76例结直肠癌患者根治术后 FOLFOX4方案辅助化疗的临床观察

目的：观察结直肠癌(CRC)根治术后患者12周期奥沙利铂(OXA)、亚叶酸钙(CF)、5-氟尿嘧啶(5-FU) FOLFOX4方案辅助化疗的完成情况,分析未完成的原因,为探索适合我国 CRC 患者的化疗剂量和化疗周期数提供依据。方法76例根治术后病理确诊为 CRC 的患者行 FOLFOX4方案辅助化疗,参见美国国立癌症研究所常见毒性反应标准3.0版本(NCI-CTCAE,v3.0)标准对化疗期间的不良反应进行分级,总结未完成化疗的原因,化疗结束后定期随访,观察无瘤生存期和复发转移发生情况。结果76例患者中10例(13.2%)未经减量完成了标准12周期FOLFOX4方案辅助化疗,全组中位化疗周期时间为7(1~12)周期,需要减量的比例31.6%(24/76),剂量调整中位周期时间为第4(2~10)周期,中止化疗的原因主要有患者依从性(30/66,45.5%)、不良反应(26/66,39.4%)等。治疗过程中的不良反应包括3~4度骨髓抑制(48/76,63.2%)、1~2度肝脏毒性(55/76,72.4%)、1~2级胃肠道反应(41/76,53.9%)、周围神经毒性(15/76,19.7%)、OXA 过敏反应(9/76,11.8%)。随访期间死亡3例,14例患者发生复发和(或)转移,其中复发4例,转移13例,3例同时复发和转移,中位复发或转移时间分别为14.0(13.8~20.5)、15.5(7.0~33.9)个月。全组患者中位无瘤生存期25.6(7.0~47.8)个月。结论 CRC 患者根治术后 FOLFOX4方案化疗可降低复发转移率,本组患者标准12周期方案完成率低,化疗期间不良事件发生率较高,需要探索适合中国人的化疗剂量和化疗周期数。

Clinical observation of FOLFOX4 for postoperative adjuvant chemotherapy on 76 patients with colorectal cancer

Objective To investigate the completion rate of 12 cycles of postoperative adjuvant chemotherapy with FOLFOX4 for colorectal cancer（CRC）patients,analyze the reasons of incompletion,and provide a basis for the suitable chemotherapy dose and cycle numbers of Chinese CRC patients.Methods Seventy-six patients who underwent radical resection and pathological diagnoses were confirmed as CRC,received postoperative chemotherapy with FOLFOX4.Adverse events were recorded during chemotherapy by NCI-CTCAE,v3.0 standard.We summarized the reasons of incompletion and observed disease-free survival time and metastasis or recurrence occurrence.Results Ten of the 76 patients （13.2% ） completed the standard 12 cycles adjuvant chemotherapy with FOLFOX4 but dose reduction.The median number of chemotherapy cycles was 7 （1-12 ）cycles,and about 31.6% （24/76 ）needed dose reduction and the median number of cycles to adjust the dose was 4 （2-10）cycles.The main reasons for suspension of chemotherapy included patient compliance （30/66,45.5%）,chemotherapy toxicity （26/66,39.4%）and so on.The main adverse reaction included myelosuppression at grades 3 to 4 （48/76,63.2%）,1 to 2 degrees of liver toxicity （55/76,72.4%）,grade 1 to 2 gastrointestinal reactions （41/76,53.9%）,peripheral neurotoxicity （15/76,19.7%）and austria platinum allergic reactions （9/76,1 1.8%）.During the follow-up,3 patients died and 14 patients developed recurrence and/or metastasis,of which 4 cases were recurrence,13 cases metastasis,and 3 cases recurrence and metastasis at the same time.The median time of recurrence or metastasis was 14.0 （13.8-20.5 ）,1 5.5 （7.0-33.9 ） months,respectively.The median time of disease-free survival was 25.6（7.0-47.8）months.Conclusion Postoperative adjuvant chemotherapy with FOLFOX4 in CRC patients can reduce the recurrence and metastasis rate.The completion rate of a standard 12-cycle program was low in this group,and a higher incidence of adverse events was observed during chemotherapy