Ⅳ期不可切除性直肠癌联合化疗后卡培他滨维持治疗的临床价值

Clinical value of capecitabine maintenance therapy after first-line combination chemotherapy in patients with unresectable stage Ⅳ rectal cancer

目的:研究Ⅳ期不可切除性直肠癌患者经联合化疗后继续行卡培他滨维持化疗,观察其有效性及安全性.方法:回顾性分析2011-06/2014-06吉安市中心人民医院收治的53例Ⅳ期不可切除性晚期直肠癌给予常规联合化疗(FOLFOX或FOLFIRI q2W方案×12周期),使肿瘤缩小,然后采用随机数字表法分组:A组(n=28)卡培他滨维持组(卡培他滨片1000 mg/m2,口服bid,d1-14,q3w),B组(n=25)对照组(未接受维持治疗).比较两组无进展生存期(progression free survival,PFS)以及A组维持化疗前后临床不良反应发生率.结果:28例卡培他滨维持治疗组患者中位PFS为11.6 mo±0.79 mo,95%CI:10.04-13.16,治疗有效率(response rate,RR)为39.2%.25例对照组患者中位无疾病进展时间为6.5 mo±1.08 mo,95%CI:4.38-8.62,RR=32%.A、B组RR间无统计学差异(P>0.05),但中位PFS疗效有统计学差异(P<0.05).联合化疗时的所有不良反应在进入维持治疗组或观察组后都有明显减少或减轻(P<0.05),而维持治疗组和对照组间除手足综合征及色素沉着外,余不良反应无统计学差异(P>0.05).结论:Ⅳ期不可切除性晚期直肠癌患者在联合方案化疗后卡培他滨单药维持治疗可获得较长的PFS,并且耐受性好,不良反应轻,值得临床推广.

AIM： To investigate the efficacy and safety of capecitabine maintenance therapy after first-line combination chemotherapy in patients with unresectable stage Ⅳ rectal cancer.METHODS： Fifty-three patients with unresectable stage Ⅳ advanced rectal cancer who achieved clinical response after first-line chemotherapy（FOLFOX or FOLFIRI, q2 w, 12 cycles） from June 2011 to June 2014 at the People＇s Hospital of Ji＇an City were randomly divided into two groups： A and B. Group A（28 patients） received maintenance therapy with capecitabine（1000 mg/m2, po, bid, d1-14, q21d）. Group B（25 patients） did not receive any further chemotherapy. Progression-free survival（PFS） and adverse reactions were compared between the two groups.RESULTS： The 28 patients treated with capecitabine maintenance therapy achieved a median progression free survival（PFS） of around 11.6 mo, significantly longer than the value（6.5 mo） in the 25 patients who did not receive maintenance treatment（P〈0.05）. The response rate（RR） after first-line chemotherapy was 39.2% in the maintenance group and 32% in the non-maintenance group（P〈0.05）. The adverse effects were reduced significantly in the maintenance therapy groupand control group compared with those in first-line combination chemotherapy（P〈0.05）. There was no statistical difference in adverse effects between the maintenance treatment and observation groups except for hand-foot syndrome and pigmentation（P〈0.05）.CONCLUSION： Patients with unresectable stage Ⅳ rectal cancer could benefit from capeciabine maintenance therapy in terms of longer PFS, better tolerance and milder adverse reactions.