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JNCI:5-FU联合奥沙利铂化疗能延长结肠癌患者生存期

  1. 5-FU
  2. 奥沙利铂
  3. 生存期
  4. 结肠癌

来源:生物谷 2012-11-18 23:12

在世界范围内,据统计结肠癌不管是发病率还是死亡率都是排名较前的肿瘤类型之一。在2011年,仅美国一国就有约101,340人被确诊患有结肠癌,并且其中大约三分之一的患者被诊断为III期晚期或是有淋巴结转移现象。

在世界范围内,据统计结肠癌不管是发病率还是死亡率都是排名较前的肿瘤类型之一。在2011年,仅美国一国就有约101,340人被确诊患有结肠癌,并且其中大约三分之一的患者被诊断为III期晚期或是有淋巴结转移现象。

最近一项发表于JNCI J Natl Cancer Inst的研究证实:临床上诊断为III期的结肠癌患者在接受5-氟尿嘧啶(5-FU)常规治疗的过程中再增加奥沙利铂(oxaliplatin)进行辅助治疗的话,患者生存率会有明显改善。

为延长III期结肠癌患者的生存率,研究人员在随机临床试验中将5-氟尿嘧啶联合运用奥沙利铂对患者进行治疗,但这种联合治疗所带来的患者生存期的改善效果仅仅只在随机临床研究中观察到。并且遗憾的是研究过程中临床患者数量只纳入了不到2%的结肠癌病例,纳入研究的临床病例对象与整个结肠癌患者人群相比,年龄普遍偏小、体质上更健康、种族间差异更小,这些因素都大大影响了研究结果的可靠性。

同时,该项研究的主要负责人维吉尼亚大学医学院的肿瘤学副教授--Hanna K. Sanoff博士等相关工作人员通过收集Medicare claims (SEER-Medicare)和其它肿瘤数据库中的监测数据、流行病学资料及最终结局,期望能够明确5-氟尿嘧啶联合奥沙利铂治疗III期结肠癌患者的确切效果。

在这项研究中,研究人员对结肠癌患者接受手术治疗后120天内,所有年龄在75岁及以下的III期结肠癌患者给予5-氟尿嘧啶联合奥沙利铂化疗,然后比较常规化疗方案与联合化疗方案对患者总体生存率的影响。结果发现5-氟尿嘧啶联合奥沙利铂化疗对III期结肠癌患者生存期的改善与随机临床研究中所得的结论是一致的,即联合化疗方案对结肠癌患者生存期的改善比常规化疗方案更显著。

研究者指出,联合用药与年龄在75岁以下确诊得结肠癌的患者生存率的延长有着密切联系,因此人们应该相信5-氟尿嘧啶联合奥沙利铂治疗结肠癌患者是一种更加有效的治疗方案。科研人员表示,由于5-氟尿嘧啶联合奥沙利铂治疗已被证明对一般结肠癌患者是有效的,接下来的研究是要重点考察5-氟尿嘧啶联合奥沙利铂治疗对结肠癌高危患者(如年龄在75以上人群或是有癌症并发症人群)的治疗效果。(生物谷 Bioon.com)

Comparative Effectiveness of Oxaliplatin vs Non–Oxaliplatin-containing Adjuvant Chemotherapy for Stage III Colon Cancer

Hanna K. Sanoff, William R. Carpenter, Christopher F. Martin, Daniel J. Sargent, Jeffrey A. Meyerhardt, Til Stürmer, et al.

Background The addition of oxaliplatin to adjuvant 5-fluorouracil (5-FU) improves survival of patients with stage III colon cancer in randomized clinical trials (RCTs). However, RCT participants are younger, healthier, and less racially diverse than the general cancer population. Thus, the benefit of oxaliplatin outside RCTs is uncertain.

Subjects and Methods Patients younger than 75 years with stage III colon cancer who received chemotherapy within 120 days of surgical resection were identified from five observational data sources—the Surveillance, Epidemiology, and End Results registry linked to Medicare claims (SEER–Medicare), the New York State Cancer Registry (NYSCR) linked to Medicaid and Medicare claims, the National Comprehensive Cancer Network (NCCN) Outcomes Database, and the Cancer Care Outcomes Research & Surveillance Consortium (CanCORS). Overall survival (OS) was compared among patients treated with oxaliplatin vs non–oxaliplatin-containing adjuvant chemotherapy. Overall survival for 4060 patients diagnosed during 2004–2009 was compared with pooled data from five RCTs (the Adjuvant Colon Cancer ENdpoinTs [ACCENT] group, n = 8292). Datasets were juxtaposed but not combined using Kaplan–Meier curves. Covariate and propensity score adjusted proportional hazards models were used to calculate adjusted survival hazard ratios (HR). Stratified analyses examined effect modifiers. All statistical tests were two-sided.

Results The survival advantage associated with the addition of oxaliplatin to adjuvant 5-FU was evident across diverse practice settings (3-year OS: RCTs, 86% [n = 1273]; SEER–Medicare, 80% [n = 1152]; CanCORS, 88% [n = 129]; NYSCR–Medicaid, 82% [n = 54]; NYSCR–Medicare, 79% [n = 180]; and NCCN, 86% [n = 438]). A statistically significant improvement in 3-year overall survival was seen in the largest cohort, SEER–Medicare, and in the NYSCR–Medicare cohort (non–oxaliplatin-containing vs oxaliplatin-containing adjuvant therapy, adjusted HR of death: pooled RCTs: HR = 0.80, 95% CI = 0.70 to 0.92, P = .002; SEER–Medicare: HR = 0.70, 95% CI = 0.60 to 0.82, P < .001; NYSCR–Medicare patients aged ≥65 years: HR = 0.58, 95% CI = 0.38 to 0.90, P = .02). The association between oxaliplatin treatment and better survival was maintained in older and minority group patients, as well as those with higher comorbidity.

Conclusion The addition of oxaliplatin to 5-FU appears to be associated with better survival among patients receiving adjuvant colon cancer treatment in the community.

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