吉西他滨与放疗同步序贯治疗局部晚期非小细胞肺癌

Concurrent or Sequential Gemcitabine Combined with Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

目的:观察吉西他滨GEM与放疗同步/序贯治疗局部晚期非小细胞肺癌的近期疗效及不良反应。方法:56例具有明确病理诊断的初治局部晚期不可手术Ⅲa/Ⅲb期非小细胞肺癌患者,KPS≥70分,经过2个周期吉西他滨联合治疗顺铂(GP)方案诱导化疗后,非随机分为两组,序贯组(SCRT):26例,放疗后续2个周期GP方案巩固化疗。同步组(CCRT):30例,放疗同步应用单药吉西他滨(G)化疗,放疗后续2个周期GP方案巩固化疗。其中GP化疗方案:吉西他滨1000 mg/m^2d1,d8,顺铂25 mg/m^2d1～3,21天为1个周期;同步G方案:吉西他滨600 mg/m^2,1次/w,共6周。放疗均采用三维适形放疗,总剂量DT 60～66Gy/30～33f/6～6.5 w。评价疗效、不良反应和长期生存。结果:中位随访时间18.5个月,序贯组vs同步组,总有效率:53.85%vs 73.33%(P>0.05),中位无进展生存期分别为9.18个月vs 11.31个月(P<0.05),1年和2年生存率分别为61.5%vs 80.0%,23.08%vs 46.67%(P>0.05),中位生存期14.6个月vs 19.2个月(P<0.05)。不良反应以骨髓抑制、放射性食管炎和放射性肺炎为主。Ⅲ～Ⅳ度中性粒细胞减少23.08%vs 33.34%(P>0.05),Ⅲ～Ⅳ度血小板减少23.08%vs 23.34%(P>0.05),≥Ⅲ级放射性食管炎19.23%vs 23.33%,放射性肺炎15.39%vs 26.67%P>0.05。结论:吉西他滨与放疗同步治疗局部晚期非小细胞肺癌近期疗效略优于序贯治疗,不良反应略有增加,但有较好耐受。

Objective： To compare the toxicity and efficacy of concurrent or sequential Gemcitabine combined with radiotherapy for locally advanced non-small cell lung cancer. Methods： Fifty-six patients with pathologically diagnosed locally advanced non-surgical Ⅲ a/Ⅲ b non-small cell lung cancer （ NSCLC ）, KPS ≥ 70, received 2 cycles of induction chemotherapy （ CT ）, induced gemcitabine （ G ） and cisplatin （ P ）, and were non-randomly divided into two groups. The sequential chemotherapy and radiotherapy （SCRT） group included 26 cases that received 2 additional cycles of consolidation chemotherapy induced GP after radiotheraphy; the concurrent chemotherapy and radiotherapy （ CCRT ） group included 30 cases that received concurrent chemotherapy induced G, followed by 2 cycles of consolidation chemotherapy. Induction and consolidation chemotherapy regimens： gemcitabine （ Gemzar ） 1000 mg/m^2 dl, d8, cisplatin 25 mg/m2 dl-3, q21d; concurrent chemotherapy： gemcitabine 600 mg/m^2 weekly, all patients received three-dimensional conformal radiotherapy （ 3DCRT ）, total dose DT60- 66Gy/30 - 33f/6 - 6.5w. The efficacy, toxicity, and long-term survival of the two groups were evaluated. Results： The median follow-up was 18.5 months. For the SCRT group compared to the CCRT group： the objective response rate （ ORR ） was 53.85% vs. 73.33% （ P〉 0.05 ）; the median progression-free survival （ mPFS ） was 9.18 months （ 95% CI, 8.09-10.26 months ） vs. 11.31 months （ 95% CI, 10.35-12.26 months ） （ P〈 0.05 ）; the 1-year survival rate was 61.5% vs. 80.0% and the 2-year survival rate was 23.08% vs. 46.67% （ P 〉 0.05 ）; the median survival time was 14.6 months vs. 19.2 months （ P 〈 0.05 ）. Common treatment-related adverse events （AEs） included marrow suppression, radiation esophagitis and radiation pneumonitis. The rate of grade 3/4 neutropenia was 23.08% vs 26.67% （ P 〉 0.05 ）, grade 3/4 thrombocytopenia 23.08% vs 23.34% （ P 〉 0.05 ）, grade 3/4 radiation esophagitis 19.23% vs 23.33%, grade 3/4 radioactive pneumonia 15.39% vs 26.67% （ P 〉 0.05 ）. Conclusion： Concurrent treatment with gemcitabine and radiotherapy for locally advanced non-small cell lung cancer tends to have better results than sequential therapy, and the increased toxicity can be better tolerated.