局部晚期直肠癌的手术前治疗
Deborah Schrag1, Qian Shi1, Martin R Weiser1
1From the Departments of Medicine (D.S., L.B.S., E.M.O.), Surgery (M.R.W.), and Radiology (M.J.G.), Memorial Sloan Kettering Cancer Center, and the Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai (K.A.G.) - both in New York; Alliance Statistics and Data Management Center (Q.S., G.D.N., B.C., A.C.D.) and the Department of Oncology (R.R.M.), Mayo Clinic, Rochester, MN; SWOG Cancer Research Network and the Department of Medicine, Baylor College of Medicine (B.L.M.), and the Department of Colon and Rectal Surgery, M.D. Anderson Cancer Center (G.J.C.) - both in Houston; the Departments of Surgery (J.G.) and Radiation Oncology (H.J.M.), Brigham and Women's Hospital, and the Department of Medical Oncology, Dana-Farber Cancer Institute (J.A.M.) - both in Boston; IHA Hematology Oncology, Ypsilanti, MI (T.A.B.); ECOG-ACRIN Cancer Research Network and Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia (J.M.F.); NRG Oncology and the University of Florida Health Cancer Center, Gainesville (T.J.G.); Canadian Cancer Trials Group, Kingston, ON (H.F.K.), and the Department of Medical Oncology and Hematology, CancerCare Manitoba, Winnipeg (V.G.) - both in Canada; Alliance Protocol Office, Chicago (A.S.); the Swiss Group for Clinical Cancer Research, Bern, Switzerland (M.M.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (A.P.V.); and the Department of Medical Oncology and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.).
新辅助性FOLFOX化疗是局部晚期直肠癌的化疗辐射疗法的可行替代方案,证明了非劣质的无疾病生存率. 这一发现为接受结节约手术的患者提供了新的治疗选择.
科学领域:
- 在瘤学瘤学.
- 手术瘤学手术瘤学
- 临床试验 临床试验
背景情况:
- 局部晚期直肠癌的标准治疗包括新辅助化学辐射疗法 (盆腔辐射加上胺化学疗法).
- 作为化疗辐射疗法的替代品,使用甲,莱可沃林和氧沙 (FOLFOX) 的新辅助化疗的疗效仍然不确定.
研究的目的:
- 为了确定新辅助药FOLFOX在局部发达直肠癌患者的无疾病生存中是否与标准化疗无劣.
- 评估二次终点,包括总生存率,局部复发,病理切除和治疗毒性.
主要方法:
- 一个多中心的,未盲目的,非劣势的,随机的试验比较了新辅助药FOLFOX与化疗放射治疗.
- 符合条件的参与者有局部晚期的直肠癌,并且是关节节能手术的候选人.
- 主要终点是无病生存期,非劣势指标以1.29的危险比上限定义.
主要成果:
- 发现FOLFOX在无病生存方面与化疗或放射治疗无差 (危险比:0.92;90.2% CI,0.74至1.14)).
- 五年无病生存率为FOLFOX的80.8%,化学放射治疗的78.6%.
- 在两组治疗中,整体存活率和局部复发率相似.
结论:
- 新辅助药FOLFOX是一种非劣质的替代新辅助化学放射治疗,用于局部晚期的直肠癌,适合进行节性手术的患者.
- 这项研究提供了证据,支持FOLFOX作为一种潜在的毒性较低或更方便的新辅助治疗选择.
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