發(fā)布時間：2018-08-17 12:09

【摘要】：目的:了解單中心真實(shí)世界中,老年AML患者的治療情況。比較傳統(tǒng)化療方案與地西他濱聯(lián)合減量化療方案對老年AML患者的治療療效及安全性。對老年AML患者進(jìn)行預(yù)后分析。方法:回顧性分析2009年5月至2016年5月吉林大學(xué)第一醫(yī)院腫瘤中心血液科收治的290例老年AML(非APL)患者的臨床、遺傳學(xué)及分子生物學(xué)資料,按WHO診斷標(biāo)準(zhǔn)確診。篩選完成1個療程傳統(tǒng)化療方案(包括DA、IA、HA、MA、AA、CAG)或者地西他濱聯(lián)合減量化療方案(包括D-CAG、D-HAG、DCA+DA)誘導(dǎo)治療的患者(共121例),在化療間歇期骨髓抑制期、恢復(fù)期行骨髓穿刺評價療效,并進(jìn)行短期療效分析。接著,篩選其中在2個療程內(nèi)達(dá)到CR的患者(共54例),納入長期生存分析及預(yù)后分析。結(jié)果:在初次誘導(dǎo)治療時使用傳統(tǒng)化療方案或地西他濱聯(lián)合減量化療方案的患者,1療程CR率為32.23%、2療程CR率為65.85%;傳統(tǒng)化療組1療程CR率為29.27%(24/82),2療程CR率為60.71%(34/56);地西他濱聯(lián)合減量化療組1療程CR率為38.46%(15/39),2療程CR率為76.92%(20/26)。將治療1療程達(dá)到CR與未達(dá)到CR的患者相比,發(fā)現(xiàn)影響CR率的因素為初診時骨髓原始細(xì)胞比例(P=0.014)與初診時外周血原始細(xì)胞比例分別為(P=0.001)。將2療程達(dá)到CR與未達(dá)到CR的患者相比,未發(fā)現(xiàn)影響其CR率的因素(P0.05)。傳統(tǒng)化療組早期死亡率(6周內(nèi))為12.20%(10/82),地西他濱聯(lián)合減量化療組早期死亡率(6周內(nèi))為7.69%(3/39),其差異無統(tǒng)計(jì)學(xué)意義(P=0.665)。傳統(tǒng)化療組與地西他濱聯(lián)合減量化療組在不良反應(yīng)方面差異無統(tǒng)計(jì)學(xué)意義(P0.05)。將在誘導(dǎo)治療中使用了傳統(tǒng)化療方案或地西他濱聯(lián)合減量化療方案,且在2個療程內(nèi)達(dá)到CR的54例患者納入生存分析。中位隨訪時間為15.0個月(1.3~81.6個月),中位生存時間為18.0個月(95%CI:15.1-20.9),中位無復(fù)發(fā)生存時間為11.0個月(95%CI:7.9-14.1)。1年OS率為62.0%,2年OS率為37.4%。1年RFS率為42.6%,2年RFS率為13.0%。標(biāo)準(zhǔn)化療組中位生存時間為20個月,中位無復(fù)發(fā)生存時間為8個月。地西他濱聯(lián)合減量化療組中位生存時間為18個月,中位無復(fù)發(fā)生存時間為14個月。對可能影響老年AML預(yù)后的因素如年齡、性別、初診WBC計(jì)數(shù)、初診時骨髓原始細(xì)胞比例、初診時外周血原始細(xì)胞比例、預(yù)后危險分層、誘導(dǎo)治療方案等進(jìn)行分析。單因素分析顯示:對于OS,初診骨髓原始細(xì)胞比例≥50%的患者(中位OS期11個月)OS明顯低于初診骨髓原始細(xì)胞比例50%的患者(中位OS期20個月)(P=0.003);初診外周血原始細(xì)胞比例≥50%的患者(中位OS期9個月)OS明顯低于初診外周血原始細(xì)胞比例50%的患者(中位OS期20個月)(P=0.005);達(dá)CR后鞏固治療1療程的患者(中位OS期4個月)OS明顯低于達(dá)CR后鞏固治療≥2療程的患者(中位OS期19個月)(P0.001),而其他因素對OS的影響無統(tǒng)計(jì)學(xué)意義。對于RFS,初診骨髓原始細(xì)胞比例≥50%的患者(中位RFS期6個月)RFS明顯低于初診骨髓原始細(xì)胞比例50%的患者(中位RFS期14個月)(P=0.009);初診外周血原始細(xì)胞比例≥50%的患者(中位RFS期5個月)RFS明顯低于初診外周血原始細(xì)胞比例50%的患者(中位RFS期14個月)(P=0.009);達(dá)CR后鞏固治療1療程的患者(中位RFS期2個月)RFS明顯低于達(dá)CR后鞏固治療≥2療程的患者(中位RFS期12個月)(P0.001);繼發(fā)性AML患者(中位RFS期0個月)RFS明顯低于原發(fā)性AML患者(中位RFS期11個月)(P0.001),而其他因素對RFS的影響無統(tǒng)計(jì)學(xué)意義。多因素分析顯示:影響老年AML患者OS的獨(dú)立預(yù)后因素為骨髓原始細(xì)胞比例(P=0.030)、外周血原始細(xì)胞比例(P=0.037)及達(dá)CR后鞏固療程數(shù)(P=0.006);影響老年AML患者RFS的獨(dú)立預(yù)后因素為外周血原始細(xì)胞比例(P=0.023)及達(dá)CR后鞏固療程數(shù)(P=0.001)。結(jié)論:1.本組患者染色體檢出率為90.13%,其中異�？寺z出率為39.80%。隨著年齡的增長,患者不良核型所占比例增高。2.傳統(tǒng)化療組患者CR率為60.71%,地西他濱聯(lián)合減量化療組患者CR率為76.92%,兩組患者在CR率上差異均無統(tǒng)計(jì)學(xué)意義(P值均0.05)。3.傳統(tǒng)化療組和地西他濱聯(lián)合減量化療組在早期死亡率(6周內(nèi))、不良反應(yīng)方面差異無統(tǒng)計(jì)學(xué)意義(P值均0.05)。4.將達(dá)到CR的54例患者納入生存分析。中位生存時間為18.0個月(95%CI:15.1-20.9),中位無復(fù)發(fā)生存時間為11.0個月(95%CI:7.9-14.1)。1年OS率為62.0%,2年OS率為37.4%。1年RFS率為42.6%,2年RFS率為13.0%。傳統(tǒng)化療組與地西他濱聯(lián)合減量化療組在長期生存上差異無統(tǒng)計(jì)學(xué)意義。多因素分析:影響老年AML患者OS的獨(dú)立預(yù)后因素為骨髓原始細(xì)胞比例(P=0.030)、外周血原始細(xì)胞比例(P=0.037)及達(dá)CR后鞏固療程數(shù)(P=0.006);影響老年AML患者RFS的獨(dú)立預(yù)后因素為外周血原始細(xì)胞比例(P=0.023)及達(dá)CR后鞏固療程數(shù)(P=0.001)。
[Abstract]:Objective:To investigate the treatment of elderly AML patients in the real world in a single center.To compare the efficacy and safety of traditional chemotherapy regimen with that of dicitabine combined with subtractive therapy regimen in elderly AML patients.To analyze the prognosis of elderly AML patients.Methods:A retrospective analysis was made from May 2009 to May 2016 in the Cancer Center of the First Hospital of Jilin University. 290 elderly patients with AML (non-APL) were diagnosed according to WHO diagnostic criteria according to clinical, genetic and molecular biology data. One course of conventional chemotherapy (including DA, IA, HA, MA, AA, CAG) or combination of dicitabine and subtractive therapy (including D-CAG, D-HAG, DCA+DA) was selected and treated intermittently. Secondly, 54 patients with CR in 2 courses were selected and included in the long-term survival analysis and prognosis analysis. Results: Patients with conventional chemotherapy regimen or combination of dicitabine reduction regimen in the initial induction therapy, 1 course C The CR rate was 32.23% and 65.85% in two courses, 29.27% (24/82) in one course and 60.71% (34/56) in two courses in the traditional chemotherapy group, 38.46% (15/39) in one course and 76.92% (20/26) in two courses in the combined subtractive therapy group. The ratio of primordial cells (P = 0.014) to peripheral blood primordial cells (P = 0.001) at the time of initial diagnosis. No factors affecting the CR rate were found in the patients who had reached CR for two courses (P 0.05). The early mortality rate (within 6 weeks) in the traditional chemotherapy group was 12.20% (10/82) and that in the combination therapy group (within 6 weeks) was 7.69% (3/39). There was no significant difference in adverse reactions between the conventional chemotherapy group and the combination therapy group (P = 0.665). The median survival analysis included 54 patients who had achieved CR in 2 courses and received conventional chemotherapy or combination therapy with the reduction therapy. Follow-up time was 15.0 months (1.3-81.6 months), median survival time was 18.0 months (95% CI: 15.1-20.9), median recurrence-free survival time was 11.0 months (95% CI: 7.9-14.1). One-year OS rate was 62.0%, two-year OS rate was 37.4%. One-year RFS rate was 42.6%, two-year RFS rate was 13.0%. The median survival time in standardized treatment group was 20 months, and median recurrence-free survival time was 8.0%. The median survival time was 18 months and the median non-recurrence survival time was 14 months in the combined subtractive therapy group. Univariate analysis showed that OS was significantly lower in patients with OS (median OS period was 11 months) than in patients with OS (median OS period was 20 months) (P = 0.003); OS was significantly lower in patients with OS (median OS period was 9 months) than in patients with OS (median OS period was 9 months). The OS of 50% patients (median OS period 20 months) (P = 0.005); the OS of 1 course of consolidation therapy after CR (median OS period 4 months) was significantly lower than that of 19 months (median OS period 19 months) after CR (median OS period > 2 courses) (P 0.001), while other factors had no significant effect on OS. In 6 months of RFS, RFS was significantly lower than that in 50% of the patients (median RFS period was 14 months) (P = 0.009); in 5 months of RFS, RFS was significantly lower than that in 50% of the patients (median RFS period was 14 months) (P = 0.009); in 1 course of consolidation therapy after CR, RFS was significantly lower than that in 50% of the patients (median RFS period was 5 months). The RFS of patients (median RFS period 2 months) was significantly lower than that of patients (median RFS period 12 months) (P 0.001) with CR consolidation therapy (> 2 months) and those of secondary AML (median RFS period 0 months) were significantly lower than those of primary AML (median RFS period 11 months) (P 0.001), while other factors had no significant effect on RFS. The independent prognostic factors of OS in ML patients were the ratio of bone marrow primordial cells (P = 0.030), the ratio of peripheral blood primordial cells (P = 0.037) and the consolidation course after reaching CR (P = 0.006); the independent prognostic factors of RFS in elderly AML patients were the ratio of peripheral blood primordial cells (P = 0.023) and the consolidation course after reaching CR (P = 0.001). The rate of CR was 60.71% in the traditional chemotherapy group and 76.92% in the combination and subtraction therapy group. There was no significant difference in the CR rate between the two groups (P 0.05). The median survival time was 18.0 months (95% CI: 15.1-20.9), and the median recurrence-free survival time was 11.0 months (95% CI: 7.9-14.1). One-year OS rate was 62.0%, and two-year OS rate was 37.4%. Multivariate analysis showed that the independent prognostic factors of OS in elderly AML patients were the ratio of bone marrow primordial cells (P = 0.030), the ratio of peripheral blood primordial cells (P = 0.037) and the consolidation course after CR (P = 0.006). The independent prognostic factors of RFS in elderly AML patients were the ratio of peripheral blood primordial cells (P = 0.023) and the number of consolidation courses after reaching CR (P = 0.001).
【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R733.71

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