超分割放疗同步NP方案化疗局部晚期非小细胞肺癌的Ⅱ期临床研究

Clinical phase Ⅱstudy on concurrent hyperfractionated radiotherapy and NP chemotherapy for locally advanced non-small cell lung cancer

目的 评价超分割放疗同步NP方案化疗局限期非小细胞肺癌的疗效及毒副反应。方法 35例局部晚期非小细胞肺癌患者KPS评分≥70，中位年龄57岁。男30例，女5例；鳞癌22例，腺癌12例，大细胞癌1例；ⅢA期5例，ⅢB期30例。采用6～8MVX线超分割放疗（1．25cGy／次，2次／d，间隔6h以上，总剂量60Gy）和NP方案同步化疗（去甲长春花碱12．5ms／m^2，第1、8、15天给药，顺铂60～80mg／m^2第2天给药，共2～4个周期）。按WHO近期疗效及毒副标准评价治疗结果，用Kaplan-Meier法计算生存率。结果 全组中位随访32个月（5～40个月）。完全缓解1例，部分缓解19例，无变化13例，进展2例，有效率为57％。1、2、3年生存率分别为54％、29％和17％，中位生存期14．5个月（11～18个月）。放射性食管炎27例，放射性肺炎9例，恶心21例，白细胞减少23例，血小板减少9例，贫血5例。结论 超分割放疗同步NP方案化疗局限期非小细胞肺癌是一种可接受的治疗方案，近期疗效有所改善，但毒副反应也有增加。

Objective To evaluate the curative effects and side reactions or toxicity of hyperfractionated radiotherapy delivered concurrently with navobine-eisplatin（NP） scheme for locally advanced non-small cell lung cancer. Methods From June 2000 to October 2003, 35 patients were allotted to this clinical phase Ⅱstudy. Of 35 patients, there were 30 males and 5 females, with a median age of 57（rang 41 to 72）. Karnofsky scores were ≥70 for all. Twenty-two patients had squamous cell carcinoma, 12 adenoearcinoma, and 1 large cell carcinoma. Five patients had clinical stage Ⅲ A and 30 Ⅲ B lesions. Hyperfractionated radiotherapy was delivered with 6-8 MV photons by an accelerator twice daily （ 1.25 cGy/f, with a 6 hour interval, to a total dose 60 Gy）. NP scheme chemotherapy was composed of 2 to 4 cycles（navelbine 12.5 mg/m^2, on D1,D8 and DIS, cisplatin 60-80 mg/m^2 on D2）. The curative effects and side-reactions or toxicity were evaluated according to the criteria of WHO. The survival rate was calculated by Kaplan-Meier method. Results The median follow-up time was 32 months. Complete response, partial response, stable disease and progressive disease was observed in 1,19, 13 and 2 patients, respectively. The efficiency rate was 57 %. The 1-, 2-, and 3-year sm＇vival rate was 54 %, 29 % and 17 %, respectively.The median survival time was 14.5 months（ range, 5-40 months）. Radiation-esophagitis, radiationpneumonia, nausea, leukocytopenia, thrombocytopemia and anemia was observed in 27,9,21,23,9 and 5 patients, respectively. Conclusions Hyperfractionated radiotherapy delivered concurrently with NP chemotherapy scheme is acceptable, with the short-term curative effects improved, whereas the side reactions or toxicity is increased.