pico pds vs nact

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    Dr. Rafyandi

    PICO

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     To determine the overall survival and relativeeect o multiple prognostic variables incohorts o patients ith advanced!stageovarian cancer treated ith platinum!based

    neoad"uvant chemotherapy in lieu o primarycytoreductive surgery.

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     Tenty!to cohorts o patients ith #tage IIIand I$ ovarian cancer %&'( patients) ereidentifed rom articles in *+D,I-+ %/&/0122()

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     The mean number o patients in each cohortas '& %median3'14 range3205()

    *edian survival time ranged rom 2.1 to 61.2months.

    7or all cohorts ta8en together4 the meaneighted median survival time as 16.(months.

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    +ach 29 increase inthe proportion opatients in each cohortundergoing ma:imalinterval cytoreductivesurgery as associatedith a ./ monthincrease in median

    survival time%/(9CI32.1' months0'.(2 months4 p32.215).

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    +ach incrementalchemotherapy cycleas signifcantlyassociated ith a 6.

    month decrease inmedian survival time%/(9CI3&. to ;2.months4 p32.26

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    +ach 29 increase inthe proportion opatients receiving ata:ane as associatedith a .< monthincrease in mediansurvival time %/(9CI32.&5 months01.1(

    months4 p=2.222()

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    +ach 29 increase in the proportion opatients ith stage I$ disease as associatedith an estimated 1.' month decrease inmedian survival time %/(9CI3;'.52 months

    to ;.22 months4 p32.221).-o statistically signifcant relationship

    beteen median cohort age and mediansurvival time %p32.66&).

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    -eoad"uvant chemotherapy in lieu o primarycytoreduction is associated ith inerioroverall survival compared to initial surgery.

    Increasing percent ma:imal cytoreduction ispositively associated ith median cohortsurvival

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     The negative survival eect o increasingnumber o chemotherapy cycles prior tointerval surgery suggests that defnitiveoperative intervention should be underta8en

    as early in the treatment program as possible.

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     To compare

    $#

    Primarydebul8ing

    surgery %PD#)olloed by

    platinum!basedchemotherapy

    -eoad"uvantchemotherapy%->CT) olloed

    by intervaldebul8ing

    surgery andadditional

    chemotherapyin advanced ovarian

    carcinoma.

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    • Patients

    +ligible patients had biopsy!proven stage IIICor I$ invasive epithelial ovarian carcinoma4primary peritoneal carcinoma4 or allopian!tubecarcinoma.

    • Study design

    Patients ere randomly assigned either to PD#

    olloed by at least si: courses o platinum!based chemotherapy or to three courses o->CT olloed by interval debul8ing surgery

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    5& patients ere enrolled

    ''< ?ere assigned to PD#''6 ?ere assignd to

    ->CT

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     The overall test or a treatment eect on globalhealth as not signifcant.

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    Overall survival as similar in the to groups in theintention!to!treat analyses %1/ months in the primary!surgery group and '2 months in the neoad"uvant!

    chemotherapy group)

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    Progression-free survival was similar in the two groups in the

    intention-to-treat analyses (12 months in both groups)

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    • Aa@ard ratio or death in the group assignedto neoad"uvant chemotherapy olloed byinterval debul8ing4 as compared ith thegroup assigned to primary debul8ing4 as

    2./& %/29 confdence interval BCI4 2.&6 to.' P 3 2.2 or nonineriority)

    • Aa@ard ratio or progressive disease as .2%/29 CI4 2.&/ to .().

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    Similar results for overall survival (hazard ratio for death, 1!!"

    #!$ %&, !' to 11" P * !!1 for noninferiority)

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    PDS(months)

    NACT(months)

    -o residual tumor %optimal result) 6( '&

    Residual tumors that measured to2 mm in diameter %suboptimalresult)

    '1 15

    Residual tumors larger than 2 mm%other result)

    1< 1(

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     The strongest independent predictors o prolongedsurvival4 in descending orderE

    • >bsence o residual tumor ater surgery %P=2.22)

    • #tage IIIC disease %P 3 2.22)

    • #mall tumor si@e beore randomi@ation %P 3 2.22)

    • +ndometrioid histologic type4 olloed indescending order by serous4 mi:ed4undierentiated4 mucinous4 and clear!cell types %P

    3 2.22()•  Founger age %P 3 2.22().

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     The standard o care or omen ith stage IIIGor earlier!stage epithelial ovarian cancer H agroup ith a better prognosis than the currentstudy population H remains primary

    cytoreductive surgery.Only those patients ith proven stage IIIC or

    I$ disease should be considered orneoad"uvant chemotherapy.

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     The clinician may assess important predictiveactors ith respect to residual macroscopicdisease ater debul8ing surgery %e.g.4presence or absence o coe:isting illnesses4

    age4 disease burden4 location o metastaticsites4 ?AO perormance status4 and tumorstage).

    ,aparoscopy4 in addition to a:ial CT4 may

    provide inormation about the disease burden

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    ->CT is not inerior to PD# or patients ithstage IIIC or I$ ovarian carcinoma.

    -o signifcant advantages o ->CT or PD#ere observed ith respect to survival4

    adverse eects4 uality o lie4 orpostoperative morbidity or mortality.

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     To evaluate the use o neoad"uvantchemotherapy %->CT) and primary debul8ingsurgery %PD#) beore and ater results rom arandomi@ed trial ere published and shoed

    nonineriority beteen ->CT and PD# in themanagement o advanced!stage ovariancarcinoma.

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    #tudy design E retrospective analysisPlace E at *emorial #loan Jettering Cancer

    Center

     Time E Kanuary 4 122& to *ay 4 12'

    Patients E all nely diagnosed patients hopresented ith stage III or I$ diseaseaccording to 7ILO staging criteria %(&<

    patients)

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    +:clusion E i they had already undergone PD#at an outside acility4 completed ->CT prior topresentation4 presented ith borderline orlo!grade histology4 or had stage I or II

    disease The decision to oer PD# as a primary

    treatment strategy as at the discretion othe individual surgical attending

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     There ere no '2!day postoperative deaths ineither the PD# or ->CT cohort

     There ere &2 %69) grade ' or 6 adverseevents in the entire cohort o (&< patients

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    PDS NACT

    *edianP7#

    1.5 months%/(9 CI4 /.(01'.&)

    './ months%/(9 CI 1.(!

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    •  The best survivaloutcomes ere observedin patients ho achieveda complete grossresection at the time o

    PD#4 although O# atercomplete gross resectionat the time o ID#%median O#4

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    In this single!institution analysis4 the bestsurvival outcomes ere observed in patientsho ere deemed eligible or PD# olloed byplatinum!based chemotherapy

    ?ith improved optimal resection rates andless adverse event in ->CT4 they concludethat ->CT is reasonable treatment strategyor advanced ovarian cancer.

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