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 29, 2008 01:45 PM Wednesday; Rod Welch

Work plan Millie start UCSF clinical study sunitinib metronomic treatment IBC 5th relapse.

1...Summary/Objective
2...Work Plan Update Task List 081016 to Start Sunitinib Clinical Study
........1...FNA biopsy test cancer................. 081022 1400
........2...Millie on vacation..................... 081026 to 081106
........3...Kaiser payment authorization........... 081107
........4...Costs to patient - ballpark estimate... 081107
........5...Meeting UCSF sign Consent documents.... 081107 0800
........6...CBC blood test......................... 081107 0830
........7...Urinalysis............................. 081107 0830
........8...CT test scheduled...................... 081107 1300
........9...Core biopsy test status change......... 081107 1600
............Status Change Core Biopsy
.......10...Echocardiogram......................... 081110 0930
.......11...Brain MRI.............................. 081108 1045
.......12...Muga test for heart damage............. cancelled
.......13...Treatment begin Sunitinib clinical study..... 081113 0830
3...Work Plan Update Submitted to UCSF Request Feedback on Progress
4...Consent Documents Signature Meeting UCSF 081107
5...FNA Biopsy Status Change at UCSF Reduce Risks Core Biopsy at Kaiser
6...Coordinate Work Plan Progress UCSF Study Coordinator


..............
Click here to comment!

CONTACTS 

SUBJECTS
Default Null Subject Account for Blank Record

0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 30 0000, ref SDS 29 0000.
040502 -
040503 -
040504 -
040505 -
040507 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - On 081016 UCSF developed a work plan to evaluate Millie for
040902 - progression of disease, and in that case to switch treatments.  The
040903 - doctor proposed treating Millie in the sunitinib clinical study.
040904 - ref SDS 18 J38U
040906 -  ..
040907 - The first step in the work plan was to perform an FNA biopsy of a
040908 - swelled node in the left supraclavicular. ref SDS 18 J36R  On 081022
040909 - Millie had an FNA biopsy at Kaiser. ref SDS 22 NZ5N  The next day on
040910 - 081023 Doctor Daamen called and reported pathology for the biopsy on
040911 - 08122 was positive for breast cancer. ref SDS 24 4Q9Q  This is Millie's
040912 - 5th relapse of IBC.  Later in the evening, Doctor Rugo advised in a
040913 - letter from UCSF that positive aspiration from the biopsy ends
040914 - Millie's treatment on the cetuximab Carboplatin clinical trial.
040915 - ref SDS 25 D65G
040917 -  ..
040918 - The next day on 081024 Millie met with the primary care physician to
040919 - review the UCSF proposal for treatment with sunitinib.  The doctor
040920 - reported experience at Kaiser using sunitinib shows patients have
040921 - adverse side effects of skin propblems. ref SDS 27 XZ9V
040923 -  ..
040924 - Goals starting the new study are to optimize recovery, and minimize
040925 - cost.  Since sunitinib is an oral treatment, this will significantly
040926 - reduce costs for standard of care.
040928 -  ..
040929 - Research attending a cancer treatment seminar on 081018 indicated that
040930 - sunitinib may yield very good results recovering from Millie's 5th
040931 - relapse of IBC.
040933 -  ..
040934 - The work plan on 081016 calls for implementing screening tests for the
040935 - sunitinib clinical study. ref SDS 18 J44X
040937 -  ..
040938 - During the meeting on 081024, the primary care physician scheduled
040939 - screening tests specified in the Consent documents for the sunitinib
040940 - clinical study.  A letter to the medical team explained progress on
040941 - tasks in the work plan. ref SDS 27 IY5J
040943 -  ..
040944 - Glenna called on Monday to begin work on Millie starting treatment in
040945 - the sunitinib clinical trial.
040946 -
040948 -  ..
040949 - Work Plan Update Task List 081016 to Start Sunitinib Clinical Study
040950 -
040951 - Follow up ref SDS 18 J36R.
040952 -
040953 - On 080306 examination made findings that cancer was progressing,
040954 - ref SDS 11 NW3N; the doctor ordered adding Carboplating to cetuximab
040955 - for Millie to start the 2nd arm of the clinical study for cetuximab
040956 - and Carboplatin. ref SDS 11 NW7K  The following week, Millie had the
040957 - first treatment with both cetuximab and Carboplatin. ref SDS 12 TZ8I
040959 -  ..
040960 - Millie had a good response to treatment from adding Carboplatin, but
040961 - had difficulty holding blood counts, which caused missing three (3)
040962 - treatments in the first 3 cycles, shown by case study on 081023.
040963 - ref SDS 23 V19M  On 080403 the doctor ordered treatment with Neupogen
040964 - to increase blood counts. ref SDS 13 6Y9K  Later on 080606 Millie
040965 - learned that the doctor decreased the dose of Carboplatin to reduce
040966 - affect on blood counts, reported on 080529. ref SDS 14 PVUQ   This
040967 - combination of Neupogen and reduced Carboplatin chemotherapy was
040968 - generally affective enabling Millie to maintain regular treatments,
040969 - missing only 1 treatment in August because a Neupogen treatment was
040970 - missed. ref SDS 15 RV8O
040972 -  ..
040973 - Millie's letter to the medical team on 081016 confirmed examination by
040974 - Doctor Rugo diagnosed progression of disease, ref SDS 18 J34U, and
040975 - explained steps for a work plan to verify Millie's cancer has spread
040976 - to the lefe supraclavicular, beginning with an FNA biopsy. ref SDS 18
040977 - J36R  Over the next few weeks, additional information has been
040978 - received from UCSF that enables summarizing the UCSF work plan.
040980 -                ..
040981 -               [On 081031 Glenna reported that UCSF work plan has been
040982 -               effective for starting Millie on the sunitinib clinical
040983 -               study, ref SDS 38 5G5H; Glenna's letter confirms plans
040984 -               to start treatment on 081113. ref SDS 39 SJ3W
040986 -                ..
040987 -               [On 081101 Millie's letter while traveling on vacation
040988 -               asks about status to start treatment. ref SDS 42 TS5H
040990 -                ..
040991 -               [On 081102 submitted response to Millie traveling on
040992 -               vacation everything is set up to start treatment on
040993 -               081113. ref SDS 43 4P84
040994 -
040996 -             ..
040997 -        1.  FNA biopsy test cancer................. 081022 1400
040998 -
040999 -            Ordered by UCSF on 081016, ref SDS 18 J36R, and
041000 -            performed and Kaiser 081022, ref SDS 24 4Q9Q, results
041001 -            positive for breast cancer reported 081023. ref SDS 25 D65G
041003 -             ..
041004 -        2.  Millie on vacation..................... 081026 to 081106
041005 -
041006 -            Approved by primary care physician on 080829, and showing
041007 -            medical tasks can begin the next day on 081107. ref SDS 16
041008 -            RP7Y
041009 -
041010 -               [On 081105 Kaiser schedules Millie for Muga test on
041011 -               081106 1030; computer mistake conflicts with work plan
041012 -               for starting medical tasks on 081107. ref SDS 49 WO72
041013 -
041015 -             ..
041016 -        3.  Kaiser payment authorization........... 081107
041017 -
041018 -            Glenna is checking if the current authorization is adequate
041019 -            in order to avoid another big battle, per telecon on
041020 -            081027. ref SDS 30 7245
041022 -             ..
041023 -            On 080829 the primary care physician asked Millie to pursue
041024 -            continuing treatment at UCSF upon progression of disease,
041025 -            and would approve payment for treatment because Kaiser does
041026 -            not have double agent "trargeted" drugs required to treat
041027 -            Millie. ref SDS 16 RP9W
041029 -             ..
041030 -            On 081024 during meeting with primary care physician the
041031 -            doctor confirmed authorization for Kaiser to pay costs of
041032 -            Millie's treatment in the sunitinib clinical study that is
041033 -            a double agent "targeted" treatment, and Kaiser does not
041034 -            have equal or better treatments for Millie. ref SDS 27 ER4I
041036 -                ..
041037 -               [On 081031 Glenna called and advised that the primary
041038 -               care physician at Kaiser signed authorzation today for
041039 -               Millie's treatment at UCSF in the sunitinib clinical
041040 -               trial. ref SDS 38 5C7J
041042 -                ..
041043 -               [On 081031 Glenna's letter advises she is following up
041044 -               with the doctor to get Kaiser's authorization for
041045 -               payment of Millie's care. ref SDS 39 458L
041047 -                ..
041048 -               [On 081112 Glenna reported Kaiser has not issued
041049 -               authorization for payment which the doctor submitted for
041050 -               Millie's treatment at Kaiser. ref SDS 62 ZX8F
041052 -                ..
041053 -               [On 081112 Michelle in Expedited Claims Department
041054 -               advised that the doctor is in charge of ordering
041055 -               treatment for the patient, and Kaiser must implement the
041056 -               doctor's orders. ref SDS 62 P28U
041058 -                ..
041059 -               [On 081112 Doctor Johnson reported ordering on 081103
041060 -               authorization for payment of Millie's treatment on
041061 -               referral at UCSF in the sunitinib clinical study, and
041062 -               Kaiser management sent a denial to him on 081110.
041063 -               ref SDS 62 YH8I
041065 -                ..
041066 -               [On 090601 Glenna, Coordinator for Sunitinib Clinical
041067 -               Trial disclosed that Kaiser paid for all costs for
041068 -               Millie's treatment with Sunitinib as the best course of
041069 -               care for Millie's patient profile. ref SDS 64 N54G
041070 -
041072 -             ..
041073 -        4.  Costs to patient - ballpark estimate... 081107
041074 -
041075 -            Glenna is investigating, per telecon on 081027, ref SDS 30
041076 -            724H, and to answer the question to Doctor Rugo in Millie's
041077 -            letter on 081024. ref SDS 27 XZ9Y
041078 -
041079 -               [On 081031 Glenna investigating cost to patient.
041080 -               ref SDS 38 PR71
041082 -                ..
041083 -               [On 090601 Glenna, Coordinator for Sunitinib Clinical
041084 -               Trial disclosed that Kaiser paid for all costs for
041085 -               Millie's treatment with Sunitinib as the best course of
041086 -               care for Millie's patient profile. ref SDS 64 N54G
041087 -
041089 -             ..
041090 -        5.  Meeting UCSF sign Consent documents.... 081107 0800
041092 -             ..
041093 -            Glenna proposed meeting at UCSF during the call on 081027.
041094 -            ref SDS 30 OT37
041095 -
041096 -               [On 081029 letter to UCSF confirms schedule to meet on
041097 -               081107 to sign Consent documents. ref SDS 0 C49R
041098 -
041099 -               [On 081031 Glenna called and confirmed meeting at UCSF
041100 -               on 081108 0800 to sign consent document and perform lab
041101 -               work to start the clinical study. ref SDS 38 ES5O
041102 -
041104 -             ..
041105 -        6.  CBC blood test......................... 081107 0830
041106 -
041107 -            Sunitinib clinical study Consent documents reviewed in the
041108 -            record on 081017 show requirements for blood tests.
041109 -            ref SDS 20 MI7S
041111 -             ..
041112 -            Glenna is checking to see if tests at UCSF on 081023 or on
041113 -            081016 are adequate.
041115 -             ..
041116 -            Schedule for Millie's labs in the Infusion Clinic are shown
041117 -            in the record on 080918. ref SDS 17 YB5H
041118 -
041119 -               [On 081031 Glenna reports another lab required for
041120 -               Millie to start sunitinib clinical trial at UCSF,
041121 -               ref SDS 38 XJ87; Glenna will order lab at UCSF Infusion
041122 -               Clinic on 081107 prior to meeting with Glenna to sign
041123 -               Consent documents at 0800. ref SDS 38 ES5O
041125 -                ..
041126 -               [On 081031 Glenna's letter confirms labs scheduled at
041127 -               UCSF after Millie meets to sign consent documents on
041128 -               081101 0800. ref SDS 39 SI4X
041130 -                ..
041131 -               [On 081103 Millie notified Catherine and Diane in the
041132 -               Infusion Clinic about blood draw on 081007. ref SDS 45
041133 -               MT9N
041135 -                ..
041136 -               [On 081103 Glenna clarifies that meeting on the 2nd
041137 -               floor scheduled 081107 0800 is a condition precendent to
041138 -               doing the blood draw for lab work on the 5th floor.
041139 -               ref SDS 46 SC5F
041141 -                ..
041142 -               [On 081107 blood drawn for labs and reports received.
041143 -               ref SDS 57 075H
041144 -
041146 -             ..
041147 -        7.  Urinalysis............................. 081107 0830
041148 -
041149 -            Consent documents for sunitinib clinical study reviewed on
041150 -            081017 do not show requirements for urinalysis, ref SDS 20
041151 -            MI7S, similar to status change biopsy test, below,
041152 -            ref SDS 0 SF3P, and brain MRI test, also not specified in
041153 -            Consent documents, per below. ref SDS 0 SE5Q
041155 -             ..
041156 -            Glenna's letter on 081027 presented this requirement and
041157 -            without citation to study documentation. ref SDS 29 309F
041159 -             ..
041160 -            Can this be done at UCSF on 081107 along with the FNA
041161 -            biopsy to check for status change?
041162 -
041163 -               [On 081031 letter to UCSF asks about scheduling
041164 -               urinalysis on 081107. ref SDS 36 NN5P
041165 -
041166 -               [On 081031 Glenna advises during a telephone call that
041167 -               the Consent documents for the sunitinib clinical study
041168 -               do not specify urnialysis. ref SDS 38 4G6N
041170 -                ..
041171 -               [On 081031 Glenna decides to order lab work to start
041172 -               sunitinib clinical trial at UCSF Infusion Clinic on
041173 -               081107 prior to meeting with Glenna to sign Consent
041174 -               documents at 0800. ref SDS 38 ES5O
041176 -                ..
041177 -               [On 081031 Glenna's letter confirms labs scheduled at
041178 -               UCSF after Millie meets to sign consent documents on
041179 -               081101 0800. ref SDS 39 SI4X
041181 -                ..
041182 -               [On 081103 Millie notified Catherine and Diane in the
041183 -               Infusion Clinic about blood draw on 081007. ref SDS 45
041184 -               5U6U
041186 -                ..
041187 -               [On 081107 test specimen for labs and reports received
041188 -               on urinalysis. ref SDS 57 BP4J
041189 -
041191 -             ..
041192 -        8.  CT test scheduled...................... 081107 1300
041193 -            ref SDS 27 XZ9P
041195 -             ..
041196 -            This requires meeting with the Infusion clinic at 1230 to
041197 -            access the Power Port.  Also requires confirmation that
041198 -            Kaiser CT Dep in Walnut Creek is ready to do tests with
041199 -            Power Port technology.
041200 -
041201 -               [...in another record today, confirm Kaiser CT
041202 -               department approves doing test using Millie's Power
041203 -               Port, access scheduled in Infusion Clinic 081107 1230.
041204 -               ref SDS 31 4E3G
041206 -                ..
041207 -               [On 081029 Steve called from Kaiser in Oakland; he will
041208 -               discuss with Angela procedures for the prior test on
041209 -               080911, and he will call Dennis at Kaiser in Walnut
041210 -               Creek with orientation for Millie's next test on 081107
041211 -               using the Bard Power Port. ref SDS 32 8G6T
041213 -                ..
041214 -               [On 081030 Steve with Bard called and reported talking
041215 -               to Angela with the CT Department at Kaiser in Oakland,
041216 -               and then to Dennis at Kaiser in Walnut Creek; Steve
041217 -               feels Kaiser in Walnut Creek is good to go for Millie's
041218 -               CT test on 081107. ref SDS 35 XN9C
041220 -                ..
041221 -               [On 081107 CT test performed using Bard Power Port at
041222 -               Kaiser in Walnut Creek. ref SDS 58 7F40
041223 -
041225 -             ..
041226 -        9.  Core biopsy test status change......... 081107 1600
041227 -            Status Change Core Biopsy
041229 -             ..
041230 -            Core biopsy test for status change ordered by UCSF with FNA
041231 -            biopsy on 081016. ref SDS 18 J36R  This evaluates prospects
041232 -            for Millie to benefit from multi-targeted treatment by
041233 -            re-evaluating Millie's triple negative status set
041234 -            originally with the biopsy on 020304, reported in the
041235 -            record meeting at Kaiser on 020321. ref SDS 1 6Q6J
041237 -             ..
041238 -            On 081016 letter to UCSF review of Consent document does
041239 -            not show requirement for status change biopsy test,
041240 -            ref SDS 18 J44R, similar to urinalysis test, ref SDS 0
041241 -            SE6W, and brain MRI test, which are also not specified.
041242 -            ref SDS 0 SE5Q  On 081017 the doctor responds that "it is
041243 -            not a study for triple negative alone." ref SDS 19 6J3T
041245 -             ..
041246 -            During a seminar on 081018, Doctor Stritter advised that
041247 -            sunitinib is designed for multi-targeted cancer treatment.
041248 -            ref SDS 21 IT8V  This may relate to Doctor Rugo's order for
041249 -            biopsy to test for change of Millie's triple negative
041250 -            status.  If Millie is no longer ER, PR, HER2neu negative,
041251 -            this may provide more "targets" for sunitinib metronomic
041252 -            treatments to relieve IBC symptioms, and prevent
041253 -            recurrence. ref SDS 21 NR5M
041255 -                ..
041256 -               [On 081031 Glenna advised that biopsy for status change
041257 -               is not a requirement for the sunitinib clinical study,
041258 -               and so recommended contacting Doctor Rugo and Doctor
041259 -               Johnson. ref SDS 36 T27H
041261 -             ..
041262 -            Performed at Kaiser on 081022, ref SDS 22 NZ5N; pathology
041263 -            on 081023 failed to test for status change. ref SDS 24 4Q5V
041264 -            Core biopsy for status change test rescheduled for 081024,
041265 -            ref SDS 24 667F; on 081024 Kaiser again rescheduled to
041266 -            081107, ref SDS 26 W15J; on 081027 Kaiser rescheduled again
041267 -            at Kaiser on 081117 1130, reported by Karen on 081027.
041268 -            ref SDS 28 G15K
041270 -             ..
041271 -            Preferably FNA biopsy test might be done at UCSF when
041272 -            Millie signs the consent document on 081107, since Kaiser
041273 -            requires a core biopsy to test for status change, and this
041274 -            presents increased risks for Millie's patient history,
041275 -            cited by Doctor Wong at Kaiser on 081024. ref SDS 26 W183
041276 -            Doctor Rugo says in a letter on 081023 that UCSF can do
041277 -            status check with less invasive FNA biopsy. ref SDS 25 KY8R
041278 -
041279 -               [On 081029 letter to UCSF discusses doing FNA biopsy for
041280 -               status check at UCSF instead of core biopsy at Kaiser.
041281 -               ref SDS 0 C49U
041283 -                ..
041284 -               [On 081031 letter to UCSF with copy to Kaiser asks about
041285 -               doing FNA biopsy at UCSF. ref SDS 36 NN5S
041287 -                ..
041288 -               [On 081031 Millie submits letter to medical team asking
041289 -               about doing the FNA biopsy to test status change at UCSF
041290 -               to reduce risks of core biopsy method. ref SDS 40 AJ6U
041292 -                ..
041293 -               [On 081101 Doctor Rugo says FNA biopsy to check for
041294 -               status change is not part of sunitinib clinical study;
041295 -               requires Kaiser approval of payment which would be very
041296 -               cost effective since FNA biopsy at UCSF would cost much
041297 -               less than the more invasive and problematic core biopsy
041298 -               Kaiser has scheduled for Millie on 081113. ref SDS 41
041299 -               5G5H
041301 -                ..
041302 -               [On 081102 Millie's letter to Doctor Rugo with copy to
041303 -               primary care physician at Kaiser asks how much the FNA
041304 -               biopsy to test for status change will cost at UCSF, and
041305 -               notes this should be less expensive than doing the core
041306 -               biopsy at Kaiser. ref SDS 44 AD3F
041308 -                ..
041309 -               [On 081103 primary care physician at Kaiser responded to
041310 -               Doctor Rugo's letter on 081101 offering to perform FNA
041311 -               biopsy test for status change and saying this requires
041312 -               separate payment authorization, by advising that Kaiser
041313 -               "will perform the procedure," without clarifying using
041314 -               FNA or core biopsy procedure. ref SDS 47 2M64
041316 -                ..
041317 -               [On 081103 UCSF responds saying in total "Great."
041318 -               ref SDS 48 BY3H
041320 -                ..
041321 -               [On 081106 Doctor Daamen called and changed the schedule
041322 -               again, ref SDS 52 5F5H, for the core biopsy back to
041323 -               081107 1600. ref SDS 52 5F68
041325 -                ..
041326 -               [On 081106 1213 letter notifies medical team that core
041327 -               biopsy to test for status change advanced from 081117 to
041328 -               081107 1600. ref SDS 54 7P68
041330 -                ..
041331 -               [On 081106 1631 Kaiser called back and said Millie was
041332 -               not scheduled for the core biopsy tomorrow on 081107
041333 -               1600, because Doctor Kahn would not be in the office,
041334 -               and Doctor Wong's schedule had changed, so nobody could
041335 -               do the biopsy. ref SDS 52 IP7L
041337 -                ..
041338 -               [On 081106 1643 Kaiser called back and advised after
041339 -               investigation that Millie is scheduled to meet with
041340 -               Doctor Kahn on 081107 1600 for the core biopsy as
041341 -               scheduled by Doctor Daamen, and the earlier problem was
041342 -               computer user issue. ref SDS 52 PQ9Y
041344 -                ..
041345 -               [On 081107 1600 status change core biopsy test performed
041346 -               at Kaiser. ref SDS 59 7P5O
041348 -                ..
041349 -               [On 081119 Kaiser submits summary of final pathology
041350 -               report, ref SDS 63 5O8G, for the biopsy on 081107,
041351 -               ref SDS 59 496L, and it shows status unchanged, ER, PR,
041352 -               Her2neu still triple negative. ref SDS 63 UQ5P
041353 -
041355 -             ..
041356 -       10.  Echocardiogram......................... 081110 0930
041357 -
041358 -            Reported in the letter to the medical team on 081024.
041359 -            ref SDS 27 XZ9S
041360 -
041361 -               [On 081106 primary care physician at Kaiser responds
041362 -               asking if an echocardiogram was ordered instead of a
041363 -               Mega test. ref SDS 53 1693
041365 -                ..
041366 -               [On 081110 echocardiogram performed at Kaiser in Walnut
041367 -               Creek. ref SDS 61 318F
041369 -                ..
041370 -               [On 081110 echocardiogram test of heart; initial
041371 -               indications Millie has strong heart that permits low
041372 -               blood pressure, no evident signs of enlarged right
041373 -               ventricle, nor enlarged heart. ref SDS 61 WL63
041374 -
041376 -             ..
041377 -       11.  Brain MRI.............................. 081108 1045
041378 -
041379 -            This is not specified in the Consent documents for
041380 -            sunitinib clinical trial, like status change biopsy test,
041381 -            ref SDS 0 4B5N, and urinalysis, above, ref SDS 0 SE6W,
041383 -             ..
041384 -            Glenna requested Millie get a brain MRI in a letter on
041385 -            081027. ref SDS 29 ML8R  Later on 081027, Glenna reports in
041386 -            a phone call that requirements for a brain MRI test are not
041387 -            in the Consent document submitted to Millie for the
041388 -            sunitinib clinical study; requirements for brain MRI are
041389 -            listed in other study protocol documents. ref SDS 30 OS68
041391 -             ..
041392 -            Millie's letter on 081027 to Glenna with copy to primary
041393 -            care physician asking Kaiser to schedule brain MR test.
041394 -            ref SDS 30 GR8V
041396 -                ..
041397 -               [...in another record today, telecon with Florida in
041398 -               Kaiser Infusion Clinic sending internal message to
041399 -               primary care physician about ordering brain MR for
041400 -               Millie. ref SDS 33 FR5H
041402 -                ..
041403 -               [On 081030 brain MRI ordered by primary care physician,
041404 -               ref SDS 34 FR5H; have to call back next day to schedule
041405 -               the time for doing the work. ref SDS 34 609T
041407 -                ..
041408 -               [On 081031 brain MRI scheduled 081108 1045 at Kaiser
041409 -               Deer Valley hospital in Antiock. ref SDS 37 IO63
041411 -                ..
041412 -               [On 081108 brain MRI performed at Kaiser in Antioch.
041413 -               ref SDS 60 ZI3K
041414 -
041416 -             ..
041417 -       12.  Muga test for heart damage............. cancelled
041418 -
041419 -               [On 081105 primary care physician at Kaiser on 081103
041420 -               ordered Muga test for heart damage, ref SDS 49 WO72,
041421 -               prior to starting sunitinib clinical study that has
041422 -               heart related side effects. ref SDS 49 PO37
041424 -                ..
041425 -               [On 081105 patient history on prior Muga testing for
041426 -               evaluating extended AC chemotherapy treatments.
041427 -               ref SDS 49 WI5L
041429 -                ..
041430 -               [On 081105 0825 letter from Glenna reports that UCSF has
041431 -               not ordered testing with Nuclear Medicine for Millie's
041432 -               screening to participate in the sinitinub clinical
041433 -               study. ref SDS 50 ZR7G
041435 -                ..
041436 -               [On 081105 letter notifies Millie's medical team that
041437 -               Kaiser added Muga test to work plan. ref SDS 51 WX4Y
041439 -                ..
041440 -               [On 081106 primary care physician at Kaiser responds
041441 -               asking if an echocardiogram was ordered instead of a
041442 -               Mega test. ref SDS 53 1693
041444 -                ..
041445 -               [On 081106 Millie notifies primary care physician at
041446 -               Kaiser that on 081024 echochardiogram was scheduled by
041447 -               the doctor for 081110. ref SDS 55 WH9N
041449 -                ..
041450 -               [On 081106 primary care physician at Kaiser asks patient
041451 -               to cancel Muga test at Nuclear Medicine as duplicating
041452 -               scope for echocardiogram. ref SDS 56 2J42
041454 -                ..
041455 -               [On 081106 Nuclear Medicine called; left message doctor
041456 -               wants to cancel Muga test for Millie on 081111, due to
041457 -               duplication with echocardiogram test the day before on
041458 -               081110. ref SDS 56 4P6J
041460 -                ..
041461 -               [On 081106 medical team notified message left for
041462 -               Nuclear Medicine that doctor wants to cancel Muga test
041463 -               on 081111. ref SDS 56 OW5R
041464 -
041466 -             ..
041467 -       13.  Treatment begin Sunitinib clinical study..... 081113 0830
041468 -
041469 -            Millie's last treatment at UCSF was on 081023. ref SDS 23
041470 -            V94O
041471 -
041472 -                [On 081031 Glenna called and reported Millie is
041473 -                scheduled to begin treatment in the sunitinib clinical
041474 -                study on 081113, starting with meeting Doctor Rugo at
041475 -                UCSF at 0830. ref SDS 38 L57F
041477 -                 ..
041478 -                [On 081031 UCSF letter confirms Millie scheduled to
041479 -                start treatment in sunitinib clinical study on 081113.
041480 -                ref SDS 39 SJ3W
041482 -                 ..
041483 -                [On 081101 Millie's letter while traveling on vacation
041484 -                asks about status getting set up to start treatment.
041485 -                ref SDS 42 TS5H
041487 -                 ..
041488 -                [On 081102 submitted response to Millie traveling on
041489 -                vacation everything is set up for Millie to start
041490 -                treatment on 081113. ref SDS 43 4P84
041492 -             ..
041493 -            Previously, when switching treatments there were
041494 -            administrative delays reported on 070119. ref SDS 3 YF8U
041495 -
041496 -                Millie had treatment on 061201
041497 -                at Kaiser and could not start
041498 -                treatment for 2 months at
041499 -                UCSF until..................... 070201, ref SDS 4 0001
041501 -                 ..
041502 -                Millie had treatment on 041021
041503 -                at Kaiser and could not get
041504 -                treatment for 3 months
041505 -                until.......................... 050104, ref SDS 2 0001
041506 -
041507 -
041509 -  ..
0416 -
0417 -
0418 - 1501
0419 -
041901 - Work Plan Update Submitted to UCSF Request Feedback on Progress
041902 -
041903 - Millie sent a letter today following up the letter to Glenna on 081027
041904 - 1611. ref SDS 30 TU5I  The letter today submits the updated work plan
041905 - prepared today, ref SDS 0 LH4O, to Glenna, study coordinator for the
041906 - sunitinib drug trial, at UCSF.
041907 -
041908 -    1.  Subject: Sunitinib Work Plan Update
041916 -         ..
041917 -    2.  Things seem to be moving on getting started with the new
041918 -        treatment.  On 081016 Doctor Rugo developed an initial work
041919 -        plan. ref SDS 18 J36R
041921 -         ..
041922 -    3.  Please check the revised work plan in the record today, and let
041923 -        me know where things stand. ref SDS 0 LH4O
041924 -
041925 -            [On 081031 letter to Glenna coordinating progress on work
041926 -            plan. ref SDS 36 UM8M
041927 -
041929 -  ..
041930 - Consent Documents Signature Meeting UCSF 081107
041931 -
041932 -
041933 -    4.  Please confirm we can meet next Friday 081107 at 0800 to sign
041934 -        consent documents [discussed with Glenna during telecon on
041935 -        081027, ref SDS 30 OT37 and listed in work plan 081029,
041936 -        ref SDS 0 LL6Q].  I usually get to UCSF at 0600 to avoid
041937 -        traffic, and work in the cafeteria until business hours at
041938 -        0800.  If you arrive early, we can meet at 0700, 0730, 0745 at
041939 -        your convenience.  Just let me know.  Since Kaiser moved the
041940 -        core biopsy from 081107 to 081117, I can meet with you in San
041941 -        Francisco, and have time to drive back to Walnut Creek in time
041942 -        for the CT test that starts at 1230 to access by port.
041943 -
041944 -            [On 081031 letter to UCSF asks about meeting on 081107 0800
041945 -            to sign Consent documents. ref SDS 36 NN5X
041946 -
041948 -  ..
041949 - FNA Biopsy Status Change at UCSF Reduce Risks Core Biopsy at Kaiser
041950 -
041951 -
041952 -    5.  Doctor Rugo indicates FNA biopsy at UCSF can test for status
041953 -        change [letter 081023. ref SDS 25 KY8R].  Doctor Wong at Kaiser
041954 -        indicates testing status change requires core biopsy [meeting
041955 -        at Kaiser on 081024, ref SDS 26 KE6J], but notes this has
041956 -        higher risk for my patient profile. [ref SDS 26 W183], Please
041957 -        take a moment to review Doctor Wong's concerns, and discuss
041958 -        with Doctor Rugo possibility of doing FNA biopsy for status
041959 -        change at UCSF [shown in work plan on 081029, ref SDS 0 LH4O].
041960 -
041961 -                [On 081031 letter to UCSF with copy to Kaiser asks
041962 -                about doing FNA biopsy at UCSF. ref SDS 36 NN5S
041964 -                 ..
041965 -                [On 081031 Millie submits letter to medical team asking
041966 -                about doing the FNA biopsy to test status change at
041967 -                UCSF to reduce risks of core biopsy method. ref SDS 40
041968 -                AJ6U
041970 -                 ..
041971 -                [On 081101 Doctor Rugo says the biopsy to check for
041972 -                status change is not part of the sunitinib clinical
041973 -                study; requires Kaiser approval of payment which would
041974 -                be very cost effective since FNA biopsy at UCSF would
041975 -                cost much less than the more invasive and problematic
041976 -                core biopsy Kaiser has scheduled for Millie on 081113.
041977 -                ref SDS 41 5G5H
041979 -                 ..
041980 -                [On 081102 Millie's letter to Doctor Rugo with copy to
041981 -                primary care physician at Kaiser asks how much the FNA
041982 -                biopsy to test for status change will cost at UCSF, and
041983 -                notes this should be less expensive than doing the core
041984 -                biopsy at Kaiser. ref SDS 44 AD3F
041986 -                 ..
041987 -                [On 081003 primary care physician at Kaiser responded
041988 -                to Doctor Rugo's letter on 081101 offering to perform
041989 -                FNA biopsy test for status change and saying this
041990 -                requires separate payment authorization, by advising
041991 -                that Kaiser "will perform the procedure," without
041992 -                clarifying using FNA or core biopsy procedure.
041993 -                ref SDS 47 2M64
041995 -                 ..
041996 -                [On 081103 UCSF responds saying in total "Great."
041997 -                ref SDS 48 BY3H
041999 -                 ..
042000 -                [On 081106 Doctor Daamen called and changed the
042001 -                schedule again, ref SDS 52 5F5H, for the core biopsy
042002 -                back to 081107 1600. ref SDS 52 5F68
042004 -                 ..
042005 -                [On 081106 1213 letter notifies medical team that core
042006 -                biopsy to test for status change advanced from 081117
042007 -                to 081107 1600. ref SDS 54 7P68
042009 -                 ..
042010 -                [On 081106 1631 Kaiser called back and said Millie was
042011 -                not scheduled for the core biopsy tomorrow on 081107
042012 -                1600, because Doctor Kahn would not be in the office,
042013 -                and Doctor Wong's schedule had changed, so nobody could
042014 -                do the biopsy. ref SDS 52 IP7L
042016 -                 ..
042017 -                [On 081106 1643 Kaiser called back and advised after
042018 -                investigation that Millie is scheduled to meet with
042019 -                Doctor Kahn on 081107 1600 for the core biopsy as
042020 -                scheduled by Doctor Daamen, and the earlier problem was
042021 -                computer user issue. ref SDS 52 PQ9Y
042023 -         ..
042024 -    6.  As you know, I am out of town.  Please call Rod for any
042025 -        clarification of the work plan.
042026 -
042033 -
042034 -
042036 -  ..
0421 -
0422 -
0423 - 1510
0424 -
042401 - Coordinate Work Plan Progress UCSF Study Coordinator
042402 -
042403 - Called Glenna at UCSF to discuss updated work plan. ref SDS 0 LH4O
042405 -  ..
042406 - She got the letter from Millie on updating the work plan, per above.
042407 - ref SDS 0 H96H
042409 -  ..
042410 - Glenna said her schedule is hectic.  She will review Millie's letter,
042411 - and the updated work plan.  Glenna will call back later today on
042412 - progress, and revisions for comprehensive planning.
042413 -
042414 -            [On 081031 letter to Glenna coordinating progress on work
042415 -            plan. ref SDS 36 UM8M
042416 -
042417 -
042418 -
042419 -
042420 -
042421 -
042422 -
0425 -