CONTACTS 

SUBJECTS
Default Null Subject Account for Blank Record

0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 37 0000. ref SDS 27 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040508 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Agenda
040902 -
040903 - The record for the meeting on 081016 has not yet been posted, so the
040904 - agenda can reflect the record for the meeting on 080918. ref SDS 13
040905 - YY3N
040907 -             ..
040908 -            CT test review
040910 -             ..
040911 -            Examination
040913 -             ..
040914 -            Neutropenia need for Neupogen
040916 -             ..
040917 -            Sunitinib cyclophosphamide reduce dose
040919 -             ..
040920 -            Schedule blood draws and meetings times
040921 -
040923 -  ..
040924 - Tara asked today about Millie's letter on 090106 submitting
040925 - an agenda for the meeting today. ref SDS 45 DB5I
040926 -
040927 -            [On 090109 Millie's letter to medical team reports
040928 -            examination on 090108 finding IBC increased particularly
040929 -            in the breastbone area after pausing treatment for 1
040930 -            week ordered during the meeting at UCSF on 081218, and
040931 -            further treatment was adjusted and continued to evaluate
040932 -            possibility of another recovery from consistent
040933 -            treatment with sunitinib. ref SDS 46 UE6R
040935 -  ..
040936 - Millie reported tearing eyes have increased in recent weeks.  Tara
040937 - prescribed Aqua Fresh over-the-counter eye drops to increase
040938 - moisture, because tearing is a response to dry eyes.
040940 -  ..
040941 - Concern about Millie's low pulse since starting the sunitinib protocol
040942 - with cyclophosphamide; Tara did a test having Millie walk down the
040943 - hallway connected to a pulse monitor.  Today, Tara was pleased to see
040944 - Millie's pulse rise during the test as a function of increased
040945 - activity.
040947 -  ..
040948 - Low pulse may relate to heart function, which is listed as a less
040949 - likely side effect of sunitinib, reviewed on 081017. ref SDS 16 VV4L
040950 -
040951 -            [On 090109 Millie's letter to medical team request Kaiser
040952 -            to order EKG. ref SDS 46 UF4V
040954 -             ..
040955 -            [On 090109 Arlette ordered EKG for Millie which can be done
040956 -            anytime next week. ref SDS 47 IF58
040958 -             ..
040959 -            [On 090112 Millie got the CT test at Kaiser. ref SDS 48
040960 -            DB5I
040962 -             ..
040963 -            [On 090116 Glenna called and requested submission of
040964 -            results for the EKG test to UCSF. ref SDS 49 JY9G
040966 -             ..
040967 -            [On 090514 0830 Doctor Rugo prescribes MPA clinical trial
040968 -            for Millie to recover from the 8th relapse of cancer, and
040969 -            assigns Millie to get MPA only in order to avoid side
040970 -            effects of cyclophosphamide that caused severe side effects
040971 -            for Millie on the sunitinib protocol. ref SDS 50 265I
040973 -  ..
040974 - Research indicates sunitinib may relate to heart problems....
040975 -
040976 -        Oncology Trends...
040977 -
040978 -              http://www.theoncologynurse.com/docs/TOP_Web_Exclusives_Nov_Dec.pdf
040979 -
040980 -        CHICAGO-Cardiac monitoring should be routine
040981 -        for recipients of sunitinib malate, according to
040982 -        Melinda Telli, MD, clinical instructor in medicine at
040983 -        Stanford University School of Medicine, Palo Alto,
040984 -        California, at the 44th annual meeting of the
040985 -        American Society of Oncology.
040986 -
040988 -         ..
040989 -        In the pivotal phase 3 trials of sunitinib for the treatment of
040990 -        metastatic renal cell carcinoma, Telli and her colleagues
040991 -        discovered that 21% of sunitinib treated patients experienced a
040992 -        reversible decline in left ventricular ejection fraction to
040993 -        below normal.
040995 -         ..
040996 -        Monitoring for cardiotoxicity is widely accepted
040997 -        with the use of trastuzumab, but guidelines for monitoring
040998 -        patients being treated with sunitinib are
040999 -        unclear, she noted. "We follow an algorithm similar
041000 -        to the one commonly followed for monitoring cardiotoxicity
041001 -        with trastuzumab for the treatment of
041002 -        breast cancer," she said. "In my opinion, the risk is
041003 -        equally high or higher with sunitinib, which displays
041004 -        toxicity when used as a single agent, whereas
041005 -        trastuzumab is used in combination with toxic
041006 -        chemotherapy."
041008 -         ..
041009 -        After observing a higher than expected incidence
041010 -        of symptomatic heart failure with sunitinib, Telli's
041011 -        group of investigators conducted a retrospective
041012 -        analysis of 48 patients who received the drug for the
041013 -        treatment of renal cell carcinoma or gastrointestinal
041014 -        stromal tumors at their institution.
041016 -         ..
041017 -        Of the 48 subjects, seven (15%) experienced
041018 -        symptomatic grade 3/4 left ventricular dysfunction
041019 -        22 to 435 days after initiating sunitinib. Three of the
041020 -        five patients with subsequent cardiac evaluations
041021 -        had persistent left ventricular dysfunction after discontinuing
041022 -        sunitinib and initiated standard therapy
041023 -        for heart failure.
041024 -
041025 -        "Most had their problem early-within the first 3
041026 -        months of therapy-so we do have concerns that
041027 -        the approach we use for trastuzumab doesn't fit well
041028 -        for sunitinib," Telli said. "We do early monitoring of
041029 -        cardiac biomarkers in the first few months of treatment
041030 -        with sunitinib, and have a low threshold for
041031 -        checking echoes in the first 3 months."
041032 -        Troponin I levels are followed early in the course
041033 -        of treatment, Telli said, and B-type natriuretic peptide
041034 -        levels are measured as needed.
041036 -         ..
041037 -        Risk factors associated with an increased risk of
041038 -        left ventricular dysfunction in sunitinib recipients
041039 -        were a history of congestive heart failure, coronary
041040 -        artery disease, and low body mass index (BMI).
041041 -        "This was true even among those patients with a
041042 -        remote history of heart disease and normal heart
041043 -        function at the time of initiation of sunitinib," Telli
041044 -        noted.
041046 -         ..
041047 -        Patients who develop symptomatic heart failure
041048 -        while taking sunitinib should discontinue the drug,
041049 -        but the proper course of action in patients who are
041050 -        asymptomatic but experience a decline in heart
041051 -        function is not clear, she said. "If the expected survival
041052 -        with treatment is 1 or 2 years, should we take
041053 -        them off the drug? Most would refer to a cardiologist
041054 -        to optimize heart function," Telli pointed out.
041055 -        "Up to this point, heart failure [with sunitinib]
041056 -        was believed to be reversible without adverse clinical
041057 -        outcomes. We had appreciable rates of symptomatic
041058 -        heart failure that was not necessarily
041059 -        reversible," she said.
041061 -         ..
041062 -        The finding that patients with low BMI were
041063 -        more susceptible to a decline in cardiac function
041064 -        suggests that serum drug levels of sunitinib may be
041065 -        higher in those with lower BMI, with dose-related
041066 -        pharmacodynamic effects of the drug at the level of
041067 -        the cardiomyocyte. This possibility, and the need for
041068 -        dose adjustment in patients with lower BMI, needs
041069 -        to be studied prospectively, Telli noted.
041071 -         ..
041072 -        Because sunitinib is currently being investigated
041073 -        in clinical trials in more than 30 different tumor
041074 -        types for advanced and early forms of cancer, careful
041075 -        study of adverse cardiac events is needed in these trials,
041076 -        Telli concluded.
041077 -
041078 -        - Wayne Kuznar
041079 -
041080 -
041081 -
041082 -
041083 -
041084 -
041085 -
041086 -
041087 -
041088 -
0411 -