CONTACTS 
0201 - University of California San Franci
020101 - Ms. Margaret Rubino
020102 - New Patient Coordinator
020104 - Admissions
0202 - University of California San Franci
020201 - Dr. Christopher C. Benz, MD
020202 - Professor of Oncology
020203 - Medical Oncology Department
020204 - Mr.  FirstName

SUBJECTS
2nd Opinion UCSF Received on Millie's Condition Treatment Plans Kais

0503 -
0503 -    ..
0504 - Summary/Objective
0505 -
050501 - Follow up ref SDS 36 0000. ref SDS 34 0000.
050502 -
050503 -
050504 -
050505 -
050506 -
050507 -
050508 -
050509 -
050511 -  ..
0506 -
0507 -
0508 - Progress
0509 -
050901 - Doctor Benz Submits 2nd Opinion from UCSF on Millie's Treatment
050902 -
050903 - Follow up ref SDS 76 SM6M, ref SDS 36 6L9O.
050904 -
050905 - During the meeting today at Kaiser in Walnut Creek Millie advised the
050906 - primary care physician that UCSF has not sumbitted a report on the 2nd
050907 - opinion consultation with Doctor Benz on 060821. ref SDS 76 0001  She
050908 - asked if Kaiser has received a 2nd opinion on the consultation?
050910 -  ..
050911 - The primary care physician reported having received an opinion from
050912 - Doctor Benz.  Millie requested a copy.  The primary care physician
050913 - left the examination room, and returned in about 5 minutes with a copy
050914 - for Millie. ref SDS 79 624L
050916 -  ..
050917 - Received ref DRT 1 0001 from Doctor Benz at UCSF and addressed to
050918 - Kaiser.  This is about a 5-page document, with normal formatting,
050919 - correcting the prior problem of getting 7 pages of single spaced text
050920 - with no paragraphs, reported on 041117. ref SDS 35 4P6G
050921 -
050922 -            [On 070130 Doctor Rugo updates medical analysis at UCSF for
050923 -            Millie to start treatment in clinical trial with cetuximab
050924 -            and carboplatin. ref SDS 93 795I
050926 -  ..
050927 - Doctor Benz says in his opinion letter to Kaiser...
050928 -
050929 -    1.  Thank you for the opportunity to provide another medical
050930 -        oncology opinion on this 70-year-old patient who has metastatic
050931 -        breast cancer. ref DRT 1 0001
050933 -         ..
050934 -    2.  HISTORY OF PRESENT ILLNESS:
050935 -
050936 -        I refer you to my note on October 18, 2004, in which I outlined
050937 -        her history, physical examination and my recommendations to
050938 -        begin capecitabine/taxotere combination for her primary breast
050939 -        cancer, which had been staged at T2 N1, but had progressed to
050940 -        inflammatory breast cancer while on Adriamycin/Cytoxan (as part
050941 -        of an ACT regimen). ref DRT 1 NF6I
050943 -  ..
050944 - The doctor refers to prior opinion for consultation at UCSF on 041018,
050945 - ref SDS 27 LW6K, and which was received into the record from UCSF on
050946 - 041117. ref SDS 35 6L9O
050948 -  ..
050949 - Doctor Benz 2nd opinion continues...
050950 -
050951 -    3.  As you recall, her tumor marker, CA 15-3 and her clinical
050952 -        evaluation showed progression of disease after only 2 cycles of
050953 -        AC; Taxotere was then instituted and 6 cycles of that were
050954 -        completed by 2002.  She received radiation therapy to the
050955 -        chest, left axilla and parclavicular fossa in July 2002.
050956 -        ref DRT 1 UR7Q
050958 -  ..
050959 - This part of the UCSF chronology is unclear.  Patient history shows
050960 - 4-cycles of AC chemotherapy treatment was prescribed on 020405,
050961 - ref SDS 9 6SWS, and this was begun as scheduled on 020423. ref SDS 10
050962 - 0001  Treatment with AC ended on 020603 after only 2-cycles, when a
050963 - PET scan test showed no response to treatment, and CA 15-3 cancer
050964 - marker spiked to 117. ref SDS 11 WO4O  Taxotere treatment began on
050965 - 020610, for 6 cycles, ending on 021204, ref SDS 13 0001, as generally
050966 - described in Benz 1 dated 041018, received on 041117. ref SDS 35 OS9R
050968 -  ..
050969 - While symptoms of IBC were reported during examination on 021206 (see
050970 - patient history on 050812, ref SDS 54 5C6K), IBC is not mentioned in
050971 - the record until a meeting at Kaiser on 040517 when the doctor handed
050972 - the patient a pathology report on a biopsy, ref SDS 23 6T5G, which the
050973 - patient had earlier requested as supplemental work for minor surgery
050974 - on performed at Kaiser 040419. ref SDS 22 789F  Kaiser formally
050975 - diagnosed IBC on 040614. ref SDS 24 6T5G  This was 2 years after
050976 - treatment with AC ended.
050978 -  ..
050979 - Doctor Benz construction of "ACT regimen" may abreviate Adriamycin
050980 - Cytoxan and Taxotere.  IBC symptoms reported on 021206, and confirmed
050981 - by biopsy on 040419, followed 6-cycles of Taxotere preceeded by
050982 - 2-cycles of AC.
050984 -  ..
050985 - Therefore, saying that disease progressed to IBC while on AC that
050986 - ended 6 months before symptoms, and 2 years before diagnosis seems a
050987 - stretch.
050989 -  ..
050990 - Doctor Benz 2nd opinion continues...
050991 -
050992 -    4.  With progression of her disease, particularly in the left neck
050993 -        that was verified by positive fine needle aspirate and
050994 -        associated with rising CA 15-3, she was started on a regimen of
050995 -        Taxol plus Avastin, which she received for 7 cycles.  This
050996 -        regimen produced clinical improvement and decline in her tumor
050997 -        marker.  However, she apparently developed complications
050998 -        (including a pulmonary embolus) on this regimen.  Therefore, in
050999 -        early 2005, she was started on Adriamycin/Cytoxan given every 3
051000 -        weeks for 4 cycles which produced no clinical response and was
051001 -        associated with rising CA 15-3. ref DRT 1 7Q7O
051003 -  ..
051004 - UCSF account should relate that disease progressed most severely in
051005 - the left breast with diagnosis of IBC on 040614, ref SDS 24 6T5G,
051006 - which changed patient status from stage IIa to stage IV, ref SDS 24
051007 - SZ3I, following biopsy on 040419 submitted to the patient on 040517
051008 - that showed findings of IBC. ref SDS 23 6T5G  Diagnosis of secondary
051009 - IBC by biopsy aligns with the earlier biopsy on 040303 that diagnosed
051010 - cancerous lymph nodes in the neck, as reported on 040309. ref SDS 19
051011 - 0001  This history is presented in Benz 1 received on 041117, and
051012 - provides context for treatment decisions. ref SDS 35 OT3U
051014 -  ..
051015 - UCSF chronology should further state that treatment was paused
051016 - approximately 3 months from 041021 due to pulmonary emboli and then to
051017 - search for a drug trial.  During this period the patient was not
051018 - treated with Taxol nor Taxotere, which had previoulsy been effective,
051019 - reported on 041104. ref SDS 32 Q59K  Treatment was resumed on 050104
051020 - with AC, hoping to qualify the patient for a drug trial. ref SDS 45
051021 - 407N  When Kaiser was unable to qualify the patient for a drug trial,
051022 - AC was contineud for 2 more cycles in an attempt to qualify the
051023 - patient for a drug trial, but it was later learned this was not
051024 - sufficient for participation in the trial protocol.  Disease
051025 - progressed during the 3 months off treatment, and increased further
051026 - with the AC chemotherapy regimen.  On 050329 Kaiser switchted to
051027 - capecitabine Taxotere, as recommended by Benz #1 on 041117.
051028 - Treatments began on 050415, as stated in Benz #2...
051030 -  ..
051031 - Doctor Benz 2nd opinion continues...
051032 -
051033 -    5.  Beginning April 15, she was started on taxotere/capecitabine
051034 -        regimen and received a total of 8 cycles of this, most recently
051035 -        on September 16, 2005. ref DRT 1 UR8U
051036 -
051037 -    6.  A palliative left mastectomy was performed after a peripheral
051038 -        biopsy and histology of the mastectomy specimen revealed only
051039 -        ductal carcinoma in situ (no invasive carcinoma) as well as
051040 -        additional benign histologic changes. ref DRT 1 LQ9I
051042 -  ..
051043 - Benz #1 opinion received on 041117 from examination on 041018 states
051044 - there is no role for surgery. ref SDS 35 OU5P
051046 -  ..
051047 - Benz #2 opinion should cite patient history for "palliative"
051048 - mastectomy, where this term first appears in the record on 051007,
051049 - ref SDS 61 IV4G, many months after after planning for surgery began on
051050 - 041210 to achieve "local control." ref SDS 43 ZV5J
051052 -  ..
051053 - On 060821, Doctor Benz asked what issues the patient wants UCSF to
051054 - address in a 2nd opinion. ref SDS 76 TQ83  The patient said the agenda
051055 - was submitted listed the letter to UCSF dated 060725, which lists the
051056 - following...
051057 -
051058 -            Biopsy left breast mastectomy tissue - how can this show no
051059 -            evidence of disease, reported on 051027, ref SDS 62 616P,
051060 -            when this tissue contained the greatest concentration of
051061 -            IBC, and now, 9 months later, adjacent tissue with no
051062 -            visible signs of IBC suddenly is an active site of disease?
051063 -            How thorough and dependable are biopsies?  Does IBC present
051064 -            unique challenges for biopsy procedures? ref SDS 72 QS4Q
051066 -  ..
051067 - UCSF opinion #2 does not address this scope requested by the patient.
051069 -  ..
051070 - Doctor Benz 2nd opinion continues...
051071 -
051072 -    7.  She was also hopsitalization in early June 2006 for a left
051073 -        lower lobe pneumonia, which responded to antibiotics.
051074 -        ref DRT 1 7S9N
051076 -  ..
051077 - This construction seems awkward; might be an error in transcribing.
051079 -  ..
051080 - Doctor Benz 2nd opinion continues...
051081 -
051082 -    8.  Since her mastectomy in October 2005, when her tumor marker was
051083 -        at its lowest point (between 28 and 34), there has been a
051084 -        gradual CA 15-3 rise over the past 8 months.  Her August marker
051085 -        value was 87 and a repeat value a week later was 73.
051086 -        ref DRT 1 9U4H
051087 -
051089 -         ..
051090 -        Biopsy Confirmation Not Yet Available Establish IBC Tumor
051091 -        IBC Rash Changed Dramatically from Inception Relapse on 060623
051092 -
051093 -
051094 -    9.  The patient has recently had reinstitution of the
051095 -        taxotere/capecitabine combination, precipitated by the
051096 -        appearance of a macular-appearing rash on the left chest wall
051097 -        around the mastectomy incision site.  By history, that rash has
051098 -        not changed much since the chemotherapy reinstitution.
051099 -        However, the patient has had only 2 cycles of this repeat
051100 -        course of taxotere/capecitabine, and we do not have biopsy
051101 -        confirmation of tumor involvement in that rash. ref DRT 1 OU4N
051102 -
051103 -           [On 070116 consent documents for cetuximab carboplatin
051104 -           clinical study drug trial call for biopsy of cancer tumor.
051105 -           ref SDS 91 5U7S  Additional tumor biopsies are also part of
051106 -           the, drug trial, but are optional based on patient history.
051107 -           ref SDS 91 0348
051109 -  ..
051110 - Physical examination describes uncertainty identifying skin lesions on
051111 - the left breast area as IBC tumor (see below), ref SDS 0 WQ8V, which
051112 - aligns with patient history presented in this part of the opinion
051113 - noting that a biopsy has not been performed.  During the meeting on
051114 - 060821, the doctor asked about this. ref SDS 76 KT7J
051116 -  ..
051117 - UCSF opinion #2 comment that the "rash has not changed much since
051118 - starting chemotherapy" on 060721 conflicts with the record.
051120 -  ..
051121 - Examination on 060623 showed only traces of IBC rash; in combination
051122 - with rising CA 15-3 cancer marker, ref SDS 68 025H, treatment was
051123 - started on 060721. ref SDS 70 407N
051125 -  ..
051126 - The patient wrote a letter to Kaiser on 060806 reporting that IBC rash
051127 - changed significantly and became much worse. ref SDS 73 OJ7S  As a
051128 - result, an emergency meeting was held 2-days later on 060808 for
051129 - review of treatment.
051131 -  ..
051132 - Doctor Benz 2nd opinion continues...
051133 -
051134 -   10.  There have been interval scans, including PET and CT scans; and
051135 -        while showing some suspicious areas, these do not clearly show
051136 -        measurable areas of metastatic disease.  In particular, both CT
051137 -        and PET scan, one performed in May and the latter in April,
051138 -        shows an apparent right axillary lymph node of about 1 cm in
051139 -        size that is hypermetabolic but potentially caused by
051140 -        inflammatory changes.  The PET scan shows a more suspicious
051141 -        interval development of a hypermetabolic focus in the left
051142 -        supraclavicular region.  The contrast CT scan does not confirm
051143 -        this as an abnormal mass. ref DRT 1 UA5L
051145 -  ..
051146 - Patient history on 060428 shows "measurable" increase in symptoms
051147 - comparing PET scan test on 040416, ref SDS 65 OX68, cited in the Benz
051148 - #2 opinion for 060821, with the prior PET scan on 060120, and reviewed
051149 - on 060126. ref SDS 64 XF41
051151 -  ..
051152 - However, for some reason, UCSF opinon #2 does not recognize this part
051153 - of patient history, reflecting failure to review the record, reported
051154 - on 060821. ref SDS 76 TQ6M
051156 -  ..
051157 - Contrast CT test study on 060505 and received on 060523, compared with
051158 - prior CT test a year earlier on 050530, and failed to compare with PET
051159 - scan test on 060414, and so does not provide effective data to assess
051160 - measureable disease. ref SDS 66 006P
051162 -  ..
051163 - Failure to report measureable disease in image testing may present an
051164 - ongoing challenge of work practices at Kaiser, further indicated by
051165 - review of the PET scan test on 060120 reported on 060126. ref SDS 64
051166 - XF3K
051168 -  ..
051169 - Case study of image test and other errors in hospital records
051170 - demonstrates need for caution and care using documentation from
051171 - Kaiser, reported on 040416. ref SDS 21 GN7J
051173 -  ..
051174 - Doctor Benz 2nd opinion continues...
051175 -
051176 -   11.  For the remainder of the history, including breast cancer risk
051177 -        factors, past medical history, family history, social history,
051178 -        I refer you to may letter on October 2004. ref DRT 1 UR52
051180 -  ..
051181 - Benz #1 opinion for examination on 041018 was received on 041117...
051182 -
051183 -          History current breast cancer........... ref SDS 35 OS7P
051184 -          Breast cancer risk...................... ref SDS 35 OT5V
051185 -          Family history.......................... ref SDS 35 OT7Q
051186 -          Medical history non-beast cancer........ ref SDS 35 KW6F
051188 -  ..
051189 - "Social" history is unclear in the Benz #1 opinion received on 041117?
051191 -  ..
051192 - Doctor Benz 2nd opinion continues...
051193 -
051194 -   12.  PHYSICAL EXAMINATION:
051196 -         ..
051197 -   13.  A woman in no apparent distress and looking somewhat younger
051198 -        than her 70s years of age.
051200 -  ..
051201 - Doctor Benz account of Millie appearing younger and stronger than her
051202 - age, aligns with recent comment by the nurse in Kaiser's Infusion
051203 - Clinic on 060929. ref SDS 78 JA4L  Very heartening for Mil.
051205 -  ..
051206 - Doctor Benz 2nd opinion continues...
051207 -
051208 -   14.  Vital signs include weight of 145 pounds, blood pressure
051209 -        140/88, peripheral pulse 67 and regular, respirations 12 and
051210 -        regular, oral temperature 98.8 degrees F.
051212 -         ..
051213 -   15.  Head and neck exam are unremarkable.  Scalp is clear; pupils
051214 -        equal, round and reactive to light and accommodation; sclerea
051215 -        are nonicteric.  Oropharynx is clear and her neck is without
051216 -        thyromegaly or adenopathy; it is supple and with full range of
051217 -        motion.
051219 -         ..
051220 -   16.  Her supraclavicular fossae show only a vague sensation of
051221 -        fullness on the left side, which I note from last examination
051222 -        in October 2004 was also present; thus, I suspect this
051223 -        represents no clinical change.
051224 -
051226 -    ..
051227 -   Biopsy Required Establish Skin Lesions Inflitrated with IBC Tumor
051228 -   Left Breast Examination IBC Not Established by Evidence So Far
051229 -   IBC Diagnosis Not Established by Patient History Examination
051230 -
051231 -
051232 -   17.  Her left chest wall shows the mastectomy site and well-healed
051233 -        surgical wound.  There is macular, erythematous mottling,
051234 -        paralleling the medial aspect of this wound and just superior
051235 -        to it, and with satellite areas in the left lower anterior
051236 -        region.  These lesions are nontender and blanch upon pressure,
051237 -        do not appear to have deep thickness or underlying fixation.
051238 -        There is no break in the skin or crushing associated with this
051239 -        rash.  Therefore, it is difficult to know whether the skin
051240 -        lesions are infiltrated with tumor cells or represent some
051241 -        other chronic or benign process, potentially secondary to her
051242 -        treatment and local therapies.
051244 -  ..
051245 - Benz presents a prospect that red rash is not cancer, not IBC.  This
051246 - would require an explanation of rising CA 15-3 cancer marker, per
051247 - patient history on 060821. ref SDS 76 087J  The doctor indicates there
051248 - may be wide spread distant metastasis too small for recognition by
051249 - image testing, ref SDS 0 7Y4K, and currently being treated
051250 - systemcially with chemotherapy.
051252 -  ..
051253 - Biopsy was proposed by Doctor Benz to establish measureable IBC
051254 - disease on the left breast area during the examination at UCSF on
051255 - 060821, ref SDS 76 KT7J  This aligns with patient history discovering
051256 - IBC with a biopsy on 040419, ref SDS 22 XU52, as reported later with
051257 - review of the pathology report on 040517. ref SDS 23 7D6F  In the
051258 - current 2nd opinion, Doctor Benz notes that Kaiser has not yet
051259 - established the diagnosis with biopsy, per above. ref SDS 0 WY79
051261 -             ..
051262 -            [On 060929 condition Doctor Benz describes observing on
051263 -            060821 is unchanged after 2 more treatments, indicating
051264 -            rash may not be IBC or that lack of blood vessels from
051265 -            removing the breast on 051021 may slow delivery of
051266 -            treatment to the infected area. ref SDS 79 UY4M
051268 -  ..
051269 - Doctor Benz 2nd opinion continues...
051270 -
051271 -   18.  Her right breast is normal, as reported earlier.  I can palpate
051272 -        no right axillary adenopathy.
051274 -         ..
051275 -   19.  On the left there is sensation of a 1.5 to 2 cm node present
051276 -        high in the axilla; however, I cannot be completely certain
051277 -        about this.
051279 -  ..
051280 - This part reports on examination during the meeting on 060821, when
051281 - the doctor advised that he recognized no evidence of cancer, and that
051282 - slight lumpiness reflects declining lymphadema, ref SDS 76 UH72,
051283 - originally reported on 060106 as a huge bulge under the left arm,
051284 - ref SDS 63 MW8J, but which has receded with physical therapy and home
051285 - treatment, reported in patient history submitted to UCSF on 060725,
051286 - and ignored by UCSF reported on 060821.
051288 -  ..
051289 - Doctor Benz 2nd opinion continues...
051290 -
051291 -   20.  Her cardiac and lung fields are clear to auscultation.  Her
051292 -        abdomen is benign, with good bowel sounds, no organomegaly, no
051293 -        fluid wave.  Her extremities show full joint range of motion
051294 -        and no peripheral edema; her peripheral pulses and reflexes are
051295 -        normal and symmetric bilaterally.  I see no other abnormal or
051296 -        suspicious skin lesions on either her extremities or her trunk.
051297 -        Her neurologic exam indicates clear mental status, grossly
051298 -        intact cerebellar function, cranial nerves, peripheral motor
051299 -        and sensory functions.
051300 -
051302 -  ..
051303 - Measureable Disease Requires Measurements Photographs??
051304 -
051305 -
051306 -   21.  ASSESSMENT AND RECOMMENDATIONS
051308 -         ..
051309 -   22.  By history, lab and scan reports, the patient not only has
051310 -        metastatic disease, but it is likely slowly progressing.  I
051311 -        cannot be convinced by clinical examination that there is
051312 -        measurable disease.
051314 -  ..
051315 - Doctor Benz view should be tempered by patient history showing from
051316 - 060428 until 060808 dramatic increase in IBC red rash on the left
051317 - breast in conjunction with steady rise over 8 months of CA 15-3 cancer
051318 - marker.  The patient's letter to Kaiser on 060806 requests an
051319 - emergency meeting to assess measurable spread of IBC red rash after
051320 - getting treatment with chemotherapy. ref SDS 73 OJ7S
051321 -
051322 -            [On 061020 examination shows disease left breast stable, no
051323 -            improvement with 3 additional treatments; patient letter
051324 -            asks Kaiser about measurements to qualify for drug trials;
051325 -            Kaiser decides against taking measurements. ref SDS 81 JQ3J
051327 -  ..
051328 - Doctor Benz discussing "metastatic disease" that is "slowly
051329 - progressing," should be explained in relation to 5 years of image
051330 - testing finding no evidence of distant metastatic disease, except for
051331 - occassional minor activity in the righ axillary, which has never risen
051332 - to the level that diagnosed cancer, per examination on 060821
051333 - reviewing image test history. ref SDS 76 EY5O
051335 -  ..
051336 - Possibly, routine examinations for primary care should include
051337 - specific physical measurements of the red rash in various directions
051338 - to aid review by specialists who only rarely see the patient.  Another
051339 - idea would be to take pictures showing measurable advance of disease.
051341 -  ..
051342 - Doctor Benz is correct to be cautious with absence of biopsy to
051343 - establish IBC, cited in the opinion (see above), ref SDS 0 WY79,
051344 - however, equally, caution requires erring on the side of assuming
051345 - disease in this case of IBC history, steady rise of CA 15-3 cancer
051346 - marker, and correlating expansion of red rash that looks like rash
051347 - that was previously diagnosed by biopsy on 040419 as IBC.
051349 -  ..
051350 - This is another "wicked problem," because on 041130 the doctor
051351 - prescribed antibiotics to treat the worsening wound on the left breast
051352 - from the punch biopsy taken 7 months earlier on 040419 to diagnose
051353 - IBC. ref SDS 37 JU6N  Then, 2 days after taking the antibiotics on
051354 - 041202 the IBC red rash expanded greatly, and Millie's temperature
051355 - rose above 101 degrees, which required treatment by the Emergency Room
051356 - department at Kaiser.  Turned out that expanding rash on the left
051357 - breast, and rising temperature were normal effects of the antibiotics,
051358 - and did not signal rising IBC. ref SDS 41 RC92
051360 -  ..
051361 - Maybe the rash on the left breast is cellulitus, and rising CA 15-3 is
051362 - signaling cancer elsewhere, and that treatment is causing the marker
051363 - to come down, not because the red rash is improving, which is occuring
051364 - only very slowly, but because other cancer noted by Benz today as
051365 - progressing very slowly, ref SDS 0 WQ5T, is being treated.
051366 -
051367 -            [On 061027 patient hospitalized temperature 102.6, left arm
051368 -            suffering lympedema, was greatly swelled, and was further
051369 -            totally enveloped throughout with red rash inflammation,
051370 -            ref SDS 82 WO6N, which was relieved then with 5 days of
051371 -            antibiotics treatment in the hopsital, reported on 061101,
051372 -            ref SDS 83 JR9N, and the red rash on the left breast was
051373 -            not affected; it did not improve nor worsen.
051375 -  ..
051376 - The same argument could be made about history treating the left breast
051377 - in 2005, when rising red rash did not respond to treatment, but got
051378 - much worse for about 3 months, then suddenly improved dramatically
051379 - when chemotherapy was switched from AC to Taxotere and capecitabine.
051381 -  ..
051382 - Seems like another "wicked problem," reviewed on 060722. ref SDS 71
051383 - 346F
051385 -  ..
051386 - Doctor Benz 2nd opinion continues...
051387 -
051388 -        The apparent discrepancy between the PET scan and the CT scan
051389 -        with regard to the left supraclavicular hypermetabolic focus is
051390 -        of concern. ref DRT 1 WN8N
051392 -  ..
051393 - The doctor repeats issue reported on 060523 where PET scan test on
051394 - 060414 cites growth of nodes in lefft supraclavicular, and requested
051395 - CT study on 060505 reports nothing in this region. ref SDS 66 IM9M
051396 - Patient asked the primary care physician about this concern in a
051397 - letter on 060524. ref SDS 67 KG4W  There was no review by Kaiser
051398 - during the meeting on 060623. ref SDS 68 II4L and ref SDS 68 II4L  On
051399 - 060711 Kaiser did not review this issue. ref SDS 69 8R6M
051400 -
051401 -            [On 061013 letter to Kaiser presents reporting practices
051402 -            and standards. ref SDS 80 I77Y
051404 -             ..
051405 -            [On 061020 CT scan test for pulmonary embolism also
051406 -            examined axillary and other regions; reported finding no
051407 -            evidence of lymphadenopathy. ref SDS 81 LP5G
051409 -  ..
051410 - The doctor does not mention similar concern for conflict in PET scan
051411 - test on 060120 reported on 060126 finding esophagitis. ref SDS 64
051412 - DH4O, and follow up test on 060404 reported on 060428 standing silent
051413 - on the same issue. ref SDS 65 PR9J
051415 -  ..
051416 - Doctor Benz 2nd opinion continues...
051417 -
051418 -        The reported 1 cm right axillary node I cannot palpate with
051419 -        certainty and may simply represent a benign process.  While
051420 -        there is slow increase in her CA 15-3, this has still not
051421 -        reached its previous peak value of greater than 100 units/mL.
051422 -        Therefore I am reluctant to say that this patient is clearly
051423 -        showing progressive metastatic disease at the present time,
051424 -        although progression may manifest itself in the very near
051425 -        future. ref DRT 1 YO9G
051427 -         ..
051428 -   23.  I have thus recommended to the patient and her husband that
051429 -        they continue on their present regimen of
051430 -        taxotere/capecitabine, until there is more unequivocal evidence
051431 -        and/or new symptoms of progressing metastatic disease.
051432 -        ref DRT 1 US8Q
051433 -
051435 -  ..
051436 - Millie Qualifies 2 Drug Trials UCSF Clincial Studies
051437 - Cetuximab Carboplatin and Abraxane with Lapatinib Drug Trials
051438 - Drug Trials Millie Qualifies for 2 UCSF Clinical Studies
051439 -
051440 -
051441 -   24.  When her disease becomes clearly measurable, she would be
051442 -        eligible for at least two of our present UCSF clinical studies
051443 -        for patients with metastatic breast cancer; the first being a
051444 -        phase II evaluation of cetuximab alone versus cetuximab plus
051445 -        carboplatin, and the second being a phase I evaluation of
051446 -        Abraxane in combination with lapatinib. ref DRT 1 QG4J
051448 -  ..
051449 - Continuing current treatment aligns with understandings from the
051450 - meeting at UCSF on 060821. ref SDS 76 PF3O  On 060825 primary care
051451 - physician at Kaiser concurred, and continued the current treatment.
051452 - ref SDS 77 PF3O
051454 -  ..
051455 - Reporting 2 trials at UCSF which Millie qualifies to participate,
051456 - confirms understandings from consultation on 060821. ref SDS 76 W66J
051458 -  ..
051459 - Doctor Benz does not present in the 2nd opinion comment on 060821 that
051460 - UCSF requires biopsy of IBC to establish measurable disease,
051461 - ref SDS 76 2X6G; and, further, the doctor presents no other criteria
051462 - for meeting this UCSF requirement.
051463 -
051464 -            [On 061020 examination shows disease left breast stable, no
051465 -            improvement with 3 additional treatments; patient letter
051466 -            asks Kaiser about measurements to qualify for drug trials;
051467 -            Kaiser decides against taking measurements. ref SDS 81 JQ3J
051469 -             ..
051470 -            [On 061208 primary care physician observes rash has spread
051471 -            from the left breast to slightly onto the right breast for
051472 -            the first time in 3 years, and so may establish measurable
051473 -            disease to qualify for UCSF drug studies. ref SDS 84 AX6G
051475 -             ..
051476 -            [On 061218 Millie letter to Kaiser assisting the doctor to
051477 -            find location in UCSF 2nd opinion that proposes 2 drug
051478 -            trials to treat Millie's cancer. ref SDS 85 Q74O
051480 -             ..
051481 -            [On 061226 Kaiser performing due diligence collaborating
051482 -            with Doctor Rugo at UCSF to consider drug trial protocols
051483 -            for Millie's patient profile. ref SDS 86 086H
051485 -             ..
051486 -            [On 061228 Kaiser's report to UCSF presents lesions on left
051487 -            chest for measurable disease, but does not cite spread of
051488 -            IBC from left to right breast indicating "measurable
051489 -            disease" that qualifies Millie for drug trials. ref SDS 87
051490 -            IQ6J
051492 -             ..
051493 -            [On 061228 letter to Kaiser reminds doctor observed
051494 -            measurable disease with spread from left to right breast.
051495 -            ref SDS 87 T66Y
051497 -             ..
051498 -            [On 061230 correspondence between Kaiser and UCSF discusses
051499 -            cetuximab trial. ref SDS 88 4L9O
051501 -             ..
051502 -            [On 061230 Kaiser's follow up letter responding to
051503 -            questions from UCSF on measurable disease does not cite IBC
051504 -            lesions nor spread from left to right breast. ref SDS 88
051505 -            PO3V
051507 -             ..
051508 -            [On 061230 MD Anderson has a phase II trial involving
051509 -            Lapatinib, but is targeted for patients newly diagnosed
051510 -            with IBC. ref SDS 88 I35L
051512 -             ..
051513 -            [On 061230 research indicates lapatinib proposed for a
051514 -            phase 1 trial by Doctor Benz today, ref SDS 0 UI9K, is a
051515 -            treatment targeted for IBC. ref SDS 88 4X6G
051517 -             ..
051518 -            [On 070101 Doctor Rugo working on scheduling meeting for
051519 -            Millie to get treatment with drug trial at UCSF, requires
051520 -            measurable disease. ref SDS 89 5V3M
051522 -             ..
051523 -            [On 070105 Doctor Johnson changes prescription from Gemzar
051524 -            to cetuximab and carboplatin as better suited to treat
051525 -            Millie's patient profile. ref SDS 90 PK7L
051527 -             ..
051528 -            [On 070130 Doctor Rugo advised that UCSF has other drug
051529 -            trials on clinical study which Millie qualifies to treat
051530 -            her IBC, if disease progresses with cetuximab drug trial.
051531 -            ref SDS 92 TG5G
051532 -
051534 -  ..
051535 - Navelbine Gemzar Single Agents or Combination with Capecitabine
051536 -
051537 -
051538 - Doctor Benz 2nd opinion continues...
051539 -
051540 -   25.  In the event that the patient does not have readily measurable
051541 -        disease progression, is not eligible for a clinical study or
051542 -        otherwise does not want to participate in any, there are other
051543 -        chemotherapy options available as I outlined in my earlier
051544 -        letter to you.  Such options would include the use of single
051545 -        agent Navelbine or Gemzar, or combinations of these with
051546 -        capecitabine. ref DRT 1 GP4O
051548 -         ..
051549 -   26.  In my opinion, it is less likely she would receive much benefit
051550 -        from newer formulations of anthracyclines or taxanes which she
051551 -        has already received, such as Doxil or Abraxane. ref DRT 1 8R5O
051553 -  ..
051554 - The last sentence seeming to say Millie would not likley benefit from
051555 - Doxil or Abraxane, seems conflicting with the proposal in the opinion
051556 - to treat Millie with Abraxane and lapatinib, per above. ref SDS 0 UI9K
051557 -
051558 -               [On 090130 report of Doctor Rugo's letter to Kaiser
051559 -               recommending referral for treatment with hyperthermia
051560 -               and Doxil. ref SDS 95 HK3V
051562 -                ..
051563 -               [On 090205 treatment plan changed from Doxil to "lower
051564 -               dose" radiation to complement hyperthermia. ref SDS 96
051565 -               EY5F
051567 -  ..
051568 - Navelbine and capecitabine combination initially presented through
051569 - research on 060711, ref SDS 69 FE3O, was on the agenda for meeting
051570 - with Doctor Benz to comment on poor results for one patient,
051571 - ref SDS 69 ZW3F, but there was not enough time for review. ref SDS 76
051572 - S07M
051574 -  ..
051575 - Gemzar treatment was planned for review with the doctor on 060821;
051576 - however, there was not enough time. ref SDS 76 576N
051578 -  ..
051579 - Previously, Doctor Benz 2nd opinion dated 041018, and received on
051580 - 041117, proposed treatment with Gemzar and Taxotere. ref SDS 35 OU6S
051581 - Does the proposal in the opinion #2 calling for Gemzar and
051582 - capecitabine change the prior recommendation?
051583 -
051584 -            [On 061218 Millie submits letter asking doctor about
051585 -            clarifying Navelbine treatment combined with Taxotere or
051586 -            capecitabine (Xeloda). ref SDS 85 Q74O
051588 -             ..
051589 -            [On 070510 patient switched to Gemzar after 10 months
051590 -            treatment on cetuximab carboplatin clinical study.
051591 -            ref SDS 94 5P88
051593 -  ..
051594 - Similarly, Navelbine was not presented in the Benz #1 opinion, and was
051595 - not mentioned in the meeting on 060821. ref SDS 76 8F7F
051597 -  ..
051598 - Accordingly, what is the source for adding Navelbine, and what
051599 - criteria support making this addition, but not others cited in the
051600 - record on 060821? ref SDS 76 K36G
051602 -  ..
051603 - Doctor Benz 2nd opinion continues...
051604 -
051605 -   27.  Thank you for the opportunity to re-evaluate and provide
051606 -        additional therapeutic recommendations regarding this patient's
051607 -        care.
051608 -
051609 -
051610 -
051611 -
051612 -
051613 -
051614 -
051615 -
051616 -
051617 -
051618 -
051619 -
051620 -
051621 -
051622 -
051623 -
0517 -