treatment options, ref SDS 0 J36R, first proposed by Doctor
650595 - Shim at Kaiser in Oakland on 050909, ref SDS 13 JX9P, and encouraged
650596 - by the report on 071007 of change in status criteria. ref SDS 18 S68T
650598 -                 ..
650599 -            1.  [On 081017 1410 visited Arlette at Kaiser in the
650600 -                Oncology Department when Millie was getting Neupogen
650601 -                treatment in the Infusion Clinic; she had talked to the
650602 -                doctor, and understood the doctor had received this
650603 -                letter, ref SDS 0 J34R, and was aware of the work plan,
650604 -                ref SDS 0 J36R, and that the needle biopsy of the node
650605 -                in the left supraclavicular to test for cancer and
650606 -                status change was being ordered for Millie at Kaiser to
650607 -                implement the prescription at UCSF today. ref SDS 43
650608 -                UP6I
650610 -                 ..
650611 -            2.  [On 081019 Millie sent a letter to Kaiser confirming
650612 -                understandings that the primary care physician is
650613 -                ordering the biopsy to test for cancer and status
650614 -                change requested by UCSF; hoping to get biopsy done OB
650615 -                081024. ref SDS 45 DZ5T
650617 -                 ..
650618 -            3.  [On 081021 Millie scheduled 081023 1045 at Kaiser in
650619 -                Surgery Department to biopsy "lump." ref SDS 48 0X9T
650620 -                Called and changed to 1445 after Millie returns to
650621 -                Concord from treatment at UCSF in San Francisco.
650622 -                ref SDS 48 4Q4C
650624 -                 ..
650625 -            4.  [On 081021 Surgery Advice Nurse considers requirements
650626 -                for case management to get biopsy results for meeting
650627 -                with doctor 081024 1145 to evaluate changing treatment
650628 -                for cancer;, ref SDS 48 IW66; checks UCSF work plan for
650629 -                FNA left supraclavicular and status change, advises
650630 -                this scope more typically performed in Head and Neck
650631 -                Department, ref SDS 48 PQ7T; Advice Nurse checks with
650632 -                surgeon; Surgery Department cancels order for biopsy,
650633 -                prepares referral to Head and Neck who can perform same
650634 -                day biopsy ref SDS 48 03GE
650636 -                 ..
650637 -            5.  [On 081021 letter to primary care physician requests
650638 -                follow up tomorrow with Head and Neck to clarify
650639 -                referral, and expedite the work. ref SDS 49 3U6S
650641 -                 ..
650642 -            6.  [On 081022 Millie visits Kaiser Head and Neck
650643 -                Department; Kaiser expedites work schedules FNA biopsy
650644 -                on the neck in the afternoon at 1400; Millie submitted
650645 -                UCSF order for the FNA biopsy and request to check for
650646 -                status change. ref SDS 52 HD85
650648 -                 ..
650649 -            7.  [On 081022 Millie notified medical team of adjustments
650650 -                to referral for FNA biopsy and checking for status
650651 -                change, and thanked the doctor for coordinating changes
650652 -                to expedite the work. ref SDS 51 2Y9T
650654 -                 ..
650655 -            8.  [On 081022 FNA biopsy performed at Kaiser; pathology
650656 -                report expected within a few days to a week,
650657 -                ref SDS 52 NZ5N; if pathology negative for cancer,
650658 -                Kaiser proposes retest with core biopsy, a more
650659 -                rigorous procedure. ref SDS 52 HH99
650661 -                 ..
650662 -            9.  [On 081022 FNA procedure checking for status change was
650663 -                not specified in referral from Surgery; the doctor
650664 -                corrected the problem by attaching UCSF order for FNA
650665 -                and checking status change to the transmittal for
650666 -                sending the specimen to the pathology lab. ref SDS 52
650667 -                RS8M
650669 -                 ..
650670 -           10.  [On 081023 FNA biopsy positive for breast cancer; need
650671 -                to do core biopsy because lab says FNA biopsy does not
650672 -                produce enough material to check for status change.
650673 -                ref SDS 54 W15N
650675 -                 ..
650676 -           11.  [On 081023 Kaiser letter advises that testing status
650677 -                change ER PR HER2 neu requires another biospy using a
650678 -                core rather than an FNA procedure, and asks if this
650679 -                test is necessary, suggesting reason to pause for
650680 -                careful consideration using a core biopsy procedure.
650681 -                ref SDS 54 4Q5V
650683 -                 ..
650684 -           12.  [On 081023 Kaiser expedited work scheduled Millie for
650685 -                core biopsy the next day on 081024 1130 to test for
650686 -                status change. ref SDS 54 667F
650688 -                 ..
650689 -           13.  [On 081023 UCSF medical team sent 5 letters saying FNA
650690 -                biopsy adequate for testing status change, ref SDS 55
650691 -                NI7S, aligned with written UCSF order today,
650692 -                ref SDS 0 J36R; the last letter says hopefully Kaiser
650693 -                will use FNA procedure to test for status change.
650694 -                ref SDS 55 KY8R
650696 -                 ..
650697 -           14.  [On 081024 Kaiser Head and Neck Department responds to
650698 -                UCSF Oncology saying the Kaiser Lab requires core
650699 -                biopsy to test for status change. ref SDS 57 008H
650701 -                 ..
650702 -           15.  [On 081024 Millie requested assistance from primary
650703 -                care physician on deciding the type of biopsy to test
650704 -                for status change that expands available treatments for
650705 -                cancer. ref SDS 58 579O
650707 -                 ..
650708 -           16.  [On 081024 Millie met with Kaiser Head and Neck
650709 -                Department; decided to perform core biopsy to test for
650710 -                status change, because Kaiser Lab uses different
650711 -                procedures from the lab UCSF uses to check biopsy
650712 -                tissue for status change; Kaiser further decided to
650713 -                defer performing core biopsy until 081107 after Millie
650714 -                returns from vacation to reduce risks of complications
650715 -                cascading out of control without ready access to Kaiser
650716 -                health care while traveling. ref SDS 61 G15K
650718 -                 ..
650719 -           17.  [On 081027 Kaiser delays core biopsy 3 times to 081117,
650720 -                providing more time to evaluate benefits justify risks
650721 -                to make core biopsy necessary. ref SDS 65 G15K
650723 -                 ..
650724 -           18.  [On 081027 Millie notified UCSF that Kaiser delayed
650725 -                core biopsy again to 081117, ref SDS 66 G15K, and asks
650726 -                if this will delay getting treatment for cancer with
650727 -                the UCSF work plan for starting the sunitinib clinical
650728 -                study. ref SDS 66 R79W
650730 -                 ..
650731 -           19.  [On 081027 Glenna's letter for UCSF later in the day
650732 -                does not mention requirements for biopsy to test status
650733 -                change. ref SDS 67 TU5I
650735 -                 ..
650736 -           20.  [On 081027 Glenna called and planned to ask Doctor Rugo
650737 -                about requirements for biopsy to test status change in
650738 -                order for Millie to start the sunitinib clinical study.
650739 -                ref SDS 68 934O
650741 -                 ..
650742 -           21.  [On 081027 Glenna clinical coordinator for sunitinib
650743 -                clinical study - Millie receives letter on setting up
650744 -                for Millie to start treatment. ref SDS 67 TU5I
650746 -                 ..
650747 -           22.  [On 081029 sunitinib work plan update proposes doing
650748 -                FNA biopsy at UCSF to check for status change.
650749 -                ref SDS 72 SF3P
650751 -                 ..
650752 -           23.  [On 081029 letter to UCSF discusses doing FNA biopsy
650753 -                for status check at UCSF instead of core biopsy at
650754 -                Kaiser. ref SDS 72 C49U
650756 -                 ..
650757 -           24.  [On 081031 letter to UCSF with copy to Kaiser asks
650758 -                about doing FNA biopsy at UCSF. ref SDS 74 NN5S
650760 -                 ..
650761 -           25.  [On 081031 Glenna called and advised that biopsy for
650762 -                status change is not a requirement for the sunitinib
650763 -                clinical trial, and so recommended contacting Doctor
650764 -                Rugo UCSF and Doctor Johnson at Kaiser. ref SDS 75 T27H
650766 -                 ..
650767 -           26.  [On 081031 Millie submits letter to medical team asking
650768 -                about doing the FNA biopsy to test status change at
650769 -                UCSF to reduce risks of core biopsy method. ref SDS 77
650770 -                AJ6U
650772 -                 ..
650773 -           27.  [On 081101 Doctor Rugo says FNA biopsy to check for
650774 -                status change is not part of the sunitinib clinical
650775 -                study; requires Kaiser approval of payment which would
650776 -                be very cost effective since FNA biopsy at UCSF would
650777 -                cost much less than the more invasive and problematic
650778 -                core biopsy Kaiser has scheduled for Millie on 081113.
650779 -                ref SDS 78 5G5H
650781 -                 ..
650782 -           28.  [On 081102 Millie's letter to Doctor Rugo with copy to
650783 -                primary care physician at Kaiser asks how much the FNA
650784 -                biopsy to test for status change will cost at UCSF, and
650785 -                notes this should be less expensive than doing the core
650786 -                biopsy at Kaiser. ref SDS 79 AD3F
650788 -                 ..
650789 -           29.  [On 081103 primary care physician at Kaiser responded
650790 -                to Doctor Rugo's letter on 081101 offering to perform
650791 -                FNA biopsy test for status change and saying this
650792 -                requires separate payment authorization, by advising
650793 -                that Kaiser "will perform the procedure," without
650794 -                clarifying using FNA or core biopsy procedure.
650795 -                ref SDS 80 2M64
650797 -                 ..
650798 -           30.  [On 081103 UCSF responds saying in total "Great."
650799 -                ref SDS 81 BY3H
650801 -                 ..
650802 -           31.  [On 081106 Doctor Daamen called and changed the
650803 -                schedule again, ref SDS 82 5F5H, for the core biopsy
650804 -                back to 081107 1600. ref SDS 82 5F68
650806 -                 ..
650807 -           32.  [On 081106 1213 letter notifies medical team that core
650808 -                biopsy to test for status change advanced from 081117
650809 -                to 081107 1600. ref SDS 83 7P68
650811 -                 ..
650812 -           33.  [On 081106 1631 Kaiser called back and said Millie was
650813 -                not scheduled for the core biopsy tomorrow on 081107
650814 -                1600, because Doctor Kahn would not be in the office,
650815 -                and Doctor Wong's schedule had changed, so nobody could
650816 -                do the biopsy for Millie on 081107. ref SDS 82 IP7L
650818 -                 ..
650819 -           34.  [On 081106 1643 Kaiser called back and advised after
650820 -                investigation that Millie is scheduled to meet with
650821 -                Doctor Kahn on 081107 1600 for the core biopsy as
650822 -                scheduled by Doctor Daamen, and the earlier problem was
650823 -                computer user issue. ref SDS 82 PQ9Y
650825 -                 ..
650826 -           35.  [On 081107 biopsy performed at Kaiser Head and Neck
650827 -                Department on 081107. ref SDS 85 7P5O
650829 -                 ..
650830 -           36.  [On 081113 Millie received partial results of the
650831 -                biopsy performed on 081107. ref SDS 87 QY5I
650833 -                 ..
650834 -           37.  [On 081119 Kaiser submits summary of final pathology
650835 -                report, ref SDS 88 5O8G, for the biopsy on 081107,
650836 -                ref SDS 85 496L, and it shows status unchanged, ER, PR,
650837 -                Her2neu still triple negative. ref SDS 88 UQ5P
650839 -                 ..
650840 -           38.  [On 081119 Millie notifies medical team of results on
650841 -                biopsy test for status change, ref SDS 89 V14I; Millie
650842 -                requests pathology report on biopsy from primary care
650843 -                physician. ref SDS 89 L34X
650845 -                 ..
650846 -           39.  [On 081120 Kaiser notifies Millie that entire pathology
650847 -                report can be submitted. ref SDS 90 VU9N
650849 -                 ..
650850 -           40.  [On 081120 Millie asks Kaiser to submit entire
650851 -                pathology report for the biopsy on 081107 that tested
650852 -                for status change. ref SDS 91 VG3X
650854 -                 ..
650855 -           41.  [On 081120 Kaiser notifies Millie the full report for
650856 -                pathology on the core biopsy performed on 081107 has
650857 -                been submitted with Kaiser's internal email system.
650858 -                ref SDS 92 OL5K
650860 -                 ..
650861 -           42.  [On 081120 Millie receives full pathology report for
650862 -                the biopsy on 081107. ref SDS 93 OL5K
650864 -                 ..
650865 -           43.  [On 081120 review pathology report shows criteria for
650866 -                HER2neu status is presented, ref SDS 93 LF9V, and
650867 -                conclusion of HER2neu negative is also presented,
650868 -                ref SDS 93 LF5V; however, the report does not seem to
650869 -                show specific findings on HER2neu that support a
650870 -                conclusion of negative. ref SDS 93 QQ3K
650872 -                 ..
650873 -           44.  [On 081202 0253 Millie's letter to medical team cites
650874 -                findings of triple negative and notes pathology report
650875 -                omits findings that support conclusion of triple
650876 -                negative status. ref SDS 94 AT4V
650878 -                 ..
650879 -           45.  [On 081202 1038 Millie's letter to Doctor Daamen at
650880 -                Kaiser requests findings for pathology on biopsy on
650881 -                081107 that support conclusion of triple negative
650882 -                status. ref SDS 95 GZ3W
650884 -                 ..
650885 -           46.  [On 081202 1253 Doctor Daamen checking with Kaiser lab
650886 -                to ensure accuracy of triple negative status
650887 -                conclusion. ref SDS 96 4P4K
650889 -                 ..
650890 -           47.  [On 081202 1314 Millie sent a letter to Kaiser
650891 -                clarifying scope of requirements on obtaining
650892 -                additional findings from the lab on status change.
650893 -                ref SDS 97 3E8M
650895 -                 ..
650896 -           48.  [On 081202 1428 Doctor Daamen reports the pathology lab
650897 -                submitted the specimen from the biopsy on 081107 for
650898 -                FISH testing to determine HER2 neu status; but have not
650899 -                received numerical analysis. ref SDS 98 4P5N
650901 -                 ..
650902 -           49.  [On 081202 1456 Kaiser submitted results of pathology
650903 -                for biopsy on 081107 showing HER2 neu FISH test = 1.1,
650904 -                ref SDS 99 FG5G, well below criteria for positive 2.0,
650905 -                and below change in criteria to 1.6 reported under
650906 -                consideration on 071007. ref SDS 18 S68T
650908 -                 ..
650909 -           50.  [On 081202 1502 Millie letter to Kaiser commends Doctor
650910 -                Daamen for outstanding work investigating details of
650911 -                tests that affect options treating cancer to extend and
650912 -                enhance quality of life, ref SDS A0 FG5G; cites risks
650913 -                of cynacism that discourage good management
650915 -  ..
650916 - Millie's letter to the medical team continues...
650917 -
650918 -        2.  I did not see anything in the study documents that mentions
650919 -            triple negative.  Please let me know where this issue is
650920 -            mentioned in the documents.
650922 -  ..
650923 - Actually, since the study documents do not specify triple negative, as
650924 - the cetuximab Carboplatin does, reported on 070116, ref SDS 16 0Q7I,
650925 - then the doctor may be using the occassion to test for cancer to check
650926 - status, and if Millie has experienced status change, and so is no
650927 - longer triple negative, then this would open a lot more treatment
650928 - options.
650930 -                 ..
650931 -                [On 081017 the doctor responds that "it is not a study
650932 -                for triple negative alone." ref SDS 41 6J3T
650934 -                 ..
650935 -                [On 081031 Glenna advised in a call that the sunitinib
650936 -                study does not require biopsy for status change.
650937 -                ref SDS 75 T27H
650939 -  ..
650940 - Opportunity to expand treatment options based on status change,
650941 - because of reports that criteria for status had changed since status
650942 - was originally tested on 020321 was presented to Doctor Rugo last year
650943 - on 071007. ref SDS 18 S68T  At that time, the doctor advised
650944 - understandings that criteria for status had not been lowered.
650945 - ref SDS 19 HH4W
650947 -                 ..
650948 -                [On 081018 Doctor Stritter presented advanced cancer
650949 -                treatments at a seminar; described sunitinib as a
650950 -                promising drug designed for "multi-targeted" treatment
650951 -                that improves performance achieved by cetuximab; if
650952 -                Millie is no longer triple negative, then ER, PR, and
650953 -                HER2neu may present additional targets for sunitinib to
650954 -                relieve current symptoms, and prevent recurrence of
650955 -                Millie's cancer. ref SDS 44 IT8V
650957 -  ..
650958 - About 4 months later, on 080207 the doctor asked about investigating
650959 - status change to assess options for treating Millie's 4th relapse.
650960 - ref SDS 20 6S6G  The next day on 080208 Millie sent a letter to the
650961 - medical team, including Kaiser, asking Kaiser to submit the report for
650962 - the biopsy on 040419 to Doctor Rugo at UCSF. ref SDS 21 OO5W  On 080213
650963 - Millie sent a letter asking if UCSF received the record from Kaiser
650964 - showing status change. ref SDS 22 7G9V  Millie sent another letter to
650965 - UCSF on 080214 asking if UCSF had received the biopsy report on status
650966 - change requested from Kaiser on 080208. ref SDS 23 Y86G  Another letter
650967 - was sent the next day on 080215 reminding UCSF to ask for data from
650968 - Kaiser to evaluate status change. ref SDS 24 ID6Q  On 080219 Millie
650969 - asked UCSF again about receiving the report on status change from
650970 - Kaiser. ref SDS 25 1K4S
650972 -  ..
650973 - On 080226 another patient reported status change occurred in her case.
650974 - ref SDS 27 M36R
650976 -  ..
650977 - On 080219 UCSF received the report for biopsy on 040419 and determined
650978 - there had been no change in Millie's triple negative status, which
650979 - would increase treatment options. ref SDS 26 VX6G
650981 -  ..
650982 - Millie's letter to the medical team continues...
650983 -
650984 -        3.  Hopefully, I can get the biopsy tomorrow afternoon, when I
650985 -            stop by for Neupogen treatment scheduled at 0200p.  I will
650986 -            try calling Arlette in the morning while hiking to see if
650987 -            things have been put in motion for the biopsy.
650988 -
650989 -                [On 081017 called Arlette at 0830; she had not yet read
650990 -                the letter with the work plan; said whe would find the
650991 -                doctor and ask about probress ordering the biopsy.
650992 -                ref SDS 43 UP5G
650994 -                 ..
650995 -                [On 081017 1410 visited Arlette at Kaiser in the
650996 -                Oncology Department when Millie was getting Neupogen
650997 -                treatment in the Infusion Clinic; she had talked to the
650998 -                doctor, and understood the doctor had received this
650999 -                letter, ref SDS 0 J34R, and was aware of the work plan,
651000 -                ref SDS 0 J36R, and that the needle biopsy of the node
651001 -                in the left supraclavicular to test for cancer and
651002 -                status change was being ordered for Millie. ref SDS 43
651003 -                UP6I
651005 -                 ..
651006 -                [On 081022 FNA biopsy performed at Kaiser; pathology
651007 -                report expected within a few days to a week,
651008 -                ref SDS 52 NZ5N; if pathology negative for cancer,
651009 -                Kaiser proposes retest with core biopsy, a more
651010 -                rigorous procedure. ref SDS 52 HH99
651012 -             ..
651013 -        4.  I can bring the form to Kaiser tomorrow, if necessary.  I
651014 -            think Doctor Johnson can order the biopsy, based on his
651015 -            findings on 080829, and patient history ordering a previous
651016 -            biopsy of this location on 040227, which resulted in
651017 -            diagnosing my first relapse, reported on 040309.
651018 -            ref SDS 4 0001
651019 -
651020 -                [On 081017 1410 visited with Arlette at Kaiesr; she
651021 -                reported the primary care physician is working on
651022 -                ordering the biopsy, and did not request documentation
651023 -                from UCSF. ref SDS 43 X47I
651025 -                 ..
651026 -                [On 081019 Millie sent a letter to Kaiser confirming
651027 -                understandings that the primary care physician is
651028 -                ordering the biopsy to test for cancer and status
651029 -                change requested by UCSF; hoping to get biopsy done OB
651030 -                081024. ref SDS 45 DZ5T
651032 -                 ..
651033 -                [On 081021 Millie scheduled 081023 1045 at Kaiser in
651034 -                Surgery Department to biopsy "lump." ref SDS 48 KS8K
651035 -                Called and changed to 1445 after Millie returns to
651036 -                Concord from treatment at UCSF in San Francisco.
651037 -                ref SDS 48 4Q4C
651039 -                 ..
651040 -                [On 081021 Surgery Advice Nurse considers requirements
651041 -                for case management to get biopsy results for meeting
651042 -                with doctor 081034 1145 to evaluate changing treatment
651043 -                for cancer;, ref SDS 48 IW66; checks UCSF work plan for
651044 -                FNA left supraclavicular and status change, advises
651045 -                this scope more typically performed in Head and Neck
651046 -                Department, ref SDS 48 PQ7T; Advice Nurse checks with
651047 -                surgeon; Surgery Department cancels order for biopsy,
651048 -                prepares referral to Head and Neck who can perform same
651049 -                day biopsy ref SDS 48 03GE
651051 -                 ..
651052 -                [On 081021 letter to primary care physician requests
651053 -                follow up tomorrow with Head and Neck to clarify
651054 -                referral, and expedite the work. ref SDS 49 3U6S
651056 -                 ..
651057 -                [On 081022 FNA procedure checking for status change was
651058 -                not specified in referral from Surgery; the doctor
651059 -                corrected the problem by attaching UCSF order for FNA
651060 -                and checking status change to the transmittal for
651061 -                sending the specimen to the pathology lab. ref SDS 52
651062 -                RS8M
651064 -             ..
651065 -        5.  Proceed with current treatment schedule, pending
651066 -            evaluation of biopsy, and other qualifying criteria.
651068 -             ..
651069 -        6.  The study requires a CT test; this can be done when I
651070 -            return from vacation on 081113, as discussed in the letter
651071 -            yesterday to the medical team. ref SDS 38 K34V
651073 -  ..
651074 - CT test is actually required on 081107, 8 weeks after the previous
651075 - test on 080911, ref SDS 33 LK3R, in time for review meeting with
651076 - medical team at UCSF on 081113.
651078 -  ..
651079 - Millie's letter to the medical team on 081015 submitting the agenda
651080 - for meeting on 081016 cited planning by the primary care physician at
651081 - Kaiser to order the CT test on 081107 at Kaiser in Walnut Creek based
651082 - on success using Millie's Power Port at Kaiser in Oakland on 080911.
651083 - ref SDS 34 SG4X  On 081015 letter to medical team on agenda to meet on
651084 - 081016 reminds about scheduling the CT test on 081107 at Kaiser in
651085 - Walnut Creek. ref SDS 38 K354
651087 -  ..
651088 - Objective is to get CT Department at Kaiser in Walnut Creek prepared
651089 - to avoid problems that occurred for the test on 080718. ref SDS 29
651090 - LK3R
651091 -
651092 -               [On 081023 agenda for meeting at Kaiser to order next
651093 -               CT test on 081107 (not 081113), 8 weeks after prior
651094 -               test on 080911. ref SDS 53 TH9K
651096 -                ..
651097 -               [On 081024 primary care physician ordered CT test at
651098 -               Kaiser in Walnut Creek on 081107 1300, and asked
651099 -               Millie to coordinate arrangements for the CT
651100 -               Department to use the Power Port, based on success
651101 -               doing the prior CT at Kaiser in Oakland. ref SDS 64
651102 -               V58K
651104 -                ..
651105 -               [On 081024 coordinated with manager CT test department
651106 -               on solving problems with prior test on 080718.
651107 -               ref SDS 64 PPVW
651109 -                ..
651110 -               [On 081028 Millie's letter to Dennis at Kaiser in Walnut
651111 -               Creek submitted background on the CT test in Oakland on
651112 -               080911, and provides work plan to do the next test at
651113 -               Kaiser in Walnut Creek. ref SDS 69 PE8X
651115 -                ..
651116 -               [On 081029 called and talked to Dennis about doing
651117 -               Millie's CT test at Kaiser in Walnut Creek. ref SDS 70
651118 -               QK7M
651120 -                ..
651121 -               [On 081029 Florida confirms Kaiser CT department
651122 -               approves doing test using Millie's Power Port, access
651123 -               scheduled in Infusion Clinic 081107 1230. ref SDS 71
651124 -               4E3G
651126 -                ..
651127 -               [On 081030 telecon Steve at Bard he has coordinated with
651128 -               Agenal who did CT test using Millie's Power Port
651129 -               successfully on 080911 at Kaiser in Oakland, ref SDS 73
651130 -               XN9C; and has further talked to Dennis at the CT
651131 -               Department at Kaiser in Walnut Creek; feels Dennis's
651132 -               team at Walnut Creek is good to go for doing Millie's CT
651133 -               test with the Bard Power Port on 081107. ref SDS 73 UF5H
651135 -  ..
651136 - Millie's letter to the medical team continues...
651137 -
651138 -        7.  If the biopsy is negative, the CT test will support the
651139 -            current treatment.
651141 -             ..
651142 -        8.  You recommended keeping the current treatment schedule [for
651143 -            laboratory work] in tact, listed on 080918, ref SDS 35
651144 -            QO4K, which can be adjusted as needed depending on results
651145 -            of the biopsy.
651146 -
651147 -                [On 081031 Glenna called and scheduled Millie to visit
651148 -                Doctor Rugo on 081113 0830 to start new treatment in
651149 -                the sunitinib clinical study; 081113 0830 was
651150 -                previously scheduled for the cetuximab Carboplatin
651151 -                study. ref SDS 74 T15L
651153 -                 ..
651154 -                [On 081031 Glenna's letter confirmed Millie get lab
651155 -                work on 081107, as previously scheduled, ref SDS 76
651156 -                SI4X, and then begin treatment the following week on
651157 -                081113 after meeting with the doctor in the monring on
651158 -                081113, as orginally scheduled. ref SDS 76 SJ3W
651160 -                 ..
651161 -                [On 081107 Millie gets lab work at UCSF implementing
651162 -                work plan to start treatment on referral from Kaiser in
651163 -                the clinical study for sunitinib at UCSF. ref SDS 84
651164 -                4G61
651166 -             ..
651167 -        9.  Thumbing through the file today, you got the impression I
651168 -            qualify for the study.  Let me know if you need support to
651169 -            assemble patient history.
651171 -             ..
651172 -       10.  My concerns about this study are primarily side effects;
651173 -            the list seems ominous.  You seemed to say today that one
651174 -            patient in the study so far has responded well for 4
651175 -            months, and with minimal side effects.
651176 -
651177 -                [On 081024 primary care physician cited experience at
651178 -                Kaiser patients treated with sunitinib have severe skin
651179 -                problems, including neuropathy. ref SDS 63 XZ9V
651181 -                 ..
651182 -                [On 090121 side effects sunitinib very severe in
651183 -                Millie's case. ref SDS A2 TW53
651184 -
651185 -
651186 -
651187 -
651188 -
651189 -
6512 -