文献标题：Randomized Phase III Study of Panitumumab With Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Compared With FOLFIRI Alone As Second-Line Treatment in Patients With Metastatic Colorectal Cancer
文献出处：J Clin Oncol 2010 Nov 1
期刊影响因子：17.793
文献类型：Clinical Trial
帕尼单抗是一种全人源抗EGFR单抗，一项新的研究表明：帕尼单抗-FOLFIRI方案能够显著改善化疗耐受的转移性结
该试验旨在根据肿瘤KRAS状况，比较帕尼单抗-FOLFIRI和FOLFIRI方案对初始失败mCRC患者的疗效和安全性。
研究者从2006年6月到2008年3月，将1186例患者按1:1比例随机分组。91%患者检测得到KRAS状况;其中597例(55%)为野生型(WT) KRAS肿瘤，486例(45%)为突变型 (MT) KRAS肿瘤。在WT KRAS亚组中，化疗加入帕尼单抗显著改善PFS(HR = 0.73; 95% CI, 0.59 -0.90; P = .004)。帕尼单抗-FOLFOX4和FOLFOX4方案中位PFS分别为5.9和3.9个月;OS也有改善，但不明显，分别为14.5和12.5 个月(HR = 0.85, 95% CI, 0.70-1.04; P = .12)。化疗加入帕尼单抗有效率从10%提高到35%。MT KRAS患者，化疗加入帕尼单抗疗效无明显改变。除了已知的抗EGFR治疗相关毒性外，两方案不良反应发生率基本相当。
最终，研究者得出结论，帕尼单抗-FOLFIRI方案，用于野生型(WT)KRAS mCRC患者二线治疗效果显著，且患者耐受良好。
医脉通推荐英文摘要
J Clin Oncol 2010 Nov 1
Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer.
Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, André T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E,Tzekova V, Collins S, Oliner KS, Rong A, Gansert J.
Abstract
PURPOSE: Panitumumab is a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS) in chemotherapy-refractory metastatic colorectal cancer (mCRC). This trial evaluated the efficacy and safety of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone after failure of initial treatment for mCRC by tumor KRAS status.
PATIENTS AND METHODS: Patients with mCRC, one prior chemotherapy regimen for mCRC, Eastern Cooperative Oncology Group performance status 0 to 2, and available tumor tissue for biomarker testing were randomly assigned 1:1 to panitumumab 6.0 mg/kg plus FOLFIRI versus FOLFIRI every 2 weeks. The coprimary end points of PFS and overall survival (OS) were independently tested and prospectively analyzed by KRAS status.
RESULTS: From June 2006 to March 2008, 1,186 patients were randomly assigned 1:1 and received treatment. KRAS status was available for 91% of patients: 597 (55%) with wild-type (WT) KRAS tumors, and 486 (45%) with mutant (MT) KRAS tumors. In the WT KRAS subpopulation, when panitumumab was added to chemotherapy, a significant improvement in PFS was observed (hazard ratio [HR] = 0.73; 95% CI, 0.59 to 0.90; P = .004); median PFS was 5.9 months for panitumumab-FOLFIRI versus 3.9 months for FOLFIRI. A nonsignificant trend toward increased OS was observed; median OS was 14.5 months versus 12.5 months, respectively (HR = 0.85, 95% CI, 0.70 to 1.04; P = .12); response rate was improved to 35% versus 10% with the addition of panitumumab. In patients with MT KRAS, there was no difference in efficacy. Adverse event rates were generally comparable across arms with the exception of known toxicities associated with anti-EGFR therapy.
CONCLUSION: Panitumumab plus FOLFIRI significantly improved PFS and is well-tolerated as second-line treatment in patients with WT KRAS mCRC.
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