CONTACTS 
0201 - Medical Offices Nima Grissom                                                                                                                                       O-00000849 0601
020101 - Ms. Mary NLN; Secretary                                                                                                                                          O-00000849 0601
020103 - Administration Department                                                                                                                                        O-00000849 0601
0202 - Medical Offices Nima Grissom                                                                                                                                       O-00000849 0101
020201 - Ms. Nima Grissom, MD                                                                                                                                             O-00000849 0101
020203 - Executive Office                                                                                                                                                 O-00000849 0101

SUBJECTS
2nd Opinion #2 Surgical Oncologist 2nd Referral by UCSF on Criteria
2nd Opinion #2 Meeting Surgeon Oncologist Referral #2 from UCSF Exam
Meeting Examination 2nd Opinion #2 Surgical Oncologist 2nd Referral

1005 -
1005 -    ..
1006 - Summary/Objective
1007 -
100701 - Follow up ref SDS 25 0000. ref SDS 24 0000.
100702 -
100703 - Excellent meeting today presenting ideas for continuing systemic
100704 - treatment, ref SDS 0 MW5M, and, also, proposing consideration of an
100705 - innovative surgical solution, which may present Millie's best chance
100706 - of disease-free survival at least for a while. ref SDS 0 V150  Second
100707 - opinion draft will be submitted for review and comment, toward
100708 - finalizing a presentation to Kaiser. ref SDS 0 YR8H
100710 -      ..
100711 -     [On 050913 Doctor Grissom's proposal for very wide mastectomy to
100712 -     reduce chance of relapse presented to primary care physician at
100713 -     Kaiser. ref SDS 32 X545
100715 -      ..
100716 -     [On 050914 received 1st draft of 2nd opinion, ref SDS 33 AI8N, and
100717 -     submitted feedback. ref SDS 33 XX4R
100719 -      ..
100720 -     [On 050920 received final draft of 2nd opinion. ref SDS 34 PQ5S
100722 -      ..
100723 -     [On 050923 surgeon at Kaiser in Walnut Creek office received
100724 -     Doctor Grissom's 2nd opinion; discussed during meeting with
100725 -     patient. ref SDS 35 7J67
100727 -      ..
100728 -     [On 051010 Doctor Grissom discusses window of opportunity for
100729 -     possible "cure" in Millie's case. ref SDS 36 GW4I
100731 -      ..
100732 -     [On 051109 letter reports results implementing Doctor Grissom's
100733 -     2nd opinion; Kaiser reports Millie is disease-free, indicating a
100734 -     complete response to treatment guided in part by Doctor Grissom's
100735 -     opinion. ref SDS 37 R29J
100736 -
100737 -
100738 -
100740 -  ..
1008 -
1009 -
1010 - Progress
1011 -
1012 -
101201 - Patient History Meeting with Doctor Grissom 2nd Opinion Surgery IBC
101202 -
101203 - Follow up ref SDS 25 P68V.
101204 -
101205 - On 050823 submitted ref DIP 7 0001 with patient history and requesting
101206 - 2nd opinion. ref SDS 25 P68V  Mary called back later that day, and
101207 - scheduled the meeting for today. ref SDS 25 P354  On 050825 notified
101208 - Mary about scope of medical records for submission to the doctor.
101209 - ref SDS 26 XK8N  On 050909 delivered medical records to Doctor
101210 - Grissom. ref SDS 31 0001
101212 -  ..
101213 - At the end of the meeting today, the doctor returned pathology slides
101214 - and the CD for use in the next meeting, and then return to Kaiser.
101216 -  ..
101217 - The letter to Doctor Grissom's office on 050823 provided a link to a
101218 - case study on patient history, ref SDS 25 Z24Q, listed in the record
101219 - on 050812. ref SDS 20 6L4M
101221 -  ..
101222 - On 050826 a doctor on internal referral at Kaiser had incorrect
101223 - understanding of patient profile because there wasn't enough time to
101224 - review patient history. ref SDS 27 V15F  The doctor's 2nd opinion
101225 - later reported on 050907 that due to limited time the case was too
101226 - complicated to review patient history, and this resulted in incorrect
101227 - representation, as the basis of recommendations. ref SDS 28 555G
101229 -  ..
101230 - During the meeting today, the doctor discussed patient history on
101231 - progression of disease, and relapse in relation to treatments.  Doctor
101232 - Grissom commented that Millie's four (4) year battle with cancer
101233 - presents a formidable, complex history that is hard to grasp in the
101234 - time available for review and analysis, cited earlier on 041209 during
101235 - work on a prior 2nd opinion. ref SDS 7 LO5L  She feels the case study
101236 - on 050812 is very helpful for converving time finding critical
101237 - details.
101239 -  ..
101240 - Doctor Grissom will follow the doctor/patient partnership model
101241 - working with Doctor Shim at Kaiser, and discussed with Doctor Bailey
101242 - on 050909.  She will submit a draft 2nd opinion through electonic mail
101243 - for timely reivew and feedback to refine accuracy and scope that aids
101244 - implemenation.
101245 -
101246 -     [On 050914 received 1st draft of 2nd opinion, ref SDS 33 AI8N, and
101247 -     submitted feedback. ref SDS 33 XX4R
101248 -
101249 -
101250 -
101251 -
101252 -
101253 -
101254 -
1013 -

SUBJECTS
Default Null Subject Account for Blank Record

1703 -
170401 -  ..
170402 - Purpose and Objectives for Examination Today
170403 - Summary of Patient History Explained During the Meeting
170404 -
170405 - Follow up ref SDS 27 R448.
170406 -
170407 - Millie summarized case history to guide discussions.
170408 -
170409 - On 020208 the patient initially complained of lumps on the left breast
170410 - and under the left arm during an examination by the gynolcologist.  A
170411 - biopsy showed cancer, reported to the patient on 020306. ref SDS 20
170412 - UF4J
170414 -  ..
170415 - On 020312 a lumpectomy was performed on the left breast, and lymph
170416 - nodes were removed.  Neoadjuvant chemotherapy and radiation treatment
170417 - occurred during 2002.  The patient received no treatment during 2003;
170418 - red rash on the left breast, and discomfort under the left axilla were
170419 - reported episodically beginning in 2003. ref SDS 20 NJ5F  Relapse was
170420 - diagnosed in 040318; IBC was diagnosed on 040614. ref SDS 20 MD5J  The
170421 - patient responded well to treatment on the Avastin and Taxol trial
170422 - protocol.  On 041103 a CT scan reported pulmonary emboli.  On 041104
170423 - the patient was removed from treatment. ref SDS 20 VZ4I  On 050104
170424 - treatment resumed with AC. ref SDS 20 T35J  IBC worsened.  On 050329
170425 - treatment was changed to Taxotere and capecitabine (Xeloda).
170426 - ref SDS 20 SK7K  The patient recovered, and on 050727 the surgeon at
170427 - Kaiser in Walnut Creek said the patient is ready for surgery.  On
170428 - 050729 the primary care physician in Oncology asked for a date to
170429 - schedule surgery. ref SDS 20 RM6F  On August 19, 2005 the patient
170430 - received Taxotere chemotherapy to begin the 7th cycle of treatment,
170431 - and has one more week of supplemental treatment with capecitabine
170432 - (Xeloda) to complete the 7th cycle. ref SDS 23 0001  Chemotherapy has
170433 - now been paused pending decision and performance of surgery, as
170434 - planned by primary care physician on 050729. ref SDS 20 T35I
170436 -  ..
170437 - This meeting was scheduled on 050805, ref SDS 15 V15F, following up
170438 - discussion with the patient on 050729, ref SDS 15 V15F, and previously
170439 - planned on 050727 for referral by the surgeon in Kaiser's Walnut Creek
170440 - hospital to obtain a 2nd opinion. ref SDS 14 O85O
170442 -  ..
170443 - The purpose of the examination is to obtain a 2nd opinion on...
170444 -
170445 -    1.  Criteria for determining patient is ready for surgery,
170446 -        primarily related to establishing there has been sufficient
170447 -        recovery from IBC, presented at Kaiser in Walnut Creek on
170448 -        050727, ref SDS 14 OV5H, and discussed with referral surgeon at
170449 -        Kaiser in Oakland on 050826. ref SDS 27 G28J
170451 -         ..
170452 -    2.  Criteria for deciding to have mastectomy on both breasts to
170453 -        reduce chances of relapse and provide tissue for skin grafts,
170454 -        on the left breast, and for patient convenience to avoid
170455 -        prostheses presented to Kaiser in Walnut Creek on 050727,
170456 -        ref SDS 14 NT9G, and discussed with referral surgeon at Kaiser
170457 -        in Oakland on 050826. ref SDS 27 NT9G
170459 -         ..
170460 -    3.  Surgery tasks and issues that may arise performing a mastectomy
170461 -        on patients with IBC that are different from experience
170462 -        performing the procedure on patients without IBC. presented to
170463 -        Kaiser in Walnut Creek on 050727, ref SDS 14 QJ3Q, including
170464 -        determining the scope and boundaries of surgical removal,
170465 -        ref SDS 14 JV5F, and discussed with referral surgeon at Kaiser
170466 -        in Oakland on 050826. ref SDS 27 FM5J
170468 -         ..
170469 -    4.  Criteria for the patient to approve surgery for disease-free
170470 -        survival without chemotherapy treatments, also, presented to
170471 -        Kaiser in Walnut Creek on 050727, ref SDS 14 VL4O, and
170472 -        discussed with referral surgeon at Kaiser in Oakland on 050826.
170473 -        ref SDS 27 JS4H
170474 -
170475 -
170476 -
170477 -
170478 -
1705 -

SUBJECTS
Default Null Subject Account for Blank Record
Examination 2nd Opinion #2 Referral #2 from UCSF Showed Patient Read

3004 -
300501 -  ..
300502 - Criteria Patient Ready for Mastectomy Surgery IBC Recovery
300503 - Patient Ready for Mastectomy Surgery Verify with Biopsies Testing
300504 - Biopsies Thin Skin Verify IBC Subsided Determine Perimeter Surgery
300505 -
300506 - The letter to Doctor Grissom on 050823 explained the purpose of the
300507 - 2nd opinion....
300509 -         ..
300510 -    1.  Patient ready for mastectomy surgery based on regression of
300511 -        inflammation of IBC, discussed with surgeon at Kaiser on
300512 -        050727. ref SDS 14 OV5H
300514 -  ..
300515 - Doctor Grissom made an examination, and commented that Millie seems
300516 - ready for surgery with respect to recovery from IBC.  The doctor
300517 - observed slight stiffness and coloration of the skin where radiation
300518 - treatments were administered in July and August of 2002.
300520 -  ..
300521 - The doctor indicated that further testing should be done to confirm
300522 - that these lingering symptoms are actually reaction to radiation, and
300523 - are not IBC.  She proposes several sliver skin biopsies and a PET scan
300524 - test to verify that IBC has fully subsided, and that there is no
300525 - distant metastasis.
300527 -  ..
300528 - The doctor indicated that if the sliver skin biopsies show that IBC is
300529 - still present in the breast, surgery would not be a good treatment;
300530 - and, also, noted that if distant metastasis is found by PET testing,
300531 - then in that case mastectomy surgery is not recommended, but rather
300532 - the patient should be treated with chemotherapy.
300533 -
300535 -         ..
300536 -    2.  Scope of surgery based on inflammation that extended beyond the
300537 -        breast toward the neck in March, though at this time seems to
300538 -        have fully regressed, following up discussions at Kaiser on
300539 -        050727. ref SDS 14 JV5F
300541 -         ..
300542 -        Both breasts for patient convenience and for skin grafts to
300543 -        close wound on left breast infected with IBC, also, discussed
300544 -        on 050727. ref SDS 14 NT9G
300546 -  ..
300547 - The doctor feels that removing both breasts is not a good treatment
300548 - procedure, because it compounds recovery and follow on treatment
300549 - issues.
300551 -  ..
300552 - Doctor Grissom proposes a "very wide" mastectomy surgery to remove
300553 - previously infected tissue, and the area that was previously radiated
300554 - in July and August 2002.  The doctor indicated this surgery is highly
300555 - complex, requiring contemporaneous reconstruction by a plastic surgeon
300556 - to close the wound in a 10 hour operation using a microvascular flap
300557 - such as a DIEP flap or possibly a TRAM.
300559 -         ..
300560 -        [On 050913 Doctor Grissom's proposal for very wide mastectomy
300561 -        to reduce chance of relapse presented to primary care physician
300562 -        at Kaiser. ref SDS 32 X545
300564 -         ..
300565 -        [On 050920 received Doctor Grissom's 2nd opinion confirming
300566 -        proposal on reducing risk of relapse that enables surgical
300567 -        wound to heal. ref SDS 34 XL8U
300569 -         ..
300570 -        [On 050923 Doctor Grissom's recommendations reviewed with
300571 -        surgeon at Kaiser planning for very wide mastectomy and closure
300572 -        by plastic surgery to reduce chance of relapse. ref SDS 35 NT9G
300574 -  ..
300575 - The doctor explained that removing previously infected skin helps
300576 - prevent relapse of cancer, which would otherwise prevent the surgical
300577 - wound from healing, as shown by Millie's experience with the punch
300578 - biopsy taken on 040419 which did not heal for over a year due to
300579 - ongoing IBC, reported on 050107. ref SDS 10 IS5N  Millie explained
300580 - today that in March of this year, IBC inflammation had spread above
300581 - the breast toward the neck, as reported by the surgeon in Kaiser's
300582 - Walnut Creek office during a meeting on 050324. ref SDS 11 YY7F  The
300583 - doctor noted that sliver skin biopsies will help define the area of
300584 - skin to remove, per above. ref SDS 0 FH6O  In addition, closure with
300585 - plastic surgery will provide skin that has not previously been
300586 - radiated, and so will provide a radiation treatment option following
300587 - surgery, which is standard for IBC treatment, reported on 040517.
300588 - ref SDS 2 JK94
300589 -
300591 -         ..
300592 -    3.  Experience of surgeon performing mastectomy surgery on IBC
300593 -        patient, previously discusssed at Kaiser on 050727. ref SDS 14
300594 -        QJ3Q
300595 -
300597 -  ..
300598 - Doctor Grissom indicated that IBC is a very rare form of cancer that
300599 - is normally diagnosed de novo.  The doctor further commented that
300600 - Millie's patient profile contracting IBC on relapse is a rare
300601 - condition of a rare disease.  As a result, there are no studies and
300602 - very little literature on criteria and guidance for assessing when a
300603 - patient is ready for surgery, and on the scope of the operation,
300604 - because there is not a lot of experience treating this particular
300605 - situation.
300607 -  ..
300608 - The doctor said that an oncologist is normally best positioned to
300609 - analyse expert advice in 2nd opinions, and coordinate medical team
300610 - planning for treatment options, including surgery, and further to help
300611 - the patient consider alternatives, risks, and benefits for a reasoned
300612 - decision based on patient history.  This was requested in a letter to
300613 - Doctor Benz at UCSF on 050819. ref SDS 22 AI8N  On 050823 UCSF made
300614 - referral to surgeons, and were again requested for guidance on
300615 - analysing Millie's treatment. ref SDS 25 QF7N
300616 -
300617 -        [On 050913 primary care physician in Oncology Department at
300618 -        Kaiser likened the role of Oncology to the leadership role of a
300619 -        General Contractor who manages and coordinates other experts.
300620 -        ref SDS 32 Q94H
300622 -  ..
300623 - Doctor Grissom indicated that planning and performing a very wide
300624 - mastectomy surgery on an IBC patient is complex and difficult,
300625 - including collaboration with the plastic surgeon, as explained above.
300626 - ref SDS 0 V150  Experience treating IBC patients with surgery is
300627 - critical for success.
300629 -  ..
300630 - There was discussion about how surgeons become experienced treating
300631 - IBC patients.  If experience is critical, do doctors initially assist
300632 - to observe the work, and learn about unique issues and practices for
300633 - operating on IBC patients?
300635 -  ..
300636 - Doctor Grissom said that doctors typically do not have time for
300637 - training by assisting other surgeons in order learn and gain
300638 - experience on highly complex, difficult, and unusual surgeries.  She
300639 - explained having started doing surgeries beginning in 1985.  Her
300640 - twenty (20) year career includes performing a number of very wide
300641 - mastectomy surgeries, and some of these, though evidently not many,
300642 - have involved IBC patients.  Doctor Grissom then indicated that any
300643 - doctor, who has experience performing mastectomy surgery can likely be
300644 - successful performing a very wide mastectomy on an IBC patient, if the
300645 - doctor consults in advance with a surgeon who has experience doing
300646 - this type of work.
300648 -  ..
300649 - There was no discussion on the scope of consultation.  Does this mean
300650 - a telephone call.  Does this entail joint examination of the patient,
300651 - and planning the layout of surgery, submitting a due diligence
300652 - checklist of steps for IBC surgery that are not common to normal
300653 - mastectomy surgeries?  How about debriefing for post-op follow up,
300654 - possibly a joint examination, does this require further consultation?
300655 - What would this cost?
300657 -  ..
300658 - The doctor indicated that her price to perform this surgery for Millie
300659 - would be $2,400.  There would be additional costs for the plastic
300660 - surgeon and for the hospital.  The doctor seemed open to performing
300661 - the work at Kaiser, but seemed more comfortable with the prospect of
300662 - doing the work at a familiar hospital and staff.  Not sure if $2,400
300663 - includes post-op follow up.
300664 -
300666 -         ..
300667 -    4.  Approval of surgery for extending longevity and quality of
300668 -        life, per background...
300669 -
300670 -            a.  Primary care physician at Kaiser recommending surgery
300671 -                at this time, reported on 050729. ref SDS 16 BZ56
300672 -
300673 -                Previously, on 041117...
300675 -                 ..
300676 -            b.  Doctor Benz at UCSF stated in a 2nd opinion there is no
300677 -                role for surgery in Millie's case at that time.
300678 -                ref SDS 6 OU5P
300680 -                 ..
300681 -            c.  Doctor Guardino at Stanford stated in a 2nd opinion
300682 -                received on 041209 there might be a role for surgery
300683 -                after regression of inflammation. ref SDS 7 SN97
300685 -                 ..
300686 -            d.  Doctor Shim on internal referral at Kaiser supports
300687 -                surgery in a 2nd opinion received on 050907,
300688 -                ref SDS 28 JS4H, as a component of a curative treatment
300689 -                model. ref SDS 28 F49H
300691 -                 ..
300692 -            e.  Doctor Bailey recommends continuing cheotherapy
300693 -                treatments and further testing at this time to assess
300694 -                recovery from IBC, reported on 050909. ref SDS 30 1G4Q
300696 -         ..
300697 -        This background presents following issues...
300699 -         ..
300700 -        Continue treatments and evalute recovery from IBC with breast
300701 -        MRI and PET scan tests?
300703 -         ..
300704 -        Criteria for determining remission to end current treatments
300705 -        with disease-free survival?
300707 -         ..
300708 -        Millie explained her goal to maintain current control of local
300709 -        and distant disease, and to reduce debilitating. side effects
300710 -        of chemotherapy.
300712 -  ..
300713 - Doctor Grissom commented that mastectomy surgery in this case is a
300714 - close call due to high risks, and therefore, Millie could control her
300715 - disease by avoiding surgery, and continuing with chemotherapy.
300717 -  ..
300718 - The doctor cited another patient who contracted IBC on relapse,
300719 - similar to Millie.  This patient decided not to have surgery, and
300720 - seems to be doing well so far on Taxotere chemotherapy.  The doctor
300721 - did not say how long this patient has had IBC, and how long she has
300722 - been treated with Taxotere and other chemotherapy.  There was no
300723 - discussion of side effects, and no discussion of the patient's age and
300724 - other factors that relate to tolerance for side effects.
300726 -  ..
300727 - Doctor Grissom said that if proposed PET scan and sliver skin biopsy
300728 - tests, called out earlier, per above, ref SDS 0 FH6O, show no
300729 - detectable cancer activity, then Millie's best chance of accomplishing
300730 - remission, so there is a period of time, near-or-long term, without
300731 - side effects from treatment with chemotherapy, is to have a successful
300732 - very wide mastectomy surgery, as outlined above. ref SDS 0 L27V  The
300733 - doctor noted that Millie's history of relapse, when off treatment,
300734 - suggests that systemic treatment may be the best course, and noted
300735 - that even if the surgery is successful, where there are no mistakes,
300736 - there could be a problem with healing, and in any case Millie's cancer
300737 - may come back.
300738 -
300740 -         ..
300741 -    5.  Retesting biopsy to evaluate change in status from ER PR and
300742 -        HER2/neu negative for expanding treatment options, proposed by
300743 -        Doctor Shim at Kaiser on 050907, ref SDS 28 AE6P, and also
300744 -        discussed by Doctor Bailey on 050909. ref SDS 30 1G8R
300746 -         ..
300747 -        Retest existing biopsy that found IBC on 040419, or take a new
300748 -        sample at present time after patient has substantially
300749 -        recovered from IBC?
300751 -  ..
300752 - Doctor Grissom concurred with Doctor Shim's recommendation on 050909
300753 - to retest the biopsy on 040419, when IBC was discovered, from among
300754 - many biopsies Millie has had, ref SDS 29 P58N, because this was near
300755 - the height of Millie's relapse, and so will provide tissue that can be
300756 - tested for status change.  This aligns with understandings from
300757 - meeting with Doctor Bailey last Friday on 050909.
300759 -            ..
300760 -           [On 050913 presented status retest proposal to primary care
300761 -           physician. ref SDS 32 JP5H
300763 -            ..
300764 -           [On 050923 surgeon at Kaiser concurs retest for status, and
300765 -           notes that biopsy on 040419 may not have enough tissue;
300766 -           discusses using tissue from new biopsies planned for
300767 -           following week to test for IBC recovery. ref SDS 35 U94M
300769 -         ..
300770 -    6.  Taxotere and capecitabine (Xeloda) current regimine causing
300771 -        significant side effects.  On 050520 strength of capecitabine
300772 -        was redueced by 25%. ref SDS 13 V43H  This was effective for
300773 -        awhile.  Side effects has subsequently accumulated.
300775 -         ..
300776 -        What authority guides calculation of dosage strength for
300777 -        Taxotere and capecitabine.  Is there published guidance on
300778 -        levels of effectiveness?
300780 -  ..
300781 - There was no discussion today of adjusting treatment dosage to reduce
300782 - side effects.
300783 -
300784 -     [On 050914 received 1st draft of 2nd opinion, ref SDS 33 AI8N, and
300785 -     submitted feedback. ref SDS 33 XX4R
300786 -
300787 -
300788 -
300789 -
300790 -
300791 -
300792 -
300793 -
300794 -
300795 -
3008 -