螺旋断层放射治疗联合重组人血管内皮抑制素治疗不可切除且不能耐受同步放化疗的Ⅲ期非小细胞肺癌

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摘要目的评估重组人血管内皮抑制素联合螺旋断层放射治疗(TOMO)不可切除且不能耐受同步放化疗的Ⅲ期非小细胞肺癌患者的有效性和安全性。方法收集2014-09至2020-01空军特色医学中心放射治疗科收治的38例非小细胞肺癌患者临床资料,均为不能接受手术且不能耐受同步放化疗的Ⅲ期患者。采用TOMO联合重组人血管内皮抑制素治疗,TOMO放疗剂量60～70 Gy,分15~25次完成,5次/周;重组人血管内皮抑制素于TOMO前一周采用静脉给药模式,剂量7.5 mg/(m²·d),至少4个周期(持续给药14 d,间隔7 d为一个周期)。评估患者治疗后疗效、安全性及生存时间。结果共纳入38例,中位随访时间[M (95% CI)]为42.6(17.2,87.4)个月。在38例中,ⅢA和ⅢB期分别为25例(65.8%)和13例(34.2%)。腺癌、鳞癌和其他类型分别为18例(47.4%)、11例(29.0%)和9例(23.7%)。所有患者均按计划完成治疗,其中重组人血管内皮抑制素治疗大于6周期的16例(42.1%)。患者中位总生存期和无进展生存期[M (95% CI)]为37.3(11.3,85.2)个月和23.1(4.6,85.2)个月;3年总生存率和无进展生存率为51.4%和39.8%。多变量分析表明,患者总生存时间和无进展生存时间主要与性别、年龄、吸烟史和TNM分期有关,而体重下降仅与总生存时间相关。放疗剂量模式仅与局部无复发生存时间相关,但与区域无复发生存和远处转移无关。1～2级急性不良反应发生率为28.9%(11例),3级5.3%(2例);1～2级晚期不良反应发生率为5.3%(2例),3级2.6%(1例)。结论 TOMO联合重组人血管内皮抑制素应用于不能手术且不能耐受同步放化疗的Ⅲ期非小细胞肺癌患者的治疗疗效显著,且不良反应可以耐受。

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关键词 ：非小细胞肺癌, 螺旋断层放射治疗, 重组人血管内皮抑制素, 不良反应

Abstract：Objective To assess the efficacy and safety of recombinant human endostatin (Rh-endostatin) in combination with tomotherapy (TOMO) in the treatment of inoperable stage Ⅲ non-small cell lung cancer (NSCLC) patients who could not tolerate concurrent chemoradiotherapy.Methods Clinical data of 38 inoperable stage Ⅲ NSCLC patients were retrospectively reviewed, who could not tolerate concurrent chemoradiotherapy in the department of radiotherapy of Characteristics Medical Center of Chinese PLA Air Force from September 2014 to January 2020. All patients were treated with TOMO therapy combined with Rh-endostatin. The dosage of TOMO was 60-70 Gy in 15-25 fractions (5 fractions /week). Rh-endostatin was administered intravenously one week before TOMO at a dose of 7.5 mg/m² qd for 14 consecutive days, and repeated at an interval of one week for at least 4 cycles. Clinical efficacy, safety, and survival were assessed after the treatment.Results All patients were followed-up for a median duration of 42.6 (17.2-87.4) months. There were 25 (65.8%) patients with stage ⅢA NSCLC, and 13 (34.2%) patients with stage ⅢB NSCLC. In terms of pathological types, there were 18 (47.4%) cases of adenocarcinoma, 11 (29.0%) cases of squamous cell carcinoma, and 9 cases (23.7%) of others. All patients completed TOMO and at least 4 cycles of Rh-endostatin therapy, and 16 (42%) patients received more than 6 cycles of Rh-endostatin therapy among them. The median total survival time and progression-free survival time were 37.3 months 95%CI (11.3,85.2) and 23.1 months 95% CI(4.6,85.2) respectively, and the 3-year OS and PFS rate were 51.4% and 39.8% respectively.Multivariate analysis suggested that gender, age, smoking history and TNM stage were significantly associated with progression-free survival (PFS) and overall survival (OS), while weight loss was associated only with OS. TOMO dosage was only associated with local recurrence-free survival, but not with regional recurrence-free survival or distant metastases. The incidences of acute toxicities of grade 1/2 was 28.9% (n=11), and grade 3 was 5.3% (n=2). The incidence of late toxicities of grade 1/2 was 5.3% (n=2) and that of grade 3 was 2.6% (n=1); No grade 4/5 late toxicity occurred.Conclusions Rh-endostatin combined with TOMO is effective in the treatment of stage III non-small cell lung cancer patients who are inoperable and cannot tolerate concurrent chemoradiotherapy, and the adverse reactions are tolerable.

Key words： non-small cell lung cancer tomotherapy Rh-endostatin toxicity

收稿日期: 2023-02-14

ZTFLH:

R738.1

基金资助:空军特色医学中心临床研究项目(2021LC009);空军特色医学中心2021年度青年博士助推计划课题(21ZT01);空军特色医学中心拔尖人才计划项目(22BJQN002)

通讯作者: 付之光,E-mail:xiaochuan8668@126.com

作者简介: 刘力华,硕士,副主任医师。

引用本文:

刘力华, 闫茂慧, 李宏奇, 付之光. 螺旋断层放射治疗联合重组人血管内皮抑制素治疗不可切除且不能耐受同步放化疗的Ⅲ期非小细胞肺癌[J]. 武警医学, 2023, 34(9): 752-756. LIU Lihua, YAN Maohui, LI Hongqi, FU Zhiguang. Efficacy and safety of recombinant human endostatin combined with tomotherapy in treatment of stage Ⅲ non-small cell lung cancer. Med. J. Chin. Peop. Armed Poli. Forc., 2023, 34(9): 752-756.

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http://journal08.magtechjournal.com/Jwk_wjyx/CN/ 或 http://journal08.magtechjournal.com/Jwk_wjyx/CN/Y2023/V34/I9/752

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