Department of Medical Oncology, Georges Francois Leclerc Cancer Center, 1 rue du professeur Marion, Dijon 21000, France.
Invest New Drugs. 2012 Apr;30(2):758-64. doi: 10.1007/s10637-010-9575-3. Epub 2010 Nov 6.
The optimal chemotherapeutic regimen suitable for metastatic colorectal cancer (mCRC) patients previously treated with 5-fluorouracil (5FU), oxaliplatin, irinotecan and biotherapies remains an unresolved issue. The aim of this study was to evaluate the activity of bevacizumab combined with FOLFIRI-3 in mCRC after failure of prior chemotherapy including fluoropyrimidine, irinotecan and oxaliplatin.
Patients were treated with bevacizumab in combination with FOLFIRI-3 every 14 days. The association between treatment efficacy and visceral fat area as measured by CT scan or Carcinoembryonic Antigen (CEA) change after 2 months was also studied.
Forty-nine consecutive patients were treated. Four hundred and twenty four cycles of chemotherapy were delivered. Median follow-up was 11 months. Eleven patients (22.4%) had an objective partial response and 26 (53.1%) were stabilized. Median progression-free survival (PFS) and overall survival (OS) were 7 and 13 months respectively. Four grade 4 adverse events occurred (1 digestive perforation, 1 rectal ulcer, 1 pulmonary embolism, and 1 febrile aplasia) but no toxic death was observed. Grade 3 adverse events occurred in 18 patients (38%) including asthenia in 15 patients (30%), nausea and vomiting in 4 patients (8%), diarrhea in 11 patients (22%), anemia in 4 patients (8%), neutropenia in 10 patients (20%) and thrombopenia in 4 patients (8%). Visceral Fat area was significantly lower in responder patients. CEA change at 2 months predicted improved overall survival.
This study suggests that bevacizumab combined with FOLFIRI3 may be active in mCRC patients after failure of all classical lines of chemotherapy.
对于先前接受过氟尿嘧啶(5FU)、奥沙利铂、伊立替康和生物治疗的转移性结直肠癌(mCRC)患者,合适的化疗方案仍然是一个未解决的问题。本研究旨在评估贝伐珠单抗联合 FOLFIRI-3 在先前接受氟嘧啶、伊立替康和奥沙利铂化疗失败后的 mCRC 患者中的疗效。
患者接受贝伐珠单抗联合 FOLFIRI-3 每 14 天治疗一次。还研究了 CT 扫描或 2 个月后癌胚抗原(CEA)变化测量的内脏脂肪面积与治疗效果之间的关联。
连续治疗了 49 例患者。共给予 424 个周期的化疗。中位随访时间为 11 个月。11 例(22.4%)患者有客观部分缓解,26 例(53.1%)患者病情稳定。中位无进展生存期(PFS)和总生存期(OS)分别为 7 个月和 13 个月。发生 4 例 4 级不良事件(1 例消化道穿孔,1 例直肠溃疡,1 例肺栓塞,1 例发热性再生障碍性贫血),但无毒性死亡。18 例(38%)患者发生 3 级不良事件,包括 15 例(30%)乏力,4 例(8%)恶心呕吐,11 例(22%)腹泻,4 例(8%)贫血,10 例(20%)中性粒细胞减少症和 4 例(8%)血小板减少症。在有反应的患者中,内脏脂肪面积明显降低。2 个月时 CEA 的变化预测总生存期的改善。
本研究表明,贝伐珠单抗联合 FOLFIRI3 可能对所有经典化疗方案失败后的 mCRC 患者有效。