CAJ | 학술논문

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。
목적：관찰결직장암(CRC)근치술후환자12주기오사리박(OXA)、아협산개(CF)、5-불뇨밀정(5-FU) FOLFOX4방안보조화료적완성정황,분석미완성적원인,위탐색괄합아국 CRC 환자적화료제량화화료주기수제공의거。방법76례근치술후병리학진위 CRC 적환자행 FOLFOX4방안보조화료,삼견미국국립암증연구소상견독성반응표준3.0판본(NCI-CTCAE,v3.0)표준대화료기간적불량반응진행분급,총결미완성화료적원인,화료결속후정기수방,관찰무류생존기화복발전이발생정황。결과76례환자중10례(13.2%)미경감량완성료표준12주기FOLFOX4방안보조화료,전조중위화료주기시간위7(1~12)주기,수요감량적비례31.6%(24/76),제량조정중위주기시간위제4(2~10)주기,중지화료적원인주요유환자의종성(30/66,45.5%)、불량반응(26/66,39.4%)등。치료과정중적불량반응포괄3~4도골수억제(48/76,63.2%)、1~2도간장독성(55/76,72.4%)、1~2급위장도반응(41/76,53.9%)、주위신경독성(15/76,19.7%)、OXA 과민반응(9/76,11.8%)。수방기간사망3례,14례환자발생복발화(혹)전이,기중복발4례,전이13례,3례동시복발화전이,중위복발혹전이시간분별위14.0(13.8~20.5)、15.5(7.0~33.9)개월。전조환자중위무류생존기25.6(7.0~47.8)개월。결론 CRC 환자근치술후 FOLFOX4방안화료가강저복발전이솔,본조환자표준12주기방안완성솔저,화료기간불량사건발생솔교고,수요탐색괄합중국인적화료제량화화료주기수。
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 (1 5/76,1 9.7%)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,so the dose and the number of chemotherapy cycles need further study to suit for Chinese CRC patients.