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Μελέτη ATAC. Δεδομένα διάμεσης παρακολούθησης διάρκειας 100 μηνών. The ATAC Trialists’ Group. Lancet Oncol 2007; In press. Εισαγωγή. Ο πρωτεύων στόχος της θεραπείας του Πρώιμου Καρκίνου του Μαστού είναι η πρόληψη της υποτροπής - PowerPoint PPT Presentation

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  • ATACThe ATAC Trialists Group. Lancet Oncol 2007; In press 100

  • , >2% >30% 15 1 , 24 , 1EBCTCG overview. Lancet 2005; 365: 1687-1717 2ATAC Trialists Group. Lancet 2005; 365: 60-62 3Coates et al. J Clin Oncol 2007; 25: 486-92 4Coombes et al. Lancet 2007; 369: 559-70A,

  • ATAC(n = 3116)ITT n = 3125 n = 3092HR+ n = 2618ITT n = 3116 n = 3094HR+ n = 2598ITT: , HR+: (n = 3125)n=3125 (n = 9366) 1:1:1 5

  • Arimidex ( ATAC) [Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial] ATAC 13 13 2 68 31The ATAC Trialists Group. Lancet 2002; 359: 2131-39 2The ATAC Trialists Group. Lancet Oncol 2006; 7: 633-43 3ATAC Trialists Group. Lancet 2005; 365: 60-62

  • ITT HR+ (84% ) Kaplan-Meier HR+ : :

  • *, , ,

    *14

  • ATAC ( ) ( ) ( ) 2007 (n = 6241)10046202170411839111481253732521 2004 (n = 6241)6833465122689869994831503328 (%)32 (47)12737 (38)478 (39)285 (32)212 (30)54 (57)422 (51)229 (46)193 (59)

  • (A T) ( )

    . 817 v 887 538 v 645 424 v 487 61 v 87 629 v 624 350 v 382 279 v 242 95% CI(0.82-0.99) (0.73-0.91) (0.75-0.98) (0.49-0.94) (0.89-1.12) (0.79-1.05) (0.94-1.33) p-0.90 0.810.860.681.000.911.120.0250.00040.0220.020.990.20.2: , T: , CI,

  • (A T) (HR+ )

    . 618 v 702 391 v 494 305 v 357 50 v 80 472 v 477 245 v 269 227 v 208 95% CI(0.76-0.94) (0.67-0.87) (0.72-0.97) (0.42-0.85) (0.86-1.11) (0.75-1.07) (0.87-1.26)0.85 0.760.840.600.970.901.05p-0.0030.00010.0220.0040.70.20.6: , T: , HR+: , CI:

  • HR+ (A) (T) (ITT) HR+ 0.20.40.60.81.01.21.52.0 (A / T) 95% CI 0.90 Hazard ratio*0.850.810.760.860.840.680.601.000.970.910.901.121.05HR+ Hazard ratio *

  • - HR+ (%)30252015105013.9%16.4%25.8%29.9%0123456789HR+HR0.8595% CI(0.76, 0.94)p-0.003 () 2.5%4.1%HR: , CI:

  • HR+ (%)302520151050012345678930252015105012.5%17.0%21.8% ()4.8%9.7%HR+HR*0.7695% CI(0.67, 0.87)p-0.0001* R:

  • (%)302520151050012345678930252015105012.5%17.0%21.8% ()9.7%2.8%4.8% HR+HR0.7695% CI(0.67, 0.87)p-0.0001 HR+

  • ; 5 2 2.7% (11.6% 5 14.3% 2 )2 CMF ( 5-) , , 3% 5 4% 10 3 ATAC, HR+ 9 4.8% 11ATAC Trialists Group, Lancet 2005; 365: 60-622EBCTCG overview, Lancet 1998; 351: 1451-1467 3EBCTCG overview: Lancet 2005; 365: 1687-1717

  • : HR+ (%) 4.03.02.01.00.04.03.02.01.00.00123456789 ()

  • TTR: Carryover effect HR+ , 2.8% 5 4.8% 9 5-9, 1 carryover effect (HR=0.75, 95% CI 0.61-0.94, p=0.01)

    TTR: 1EBCTCG overview: Lancet 2005; 365: 1687-1717

  • : HR+ (%)30252015105001234567897.8%9.1%13.2%15.6% ()HR+

    HR0.84

    95% CI(0.72, 0.97)p-value0.022 1.3%2.4%

  • : HR+ (%)

    3.02.01.00.03.02.01.00.00123456789 ()

  • 100-, 30% 68 (911 699 ) , , 1.3% 2,4% 5 9 ,

  • HR+ (%)54321001234567895432101.0%1.8%2.5%4.2% ()HR+HR0.6095% CI(0.42, 0.85)p-value0.004 0.8%1.7%

  • HR+ (%)3025201510500123456789 ()HR+HR0.9795% CI(0.86, 1.11)p-value0.70

  • ITT HR+ 72 HR+ , 48% 44% , , ,

  • 50 10 ,

    Hanrahan et al. J Clin Oncol 2007; 25: 4952-60

  • Hanrahan et al. J Clin Oncol 2007; 25: 4952-60101500.00.10.20.30.45 () 50 ER+ER+,

  • HR+ (%)3025201510500123456789302520151050 ()HR+HR0.90

    95% CI(0.75, 1.07)p-value0.20

  • * , 10%, (p=0.2), 90% * ATAC

  • HR+ (%)3025201510500123456789302520151050 ()HR+

    HR1.05

    95% CI(0.87, 1.26)p-value0.60

  • (A T) HR+ : , T: 0.84 (0.70-1.00)0.48 (0.23-1.00)0.68 (0.55-0.84)0.81 (0.66-0.98)0.74 (0.62-0.88)0.71 (0.61-0.83)0.89 (0.70-1.13)0.42 (0.31-0.58)0.87 (0.74-1.02)0.76 (0.63-0.91)0.77 (0.63-0.93)0.76 (0.67-0.87) 0.20.40.60.81.01.21.52.0 (A / T) 95% CI (95% CI)
  • : ER+/PgR- (19% ER+ ) ER+/PgR+ (p
  • - / () 1102 (35.6)394 (12.7)578 (18.7)599 (19.4)1104 (35.7)167 (5.4)110 (3.6)130 (4.2)64 (2.1)87 (2.8)48 (1.6)189 (6.1) 79 (2.5)1263 (40.8)358 (12.4)544 (17.6)555 (17.9)915 (29.6)319 (10.3)409 (13.2)106 (3.4)91 (2.9)141 (4.6)75 (2.4)218 (7.0)22 (0.7)(N = 3092)(N = 3094)

  • : ( ) *

    127811054 (8.25) 123311125 (9.12)9351356 (3.81)9448339 (3.59) 153 (1.20)284 (2.30)49 (0.52)57 (0.60) 4 (0.03)12 (0.10)1 (0.01)12 (0.13) 34 (0.27)33 (0.27)26 (0.28)28 (0.30) 20 (0.16)34 (0.28)22 (0.24)20 (0.21) *375 (2.93)234 (1.90)146 (1.56)143 (1.51)

  • ,

  • ( )* / / / (n = 3092)292 (9.4)12 (0.4)8 (0.3)56 (1.8)42 (1.4)96 (3.1)8 (0.3)12 (0.4)5 (0.2)2 (0.1)17 (0.5)22 (0.7)37 (1.2)(n = 3094)288 (9.3)5 (0.2)6 (0.2)36 (1.2) 24 (0.8)107 (3.5)18 (0.6)26 (0.8)24 (0.8)6 (0.2)15 (0.5)19 (0.6)32 (1.0). (%)*

  • * ,1 , , * * Bonferroni 1Fisher et al. J Natl Cancer Inst 1994; 86: 527-37

  • (ITT )

    . (n = 3125) 629 (20)350 (11)279 (9)67 (2)25 (1)84 (3)103 (3)(n = 3116) 624 (20)382 (12)242 (8)66 (2)29 (1)60 (2)87 (3). (%)

  • 732 911 ( 1183 ) ,

  • ( ) / Colle A N=3092 (%)421 (13.6)49 (1.6)60 (1.9)94 (3.0)270 (8.7)T N=3094 (%)311 (10.1)42 (1.4)37 (1.2)83 (2.7)191 (6.2) Odds ratio*1.41 1.17 1.64 1.14 1.46 A T 95% CI1.21-1.65 0.75-1.82 1.08-2.48 0.84-1.54 1.20-1.77 p-
  • 29842976 :AT28592824274526992640257224962419230622082077200017131645702659 () (%)Tamoxifen (T) Anastrozole (A)012345678902341

  • (IRR=1.03, )IRR: (incidence rate ratio)

  • 100 , : :HR+ : 2.8% 5 4.8% 9 HR = 0.75; p=0.01 : ,

  • : (%)302520151050012345678912.5%17.0%21.8% ()9.7%2.8%4.8% Tamoxifen (T)Anastrozole (A) () (%)Tamoxifen (T)Anastrozole (A) 012345678902341

  • carryover effect 9 ,

    (carryover effects) .

    ATAC (1 mg/) (20 mg/), . ( 33 ), . ATAC. ATAC 100 .

    The ATAC Trialists' Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet 2002;359:2131-9.The ATAC Trialists' Group. Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Lancet Oncol 2006;7:633-43.ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 2005;365:60-2.

    , , . : , , ( , ) , ( ) . , . 14 , ( ). (14 ), ( ) ( ). ATAC. 100 , 40% 30% 68 (911 699 ).

    ATAC , , . , , . , 100 , . 9% (p=0.2), 90% . , . . . ( 72 )

    ATAC , , . , , . , 100 , . 9% (p=0.2), 90% . , . . . ( 72 )

    ATAC , , . , , . , 100 , . 9% (p=0.2), 90% . , . . . ( 72 )

    : - . - , 15% 4.1% , 9 . , 1 , 9 , . (carry-over effect) .* ( )* HR+ , 2.8% 5 4.8% 9 . carry-over effect 5-9, 2/3 . carry-over effect (HR=0.75, 95% CI 0.61-0.94, p=0.01).

    .

    ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 2005;365:60-2.Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998;351:1451-67.Early Breast Cancer Trialists' Collaborative Group. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the