From the University of Pennsylvania; Fox Chase Cancer Center; Thomas Jefferson University, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA; Mayo Clinic, Rochester, MN; Mount Sinai Medical Center, Miami, FL; and Northwestern University, Chicago, IL.
J Clin Oncol. 2023 Jul 20;41(21):3670-3675. doi: 10.1200/JCO.22.02761.
Colorectal cancer is the second leading cause of cancer mortality in the United States. Antiangiogenic therapy with bevacizumab combined with chemotherapy improves survival in previously untreated metastatic colorectal cancer. This study was conducted to determine the effect of bevacizumab (at 10 mg/kg) on survival duration for oxaliplatin-based chemotherapy in patients with previously treated metastatic colorectal cancer.
Eight hundred twenty-nine metastatic colorectal cancer patients previously treated with a fluoropyrimidine and irinotecan were randomly assigned to one of three treatment groups: oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) with bevacizumab; FOLFOX4 without bevacizumab; or bevacizumab alone. The primary end point was overall survival, with additional determinations of progression-free survival, response, and toxicity.
The median duration of survival for the group treated with FOLFOX4 and bevacizumab was 12.9 months compared with 10.8 months for the group treated with FOLFOX4 alone (corresponding hazard ratio for death = 0.75; = .0011), and 10.2 months for those treated with bevacizumab alone. The median progression-free survival for the group treated with FOLFOX4 in combination with bevacizumab was 7.3 months, compared with 4.7 months for the group treated with FOLFOX4 alone (corresponding hazard ratio for progression = 0.61; < .0001), and 2.7 months for those treated with bevacizumab alone. The corresponding overall response rates were 22.7%, 8.6%, and 3.3%, respectively ( < .0001 for FOLFOX4 with bevacizumab FOLFOX4 comparison). Bevacizumab was associated with hypertension, bleeding, and vomiting.
The addition of bevacizumab to oxaliplatin, fluorouracil, and leucovorin improves survival duration for patients with previously treated metastatic colorectal cancer.
结直肠癌是美国癌症死亡的第二大主要原因。贝伐单抗联合化疗的抗血管生成治疗可改善未经治疗的转移性结直肠癌患者的生存。本研究旨在确定贝伐单抗（10mg/kg）对既往接受过治疗的转移性结直肠癌患者基于奥沙利铂的化疗的生存时间的影响。
829 名既往接受氟嘧啶和伊立替康治疗的转移性结直肠癌患者被随机分为三组：贝伐单抗联合奥沙利铂、氟尿嘧啶和亚叶酸（FOLFOX4）；FOLFOX4 联合贝伐单抗；或单独使用贝伐单抗。主要终点是总生存，另外还确定了无进展生存、反应和毒性。
FOLFOX4 联合贝伐单抗组的中位生存时间为 12.9 个月，而 FOLFOX4 单独治疗组为 10.8 个月（死亡风险比为 0.75； =.0011），单独使用贝伐单抗组为 10.2 个月。FOLFOX4 联合贝伐单抗组的中位无进展生存期为 7.3 个月，而 FOLFOX4 单独治疗组为 4.7 个月（进展风险比为 0.61； <.0001），单独使用贝伐单抗组为 2.7 个月。相应的总反应率分别为 22.7%、8.6%和 3.3%（FOLFOX4 联合贝伐单抗与 FOLFOX4 比较， <.0001）。贝伐单抗与高血压、出血和呕吐有关。
贝伐单抗联合奥沙利铂、氟尿嘧啶和亚叶酸可延长既往接受过治疗的转移性结直肠癌患者的生存时间。
