4月2日，在線發(fā)表在Journal of Clinical Oncology雜志上的一項多中心研究表明,，將西妥昔單抗添加到新輔助化療和放療中,，可提高高風(fēng)險直腸癌切除術(shù)后的總體存活率。但是,，沒有提高完全緩解率,。
雖然結(jié)果證實了新輔助化療在治療高風(fēng)險局部直腸癌的療效，但是作者說到，我們目前不推薦西妥昔單抗在該類病人中的常規(guī)應(yīng)用,。
David Cunningham博士指出,，西妥昔單抗是一種有效的放射增敏劑，之前他們曾進行的II期試驗表明,，對于預(yù)后差的直腸癌患者在化療和全直腸系膜切除之前實行奧沙利鉑和卡倍他濱（CAPOX）新輔助化療的可行性,。
在目前的研究中，他們調(diào)查了每周加入西妥昔單抗到CAPOX療程中的療效,，他們的分析集中在90個具有KRAS/BRAF野生型直腸癌的病人,，這類病人對抗EGFR治療易感。
主要終點是完全緩解率,，加不加西妥昔單抗沒有造成統(tǒng)計學(xué)差異,，無進展生存率在兩組中也類似。
西妥昔單抗確實提高了某些次要指標,，兩組的放射反應(yīng)率新輔助化療后分別為71% vs 51%（p=0.038）,，術(shù)前放化療后分別為93% vs 75%（p=0.028）。此外,，西妥昔單抗可帶來更好的總體生存率,。
他們得出結(jié)論，在這些成果的基礎(chǔ)上,，有足夠的數(shù)據(jù)表明西妥昔單抗有一定的生物學(xué)活性,，聯(lián)合其他化療方案的進一步評估可能會產(chǎn)生更可喜的成果。（生物谷Bioon.com）
doi:10.1200/JCO.2011.39.6036
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Multicenter Randomized Phase II Clinical Trial Comparing Neoadjuvant Oxaliplatin, Capecitabine, and Preoperative Radiotherapy With or Without Cetuximab Followed by Total Mesorectal Excision in Patients With High-Risk Rectal Cancer (EXPERT-C)
Alice Dewdney, David Cunningham?, Josep Tabernero, Jaume Capdevila, Bengt Glimelius, Andres Cervantes, Diana Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez de Castro, Yu Jo Chua, Rachel Wong, Yolanda Barbachano, Jacqueline Oates and Ian Chau
Purpose To evaluate the addition of cetuximab to neoadjuvant chemotherapy before chemoradiotherapy in high-risk rectal cancer.
Patients and Methods Patients with operable magnetic resonance imaging–defined high-risk rectal cancer received four cycles of capecitabine/oxaliplatin (CAPOX) followed by capecitabine chemoradiotherapy, surgery, and adjuvant CAPOX (four cycles) or the same regimen plus weekly cetuximab (CAPOX+C). The primary end point was complete response (CR; pathologic CR or, in patients not undergoing surgery, radiologic CR) in patients with KRAS/BRAF wild-type tumors. Secondary end points were radiologic response (RR), progression-free survival (PFS), overall survival (OS), and safety in the wild-type and overall populations and a molecular biomarker analysis.
Results One hundred sixty-five eligible patients were randomly assigned. Ninety (60%) of 149 assessable tumors were KRAS or BRAF wild type (CAPOX, n = 44; CAPOX+C, n = 46), and in these patients, the addition of cetuximab did not improve the primary end point of CR (9% v 11%, respectively; P = 1.0; odds ratio, 1.22) or PFS (hazard ratio [HR], 0.65; P = .363). Cetuximab significantly improved RR (CAPOX v CAPOX+C: after chemotherapy, 51% v 71%, respectively; P = .038; after chemoradiation, 75% v 93%, respectively; P = .028) and OS (HR, 0.27; P = .034). Skin toxicity and diarrhea were more frequent in the CAPOX+C arm.
Conclusion Cetuximab led to a significant increase in RR and OS in patients with KRAS/BRAF wild-type rectal cancer, but the primary end point of improved CR was not met.
