乳腺癌TKI治疗课件
42页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
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