摘要
目的 比较晚期肺腺鳞癌患者采用培美曲塞、紫杉醇类/吉西他滨为主的一线化疗方案治疗的效果,探讨对患者生存期的影响.方法 2012年1月-2022年4月福建省肿瘤医院、漳州正兴医院、莆田学院附属医院、福建医科大学附属漳州市医院、厦门大学附属第一医院、厦门大学附属中山医院、福鼎市医院、泉州市第一医院诊治晚期肺腺鳞癌患者71例,采用培美曲塞为主的方案化疗者16例为培美曲塞组,采用紫杉醇类/吉西他滨为主的方案化疗者55例为紫杉醇类/吉西他滨组,2组化疗期间均依据基因检测结果等联合应用表皮生长因子受体络氨酸激酶抑制剂或抗血管生成治疗药物或免疫检查点抑制剂,每化疗1～2个周期评价疗效1次.比较2组性别比例、年龄、吸烟史、确诊晚期时美国东部肿瘤协作组(ECOG)评分以及脑转移、肝转移、骨转移、基因突变、程序性死亡配体1(PD-L1)表达情况和一线化疗的近期疗效.随访至2022年10月,比较2组中位无进展生存期(mPFS);比较不同性别、年龄、ECOG评分以及有无脑转移、肝转移、骨转移、基因突变者mPFS.结果 (1)培美曲塞组女性比率(56.2％)高于紫杉醇类/吉西他滨组(23.6％)(x2=6.165,P=0.017),年龄≥65岁、ECOG评分≥2分、吸烟、脑转移、肝转移、骨转移比率与紫杉醇类/吉西他滨组比较差异均无统计学意义(P＞0.05).(2)培美曲塞组7例行基因检测,均检出EGFR突变.紫杉醇类/吉西他滨组33例行基因检测,检出EGFR突变6例,EGFR突变合并c-MET扩增1例,ALK基因突变1例,HER2突变1例,KRAS突变1例,TP53突变1例,TP53突变合并BRAF突变1例.培美曲塞组1例检测PD-L1表达,为阴性;紫杉醇类/吉西他滨组7例检测PD-L1表达,3例阳性,4例阴性.(3)培美曲塞组客观缓解率、疾病控制率(43.8％、75.0％)与紫杉醇类/吉西他滨组(41.8％、76.4％)比较差异均无统计学意义(x2=0.019,P=0.556;x2=0.013,P=0.574).(4)随访至2022年10月,6例失访,65例生存.培美曲塞组mPFS[4.1个月(95％CI:0～10.25)]与紫杉醇类/吉西他滨组[6.4个月(95％CI:4.27～8.53)]比较差异无统计学意义(P=O.116).(5)确诊晚期时ECOG评分0～1分者mPFS[6.4个月(95％CI:5.19～7.61)]长于 ECOG 评分≥2分者[2.0 个月(95％CI:0～4.87)](P=0.020),无肝转移者 mPFS[6.7 个月(95％CI:5.11～8.35)]长于有肝转移者[2.0个月(95％CI:0.31～3.63)](P=0.003),不同性别、年龄、是否吸烟及有无脑转移、骨转移、基因突变者mPFS比较差异均无统计学意义(P＞0.05).结论 晚期肺腺鳞癌患者采用培美曲塞为主或紫杉醇类/吉西他滨为主的一线方案化疗的近期疗效及mPFS相当,确诊晚期时ECOG评分≥2分及有肝转移者mPFS缩短.
Abstract
Objective To compare the therapeutic efficacy of pemetrexed versus paclitaxel/gemcitabine-based first-line chemotherapy regimen on advanced lung adenosquamous carcinoma,and to explore their influences on the survival of patients.Methods From January 2012 to April 2022,71 patients with advanced lung adenosquamous carcinoma were diagnosed and treated in Fujian Cancer Hospital,Zhangzhou Zhengxing Hospital,the Affiliated Hospital of Putian University,the Affiliated Zhangzhou Hospital of Fujian Medical University,the First Affiliated Hospital of Xiamen University,the Affiliated Zhongshan Hospital of Xiamen University,Fuding City Hospital and the First Hospital of Quanzhou,among whom 16 patients received pemetrexed chemotherapy regimen(pemetrexed group)and 55 patients received paclitaxel/gemcitabine chemotherapy regimen(paclitaxel/gemcitabine group).During chemotherapy,epidermal growth factor receptor tyrosine kinase inhibitor,antiangiogenic drugs,or immune checkpoint inhibitors were applied in combination according to gene detection results and other factors,and the efficacy was evaluated once every 1 to 2 cycles of chemotherapy.The gender ratio,age,smoking habits,Eastern Cooperative Oncology Group(ECOG)score,brain metastasis,liver metastasis,bone metastasis,gene mutation,and expression of programmed death ligand 1(PD-L1)were compared between two groups.The short-term efficacy of first-line chemotherapy was compared between two groups.The latest follow-up was conducted in October 2022,and the median progression-free survival(mPFS)was compared between two groups,and also in patients with different gender,age,ECOG score,and with and without brain metastasis,liver metastasis,bone metastasis and gene mutations.Results(1)The female ratio was higher in pemetrexed group(56.2％)than that in paclitaxel/gemcitabine group(23.6％)(x2=6.165,P=0.017).There were no significant differences in the proportions of patients with age ≥65 years,ECOG score ≥2,smoking habits,brain metastasis,liver metastasis,and bone metastasis between two groups(P＞0.05).(2)In pemetrexed group,7 patients received gene detection,and EGFR mutation was detected in all patients.In paclitaxel/gemcitabine group,33 patients received gene detection,revealing EGFR mutation in 6 patients,EGFR mutation combined with c-MET amplification in 1,ALK mutation in 1,HER2 mutation in 1,KRAS mutation in 1,TP53 mutation in 1,and TP53 mutation combined with BRAF mutation in 1.In pemetrexed group,PD-L1 expression was negative in 1 patient.PD-L1 was expressed in 7 patients(including 3 patients with positive expression and 4 with negative expression)in paclitaxel/gemcitabine group.(3)There were no significant differences in the objective response rate and disease control rate between pemetrexed group(43.8％,75.0％)and paclitaxel/gemcitabine group(41.8％,76.4％)(x2=0.019,P=0.5556;x2=0.013,P=0.574).(4)In the follow-up till October 2022,6 were lost and 65 survived.There was no significant difference in the mPFS between pemetrexed group[4.1 months(95％CI:0-10.25)]and paclitaxel/gemcitabine group[6.4 months(95％CI:4.27-8.53)](P=0.116).(5)The mPFS was longer in advanced cancer patients with ECOG score 0-1[6.4 months(95％CI:5.19-7.61)]than that in patients with ECOG score ≥2[2.0 months(95％CI:0-4.87)](P=0.020),and in patients without liver metastasis[6.7 months(95％CI:5.11-8.35)]than that in patients with liver metastasis[2.0 months(95％CI:0.31-3.63)](P=0.003).There was no significant difference in the mPFS in patients with different gender,age,and with and without brain metastasis,bone metastasis and gene mutations(P＞0.05).Conclusion In patients with advanced lung adenosquamous carcinoma,the short-term efficacy of first-line chemotherapy with pemetrexed or paclitaxel/gemcitabine-based regimen and the mPFS are comparable,and the mPFS would be shortened in patients with ECOG score ≥2 and liver metastasis.
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维普
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