卡瑞利珠单抗治疗复发或晚期转移性食管鳞癌临床疗效及免疫相关不良反应观察

目的:探讨卡瑞利珠单抗治疗复发或晚期转移性食管鳞癌的临床疗效以及免疫相关不良反应。方法:回顾性分析88例复发或晚期转移性食管鳞癌患者的治疗经过和疗效,将患者随机分为免疫联合化疗组、化疗组各44例,统计客观缓解率（objective remission rate,ORR)、疾病控制率(disease control rate,DCR)、无进展生存期(progress free survival,PFS)、总生存期（overall survival,OS）,用Kaplan-Meier法绘制生存曲线,用log-rank检验进行影响PFS和OS的单因素分析、COX风险回归模型进行多因素分析,并观察免疫相关不良反应。结果:免疫联合化疗组和化疗组的ORR分别为8例（18%）和4例（9%）,DCR分别为31例（70%）和20例（45%）,免疫联合化疗较单纯化疗可延长患者mPFS（5.5个月vs 3.5个月,P=0.007）和mOS（11.25个月vs 7.75个月,P＜0.001）。ECOG评分、肿瘤分化程度和转移部位数量是PFS和OS的影响因素。免疫相关不良反应主要有毛细血管增生症、甲状腺功能减低、乏力、食欲减退等,但多为1-2级,经对症处理后均可缓解。结论:卡瑞利珠单抗联合化疗较单纯化疗在复发或晚期转移性食管鳞癌中可明显延长PFS和OS,临床疗效显著,且安全性良好。     

白蛋白结合型紫杉醇对比紫杉醇二线治疗晚期肺鳞癌回顾性分析

目的:回顾性分析白蛋白结合型紫杉醇(Nab-PTX)对比紫杉醇(PTX)作为二线化疗方案对晚期肺鳞癌的疗效及安全性。方法:选取于2016年03月至2018年06月在我院行二线单药化疗的肺鳞癌患者（方案为:Nab-PTX或PTX）的资料,根据其治疗情况分为Nab-PTX组和PTX组。分析符合入组条件患者的临床特征,比较两组患者的近期疗效、生存情况及毒副反应。结果:共有52例患者符合入组条件（每组各26例）,两组患者的临床特征比较差异无统计学意义。Nab-PTX组RR为38.5%,PTX组为34.6%,两组比较差异无统计学意义(P＞0.05);Nab-PTX组DCR为73.1%,PTX组为57.7%,两组比较差异具有统计学意义(P＜0.05)。Nab-PTX组患者中位PFS为6个月、中位OS为11个月;PTX组患者中位PFS为4.5个月、中位OS为8个月。两组的PFS及OS比较,差异均有统计学意义(P＜0.05)。血液毒性主要是白细胞减少、中性粒细胞减少和贫血,Nab-PTX组与PTX组在Ⅲ-Ⅳ级白细胞减少（23.1% vs 46.2%）和贫血（11.5% vs 26.9%）方面比较,差异具有统计学意义(P＜0.05);Ⅲ-Ⅳ级非血液学毒副反应分别为:疲劳(7.7% vs 11.5%)、周围神经病变(3.8% vs 15.4%)、肌痛/关节痛(7.7% vs 15.4%),差异均无统计学意义(P＞0.05)。结论:Nab-PTX较PTX更是一种治疗晚期肺鳞癌患者有效且耐受性良好的二线治疗方案。     

尼妥珠单抗联合多西他赛和顺铂一线治疗复发或转移性头颈部鳞癌疗效观察

目的 观察尼妥珠单抗联合多西他赛和顺铂一线治疗复发或转移性头颈部鳞癌的疗效及安全性.方法 回顾性分析28例尼妥珠单抗联合多西他赛+顺铂(观察组)及30例多西他赛+顺铂(对照组)一线治疗复发或转移性头颈部鳞癌患者的临床资料,比较两种方案的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存时间(PFS)及总生存时间(O...     

含奥沙利铂方案与FOLFIRI方案一线化疗对K-ras基因不同状态晚期大肠癌患者的疗效及预后影响比较

目的 探究含奥沙利铂方案与FOLFIRI方案对Ⅳ期结直肠癌化疗疗效及预后影响的差别与K-ras基因状态的关系。方法 收集2010年1月至2012年1月的118例接受含奥沙利铂方案或FOLFIRI方案化疗的Ⅳ期结直肠癌患者临床资料,统计患者的治疗有效率（ORR）、疾病控制率（DCR）、无进展生存时间（PFS）和总生存期（OS）。采用χ²检验比较各组临床因素差别和两种治疗方案的有效率及疾病控制率,采用Kaplan-Meier法比较无进展生存时间以及总生存期。结果 118例患者中,接受含奥沙利铂方案化疗的K-ras突变型患者PFS及OS较接受FOLFIRI方案化疗患者延长（P=0.048;P=0.037）,ORR及DCR较接受FOLFIRI方案化疗患者无明显差别（P=0.961;P=0.931）。接受含奥沙利铂方案化疗的K-ras野生型患者ORR、DCR、PFS及OS较接受FOLFIRI方案化疗患者无明显差别（P=0.900;P=0.802;P=0.738;P=0.904）。结论 采用含奥沙利铂方案一线化疗较FOLFIRI方案对K-ras突变型Ⅳ期结直肠癌患者更有优势,而对于K-ras野生型Ⅳ期结直肠癌患者,含奥沙利铂方案与FOLFIRI方案疗效及预后情况相当。     

西妥昔单抗联合化疗治疗K-ras基因不明的晚期结直肠癌

目的 探讨西妥昔单抗联合化疗对K-ras基因状态不明的晚期结直肠癌患者的疗效和安全性.方法 收集2005年3月至2008年12月间在中山大学肿瘤防治中心接受西妥昔单抗联合化疗的102例晚期结直肠癌患者的资料,统计患者的有效率(ORR)、疾病控制率(DCR)、无进展生存时间(PFS)和总生存期(OS).比较一线与非一线化疗联合应用西妥昔单抗、含奥沙利铂方案与含伊立替康方案的ORR、DCR、PFS和OS的差异.结果 102例患者的ORR和DCR分别为43.1%和74.5%,中位PFS和OS分别为4.0个月和28.5个月,1、3和5年生存率分别为89.2%、50.9%和27.5%.一线与非一线应用西妥昔单抗联合化疗患者的ORR(50.0%和40.0%,P=0.344)、DCR(78.1%和72.9%,P=0.571)和OS(51.0和35.0个月,P=0.396)差异均无统计学意义,但一线应用西妥昔单抗联合化疗患者的PFS(5.5个月)较非一线者显著延长(3.0个月,P=0.001).应用含奥沙利铂方案治疗与应用含伊立替康方案治疗患者的ORR(54.2%和40.0%,P=0.223)、DCR(79.2%和74.7%,P=0.654)、PFS(5.0个月和3.0个月,P=0.726,)和OS(36.0个月和40.0个月,P=0.759)比较,差异均无统计学意义.常见的不良反应有痤疮样皮疹(80.4%,3～4级9.8%)、中性粒细胞下降(66.7%,3～4级18.6%)、腹泻(19.6%,3～4级5.9%),无与治疗相关性死亡病例.结论 西妥昔单抗联合化疗治疗K-ras基因状况不明的晚期结直肠癌患者的有效率较高,中位生存时间较长,不良反应少且程度轻.比较一线与非一线应用西妥昔单抗治疗、含奥沙利铂方案与含伊立替康方案间的疗效均无明显差异.     

The efficacy of bevacizumab in Chinese patients with metastatic colorectal cancer and its effect in different line setting

Objective:We aimed to evaluate the ef ect of bevacizumab in the pal iative treatment of Chinese metastatic colorectal cancer (mCRC) and its ef icacy in dif erent lines. Methods:Patients of mCRC treated with bevacizumab or not at Sun Yat-sen University Cancer Center from 2005 to 2013 were recruited as the study group and control group. The endpoints were objective response rate (ORR), disease control rate (DCR), overal survival (OS) and progression free survival (PFS). The OS and PFS of first-, second-and third-line treatment groups were compared between study group and control group. Re-sults:The median PFS of the study and the control group were 8.2 months (7.0-9.4 months), 5.7 months (4.7-6.6 months), P=0.001;OS were 26 months (5.4-130.5 months), 18 months (16.6-19.4 months), P<0.001, respectively. The ORR and DCR of first-, second-and third-line were 30.3%(20/66), 20%(6/30), 17.6%(3/17) and 97%(64/66), 86.7%(26/30), 100%(17/17). In the first-line chemotherapy group, the OS of the study group and the control group were 22.9 (5.4-96.7) months and 18 (16.6-19.4) months (P<0.001);PFS were 9.4 (8.4-10.4) months and 5.7 (4.7-6.6) months (P<0.001), respectively. While in the second-and third-line setting, only OS were statistical y dif erent, PFS had no significant dif erence. Conclusion:The combination of bevacizumab and chemotherapy had a promising short-term and long-term ef icacy in Chinese mCRC patients than those without bevacizumab regimens, and the ef ect could be better reflected in the first-line treatment.     

贝伐珠单抗序贯联合mFOLFOX或FOLFIRI方案治疗转移性结直肠癌的临床疗效观察

目的:探讨贝伐珠单抗联合mFOLFOX或FOLFIRI方案作为一线治疗,进展后相互转换为二线治疗在转移性结直肠癌治疗中的真实疗效对比。方法:选取我院于2017年01月至2021年06月收治的101例晚期结直肠癌患者,采取贝伐珠单抗联合mFOLFOX或FOLFIRI方案作为一线治疗,进展后相互转换为二线治疗,观察临床疗效及不良反应情况。结果:贝伐珠单抗先联合mFOLFOX后FOLFIRI组(以下称先mFOLFOX组/pre mFOLFOX)的一线ORR(objective response rate)为44.2%,DCR(disease control rate)为86.5%;二线ORR为24%,DCR为60%。贝伐珠单抗先联合FOLFIRI后mFOLFOX组(以下称先FOLFIRI组/pre FOLFIRI)的一线ORR为42.9%,DCR为81.6%;二线ORR为29.2%,DCR为62.5%。两组间的一/二线ORR及DCR差异均未达统计学意义。Kaplan-Meier分析显示先mFOLFOX6组与先FOLFIRI组的中位PFS(progression-free survival)-...     

吉西他滨联合长春瑞滨与联合紫杉醇姑息治疗铂类耐药的Ⅳ期鼻咽癌患者的随机对照试验

目的:观察吉西他滨联合长春瑞滨与联合紫杉醇方案作为姑息治疗方案治疗铂类耐药的Ⅳ期鼻咽癌患者的有效性及安全性。方法:收集2012年7月至2014年7月含铂一线治疗失败的晚期鼻咽癌患者共105例的临床资料,随机分为吉西他滨联合长春瑞滨组（GV组）与吉西他滨联合紫杉醇组（GT组）,比较两方案在总有效率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）及不良反应发生率等方面的差异。采用Log-rank检验比较PFS及OS。结果:两组间的ORR无统计学差异（P=0.491）,DCR存在统计学差异（GT组较优,P=0.034）。两组间的PFS、OS的差别均无统计学意义（P=0.387,P=0.673）。不良反应方面,GV组Ⅰ度感觉异常较多,而GT组Ⅲ度白细胞降低、Ⅰ度疲乏无力、过敏反应、肌肉关节疼痛、脱发及Ⅱ度脱发较多,差别均有统计学意义。结论:GV、GT两种方案治疗铂类耐药的晚期鼻咽癌患者在总有效率、无进展生存期及总生存期上近似,GT方案可提高患者疾病控制率（DCR）,不良反应较GV方案多,多为轻中度,患者可耐受。     

A retrospective study of docetaxel or paclitaxel in patients with advanced or recurrent esophageal squamous cell carcinoma who previously received fluoropyrimidine- and platinum-based chemotherapy

Introduction

Fluoropyrimidine plus platinum (FP)-based chemotherapy has been widely used as a first-line regimen for advanced or recurrent esophageal cancer, and taxanes have shown efficacy after FP-based chemotherapy, but there is no standard regimen for second-line chemotherapy (SLC). We retrospectively investigated the clinical features of taxane therapy in SLC for esophageal squamous cell carcinoma (ESCC).

Methods

The selection criteria were pathologically proven ESCC; advanced or recurrent disease previously treated with FP at our hospital; performance status (PS) 0–2; and adequate organ function. Docetaxel (DTX) was administered 3-weekly at 70 mg/m². Paclitaxel (PTX) was administered at 100 mg/m² weekly for 6 weeks, with 1 week’s rest.

Results

The analysis covered 163 patients from August 2006 to June 2012. Median age was 64 years (range 37–83: DTX group 132 patients and PTX group 31). Progression-free survival and median overall survival (OS) were 2.3 and 6.1 months, respectively, with PTX and 2.3 and 5.3 months with DTX. Response rates were 20.7 % for PTX and 5.9 % for DTX. The rate of grades 3–4 neutropenia was higher with DTX (32.6 %) than with PTX (16.1 %). Grade 3 febrile neutropenia was seen in 6.1 % of DTX recipients but in no PTX group. According to multivariate analyses of OS, PS 2, number of metastatic sites ≧2, and CRP ≧1 mg/dL were independent predictors of poor prognosis.

Conclusions

PTX and DTX were both effective in SLC for ESCC, but their toxicity profiles differed. In terms of febrile neutropenia, PTX seems more appropriate.     

培美曲塞用于转移性或晚期宫颈癌患者三线及以上治疗的疗效及安全性

目的:观察培美曲塞用于转移性或晚期宫颈癌三线及以上治疗的近期疗效及安全性。方法:收集2016年1月至2016年12月在空军军医大学西京医院肿瘤科住院的转移性或晚期宫颈鳞癌患者,接受三线及以上治疗者共11例,选择培美曲塞为基础的化疗方案。每2周期进行疗效及安全性评估,主要指标包括客观缓解率（objective response rate,ORR）、疾病控制率（disease control rate,DCR）、无进展生存期（progression-free survival,PFS）和不良反应。结果:11例中10例患者为三线治疗,1例患者为四线治疗。疗效评估:部分缓解（partial remission,PR）4例（36%）,稳定（stable disease,SD）5例（45%）,病情进展（progressive disease,PD）2例（18%）。ORR为36%（4例）,DCR为82%（9例）,中位PFS 6.3个月（3.0~10.6个月）。安全性评估:3级及以上不良反应包括中性粒细胞减少（3例,27%）、血小板减少（2例,18%）、总胆红素升高（1例,9%）、间接胆红素升高（1例,9%）。结论:培美曲塞用于转移性或晚期宫颈癌三线及以上化疗具有良好的疗效和安全性。     

阿帕替尼单药在标准方案治疗失败晚期结直肠癌患者中的疗效及安全性

目的：探讨阿帕替尼单药在标准治疗方案失败晚期结直肠癌（colorectal cancer,CRC）患者中的疗效和安全性。方法：本研究为前瞻性研究设计,用PASS15 软件计算研究所需的样本量,从2017 年7 月到2018 年8 月入组标准方案治疗失败的晚期CRC患者52 例,给予阿帕替尼起始剂量750 mg或500 mg单药治疗;评估患者的客观缓解率（ORR）和疾病控制率（DCR）,随访评价患者的无进展生存期（PFS）和总生存期（OS）,并记录治疗过程中出现的不良反应。主要研究终点为PFS,次要研究终点为ORR、DCR、OS和安全性。结果：纳入研究的52 例CRC患者中45 例可以评价疗效及安全性,其均为既往接受过至少2 次系统性化疗的晚期CRC患者。疗效：完全缓解0 例、部分缓解5 例、疾病稳定30 例、疾病进展10 例,ORR为11.11%、DCR为77.78%;预后：45 例患者的中位PFS 为3.95 个月（95% CI=3.16~4.74）,中位OS为10.3 个月（95% CI=5.70~14.90）;3 级以上不良反应：手足综合征6 例（13.33%）,高血压5 例（11.11%）,蛋白尿5 例（6.67%）,转氨酶升高4 例（8.89%）,腹泻3 例（6.67%）,疲劳2 例（4.44%）,出血1例（2.22%）。结论：阿帕替尼单药治疗标准方案失败的晚期CRC患者具有潜在的临床获益,安全性事件总体可控。     

奥沙利铂联合紫杉醇脂质体治疗晚期胃癌的疗效分析

目的 探讨奥沙利铂联合紫杉醇脂质体或替吉奥治疗晚期胃癌的临床疗效及不良反应.方法 选取46例晚期胃癌患者作为研究对象.按照随机数字表法将46例晚期胃癌患者随机分为A组和B组,每组23例.其中,A组患者接受奥沙利铂联合紫杉醇脂质体方案化疗,B组患者接受奥沙利铂联合替吉奥方案化疗.比较两组患者的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)和不良反应发生情况.结果 A组患者的ORR为47.8%,DCR为78.3%;B组患者的ORR为43.5%,DCR为69.6%;两组患者的ORR和DCR比较,差异均无统计学意义(P=0.767、0.502).A组和B组患者的中位OS分别为9.4个月和9.5个月,两组比较,差异无统计学意义(P=0.911).A组患者的中位PFS为6.9个月(95%CI:6.2~7.8个月),长于B组患者的5.4个月(95%CI:4.0~5.9个月),差异有统计学意义(P=0.048).两组患者的中性粒细胞减少、血小板减少、贫血、疲劳乏力、腹泻、关节肌肉疼痛、恶心呕吐以及神经毒性的发生率比较,差异均无统计学意义(P﹥0.05).结论 奥沙利铂联合紫杉醇脂质体方案和奥沙利铂联合替吉奥方案治疗晚期胃癌的临床疗效接近,但在晚期胃癌患者的无进展生存期方面,奥沙利铂联合紫杉醇脂质体方案可能优于奥沙利铂联合替吉奥方案.     

mXELIRI和mFOLFIRI方案联合西妥昔单抗一线治疗转移性左半结肠癌的临床观察CSCD

目的初步比较mXELIRI与mFOLFIRI方案联合西妥昔单抗一线治疗转移性左半结肠癌的临床疗效及安全性。方法回顾性分析68例接受西妥昔单抗联合mXELIRI或mFOLFIRI方案治疗的转移性左半结肠癌患者临床资料,比较西妥昔单抗联合两种化疗方案的客观缓解率(ORR)、疾病控制率(DCR)及无进展生存时间(PFS),并评估安全性。结果mXELIRI组和mFOLFIRI组的客观缓解率分别为62.5%和58.4%,疾病控制率为87.5%和88.9%,中位PFS分别为10.5和9.9月,差异均无统计学意义(均P>0.05);mXELIRI组手足综合征发生率明显高于mFOLFIRI组(37.5%vs.13.9%,P=0.025)。结论西妥昔单抗联合mXELIRI或mFOLFIRI方案一线治疗转移性左半结肠癌的疗效及安全性相当。     

阿帕替尼治疗多线治疗失败的转移性乳腺癌的疗效观察

目的 观察阿帕替尼治疗难治性乳腺癌的疗效及不良反应.方法 回顾性分析29例经多线治疗失败后进行阿帕替尼化疗的转移性乳腺癌患者的临床资料,分析阿帕替尼单药化疗和阿帕替尼联合化疗患者的无进展生存期(PFS)、客观有效率(ORR)和疾病控制率(DCR).结果 29例患者中,1例死亡,1例由于血小板降低而停止用药,可评价疗效的患者共27例.27例患者的中位PFS为3.1个月(1.0~6.1个月).阿帕替尼联合化疗患者的PFS为3.10个月,阿帕替尼单药化疗患者的中位PFS为3.46个月,差异无统计学意义(P>0.05).治疗后部分缓解3例,疾病稳定12例,疾病进展12例,ORR为11.11%,DCR为55.56%.多因素分析结果显示,既往化疗方案数是影响乳腺癌患者PFS的独立危险因素(P<0.05).化疗后患者的3~4级不良反应包括手足综合征2例(6.90%),高血压2例(6.90%),低血小板血症1例(3.45%).结论 阿帕替尼单药及联合化疗治疗转移性乳腺癌有一定疗效,值得进一步研究.     

Characteristics and response to next-generation sequencing-guided therapy in locally advanced or metastatic esophageal cancer

Esophageal cancer (EC) is a main cause of cancer-related deaths. However, genomic alterations and the clinical value of next-generation sequencing (NGS) in advanced or metastatic EC for precision therapy remain largely unclear. Herein, we performed comprehensive analyses on a cohort of 47 individuals with advanced or metastatic EC who underwent NGS between May 2017 and February 2020. Eventually, 227 mutated genes were identified in the cohort. TP53, NQO1, DPYD, GSTM1, XRCC1 and ERCC1 were the most mutated genes and associated with immune cell infiltration, autophagy and hypoxia. Patients who received NGS-guided treatments exhibited better objective remission rate (ORR) (72.22%), disease control rate (DCR) (88.89%), overall survival (OS) (P = .0019) and progression-free survival (PFS) (P = .0077) than those not receiving NGS-guided therapies. The multivariate analyses further demonstrated that the NGS-guided therapy was an independently prognostic factor (OS: hazard radio [HR] 0.31, 95% coincidence interval [CI] 0.1-0.97, P = .04). In conclusion, we depicted a comprehensive mutational landscape of 47 patients with locally advanced or metastatic EC and illustrated the utility of NGS testing to guide clinical management in improving ORR, DCR, OS and PFS.     

Bevacizumab combined with chemotherapy in the second-line treatment of metastatic colorectal cancer: results from the phase II BEVACOLOR study

BackgroundThis prospective phase II study assessed the efficacy and safety of bevacizumab plus chemotherapy regimens commonly used in the second-line treatment of metastatic colorectal cancer (mCRC).MethodsPatients with mCRC who progressed or relapsed after first-line oxaliplatin-based or irinotecan-based treatment received bevacizumab 2.5 mg/kg/week plus chemotherapy until disease progression. The primary endpoint was disease-control rate (DCR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety.ResultsFifty-three patients (66% men; median age, 62 years old) received second-line bevacizumab plus folinic acid, fluorouracil, and irinotecan (FOLFIRI; 57%), folinic acid, fluorouracil, oxaliplatin (FOLFOX; 26%), irinotecan (15%), or capecitabine plus irinotecan (XELIRI; 2%). The DCR was 87% (95% CI, 77%-97%); ORR was 32% (95% CI, 19%-46%). Median PFS was 6.5 months (95% CI, 5.8-7.8 months) and median OS 19.3 months, (95% CI, 14.2-25.1 months).The most frequent grade 3/4 adverse events included neutropenia (21%), diarrhea (15%), asthenia, and vomiting (9% each). Five patients (9%) had grade 3/4 targeted toxicities: grade 3 hypertension (n = 2), grade 3 venous thromboembolism (n = 2), and grade 4 arterial thromboembolism (n = 1). None of these events led to death during the study.ConclusionBevacizumab plus standard second-line chemotherapy is highly active in patients with mCRC and has an acceptable safety profile.     

Phase II Trial of Combination Nab-paclitaxel and Gemcitabine in Non–squamous Non–small Cell Lung Cancer After Progression on Platinum and Pemetrexed

BackgroundBetter therapies are needed to improve survival in metastatic non–small cell lung cancer (NSCLC). Given the synergy of combination nab-paclitaxel and gemcitabine in metastatic pancreatic cancer and their individual activity in advanced NSCLC, we sought to determine whether the same combination would confer a therapeutic benefit in the second-line therapy of recurrent or metastatic non–squamous (NSQ) NSCLC.Materials and MethodsThis single-arm phase II trial of nab-paclitaxel and gemcitabine was performed from June 2015 to April 2020 at an academic referral cancer center. Patients with advanced NSQ-NSCLC whose disease progressed on first-line pemetrexed plus platinum +/- immunotherapy were enrolled. Patients received intravenous nab-paclitaxel 100 mg/m² and gemcitabine 1000 mg/m² on days 1 and 8 of each 21-day cycle. The primary endpoint was objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Safety and tolerability were evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.ResultsThirty-seven patients (15 men [41%] and 22 women [59%]; median age, 66 years [range, 41-81 years]) were accrued. ORR was 13.5% (95% CI, 2.5-24.5%). DCR was 59.5% (95% CI, 43.5-75.5%). Median PFS was 2.6 months (95% CI, 1.4-3.8 months). Median OS was 6.2 months (95% CI, 4.2-8.2 months). 1-year OS was 24% (95% CI, 10-38%). Safety and tolerability were similar to other second-line chemotherapies, although there was an 11% incidence of grade 2-3 pneumonitis.ConclusionCombination nab-paclitaxel and gemcitabine after platinum and pemetrexed for NSQ-NSCLC was not associated with greater efficacy than would be expected for single-agent chemotherapy in this setting. The higher-than-expected risk of pneumonitis was also concerning.Trial RegistrationClinicalTrials.gov Identifier: NCT02303977Micro-AbstractIn this phase II trial, 37 patients with metastatic non–squamous non–small cell lung cancer were treated with nab-paclitaxel/gemcitabine in second-line. ORR = 13.5% (95% CI, 2.5%-24.5%). Median PFS = 2.6 months (95% CI, 1.4-3.8 months). Median OS = 6.2 months (95% CI, 4.2-8.2 months). Nab-paclitaxel and gemcitabine was not associated with greater efficacy than would be expected for single-agent chemotherapy in this setting.     

PD-1单抗治疗晚期肿瘤的临床疗效

目的:观察PD-1单抗治疗晚期肿瘤的临床疗效及安全性。方法:回顾性分析PD-1单抗治疗48 例晚期肿瘤患者的临床效果,评价其客观有效率、无疾病进展生存期、总生存期及不良反应。结果:48 例患者在接受PD-1单抗2周期治疗后,完全缓解（CR）0例,部分缓解（PR）3例,疾病稳定（SD）33例,疾病进展（PD）12例,客观有效率（ORR）为6.25%,疾病控制率（DCR）为75%。截至随访结束,33例出现无进展生存期（PFS） 终点事件,12例出现总生存期（OS）终点事件,全组客观有效率（ORR）为6.25%,疾病控制率（DCR）为75%,中位 PFS 为106.5天,中位OS为185天。肺癌亚组客观有效率（ORR）为4.55%,疾病控制率（DCR）为81.8%,中位PFS为106.5天,中位OS为202天。全组不良反应发生率为 31.2%,主要为恶心呕吐7 例（14.5%）,骨髓抑制5例（10.4%）,发热2例（4.2%）,皮疹1例（2.1％）,肝功能损害 2例（4.2％）。结论:PD-1单抗治疗晚期肿瘤具有一定疗效,患者耐受性良好。     

晚期胰腺癌常用一线化疗方案真实世界临床疗效观察

目的:比较白蛋白结合型紫杉醇联合吉西他滨(AG)、白蛋白结合型紫杉醇联合替吉奥(AS)、吉西他滨联合奥沙利铂(GEMOX)、吉西他滨联合替吉奥(GS)方案在真实世界一线治疗晚期胰腺癌的有效性及安全性。方法:回顾性分析2016年1月至2021年6月于我院诊治的165例晚期胰腺癌患者的病例资料,根据化疗方案不同分为四组：AG组(n=40)、AS组(n=31)、GEMOX组(n=31)、GS组(n=63),按照实体肿瘤临床疗效评价标准(RECIST)1.1版本评估临床疗效和常见不良事件评价标准(CTCAE)5.0版本评估患者的不良反应,主要研究终点为总生存期(overall survival, OS)和无进展生存期(progression-free survival, PFS),次要研究终点为客观缓解率(objective response rate, ORR)和疾病控制率(disease control rate, DCR)以及治疗相关不良反应,采用Cox风险比例模型分析影响患者预后的因素。结果:165例患者的中位OS时间为10.5个月,中位PFS时间为6.0个月,AG、AS、GEMOX、...     

Real World First-Line Treatments and Outcomes of Nab-Paclitaxel Plus Gemcitabine,mFOLFIRINOX and GEMOX in Unresectable Pancreatic Cancer from a Chinese Single Institution

Background: There have not been any head-to-head prospective studies to compare the effects of different chemotherapy regimens as first-line treatments for unresectable pancreatic cancer (UPC). We aimed to compare the effectiveness of nab-paclitaxel plus gemcitabine, mFOLFIRINOX and gemcitabine plus oxaliplatin (GEMOX) as first-line treatments by using real-world data from Chinese patients. Methods: We retrospectively included patients with UPC treated with nab-paclitaxel plus gemcitabine, mFOLFIRINOX or GEMOX as a first-line treatment at Sun Yat-sen University Cancer Center. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were assessed. Results: A total of 117 patients were administered nab-paclitaxel plus gemcitabine (n = 62), mFOLFIRINOX (n = 30) or GEMOX (n = 25) as first-line chemotherapy. The median OS was 11.1, 10.1 and 10.2 months (p = 0.75) in the nab-paclitaxel plus gemcitabine, mFOLFIRINOX and GEMOX, respectively. The ORR was similar among the three groups (24%, 23% and 32%, p = 0.76) and the DCR was higher in the nab-paclitaxel-gemcitabine group (82%) than the other two groups (60% and 64%, p = 0.04). The most common adverse events of grade 3 or 4 were neutropenia (32%, 28% and 5%), peripheral neuropathy (13%, 16% and 0) and fatigue (9%, 16% and 5%). Febrile neutropenia occurred in 2%, 4% and 5% of the patients in the three groups. Conclusion: In the first line treatment of UPC, our results suggest that nab-paclitaxel plus gemcitabine was associated with a higher DCR than mFOLFIRINOX or GEMOX, while all groups demonstrated similar OS, PFS and ORR.