在世界范圍內(nèi)，據(jù)統(tǒng)計(jì)結(jié)腸癌不管是發(fā)病率還是死亡率都是排名較前的腫瘤類型之一,。在2011年,，僅美國一國就有約101,340人被確診患有結(jié)腸癌，并且其中大約三分之一的患者被診斷為III期晚期或是有淋巴結(jié)轉(zhuǎn)移現(xiàn)象,。
最近一項(xiàng)發(fā)表于JNCI J Natl Cancer Inst的研究證實(shí)：臨床上診斷為III期的結(jié)腸癌患者在接受5-氟尿嘧啶(5-FU)常規(guī)治療的過程中再增加奧沙利鉑（oxaliplatin）進(jìn)行輔助治療的話,，患者生存率會(huì)有明顯改善。
為延長III期結(jié)腸癌患者的生存率,，研究人員在隨機(jī)臨床試驗(yàn)中將5-氟尿嘧啶聯(lián)合運(yùn)用奧沙利鉑對(duì)患者進(jìn)行治療,，但這種聯(lián)合治療所帶來的患者生存期的改善效果僅僅只在隨機(jī)臨床研究中觀察到。并且遺憾的是研究過程中臨床患者數(shù)量只納入了不到2%的結(jié)腸癌病例,，納入研究的臨床病例對(duì)象與整個(gè)結(jié)腸癌患者人群相比,，年齡普遍偏小、體質(zhì)上更健康,、種族間差異更小,，這些因素都大大影響了研究結(jié)果的可靠性。
同時(shí),，該項(xiàng)研究的主要負(fù)責(zé)人維吉尼亞大學(xué)醫(yī)學(xué)院的腫瘤學(xué)副教授--Hanna K. Sanoff博士等相關(guān)工作人員通過收集Medicare claims (SEER-Medicare)和其它腫瘤數(shù)據(jù)庫中的監(jiān)測數(shù)據(jù),、流行病學(xué)資料及最終結(jié)局,，期望能夠明確5-氟尿嘧啶聯(lián)合奧沙利鉑治療III期結(jié)腸癌患者的確切效果。
在這項(xiàng)研究中,，研究人員對(duì)結(jié)腸癌患者接受手術(shù)治療后120天內(nèi),，所有年齡在75歲及以下的III期結(jié)腸癌患者給予5-氟尿嘧啶聯(lián)合奧沙利鉑化療，然后比較常規(guī)化療方案與聯(lián)合化療方案對(duì)患者總體生存率的影響,。結(jié)果發(fā)現(xiàn)5-氟尿嘧啶聯(lián)合奧沙利鉑化療對(duì)III期結(jié)腸癌患者生存期的改善與隨機(jī)臨床研究中所得的結(jié)論是一致的,，即聯(lián)合化療方案對(duì)結(jié)腸癌患者生存期的改善比常規(guī)化療方案更顯著。
研究者指出,，聯(lián)合用藥與年齡在75歲以下確診得結(jié)腸癌的患者生存率的延長有著密切聯(lián)系,，因此人們應(yīng)該相信5-氟尿嘧啶聯(lián)合奧沙利鉑治療結(jié)腸癌患者是一種更加有效的治療方案?？蒲腥藛T表示,，由于5-氟尿嘧啶聯(lián)合奧沙利鉑治療已被證明對(duì)一般結(jié)腸癌患者是有效的，接下來的研究是要重點(diǎn)考察5-氟尿嘧啶聯(lián)合奧沙利鉑治療對(duì)結(jié)腸癌高?；颊撸ㄈ缒挲g在75以上人群或是有癌癥并發(fā)癥人群）的治療效果,。(生物谷 Bioon.com)
doi:10.1093/jnci/djr524
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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.
