【摘要】：背景與目的肺癌是惡性程度極高的腫瘤,居男性癌癥死亡率第一位,在女性癌癥中死亡率僅次于乳腺癌,居第二位。最新數(shù)據(jù)顯示,在過去一年中我國肺癌新發(fā)病例73萬,死亡病例61萬,分別占全部惡性腫瘤的17.1%和21.7%,且大多數(shù)患者確診時已屬晚期,一半以上在1年內(nèi)死亡,5年生存率不足18%。目前治療肺癌的常用方法有手術(shù)、化療、放療及免疫治療,這些治療手段僅能在一定程度上緩解病情,當(dāng)腫瘤復(fù)發(fā)或轉(zhuǎn)移后往往沒有特效的藥物治療。吉非替尼、厄洛替尼以及克唑替尼是肺癌常用的靶向治療藥物,但它們只能局限于基因突變陽性的患者,并不能夠在臨床上廣泛應(yīng)用。阿帕替尼是一種小分子的血管內(nèi)皮生長因子受體酪氨酸激酶抑制劑,能夠抑制腫瘤新生血管的生成。在關(guān)于胃癌的各期臨床試驗中均顯示出了抗腫瘤效果,m PFS和m OS分別達(dá)3.67個月、4.83個月之久。有鑒于此,中國FDA于2014年10月批準(zhǔn)阿帕替尼上市,用于二線或二線以上治療失敗的晚期胃腺癌及胃-食管結(jié)合部腺癌的治療。目前關(guān)于阿帕替尼的研究主要集中于胃癌,在肺癌、乳腺癌、膽管癌及結(jié)直腸癌中的研究較少。本研究旨在探討阿帕替尼用于晚期肺癌的臨床療效及安全性,并探討預(yù)后的影響因素。收集2015年1月~2017年3月鄭州大學(xué)第一附屬醫(yī)院診治的經(jīng)病理組織學(xué)或細(xì)胞學(xué)證實,接受過二線或二線以上治療,且病情進(jìn)展的IIIA~IV期肺癌患者39例。給予阿帕替尼425mg/d,28天為一個治療周期,直至病情進(jìn)展或出現(xiàn)無法耐受的不良反應(yīng)。觀察臨床治療效果及不良反應(yīng)發(fā)生情況。資料統(tǒng)計學(xué)方法采用SPSS 17.0軟件對數(shù)據(jù)進(jìn)行分析,應(yīng)用Kaplan-Meier法進(jìn)行生存分析,應(yīng)用Log-Rank時序檢驗進(jìn)行單因素分析篩選出影響預(yù)后的因素,應(yīng)用Cox回歸模型對多因素進(jìn)行分析確認(rèn)獨立影響因素。P0.05為差異有統(tǒng)計學(xué)意義。結(jié)果1.生存情況:共入組39例晚期肺癌患者,中位年齡62歲(33~75歲),均可進(jìn)行數(shù)據(jù)分析。中位無進(jìn)展生存期為3.5個月,中位總生存期為5.1個月。完全緩解(CR)占0%,部分緩解(PR)占2.6%,疾病穩(wěn)定(SD)占58.9%,疾病進(jìn)展(PD)占38.5%�？偩徑饴�(ORR)和疾病控制率(DCR)分別為2.6%和61.5%。2.不良反應(yīng)發(fā)生情況:主要有高血壓(35.9%)、蛋白尿(25.6%)、手足綜合征(25.6%)、腹瀉(20.5%)以及骨髓抑制(38.5%),給予積極對癥處理后均可獲得緩解。3.單因素分析結(jié)果:組織分化程度、ECOG評分、服用阿帕替尼后不良反應(yīng)發(fā)生程度均與患者的預(yù)后相關(guān),其中高分化、ECOG評分0~1分、不良反應(yīng)≤2級的患者預(yù)后較好。性別、年齡、病理類型、腫瘤大小等與預(yù)后無關(guān)。4.多因素分析結(jié)果:組織分化程度、ECOG評分、服用阿帕替尼后不良反應(yīng)發(fā)生程度為阿帕替尼治療晚期肺癌的獨立影響因素。結(jié)論:阿帕替尼用于二線或二線以上治療失敗的晚期肺癌,仍具有一定的臨床療效,不良反應(yīng)可控制。組織分化程度好,體能狀況較佳且服藥后不良反應(yīng)輕微的患者預(yù)后更好。
[Abstract]:Background & objective Lung cancer is a malignant tumor with the highest mortality rate in males and the second highest mortality rate in females after breast cancer. The latest data show that in the past year, 730000 new cases of lung cancer and 610000 cases of death were found in China, accounting for 17.1% and 21.7of all malignant tumors, respectively. Most of the patients were diagnosed with advanced stage, more than half died within one year, and the 5-year survival rate was less than 18%. At present, the commonly used methods for the treatment of lung cancer are surgery, chemotherapy, radiotherapy and immunotherapy. These treatments can only alleviate the disease to a certain extent. When the tumor recurs or metastases, there is no special drug treatment. Gefitinib, erlotinib and czoltinib are common target drugs for lung cancer, but they can only be used in patients with positive gene mutation and can not be widely used in clinic. Apatinib is a small molecular inhibitor of vascular endothelial growth factor receptor tyrosine kinase, which can inhibit tumor angiogenesis. The antitumor effects of, m PFS and m OS were 3.67 months and 4.83 months, respectively. In view of this, the Chinese FDA approved the Apatinib listing in October 2014 for the treatment of advanced gastric adenocarcinoma and gastroesophageal adenocarcinoma with failure of second-line or second-line treatment. Current studies on apatinib focus on gastric cancer, but less on lung cancer, breast cancer, bile duct cancer, and colorectal cancer. The purpose of this study was to investigate the clinical efficacy and safety of apatinib in the treatment of advanced lung cancer and to explore the prognostic factors. From January 2015 to March 2017, 39 patients with IIIA~IV stage lung cancer who were diagnosed and treated in the first affiliated Hospital of Zhengzhou University were confirmed by histopathology or cytology. Apatinib 425 mg / d was given for 28 days as a treatment cycle until the disease progressed or an intolerable adverse reaction occurred. To observe the effect of clinical treatment and the occurrence of adverse reactions. Data were analyzed by SPSS 17.0 software, survival analysis by Kaplan-Meier method and univariate analysis by Log-Rank time series test. Cox regression model was used to analyze the multiple factors to confirm the independent factors. P0.05 as the difference was statistically significant. Result 1. Survival: a total of 39 patients with advanced lung cancer, median age 62 (3375 years), can be analyzed. The median progression-free survival was 3.5 months and the total median survival was 5.1 months. Complete remission (CR) accounted for 0%, partial remission (PR) accounted for 2.6%, disease stable (SD) accounted for 58.9%, disease progression (PD) accounted for 38.5%. Total remission rate (ORR) and disease control rate (DCR) were 2.6% and 61.5%, respectively. The main adverse reactions were hypertension (35.9%), proteinuria (25.6%), hand and foot syndrome (25.6%), diarrhea (20.5%) and bone marrow depression (38.5%). The results of univariate analysis showed that the degree of tissue differentiation, ECOG score and the degree of adverse reactions after taking apatinib were all related to the prognosis of the patients. The patients with high differentiation, ECOG score 0 ~ 1 and adverse reactions 鈮，

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