柳科沃林和甲与或没有氧化作为先进结肠直肠癌的第一线治疗
A de Gramont1, A Figer1, M Seymour1
1From the Service de Médecine Interne-OncologieHôpital Saint-Antoine, Paris; Debiopharm, Charenton; Service d'Oncologie Médicale, Centre Hospitalier Lyon Sud, Pierre-Benite; and Centre Hospitalier René Dubos, Pontoise, France; Institute of Oncology, Belinson Medical Center, Petach Tikva, Israel; Imperial Cancer Research Fund Cancer Medicine Research Unit, University of Leeds; Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen; Department of Medical Oncology, St Bartholomew's Hospital, London; and Addenbrooke's National Health Service Trust, Cambridge, United Kingdom; Servizio di Oncologia Medica, Arcispedale S. Maria Nuova, Reggio Emilia; Instituto Europeo di Oncologia, Milan; and Clinical Oncology Centre, Service d'Oncologie Médicale, Div Oncologia Medica Azienda, Ospedaliera di Verona, Verona, Italy; Servicio de Oncología, the Hospital 12 de Octubre, Madrid; and Servicio de Onco-Hematologia, Hospital Clinico Universitario, Valencia, Spain.
添加oxaliplatin到leucovorin (LV) 加上fluorouracil (5FU) 治疗方案显著改善了晚期结直肠癌患者的无进展生存率. 这种组合疗法显示出更好的反应率,并保持了生活质量,尽管毒性增加.
科学领域:
- 在瘤学瘤学.
- 胃肠道癌症 胃肠道癌症
- 药理疗法 药理疗法 药理疗法
背景情况:
- 之前的研究证实了leucovorin (LV) 加上fluorouracil (5FU) 治疗方案 (LV5FU2) 在晚期结直肠癌中的疗效.
- 之前已经证明,标准的5FU/LV5FU/LV5FU2治疗方案的有效性低于LV5FU2治疗方案.
- 研究新的组合疗法对于改善晚期结直肠癌的治疗结果至关重要.
研究的目的:
- 评估将氧沙与LV5FU2疗法作为先进结直肠癌的第一线治疗方案的疗效和安全性.
- 为了确定氧沙加LV5FU2对无进展生存 (PFS),反应率和整体生存时间的影响.
- 评估与组合疗法相关的耐受性和生活质量 (QoL).
主要方法:
- 一项III期随机对照试验,涉及420名先前未接受治疗的患有可测量的晚期结直肠癌的患者.
- 患者接受LV5FU2单独或LV5FU2与氧沙结合.
- 治疗包括每2周一次的2天疗程,PFS是主要终点.
主要成果:
- 氧沙与LV5FU2组的PFS显着更长 (中位数为9.0个月与6.2个月;P = .0003) 和响应率更高 (50.7%与22.3%;P = .0001).
- 总体生存率的改善没有达到统计学意义 (中位数为16.2个月与14.7个月;P = .12).
- 随着牛氧的使用,观察到毒性增加,包括中性质衰竭和腹,但QoL保持不变,没有疾病进展的生存率得到改善 (P = .004).
结论:
- LV5FU2加氧沙的组合是一种有益的第一线治疗晚期结直肠癌,显著改善PFS.
- 这种疗法提供了可接受的耐受性,并保持了患者的生活质量,尽管某些毒性的发病率较高.
- 与LV5FU2结合的牛津是一种有效的策略,可以在晚期结直肠癌中延长疾病控制.
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