晚期NSCLC一线EGFR-TKI治疗缓慢进展后的不同治疗方案临床疗效观察
发布时间：2018-12-11 15:57
【摘要】：目的:几乎所有接受EGFR-TKI治疗的非小细胞肺癌患者最终都不可避免地出现疾病进展。而对于无症状缓慢进展的患者的后续治疗手段如何选择已成为亟待解决的问题。本研究旨在比较这类患者接受原EGFR-TKI治疗、单纯化疗以及化疗间插原EGFR-TKI三种治疗方法的近期疗效及不良反应。方法:选取2013年1月至2015年12月就诊于青海大学附属医院及青海省人民医院经组织病理学证实EGFR突变阳性且既往一线行吉非替尼治疗后出现疾病缓慢进展的56例晚期NSCLC患者56例,随机分成3组,其中20例接受吉非替尼治疗(G组),20例接受单化疗治疗(C组),16例接受化疗间插吉非替尼治疗(CG组),21天为1个周期,G组每1个周期后进行疗效及不良反应评价,C组和CG组至少完成2个周期后进行疗效及不良反应评价。结果:(1)临床疗效评价结果显示:G组20例,中位PFS为4个月,临床有效者16例(80%),包括CR 0例(0%),PR 1例(5%),SD 15例(75%);C组20例,中位PFS为5个月,临床有效者14例(70%),包括CR 0例(0%),PR 4例(20%),SD 10例(50%);CG组16例,中位PFS为4个月,临床有效者11例(68.75%),包括CR 0例(0%),PR 3例(18.75%),SD 8例(50%)。不同组别间ORR、DCR及中位PFS差异均无统计学意义(P0.05)。(2)不良反应:G组中皮疹14例(70.0%),包括1例重度皮疹,轻度消化道反应3例(15.0%),轻度骨髓抑制1例(5.0%);C组轻度皮疹1例(5.0%),消化道反应13例(65.0%),包括2例重度反应,骨髓抑制13例(65.0%),包括1例重度抑制,轻度听力下降1例(5.0%);CG组轻度皮疹9例(56.25%),消化道反应11例(68.75%),包括1例重度反应,骨髓抑制13例(81.25%),包括1例重度抑制。其中G组轻度骨髓抑制发生率明显低于C组及CG组(5.0%vs60.0%,5.0%vs 75.0%),差异均具有统计学意义(P0.001);C组轻度皮疹发生率明显低于G组及CG组(5.0%vs 65.0%,5%vs 56.25%),差异均具有统计学意义(P0.001)。三组间III-IV度不良反应差异均无统计学意义(P0.05)。结论:1、对于既往一线吉非替尼治疗后无症状缓慢进展的患者的后续治疗,给予吉非替尼治疗、单纯PP/DP方案化疗以及PP/DP方案间插吉非替尼三种治疗方法的近期疗效相同。2、从不良反应方面来看,改为PP/DP方案化疗会减轻皮疹的发生率,而化疗间插吉非替尼会增加骨髓抑制及皮疹的发生率。3、对化疗耐受性较差或高龄患者,选择继续原TKI治疗,在临床获益的同时可能获得更高的生存质量;TKI耐药后改为化疗,再次进展后继续TKI治疗是一种克服耐药及延长患者生存的尝试;化疗间插吉非替尼临床无获益,毒副反应明显增高,不适宜晚期多疗程复发耐药患者治疗选择;从药效经济学方面考虑化疗联合TKI治疗可能并不是耐药患者治疗合适的选择。
[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.
【学位授予单位】：青海大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R734.2
本文编号：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.
【学位授予单位】：青海大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R734.2
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