Sravnenie terapii paklitakselom i bevatsizumabom i monoterapii paklitakselom u patsientok s metastaticheskim rakom molochnoy zhelezy

  • Authors: Miller K.1,2,3,4,5,6,7,8,9, Wang M.1,2,3,4,5,6,7,8,9, Gralow J.1,2,3,4,5,6,7,8,9, Dickler M.1,2,3,4,5,6,7,8,9, Cobleigh M.1,2,3,4,5,6,7,8,9, Perez E.A1,2,3,4,5,6,7,8,9, Shenkier T.1,2,3,4,5,6,7,8,9, Davidson N.E1,2,3,4,5,6,7,8,9
  • Affiliations:
    1. Indiana University Cancer Center
    2. Dana-Farber Cancer Institute
    3. Puget Sound Oncology Consortium
    4. Memorial Sloan-Kettering Cancer Center
    5. Rush-Presbyterian-St. Luke's Medical Center
    6. Mayo Clinic
    7. British Columbia Cancer Agency-Vancouver Cancer Center
    8. Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University
    9. Johns Hopkins Kimmel Comprehensive Cancer Center
  • Issue: No 2S (2008)
  • Pages: 60-68
  • Section: Articles
  • URL: https://journals.eco-vector.com/2073-4034/article/view/275777
  • ID: 275777

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Abstract

В открытом рандомизированном исследовании III фазы сравнивались эффективность и безопасность терапии паклитакселом с аналогичными показателями при применении паклитаксела и бевацизумаба (Авастина) - моноклонального антитела к фактору роста эндотелия сосудов, в качестве 1-й линии терапии метастатического рака молочной железы (РМЖ). После рандомизации пациенткам назначался паклитаксел в дозе 90 мг/м 2 в 1-й, 8-й и 15-й дни каждые 4 недели либо в виде монотерапии, либо в сочетании с бевацизумабом в дозе 10 мг/кг в 1-й и 15-й дни. Главным критерием эффективности терапии была выживаемость без прогрессирования заболевания, общая выживаемость была дополнительным критерием эффективности. С декабря 2001 по май 2004 г. в исследование были включены в общей сложности 722 пациентки. Бевацизумаб в сочетании с паклитакселом значительно увеличивал выживаемость без прогрессирования заболевания по сравнению с паклитакселом в монотерапии (медиана -11,8 и 5,9 месяца соответственно; относительный риск (ОР) прогрессирования - 0,6; р < 0,001) и повышал частоту объективного ответа (36,9 и 21,2 % соответственно; р<0,001). Тем не менее уровень общей выживаемости был практически одинаковым в обеих группах (медиана - 26,7 и 25,2 месяца соответственно; ОР - 0,88; р = 0,16). У пациенток, получавших паклитаксел в сочетании с бевацизумабом, чаще отмечались: артериальная гипертензия III или IV степени (14,8 по сравнению с 0,0 %, р < 0,001), протеинурия (3,6 по сравнению с 0,0 %, р < 0,001), головная боль (2,2 по сравнению с 0,0 %, р = 0,008) и цереброваскулярная ишемия (1,9 по сравнению с 0,0 %, р = 0,02). У пациенток, получавших паклитаксел и бевацизумаб, чаще встречались инфекции (9,3 по сравнению с 2,9 %, р < 0,001), хотя фебрильная нейтропения отмечалась редко (менее 1 % общего числа). Результаты исследования показали, что применение паклитаксела и бевацизумаба в 1-й линии терапии метастатического РМЖ позволяет увеличить выживаемость без прогрессирования заболевания по сравнению с монотерапией паклитакселом. (Идентификационный номер исследования на ClinicalTrials.gov: NCT00028990.)

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About the authors

K. Miller

Indiana University Cancer Center; Dana-Farber Cancer Institute; Puget Sound Oncology Consortium; Memorial Sloan-Kettering Cancer Center; Rush-Presbyterian-St. Luke's Medical Center; Mayo Clinic; British Columbia Cancer Agency-Vancouver Cancer Center; Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Johns Hopkins Kimmel Comprehensive Cancer Center

M. Wang

Indiana University Cancer Center; Dana-Farber Cancer Institute; Puget Sound Oncology Consortium; Memorial Sloan-Kettering Cancer Center; Rush-Presbyterian-St. Luke's Medical Center; Mayo Clinic; British Columbia Cancer Agency-Vancouver Cancer Center; Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Johns Hopkins Kimmel Comprehensive Cancer Center

J. Gralow

Indiana University Cancer Center; Dana-Farber Cancer Institute; Puget Sound Oncology Consortium; Memorial Sloan-Kettering Cancer Center; Rush-Presbyterian-St. Luke's Medical Center; Mayo Clinic; British Columbia Cancer Agency-Vancouver Cancer Center; Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Johns Hopkins Kimmel Comprehensive Cancer Center

M. Dickler

Indiana University Cancer Center; Dana-Farber Cancer Institute; Puget Sound Oncology Consortium; Memorial Sloan-Kettering Cancer Center; Rush-Presbyterian-St. Luke's Medical Center; Mayo Clinic; British Columbia Cancer Agency-Vancouver Cancer Center; Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Johns Hopkins Kimmel Comprehensive Cancer Center

M. Cobleigh

Indiana University Cancer Center; Dana-Farber Cancer Institute; Puget Sound Oncology Consortium; Memorial Sloan-Kettering Cancer Center; Rush-Presbyterian-St. Luke's Medical Center; Mayo Clinic; British Columbia Cancer Agency-Vancouver Cancer Center; Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Johns Hopkins Kimmel Comprehensive Cancer Center

E. A Perez

Indiana University Cancer Center; Dana-Farber Cancer Institute; Puget Sound Oncology Consortium; Memorial Sloan-Kettering Cancer Center; Rush-Presbyterian-St. Luke's Medical Center; Mayo Clinic; British Columbia Cancer Agency-Vancouver Cancer Center; Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Johns Hopkins Kimmel Comprehensive Cancer Center

T. Shenkier

Indiana University Cancer Center; Dana-Farber Cancer Institute; Puget Sound Oncology Consortium; Memorial Sloan-Kettering Cancer Center; Rush-Presbyterian-St. Luke's Medical Center; Mayo Clinic; British Columbia Cancer Agency-Vancouver Cancer Center; Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Johns Hopkins Kimmel Comprehensive Cancer Center

N. E Davidson

Indiana University Cancer Center; Dana-Farber Cancer Institute; Puget Sound Oncology Consortium; Memorial Sloan-Kettering Cancer Center; Rush-Presbyterian-St. Luke's Medical Center; Mayo Clinic; British Columbia Cancer Agency-Vancouver Cancer Center; Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Johns Hopkins Kimmel Comprehensive Cancer Center

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