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目的 :前瞻性观察和评估吉西他滨 (健择 )联合顺铂 3周方案作为一线化疗方案治疗晚期非小细胞肺癌患者的疗效和安全性。方法 :采用吉西他滨联合顺铂 3周方案作为一线化疗方案 ,治疗ⅢB或Ⅳ期非小细胞肺癌患者 ,进行观察性研究 ,疗效评估指标包括临床获益和显著临床缓解 (significantclinicalresponse ,SCR)。 结果 :入组患者 2 2 1例 ,其中 2 0 9例可进行疗效和安全性评估。患者中位年龄 5 8岁 (2 9～ 79岁 ) ;男女比 :6 7.5 %∶32 .5 % ;Ⅳ与ⅢB期比 :5 2 .2 %∶4 7.8% ;KPS <80 :80与 10 0者比 :37.3%∶6 2 .7% ;腺癌与非腺癌比 :5 9.8%∶4 0 .2 % ;平均化疗周期数为 3周期。经治后患者平均KPS评分从基线时的 79.5 0上升至 90 (P <0 .0 0 1) ;疼痛、吸困难和咳嗽LCSS分数分别从 77,74和 6 3分别为 92 ,90和 86 (P <0 .0 0 1) ;临床获益率为 85 .2 % (95 %可信区间 :80 .3%～ 90 % ) ;SCR达 89.5 % (95 %可信区间 :85 .3%到 93.7% ) ;中位生存时间为 7.83个月 (95 %可信区间 :7.0 3～ 9.0 3个月 )。本方案的主要剂量限制性毒性为骨髓抑制 ,18.7%患者出现粒性白细胞缺乏性相关感染 ,血小板减少症见于 10 .5 %的患者 ;仅 1例患者 (0 .4 8% )因化疗相关副反应而住院 ;致命性毒性见于 2例患者 (0 .96 % )。
Objective: To prospectively observe and evaluate the efficacy and safety of gemcitabine (Gemzar) combined with cisplatin 3 weeks as a first-line chemotherapy in patients with advanced non-small cell lung cancer. Methods: Gemcitabine combined with cisplatin 3 weeks as a first-line chemotherapy for treatment of stage ⅢB or Ⅳ non-small cell lung cancer patients, observational studies, efficacy evaluation indicators include clinical benefit and significant clinical response (SCR). Results: Twenty-one patients were enrolled, of whom 209 cases were evaluated for efficacy and safety. The median age of the patients was 58 years old (29-29 years old); the ratio of men to women was 7.5 7.5%; the ratio of Ⅳ to Ⅲ B was 52.2%: 7.88%; KPS <80:80 and 10 0 ratio: 37.3%: 62.7%; adenocarcinoma and non-adenocarcinoma ratio: 9.8%: 4.02%; the average number of cycles of chemotherapy is 3 cycles. The average KPS score of patients after treatment increased from 79.5 0 at baseline to 90 (P <0.01). The pain scores, dyspnea scores and cough LCSS scores ranged from 77, 74 and 63 respectively to 92, 90 and 86 P <0.001). The clinical benefit rate was 85.2% (95% confidence interval: 80.3% -90%). SCR reached 89.5% (95% confidence interval: 85.3% 93.7%). The median survival time was 7.83 months (95% confidence interval: 7.03-9.0 months). The main dose-limiting toxicity of this regimen was myelosuppression, with granulocytic leukosis associated infection in 18.7% of patients and in 10.5% of patients with thrombocytopenia; in only 1 patient (0.48%) due to chemotherapy-related side effects Response and hospitalization; fatal toxicity seen in 2 patients (0.96%).