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: January 30, 2007 04:17 PM Tuesday; Rod Welch

UCSF reports to Kaiser Millie begins treatment with cetuximab on clinial trial.

1...Summary/Objective
2...Doctor Reports to Primary Care Physician Understandings Patient History


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SUBJECTS
UCSF Consultation Begin Treatment Clinical  Tial Cetuximab Carboplat

2003 -
2003 -    ..
2004 - Summary/Objective
2005 -
200501 - Follow up ref SDS 30 0000, ref SDS 29 0000.
200502 -
200503 -
200504 -
200506 -  ..
2006 -
2007 -
2008 - Progress
2009 -
200901 - Doctor Reports to Primary Care Physician Understandings Patient History
200902 -
200903 - The doctor met Millie today and reviewed patient history. ref SDS 30
200904 - 0001
200905 -
200906 -     [On 081223 followed up. ref SDS 34 ER5L
200908 -  ..
200909 - Millie received ref DRT 1 0001 where the doctor submitted results of
200910 - the meeting to the primary care physician at Kaiser who made the
200911 - referral on 061230. ref SDS 28 PN5X  This 7-page report updates the
200912 - work by Doctor Benz at UCSF, which was received from Kaiser on 060929.
200913 - ref SDS 25 2L8K
200915 -  ..
200916 - UCSF report to Kaiser says...
200917 -
200918 -    1.  History of Present Illness:
200920 -         ..
200921 -        As you well know, she is a 71-year-old female with inflammatory
200922 -        breast cancer here to discuss enrollment into our
200923 -        triple-negative study of cetuximab plus or minus carboplatin.
200924 -        Her history is as follows. ref DRT 1 YY6M
200925 -
200926 -               [On 080109 request updating patient history, planning,
200927 -               and prognosis with annual review. ref SDS 33 EG8W
200929 -             ..
200930 -        1.  She presented in 2002 with a walnut-size lesion in her left
200931 -            breast at about the 12 o'clock position.  Core biopsy
200932 -            showed her to have high-grade infiltrating ductal
200933 -            carcinoma, estrogen receptor negative, progesterone
200934 -            reception negative and HER-2 negative.  On March 12, 2002,
200935 -            she underwent a left breast lumpectomy and left breast
200936 -            sentinel lymph node biopsy.  She was found to have a 2 cm
200937 -            high-grade invasive ductal carcinoma with high-grade ductal
200938 -            carcinoma in situ. ref DRT 1 YY74
200940 -             ..
200941 -        2.  A sentinal node was found to be positive and she was found
200942 -            to have positive margins.  She had 2 additional sentinel
200943 -            lymph nodes removed and they were positive as well, 4 out
200944 -            of 4 nodes that were positive. ref DRT 1 YY82
200946 -             ..
200947 -        3.  On March 27, 2004, she underwent a surgical reexcision to
200948 -            obtain clear margins. ref DRT 1 YY86
200950 -             ..
200951 -        4.  She started adjuvant chemotherapy in May 2000.  She
200952 -            initially received Adriamycin and cyclophosphamide for 2
200953 -            cycles.  Prior to starting therapy her CA 15-3 was elevated
200954 -            at 85.  After two cycles of AC, she had no improvement.  At
200955 -            that point, the decision was made to switch her to
200956 -            Taxotere.  She received 2 cycles of Taxotere and then
200957 -            received radiation therapy to the chest, left axilla,
200958 -            periclavicular fossa which she began on July 8, 2002.
200959 -            After completing radiation therapy, she received an
200960 -            additional 4 cycles of Taxotere for a total of 6 cycles and
200961 -            she concluded adjuvant chemotherapy in December 2002.
200962 -            ref DRT 1 YY89
200964 -             ..
200965 -        5.  Unfortunately, within 2 months of finishing adjuvant
200966 -            chemotherapy, the patient noticed a rash along her left
200967 -            breast initially treated with antibiotocs.  The rash did
200968 -            not go away and progressed. ref DRT 1 YY99
200970 -  ..
200971 - There is no evidence the patient noticed rash on the left breast
200972 - within 2 months of completing chemotherapy treatment on 021204,
200973 - reported on 021206. ref SDS 1 SM6M  The Benz report dated 041018 on
200974 - this aspect of patient history is not supported by the record, shown
200975 - on 041117. ref SDS 19 OS6W
200977 -  ..
200978 - Inflammation and stiff skin on the left breast were observed by the
200979 - doctor and attributed to side effects of radiation treatment beginning
200980 - on 021206, ref SDS 1 SG7J, and a month later on 030109, ref SDS 2
200981 - KW5F  The rash did not persist, but rather was treated for Cellulitis
200982 - on 030109, ref SDS 2 0T6N, and seemed to subside.  A month later,
200983 - examination on 030220 showed that treatment with antibiotics reduced
200984 - red rash on the left breast. ref SDS 3 0T6N  The Benz description of
200985 - waxed and waned through 2003 is therefore correct. (see again on
200986 - 41117. ref SDS 19 OS6W)
200988 -  ..
200989 - In late May 2003, the patient noticed severe red rash on the left
200990 - breast, and requested an emergency meeting with the doctor.
200991 - ref SDS 4 7C6W  Examination on 030606 showed the rash subsided,
200992 - seemingly had gone away. ref SDS 4 MM6J  At that time, the doctor
200993 - observed stiff skin on left breast and diagnosed reaction to radiation
200994 - treatment a year earlier. ref SDS 4 O16M
200996 -  ..
200997 - The following month on 030710 a CT test reported symptoms of breast
200998 - cancer, and said this was presumably due to radiation treatment.
200999 - ref SDS 5 VM7I  The patient asked about further testing, including
201000 - biopsy test for possible cancer noted in the test report. ref SDS 5
201001 - T64L  Kaiser deferred testing on grounds that symptoms were more
201002 - likely due to radiation treatment. ref SDS 5 WQ5K
201004 -  ..
201005 - UCSF report to Kaiser continues...
201006 -
201007 -        6.  In early 2004, she also noticed a left neck node.  She
201008 -            underwent workup at that point.  On March 3, 2004, she
201009 -            underwent fine needle aspiration of the left neck and the
201010 -            posterior triangle of the neck.  This pathology was
201011 -            revealed to be positive for metastatic breast cancer.
201012 -            ref DRT 1 YY42
201014 -             ..
201015 -        7.  On April 19, 2004, she underwent a left breast punch biopsy
201016 -            of the rash that she had and this was read as inflammatory
201017 -            breast cancer.  She then undertook enrollment in the ECOG
201018 -            trial of Taxol plus bevacizumab.  She received a total of 7
201019 -            cycles. ref DRT 1 YY49
201021 -  ..
201022 - On 040318 the doctor observed inflammation of the left breast and so
201023 - delayed starting treatment for cancer in order to treat for Cellulitis
201024 - with antibiotics. ref SDS 8 IM6J
201026 -  ..
201027 - The doctor ordered minor surgery to install a port catheter for
201028 - increased infusion treatments with less trauma to the right arm.
201029 - ref SDS 8 CO3G
201031 -  ..
201032 - On 040402 skin firmness, redness left breast persisted; diagnosis was
201033 - changed from cellulitus to reaction from radiation treatments in July
201034 - 2002; steriods prescribed to treat breast redness; patient cleared to
201035 - begin chemotherapy treatments on Taxol and Avastin trial. ref SDS 9
201036 - IM6J
201038 -  ..
201039 - The port catheter was installed on 040419.  After this minor surgery,
201040 - the doctor was asked to examine the left breast to expand analysis on
201041 - 040318 of persistant inflammation. ref SDS 10 789F  The surgeon at that
201042 - time took a biopsy. ref SDS 10 1572
201044 -  ..
201045 - The next day, on 040420, Millie began treatment in a clinical trial
201046 - for bevacizumab (Avastin) and Taxotere, ref SDS 11 W55O, to treat
201047 - relapse of cancer shown by the biopsy in the neck on 040303,
201048 - ref SDS 6 Y171, and with findings reported on 040309. ref SDS 7 0001
201049 - This treatment had been ordered on 040318, ref SDS 8 PU6M, and was
201050 - delayed several weeks treating inflammation in the left breast for
201051 - Cellulitis. ref SDS 8 IM6J
201053 -  ..
201054 - On 040429 the surgeon met with the patient and advised the biopsy
201055 - showed cancer, but did not report IBC. ref SDS 12 F66N  On 040517 the
201056 - primary care physician submitted the biopsy report, but did not
201057 - explain findings.  After the meeting, review showed the biopsy
201058 - reported finding IBC. ref SDS 13 6T5G  On 040614 Kaiser advised that
201059 - Millie was diagnosed with IBC. ref SDS 14 6T5G
201061 -  ..
201062 - UCSF report to Kaiser continues...
201063 -
201064 -        8.  This course was complicated by development of a pulmonary
201065 -            embolism in November 2004.  At that point, she was switched
201066 -            to Adriamycin and Cyctoxan.  She started therapy in January
201067 -            2005 and receivd a total of 4 cycles.  However, she did not
201068 -            show any response with her CA 15-3 continuing to be
201069 -            elevated and continued progression of her inflammatory
201070 -            disease. ref DRT 1 YY5S
201072 -  ..
201073 - UCSF does not report that testing for development of pulmonary
201074 - embolism was resisted by Kaiser for 5 months, shown on 040909,
201075 - ref SDS 16 RZ4I, until recommendation by Doctor Benz during a meeting
201076 - at UCSF on 041018. ref SDS 17 LX96  On 041104 Kaiser reported a CT
201077 - test with a special protocol was prescribed and this discovered PE,
201078 - which required emergency action. ref SDS 18 RZ4I
201080 -  ..
201081 - UCSF does not report that Kaiser delayed treatment to search for
201082 - another clinical trial, shown in the record on 041130. ref SDS 20 028N
201083 - Treatment was prescribed with AC on 041230 in order to qualify the
201084 - patient for another clinical trial. ref SDS 21 XQ41
201086 -  ..
201087 - UCSF report to Kaiser continues...
201088 -
201089 -        9.  She was therefore started on Taxotere and Xeloda on April
201090 -            15, 2005.  She received a total of 8 cycles of chemotherapy
201091 -            with Taxotere and Xeloda which she ended on September 16,
201092 -            2005, that resulted in complete resolution of the
201093 -            erythematous rash on her breast. ref DRT 1 YY6R
201095 -  ..
201096 - UCSF reports aligns with the record on 050916 when Millie received the
201097 - 8th and last treatment with capecitabine and Taxotere. ref SDS 22 407N
201099 -  ..
201100 - Kaiser reported on 051007 that IBC rash was completely resolved.
201101 - ref SDS 23 025H
201103 -  ..
201104 - UCSF report to Kaiser says...
201105 -
201106 -       10.  She at that point, underwent a palliative left mastectomey
201107 -            on October 21, 2005.  The patient did well but eventually
201108 -            the rash and redness redeveloped in her left chest wall by
201109 -            June 2006 so she was restarted once again on Taxotere and
201110 -            Xeloda on July 21, 2006.  She received a total of 7 to 8
201111 -            cycles with the last cycle being given on December 1, 2006.
201112 -            ref DRT 1 YY6V
201114 -             ..
201115 -       11.  The patient now presents to us to discuss our triple
201116 -            negative study. ref DRT 1 YZ3Q
201118 -         ..
201119 -    2.  Review of Systems:
201120 -
201121 -        On review of systems, she reports having low energy.  She also
201122 -        reports that the rash over her left chest wall is now worsening
201123 -        with extension to the medial aspect of her right breast and
201124 -        also extending to the lower abdominal area.  She reports
201125 -        positive dyspnea on exertion, continued chronic swelling of her
201126 -        left upper extremity and reports having some right hip pain
201127 -        with prolonged sitting.  The rest of the review of systems is
201128 -        negative. ref DRT 1 YQ3Y
201130 -  ..
201131 - Spread of cancer to the right breast was first observed at Kaiser on
201132 - 061208. ref SDS 27 025H
201134 -  ..
201135 - UCSF report to Kaiser says...
201136 -
201137 -    3.  Past Medical History:
201138 -
201139 -        1.  Pulmnary embolism that she developed initially in November
201140 -            2004 while on Taxotere and Avastin Trial.  She received
201141 -            Coumadin for one year then went off Coumadin.  However, she
201142 -            redeveloped a second pulmonary emobolism on September 19,
201143 -            2006, and was restarted on Coumadin in October 2006 and is
201144 -            on Coumadin currently. ref DRT 1 YZ49
201146 -  ..
201147 - PE was reported initially on 041104, per above, ref SDS 0 R17G;
201148 - symptoms were reported beginning on 040517. ref SDS 13 RZ4I
201150 -  ..
201151 - Treatment with Coumadin was started on 041104.  Follow up testing on
201152 - 041210 was reported on 041230 showing prior PE condition was no longer
201153 - visualized. ref SDS 21 RZ4I
201155 -  ..
201156 - UCSF report to Kaiser says...
201157 -
201158 -        2.  Reported history of an enlarged right ventricle.
201159 -            ref DRT 1 01RX
201161 -  ..
201162 - Enlarged right ventrical was reported in the CT test on 060930 which
201163 - was reviewed on 061010. ref SDS 26 7E5L
201164 -
201165 -              [On 071213 CT test reports findings of slightly enlarged
201166 -              heart. ref SDS 32 SR5I
201168 -  ..
201169 - UCSF report to Kaiser says...
201170 -
201171 -        3.  Glaucoma. ref DRT 1 YZ6P
201173 -             ..
201174 -        4.  Lymphedema of the left upper extremity with episodes of
201175 -            cellulitis off and on in the past. ref DRT 1 YZ6R
201176 -
201177 -                 [On 070607 Cellulitis recurrence during treatment at
201178 -                 UCSF. ref SDS 31 ZI35
201180 -         ..
201181 -    4.  Family History:
201182 -
201183 -        Family history is noncontributory for breast cancer.  She does,
201184 -        however, have a family history of hypercoagulable state with
201185 -        her mother dying at age 40 secondary to what sounds to be a
201186 -        pulmonary embolism and her son as well has a history of
201187 -        pulmonary embolism x2 in his 50s. ref DRT 1 YZ6U
201189 -  ..
201190 - Family history of hypercoagulable conditions was reported to Kaiser on
201191 - 040812. ref SDS 15 MG5K  On 060722 oldest son suffered recurrent PE;
201192 - reports doctors performed tests and found genetic cause of blood clots
201193 - that will require continuing treatment. ref SDS 24 3D9T
201195 -  ..
201196 - UCSF report to Kaiser says...
201197 -
201198 -    5.  Social History
201199 -
201200 -        She is married.  She lives in Concord, no smoking, occassional
201201 -        alcholol. ref DRT 1 YZ7S
201203 -         ..
201204 -    6.  Allergies:
201205 -
201206 -        No allergies to medications. ref DRT 1 YZ7I
201208 -         ..
201209 -    7.  Current Medications:
201210 -
201211 -        Current medicaitons include Coumadin 4 mg 6 days a week and
201212 -        then 2 mg once a week and the second medicaiton is eyedrops for
201213 -        her glaucoma. ref DRT 1 YZ8N
201215 -         ..
201216 -    8.  Physical Examination:
201217 -
201218 -        1.  Vital Signs:  Temperature 98.7, blood pressure 141/94,
201219 -            pulse 89, respiratory rate 26, height 62 inches, weight 151
201220 -            punds.  ECOG performance status is 1. ref DRT 1 YZ8U
201222 -             ..
201223 -        2.  General:  Well nourished, well developed and in no apparent
201224 -            distress. ref DRT 1 YZ96
201226 -             ..
201227 -        3.  Skin:  Examination shows a Port-a-Cath in the right chest
201228 -            wall that looked clean, dry and intact.  There was some
201229 -            erythema on the superior aspect of the Port-a-Cath area but
201230 -            no tenderness and no warmth. ref DRT 1 01VW
201232 -             ..
201233 -        4.  HEENT:  She had some redness over the right sclera
201234 -            laterally. ref DRT 1 YZ43
201236 -             ..
201237 -        5.  Breasts:  Examination showed her to have a macular rash
201238 -            located on the left chest wall extending to the right
201239 -            medial aspect of her right breast and also extending to the
201240 -            abdominal area.  On measurement, the largest diameter of
201241 -            the lesion was 10 cm x 22 cm in size.  She does have
201242 -            another area where it is 4 cm x 4 cm in size and one other
201243 -            area that is 0.5 cm below her mastectomy scar. ref DRT 1
201244 -            YZ44
201246 -             ..
201247 -        6.  Extremities:  She does have left upper extremity edema.
201248 -            ref DRT 1 YZ5G
201250 -             ..
201251 -        7.  Neurologic: Nonfocal.
201253 -             ..
201254 -        8.  The rest of the physical examination is unremarkable.
201255 -            ref DRT 1 01YT
201257 -         ..
201258 -    9.  Laboratory Studies:
201259 -
201260 -        Labs from January 23, 2007, show her to have an AST of 37, ALT
201261 -        of 24, alkaline phosphatase 48, total bilirubin 0.6, white
201262 -        count 4.4, hemoglogin 15.6 hematocrit 41.5, platelets 246, INR
201263 -        2.3, creatinine level 0.7.  The CA 15-3 on January 23, 2007,
201264 -        was 52, on January 18, 2007, was 68, on January 4, 2007, was
201265 -        56. ref DRT 1 YZ5W
201267 -         ..
201268 -   10.  Imaging Studies:
201269 -
201270 -        She had a PET/CT performed on December 27, 2006, that showed
201271 -        her to have relatively mild activity along the left chest wall,
201272 -        likely inflammatory in nature, otherwise unremarkable.  Brain
201273 -        MRI on July 18, 2006, was negative.  The last CT of the neck,
201274 -        chest and abdomen on August 5, 2006, showed her to have a less
201275 -        than 1 cm right axillary lymph node, no significant change
201276 -        compared to the one in April 2005. ref DRT 1 YZ6V
201278 -         ..
201279 -   11.  Summary:
201280 -
201281 -        In summary, the patient is a 71-year-old female with triple
201282 -        marker-negative inflammatory breast cancer status post
201283 -        Taxol/Avastin which was complicated by a pulmonary embolism,
201284 -        Adriamycin/Cytoxan x 4 cycles, and most recently Taxotere and
201285 -        Xeloda.  The patient is here to discuss our triple negative
201286 -        trial of cetuximab plus or minus carboplatin.  The patient
201287 -        understands and agrees to take part in the trial.  She has
201288 -        signed consent. ref DRT 1 Y13E
201290 -         ..
201291 -        The plan at this point will be for her to be scanned either
201292 -        tomorrow or Thursday and to start the trial on Thursday or
201293 -        Friday of this week.  The patient thereafter will return to
201294 -        clinic per protocol.  We did discuss the side effects of
201295 -        cetuximab such as hypersensitivity reaction for which she will
201296 -        be premedicated and the fact that there is a good change that
201297 -        that she will develop a rash.  The patien is aware. ref DRT 1
201298 -        4M5F
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