加速超分割放疗和化疗综合治疗局限期小细胞肺癌——临床ⅠⅡ期试验初步结果报告

Concurrent cisplatin/etoposide chemotherapy plus twice daily thoracic radiotherapy in limited stage small cell lung cancer:a preliminary report of clinical phase Ⅰ/Ⅱ trial

目的 :研究加速超分割放疗和化疗综合治疗局限期小细胞肺癌 (Limitedstagesmall celllungcancer,LSCLC)的耐受性、急性副反应和即期疗效。方法 :入组标准是经组织学或细胞学证实的SCLC ;局限期 (美国退伍军人医院分期法 ) ,但不包括恶性胸腔积液 ;年龄 18— 70岁 ;KPS≥ 6 0 ;无明显心、肺、肝、肾和骨髓功能损害 ;既往无肿瘤病史。入组前检查 :胸部X片、胸CT、脑CT、腹部B超、骨ECT、肺功能、心电图 ,血生化检查 (LDH、AKP、SGPT、SGOT、A G、Na+ )。治疗方法 :首治病人化疗 1疗程后放疗 ,继以化疗 5疗程 ;已治病人化疗 3疗程后放疗 ,继以化疗3疗程。化疗方案 :EP(DDP 2 5— 30mg m2 d1— 3+VP16 5 0— 70mg m2 d1— 3)。放疗方法 :放射源 6MVX线或6 0 Coγ线 ,照射方法 :1 4Gy 次Bid ,间隔≥ 6h ,5天 周 ,总剂量 5 6Gy 40次 4周。第 1— 3周前胸后背相对野照射 ,第 4周改为斜野 ,以避开脊髓。照射范围 :胸部CT显示的原发肿瘤灶及淋巴结转移灶。结果 :按RTOG早期放射反应评价标准评价早期放射反应。放疗后两月评价即期疗效 (按WHO肿瘤即期疗效评价标准 )。 1997年 6月— 2 0 0 0年 3月 ,5 0例病人进入本研究组。男 45例 ,女 5例 ,中位年龄 5 8岁 ( 2 5— 70 )。放疗在第 1疗程化疗后立即开始者 70 %(

Purpose:To investigate the feasibility, toxicity and the efficacy of concurrent cisplatin/etoposide chemotherapy plus twice daily thoracic radiotherapy in limited stage small cell lung cancer (LSCLC).Methods:From June 1997 to March 2000,50 patients with LSCLC had been enrolled for concurrent cisplatin/etoposide chemotherapy plus accelerated hyperfractionated radiotherapy. All patients received intravenously cisplatin (P)=25—30 mg/m 2 days 1—3,plus etoposide (E)=50—70 mg/m 2 days 1—3,at 3—4 week intervals for six cycles.Irradiated patients received 56 Gy in two daily fractions (1.4 Gy, Bid, with ≥6 hour interval),5 days a week,from week 2 to week 5. The radiation fields just covered clinical tumors, which were determined by thoracic CT with 1.5 cm margins. Results:All patients were evaluable for response. Acute radiation esophagitis developed in 38% of patients with Grade Ⅰ—Ⅱ(RTOG), and 8% with Grade Ⅲ. Acute radiation pneumonitis developed in 30 % of patients with Grade Ⅰ—Ⅱ (RTOG). Neutropenia occurred in 66% of patients with Grade Ⅰ—Ⅱ (RTOG), 22% with Grade Ⅲ, and 2% with Grade Ⅳ. 28(56%) achieved a complete response, 16(32%) had a partial response, 5(10%) had stable disease and 1 (2%) had a progression disease. The overall response rate (CR+PR) was 88%.Conclusions:Concurrent cisplatin/etoposide chemotherapy plus twicedaily thoracic radiotherapy in limited stage small cell lung cancer (LSCLC) could be well tolerated. The immediate response was encouraging.