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乳腺癌TKI治疗课件

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    • 1、复旦大学附属肿瘤医院乳腺癌TKI治疗2010ASCO胡夕春内容 Sunitinib in Combination with Docetaxel vs. Docetaxel Alone for the First-line Treatment of Advanced Breast Cancer Phase 3 Trial of Sunitinib in Combination with Capecitabine vs. Capecitabine in Previously Treated Advanced Breast Cancer 多靶点TKI治疗Sunitinib in Combination with Docetaxel vs. Docetaxel Alone for the First-line Treatment of Advanced Breast CancerRationale Sunitinib inhibits multiple RTKs These RTKs may be of importance in the pathogenesis, microvascular

      2、 support, and metastatic progression of BC Sunitinib alone and in combination with docetaxel inhibited tumor growth and increased survival in preclinical BC models1 An exploratory clinical study suggested that sunitinib in combination with docetaxel had promising antitumor activity in patients with HER2- negative ABC (N=22):2 ORR: 74% Duration of response: 7.2 months PFS: 8.7 months1Abrams TJ, et al. Mol Cancer Ther 2003;2:10112Mariani G, et al. J Clin Oncol 2008;26:suppl (abstr 14534)SUN 1064 D

      3、esignStratification 2/2 metastatic sites Estrogen receptor status Disease-free interval /12 months Key eligibility criteria HER2-negative ABC Measurable or bone-only disease Disease-free 12 months after neo/adjuvant taxane No prior chemotherapy for ABCDocetaxel 75 mg/m2 IV day 1 q3w + Sunitinib 37.5 mg po days 215 q3w N=296Docetaxel 100 mg/m2 IV q3wN=2971:1R A N D O M I Z A T I O NTrial funded and conducted by Pfizer Inc.EuropeAsiaPacificNorth AmericaSouth AmericaAfricaUnited KingdomFranceGerman

      4、yItalySpainTurkeyAustraliaKoreaColumbiaArgentinaCanadaSUN 1064 was funded by Pfizer Inc.Editorial support was provided by Wendy Sacks at ACUMED (Tytherington, UK) and funded by Pfizer Inc.593 patients; 127 centers; 27 countriesAustriaBelgiumCzech RepublicFinlandHungaryIrelandNetherlandsPanamaPolandPortugalRomaniaRussian FederationSlovakiaSwedenUkraineUSAEndpoints and Statistical HypothesisPrimary endpoint: PFS Hypothesis: 50% increase in median PFS (from 6 to 9 months) in ITT population (indepen

      5、dent central review), based on 285 events, power of 90%, alpha error 0.025, one sided log-rank testSecondary endpoints PFS (investigator assessment) ORR, duration of response OS SafetyMedian follow-up: 18.0 months (95% CI: 17.618.4)Patient Characteristics (ITT Population) CharacteristicSU + DOC N=296DOC N=297Median age, years (range)54 (3184)56 (2878)ECOG performance status 0/1, %56/4254/46Prior neoadjuvant/adjuvant chemotherapy, %8382Anthracycline7774Taxane1925No prior chemotherapy, %1717Estrog

      6、en receptor-positive, % 7470Triple-negative disease, %20232 metastatic sites, %4748Disease-free interval 12 months, %2828Treatment Administration (AT Population) SU + DOC N=295DOC N=293SUDOCDOCMedian dose per cycle (range)37.5 mg* (2641)73 mg/m2 (3987)96 mg/m2 (65112)Median relative dose intensity, % (range)94 (14142)92 (52108)93 (57112)Median duration of treatment, weeks (range)26 (2329)18 (1721)18 (1619)Cycles started, median (range)8 (132)7 (123)6 (126)AT = as-treated *Median daily doseObject

      7、ive Response in Patients with Measurable DiseaseP=0.001P=0.01655%42%58%Investigator assessmentCentral reviewMedian duration of response (months):706050403020100Objective responses (%)SU + DOC n=269 7.5DOC n=269 7.2SU + DOC n=269 6.9DOC n=269 5.848%CR PRPatients at riskSU + DOC296241162804019820DOC29722496432316622Progression-free Survival(Central Review; ITT Population) SU + DOC N=296DOC N=297 PFS events, n (%)147 (50)109 (37)Median, months8.68.3HR (95% CI)0.92 (0.721.19)0.265P value (1-sided)03

      8、69121518212427Time (months)100806040200PFS probability (%)Overall Survival (ITT Population)SU + DOC N=296DOC N=297 OS events, n (%)107 (36)91 (31) Median, months24.825.5 HR (95% CI)1.21 (0.911.60) P value (1-sided )0.9040369121518212427303336 Time (months)100806040200OS probability (%)Patients at risk SU + DOC296284264235213164955026832DOC2972902692462221731045223610Common All-Causality AEs (AT Population)Patients (%)SU + DOC N=295DOC N=293AEAny gradeGrade 3/4Any gradeGrade 3/4 Neutropenia564649

      9、44 Handfoot syndrome4117*91 Fatigue4312348 Diarrhea6010384Asthenia339307Stomatitis325261 Decreased appetite324241 Hypertension12210Nausea401392Dysgeusia302 metastatic sitesTriple-negative disease vs. all others 1/1 prior chemotherapy regimen 1:1R A N D O M I Z A T I O NCAP 2,500 mg/m2 po days 114 q3wN=221SU 37.5 mg po CDD + CAP 2,000 mg/m2 po days 114 q3wN=221Optional “crossover“ to SU 37.5 mg po CDDDisease progressionTrial funded and conducted by Pfizer Inc.RomaniaEuropeAsiaPacificNorth AmericaSouth AmericaAfricaUnited KingdomFranceGermanyItalySpainCanadaSUN 1099 was funded by Pfizer Inc.Editorial support was provided by Wendy Sacks at ACUMED (Tytherington, UK) and funded by Pfizer Inc.AustriaBelgiumCzech RepublicIrelandNetherlandsPolandRussian FederationUSAGreeceDenmarkNorwayEndpoints and Statistical HypothesisPrimary endpoint: PFS Hypothesis: 50% increase in median PFS (f

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