Emmanouilides Christos, Sfakiotaki Georgia, Androulakis Nikolaos, Kalbakis Kostas, Christophylakis Charalambos, Kalykaki Antonia, Vamvakas Lambros, Kotsakis Athanasios, Agelaki Sofia, Diamandidou Eleni, Touroutoglou Nikolaos, Chatzidakis Adam, Georgoulias Vassilis, Mavroudis Dimitris, Souglakos John
Department of Medical Oncology, Interbalkan Medical Center, Thessaloniki, Greece.
BMC Cancer. 2007 May 30;7:91. doi: 10.1186/1471-2407-7-91.
To evaluate the efficacy and the toxicity of front line FOLFOX4 combined with bevacizumab in patients with metastatsic CRC (mCRC).
Chemotherapy-naïve patients with mCRC, received bevacizumab (5 mg/kg every 2 weeks d1), oxaliplatin (85 mg/m2 on d1), leucovorin (200 mg/m2) on days 1 and 2 and 5-Fluorouracil (400 mg/m2 as i.v. bolus and 600 mg/m2 as 22 h i.v. continuous infusion on days 1 and 2) every 2 weeks.
Fifty three patients (46 with a PS 0-1) were enrolled. Complete and partial response was achieved in eight (15.1%) and 28 (52.8%) patients, respectively (ORR: 67.9%; 95% C.I.: 53.8%-92%); 11 (20.7%) patients had stable disease and six (11.3%) progressive disease. With a median follow up period of 13.5 months, time to tumor progression was 11 months while the median survival has not yet been reached; the probability of 1-, 2- and 3- year survival was 79.8%, 63.8% and 58.3%, respectively; Two patients relapsed during the follow up period. Eight (15%) patients underwent metastasectomy with R0 resections. Grade 3-4 neutropenia occurred in 15.1% of patients and one (1.9%) of them presented febrile neutropenia. Non-hematologic toxicity included grade 3 diarrhea (7.6%) and grade 2 and 3 neurotoxicity in 16.9 and 15.1% of patients, respectively. One (1.9%) patient presented pulmonary embolism and one (1.9%) cardiac ischaemia. There was one (1.9%) sudden death after the first cycle.
The combination of FOLFOX4/bevacizumab appears to be highly effective, well tolerated and merits further evaluation in patients with mCRC.
评估一线FOLFOX4方案联合贝伐单抗治疗转移性结直肠癌（mCRC）患者的疗效和毒性。
初治的mCRC患者接受贝伐单抗（每2周1次，第1天5 mg/kg）、奥沙利铂（第1天85 mg/m²）、亚叶酸钙（第1天和第2天200 mg/m²），以及每2周1次的氟尿嘧啶（第1天和第2天，400 mg/m²静脉推注，600 mg/m²持续静脉输注22小时）。
入组53例患者（46例PS为0 - 1）。分别有8例（占15.1%）和28例（占52.8%）患者达到完全缓解和部分缓解（客观缓解率：67.9%；95%置信区间：53.8% - 92%）；11例（占20.7%）患者疾病稳定，6例（占11.3%）疾病进展。中位随访期为13.5个月，肿瘤进展时间为11个月，中位生存期尚未达到；1年、2年和3年生存率分别为79.8%、63.8%和58.3%；2例患者在随访期内复发。8例（占15%）患者接受了R0切除转移灶切除术。15.1%的患者发生3 - 4级中性粒细胞减少，其中1例（占1.9%）出现发热性中性粒细胞减少。非血液学毒性包括3级腹泻（占7.6%）以及分别占16.9%和15.1%患者的2级和3级神经毒性。1例（占1.9%）患者发生肺栓塞和1例（占1.9%）心脏缺血事件。第1周期后有1例（占1.9%）患者猝死。
FOLFOX4/贝伐单抗联合方案似乎疗效显著、耐受性良好，值得在mCRC患者中进一步评估。
