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Multimodality treatment of stage III non-small cell lung cancer: analysis of a phase II trial using preoperative cisplatin and gemcitabine with concurrent radiotherapy

机译:III期非小细胞肺癌的多模式治疗:术前顺铂和吉西他滨联合放疗的II期试验分析

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INTRODUCTION: \ud\udWe report the results of a phase II trial exploring the efficacy and the feasibility of combination of gemcitabine and cisplatin concurrent with radiotherapy followed by surgery in patients with stage III non-small cell lung cancer.\ud\udMETHODS: \ud\udPatients with histocytologically confirmed non-small cell lung cancer were treated with cisplatin 80 mg/sqm/wk of 1 and 4 or 20 mg/sqm/d of weeks 1 and 4 and weekly gemcitabine at 300 to 350 mg/m2 plus involved field radiotherapy. A 3D-conformal radiotherapy was delivered up to 50.4 Gy, with daily fractionation of 1.8 Gy. After clinical, radiologic, and pneumological reassessment, patients who reentered criteria for resectability were operated.\ud\udRESULTS: \ud\udThe stage at diagnosis was IIIA-N2 in 29 patients and IIIB-T4N0-2 for vascular direct infiltration for the remaining 21. Fifteen patients (30%) experienced acute grade 3 to 4 hematological toxicity, whereas acute grade 3 esophageal toxicity was recorded in three patients (6%). One patient developed a grade 4 pulmonary toxicity (2%). Clinical response was 40 (80%) partial response, one (2%) stable disease, and nine (18%) progressive disease. Thirty-six patients (72%) underwent surgery. Final pathology showed a downstaging to stage 0 to I in 25 cases (50%). Median overall survival for all patients was 21.8 months, with a 3-year survival of 40.2%.\ud\udCONCLUSIONS: \ud\udThe results of this phase II trial confirm the feasibility and the efficacy of concurrent chemoradiotherapy followed by surgery.
机译:简介:\ ud \ ud我们报告了一项II期临床试验的结果,该试验探索了吉西他滨和顺铂联合放疗并联合放射治疗在III期非小细胞肺癌患者中的疗效和可行性。 ud \ ud经组织学检查证实为非小细胞肺癌的患者,在第1和第4周用顺铂80 mg / sqm / wk的1和4或20 mg / sqm / d进行治疗,每周吉西他滨的治疗剂量为300至350 mg / m2野外放疗。 3D保形放射治疗的最大剂量为50.4 Gy,每日分馏为1.8 Gy。经过临床,影像学和肺病学重新评估后,对重新确定可切除性标准的患者进行了手术。\ ud \ ud结果:\ ud \ ud诊断阶段为29例患者为IIIA-N2,其余患者的血管直接浸润为IIIB-T4N0-2 21. 15名患者(30%)经历了急性3至4级血液学毒性反应,而三名患者(6%)则记录了3级急性食道毒性。一名患者发生了4级肺毒性(2%)。临床反应为40(80%)部分反应,一种(2%)稳定疾病和九(18%)进行性疾病。三十六名患者(72%)接受了手术。最终的病理结果显示,有25例病例(50%)降级为0至I期。所有患者的平均总生存时间为21.8个月,3年生存率为40.2%。结论:II期临床试验的结果证实了同时放化疗联合手术的可行性和有效性。

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