晚期NSCLC一線EGFR-TKI治療緩慢進(jìn)展后的不同治療方案臨床療效觀察
發(fā)布時(shí)間：2018-12-11 15:57
【摘要】：目的:幾乎所有接受EGFR-TKI治療的非小細(xì)胞肺癌患者最終都不可避免地出現(xiàn)疾病進(jìn)展。而對(duì)于無(wú)癥狀緩慢進(jìn)展的患者的后續(xù)治療手段如何選擇已成為亟待解決的問(wèn)題。本研究旨在比較這類患者接受原EGFR-TKI治療、單純化療以及化療間插原EGFR-TKI三種治療方法的近期療效及不良反應(yīng)。方法:選取2013年1月至2015年12月就診于青海大學(xué)附屬醫(yī)院及青海省人民醫(yī)院經(jīng)組織病理學(xué)證實(shí)EGFR突變陽(yáng)性且既往一線行吉非替尼治療后出現(xiàn)疾病緩慢進(jìn)展的56例晚期NSCLC患者56例,隨機(jī)分成3組,其中20例接受吉非替尼治療(G組),20例接受單化療治療(C組),16例接受化療間插吉非替尼治療(CG組),21天為1個(gè)周期,G組每1個(gè)周期后進(jìn)行療效及不良反應(yīng)評(píng)價(jià),C組和CG組至少完成2個(gè)周期后進(jìn)行療效及不良反應(yīng)評(píng)價(jià)。結(jié)果:(1)臨床療效評(píng)價(jià)結(jié)果顯示:G組20例,中位PFS為4個(gè)月,臨床有效者16例(80%),包括CR 0例(0%),PR 1例(5%),SD 15例(75%);C組20例,中位PFS為5個(gè)月,臨床有效者14例(70%),包括CR 0例(0%),PR 4例(20%),SD 10例(50%);CG組16例,中位PFS為4個(gè)月,臨床有效者11例(68.75%),包括CR 0例(0%),PR 3例(18.75%),SD 8例(50%)。不同組別間ORR、DCR及中位PFS差異均無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。(2)不良反應(yīng):G組中皮疹14例(70.0%),包括1例重度皮疹,輕度消化道反應(yīng)3例(15.0%),輕度骨髓抑制1例(5.0%);C組輕度皮疹1例(5.0%),消化道反應(yīng)13例(65.0%),包括2例重度反應(yīng),骨髓抑制13例(65.0%),包括1例重度抑制,輕度聽(tīng)力下降1例(5.0%);CG組輕度皮疹9例(56.25%),消化道反應(yīng)11例(68.75%),包括1例重度反應(yīng),骨髓抑制13例(81.25%),包括1例重度抑制。其中G組輕度骨髓抑制發(fā)生率明顯低于C組及CG組(5.0%vs60.0%,5.0%vs 75.0%),差異均具有統(tǒng)計(jì)學(xué)意義(P0.001);C組輕度皮疹發(fā)生率明顯低于G組及CG組(5.0%vs 65.0%,5%vs 56.25%),差異均具有統(tǒng)計(jì)學(xué)意義(P0.001)。三組間III-IV度不良反應(yīng)差異均無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。結(jié)論:1、對(duì)于既往一線吉非替尼治療后無(wú)癥狀緩慢進(jìn)展的患者的后續(xù)治療,給予吉非替尼治療、單純PP/DP方案化療以及PP/DP方案間插吉非替尼三種治療方法的近期療效相同。2、從不良反應(yīng)方面來(lái)看,改為PP/DP方案化療會(huì)減輕皮疹的發(fā)生率,而化療間插吉非替尼會(huì)增加骨髓抑制及皮疹的發(fā)生率。3、對(duì)化療耐受性較差或高齡患者,選擇繼續(xù)原TKI治療,在臨床獲益的同時(shí)可能獲得更高的生存質(zhì)量;TKI耐藥后改為化療,再次進(jìn)展后繼續(xù)TKI治療是一種克服耐藥及延長(zhǎng)患者生存的嘗試;化療間插吉非替尼臨床無(wú)獲益,毒副反應(yīng)明顯增高,不適宜晚期多療程復(fù)發(fā)耐藥患者治療選擇;從藥效經(jīng)濟(jì)學(xué)方面考慮化療聯(lián)合TKI治療可能并不是耐藥患者治療合適的選擇。
[Abstract]:Objective: almost all patients with non-small cell lung cancer treated with EGFR-TKI eventually develop unavoidably. However, how to select follow-up treatment for asymptomatic patients with slow progression has become an urgent problem. The aim of this study was to compare the short term efficacy and adverse reactions of EGFR-TKI alone chemotherapy and chemotherapeutic intercalation of EGFR-TKI in these patients. Methods: from January 2013 to December 2015, 56 patients who were admitted to the affiliated Hospital of Qinghai University and the people's Hospital of Qinghai Province by histopathologically confirmed positive mutation of EGFR and had been treated with Gifitinib were selected. 56 patients with advanced NSCLC, They were randomly divided into 3 groups: 20 cases received gifetini (group G), 20 cases received single chemotherapy (group C), and 16 cases received interventional therapy (CG group). The efficacy and adverse reactions were evaluated after each cycle in group G, and those in group C and group CG were evaluated after at least 2 cycles. Results: (1) the results of clinical efficacy evaluation showed that in group G, the median PFS was 4 months, 16 cases (80%) were clinically effective, including 0 case (0%) of CR (1 case of), PR, 5% of), SD, 15 cases (75%); In group C, the median PFS was 5 months. 14 cases (70%) were clinically effective, including 0 cases (0%), PR (0%), PR) (10 cases (20%), SD). In CG group, the median PFS was 4 months, 11 cases (68.75%) were clinically effective, including 0% (0%), PR (3 cases) (18.75%), SD (50%). There was no significant difference in ORR,DCR and median PFS among different groups (P0.05). (2). In group G, there were 14 cases (70.0%) of skin rash, including 1 case of severe rash, 3 cases of mild digestive tract reaction (15.0%). Mild bone marrow suppression in 1 case (5.0%); In group C, mild rash was found in 1 case (5.0%), digestive tract reaction in 13 cases (65.0%), including 2 cases of severe reaction, 13 cases of bone marrow depression (65.0%), including 1 case of severe inhibition and 1 case of mild hearing loss (5.0%). In CG group, 9 cases (56.25%) had mild rash, 11 cases (68.75%) had digestive tract reaction, including 1 case of severe reaction, 13 cases of bone marrow depression (81.25%), including 1 case of severe inhibition. The incidence of mild bone marrow suppression in group G was significantly lower than that in group C and CG (5.0 vs 5.0 vs 75.0%), and the difference was statistically significant (P0.001). The incidence of mild rash in group C was significantly lower than that in group G and CG (5.0%vs 65.0 vs 56.25%), and the difference was statistically significant (P0.001). There was no significant difference in III-IV degree adverse reactions among the three groups (P0.05). Conclusion: 1. For patients with asymptomatic and slow progression after previous first-line gifitinib treatment, gifetini was given. The short-term efficacy of PP/DP regimen alone and PP/DP regimen intercalation with gefitinib was the same. 2. In terms of adverse reactions, chemotherapy with PP/DP regimen could reduce the incidence of rashes. The incidence of bone marrow depression and rashes was increased by interventional injection of gefitinib. 3. For patients with poor chemotherapeutic tolerance or elderly patients, the treatment of TKI may gain higher quality of life while benefiting from clinical practice. It is an attempt to overcome the drug resistance and prolong the survival of patients with TKI after drug resistance is changed to chemotherapy and then continue to be treated with TKI after further progress. Chemotherapeutic interventional injection of gefitinib was not beneficial in clinical practice, and the side effects were significantly increased, so it was not suitable for patients with recurrent drug resistance in late multicourse. Considering the pharmacodynamic economics, chemotherapy combined with TKI might not be the appropriate choice for drug resistant patients.
【學(xué)位授予單位】：青海大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R734.2
本文編號(hào)：2372819
[Abstract]:Objective: almost all patients with non-small cell lung cancer treated with EGFR-TKI eventually develop unavoidably. However, how to select follow-up treatment for asymptomatic patients with slow progression has become an urgent problem. The aim of this study was to compare the short term efficacy and adverse reactions of EGFR-TKI alone chemotherapy and chemotherapeutic intercalation of EGFR-TKI in these patients. Methods: from January 2013 to December 2015, 56 patients who were admitted to the affiliated Hospital of Qinghai University and the people's Hospital of Qinghai Province by histopathologically confirmed positive mutation of EGFR and had been treated with Gifitinib were selected. 56 patients with advanced NSCLC, They were randomly divided into 3 groups: 20 cases received gifetini (group G), 20 cases received single chemotherapy (group C), and 16 cases received interventional therapy (CG group). The efficacy and adverse reactions were evaluated after each cycle in group G, and those in group C and group CG were evaluated after at least 2 cycles. Results: (1) the results of clinical efficacy evaluation showed that in group G, the median PFS was 4 months, 16 cases (80%) were clinically effective, including 0 case (0%) of CR (1 case of), PR, 5% of), SD, 15 cases (75%); In group C, the median PFS was 5 months. 14 cases (70%) were clinically effective, including 0 cases (0%), PR (0%), PR) (10 cases (20%), SD). In CG group, the median PFS was 4 months, 11 cases (68.75%) were clinically effective, including 0% (0%), PR (3 cases) (18.75%), SD (50%). There was no significant difference in ORR,DCR and median PFS among different groups (P0.05). (2). In group G, there were 14 cases (70.0%) of skin rash, including 1 case of severe rash, 3 cases of mild digestive tract reaction (15.0%). Mild bone marrow suppression in 1 case (5.0%); In group C, mild rash was found in 1 case (5.0%), digestive tract reaction in 13 cases (65.0%), including 2 cases of severe reaction, 13 cases of bone marrow depression (65.0%), including 1 case of severe inhibition and 1 case of mild hearing loss (5.0%). In CG group, 9 cases (56.25%) had mild rash, 11 cases (68.75%) had digestive tract reaction, including 1 case of severe reaction, 13 cases of bone marrow depression (81.25%), including 1 case of severe inhibition. The incidence of mild bone marrow suppression in group G was significantly lower than that in group C and CG (5.0 vs 5.0 vs 75.0%), and the difference was statistically significant (P0.001). The incidence of mild rash in group C was significantly lower than that in group G and CG (5.0%vs 65.0 vs 56.25%), and the difference was statistically significant (P0.001). There was no significant difference in III-IV degree adverse reactions among the three groups (P0.05). Conclusion: 1. For patients with asymptomatic and slow progression after previous first-line gifitinib treatment, gifetini was given. The short-term efficacy of PP/DP regimen alone and PP/DP regimen intercalation with gefitinib was the same. 2. In terms of adverse reactions, chemotherapy with PP/DP regimen could reduce the incidence of rashes. The incidence of bone marrow depression and rashes was increased by interventional injection of gefitinib. 3. For patients with poor chemotherapeutic tolerance or elderly patients, the treatment of TKI may gain higher quality of life while benefiting from clinical practice. It is an attempt to overcome the drug resistance and prolong the survival of patients with TKI after drug resistance is changed to chemotherapy and then continue to be treated with TKI after further progress. Chemotherapeutic interventional injection of gefitinib was not beneficial in clinical practice, and the side effects were significantly increased, so it was not suitable for patients with recurrent drug resistance in late multicourse. Considering the pharmacodynamic economics, chemotherapy combined with TKI might not be the appropriate choice for drug resistant patients.
【學(xué)位授予單位】：青海大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R734.2
【參考文獻(xiàn)】
相關(guān)期刊論文 前6條
1 陳萬(wàn)青;鄭榮壽;曾紅梅;鄒小農(nóng);張思維;赫捷;;2011年中國(guó)惡性腫瘤發(fā)病和死亡分析[J];中國(guó)腫瘤;2015年01期
2 陳萬(wàn)青;張思維;曾紅梅;鄭榮壽;鄒小農(nóng);趙平;吳良有;李光琳;赫捷;;中國(guó)2010年惡性腫瘤發(fā)病與死亡[J];中國(guó)腫瘤;2014年01期
3 吳一龍;廖美琳;周清華;蔣國(guó)j;陸舜;王潔;程穎;張力;張緒超;劉曉晴;韓寶惠;鐘文昭;周彩存;宋勇;馬勝林;王長(zhǎng)利;楊學(xué)寧;毛偉敏;王俊;許林;陳海泉;傅小龍;馮繼鋒;宋啟斌;于世英;伍鋼;朱廣迎;陳公琰;熊建萍;楊衿記;王建軍;陳克能;申屠陽(yáng);張沂平;胡艷萍;于丁;宋恕平;胡成平;宋向群;常建華;陳剛;張賀龍;李偉雄;王震;;非小細(xì)胞肺癌小分子靶向藥物耐藥處理共識(shí)[J];循證醫(yī)學(xué);2013年02期
4 吳一龍;;靶向時(shí)代藥物療效評(píng)價(jià)的思考[J];循證醫(yī)學(xué);2013年01期
5 王洋;梁岳培;;抗VEGF和抗EGFR靶向治療非小細(xì)胞肺癌的研究進(jìn)展[J];臨床醫(yī)學(xué)工程;2011年02期
6 彭培建;林忠;張紅雨;肖妹;陳楠;韓軍;;厄羅替尼治療晚期非小細(xì)胞肺癌患者的療效及安全性研究[J];中國(guó)全科醫(yī)學(xué);2010年13期
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