BACKGROUND:Progression-free survival(PFS)has not been extensively investigated as a surrogate for survival in the firstline treatments of pancreatic cancer.The aim of this review was to evaluate PFS as a potential ...BACKGROUND:Progression-free survival(PFS)has not been extensively investigated as a surrogate for survival in the firstline treatments of pancreatic cancer.The aim of this review was to evaluate PFS as a potential surrogate endpoint for overall survival(OS)in advanced pancreatic cancer in trials comparing poly-chemotherapy to gemcitabine alone.DATA SOURCES: A systematic literature search in PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials was conducted. The key words included randomized trial, first-line chemotherapy, pancreatic cancer, gemcitabine and poly-chemotherapy. Adjusted weighted linear regression was used to calculate Rs (Spearman's rank-order correlation coefficient) between PFS and post-progression survival (PPS) with OS (Rs) and between treatment effects on PFS and OS (RHR). RESUEFS: A total of 30 trials including 8467 patients met the inclusion criteria. Correlation between the treatment effects on PFS and OS (RHR=0.78) and between the endpoint PFS and OS was high across all studies (Rs=0.75). The slope of the re- gression line was 0.76±0.26, indicating that an agent produc- ing a 10% risk reduction for PFS will provide a 7.6%±2.6% risk reduction for OS. Correlation between PPS and OS was very strong (Rs=0.71) and accounted for more than 50% of the whole OS variability (R2=0.57). CONCLUSION: Because of the robust correlation with OS and the potential influence of PPS caused by the second line therapies, it may be justified to consider PFS as a surrogate endpoint in trials evaluating new cytotoxic agents when gemcitabine is the control arm.展开更多
Glioblastoma-multiforme(GBM), the most aggressive glial tumor, has a worldwide age-adjusted incidence ranging from 0.59-3.69/100000 persons. Despite current multimodal-treatment approach, median-survival time and prog...Glioblastoma-multiforme(GBM), the most aggressive glial tumor, has a worldwide age-adjusted incidence ranging from 0.59-3.69/100000 persons. Despite current multimodal-treatment approach, median-survival time and progression-free survival(PFS) remains short. Glioblastomas display a variety of molecular alterations, which necessitates determining which of these have a prognostic significance. This is a case of a 45-yearold patient who presented with progressive slurring of speech and features of raised intracranial pressure. Computed tomography(CT) scan revealed a large heterogeneously enhancing lesion in the left front-temporalperisylvian region with solid, cystic areas, suggestive of malignant glioma. Partial tumor-excision was followed by concurrent chemo-radiotherapy. Histopathologically, the tumor was astrocytoma grade-IV. Patient had an extended PFS of 12 mo, with an overall survival of 26 mo. Primary-GBM was confirmed using molecular markers and the immunophenotypic signature was defined by evaluating systemic expression of human telomerase reverse transcriptase, interleukin-6, neutrophil-lymphocyte ratio, tissue inhibitor of metalloproteinases-1, human chitinase-3-like-protein-1(YKL-40) and high mobility group-A1. Current findings suggest that this signature can identify worst outcomes, independent of clinical criteria.展开更多
目的:通过检测三阴性乳腺癌(triple-negative breast cancer,TNBC)组织中肿瘤相关中性粒细胞(tumor-associated neutrophils,TANs)浸润密度及程序性死亡配体-1(PD-L1)的表达情况来分析二者的相关性,并探究其临床意义。方法:选取141例我...目的:通过检测三阴性乳腺癌(triple-negative breast cancer,TNBC)组织中肿瘤相关中性粒细胞(tumor-associated neutrophils,TANs)浸润密度及程序性死亡配体-1(PD-L1)的表达情况来分析二者的相关性,并探究其临床意义。方法:选取141例我院三阴性乳腺癌患者组织标本,使用抗体CD66b作为TANs的标记物,通过免疫组织化学法检测TNBC肿瘤组织内TANs浸润和PD-L1表达的情况。采用Pearson积差相关或Spearman等级相关分别分析TANs浸润密度和PD-L1表达与临床病理特征的相关性,以及TNBC肿瘤组织内TANs浸润密度与PD-L1阳性表达之间的相关性;采用Kaplan-Meier曲线对TNBC患者进行生存分析。结果:TANs高浸润密度与高Ki67增殖指数、高组织学分级以及淋巴结转移均呈正相关(P<0.05)。PD-L1表达与高Ki67增殖指数及高组织学分级均呈正相关(P<0.05)。TNBC中TANs的浸润密度与PD-L1阳性表达呈正相关(P<0.05)。生存分析显示,TANs浸润密度和PD-L1表达均与TNBC患者的无进展生存期呈负相关(P<0.05)。结论:TNBC肿瘤组织内TANs浸润密度和PD-L1表达与多项临床病理特征以及不良预后密切相关,这提示TANs及PD-L1可作为TNBC预后评估的重要指标,并为探索TNBC免疫治疗潜在靶点提供研究依据。展开更多
Interim Positron-Emission Tomography (int-PET) and the peripheral blood absolute lymphocyte/monocyte ratio at di- agnosis (ALC/AMC-DX) have been shown to be predictors for progression-free survival (PFS) and time to p...Interim Positron-Emission Tomography (int-PET) and the peripheral blood absolute lymphocyte/monocyte ratio at di- agnosis (ALC/AMC-DX) have been shown to be predictors for progression-free survival (PFS) and time to progression (TTP) in classical Hodgkin lymphoma (cHL). Therefore, we studied if the combination of ALC/AMC-DX and the (int-PET) can further stratified PFS and TTP in cHL patients. Patients were required to be diagnosed, treated, and followed with int-PET at Mayo Clinic, Rochester, Minnesota. From 2000 until 2008, 111 cHL patients qualified for the study. The median follow-up was 2.8 years (range: 0.3 - 10.4 years). Patients with a negative int-PET (N = 98) pre- sented with a higher ALC/AMC-DX (median of 2.32, range: 0.26 - 37.5) compared with patients with a positive int-PET (N = 13) (median of 0.9, range: 0.29 - 3.10), p 1.1. Group 1 experienced superior PFS and TTP in comparison with the other groups. In conclusion, the combination of ALC/AMC-DX and the int-PET provides a simple model to assess clinical outcomes in cHL.展开更多
目的:分析扶正抑瘤方联合程序性死亡受体1(programmed cell death protein,PD-1)和配体1(programmed cell death protein ligand1,PD-L1)抑制剂对晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)不同证型治疗效果。方法:对入选的13...目的:分析扶正抑瘤方联合程序性死亡受体1(programmed cell death protein,PD-1)和配体1(programmed cell death protein ligand1,PD-L1)抑制剂对晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)不同证型治疗效果。方法:对入选的137例接受扶正抑瘤方联合PD-1/PD-L1抑制剂的NSCLC患者进行分型,并收集患者的临床资料,统计无进展生存期(Progression-free Survival,PFS),并通过功能状态(Karnofsky,KPS)评分和中医证候积分对患者治疗4周后功能状态和证候变化进行评估分析。结果:入选患者中肺脾气虚30例(21.74%),气虚痰湿证46例(33.33%),气血瘀滞证34例(24.64%),气阴两虚证28例(20.29%)。总体中位PFS(media Progressionfree Survival,mPFS)为6.0个月(95%CI:4.5~8.4)。其中气血瘀滞证mPFS最高为7.8个月(95%CI:5.5~10.0),气阴两虚证mPFS最低仅为4.5个月(95%CI:3.0~4.8)。不同证型之间mPFS差异有统计学意义(χ^(2)=15.527,P<0.01)。治疗4周后客观缓解率(Objective Response Rate,ORR)为23.66%,疾病控制率(Disease Control Rate,DCR)为62.6%。四个证型组的患者治疗4周期后KPS评分总改善有效率为63.36%,其中气血瘀滞证患者KPS改善率最高,为76.67%,其次为气虚痰湿72.73%;气阴两虚证患者KPS改善率最低,为35.71%。四证型组差异有统计学意义,气虚痰湿和气血瘀滞明显高于气阴两虚(P<0.01)。四个证型组的患者治疗满4周期后中医积分改善有效率为63.36%。其中肺脾气虚有效率为34.48%;气虚痰湿有效率为36.36%;气血瘀滞有效率为60%;气阴两虚有效率为25%。四个证型有效率对比差异有统计学意义,气血瘀滞证明显高于其他证型(P<0.05)。患者不良反应发生率为83.97%。主要包括疲劳,皮肤瘙痒、红肿、水泡,肺炎,肝、肾、甲状腺、心脏功能异常、消化道不良反应和骨髓抑制。结论:非小细胞肺癌主要可分为肺脾气虚证、气虚痰湿证、气血瘀滞证、气阴两虚证,扶正抑瘤方联合PD-1/PD-L1抑制剂对不同证型治疗效果不一,气阴两虚证治疗效果最差,可考虑更换方剂。展开更多
Background Significant efforts have been made to identify factors that differentiate patients treated with novel therapies,such as bortezomib in multiple myeloma (MM).The exact expression pattern and prognostic valu...Background Significant efforts have been made to identify factors that differentiate patients treated with novel therapies,such as bortezomib in multiple myeloma (MM).The exact expression pattern and prognostic value of the cancer/testis antigen preferentially expressed antigen of melanoma (PRAME) in MM are unknown and were explored in this study.Methods The transcript level of PRAME was detected in bone marrow specimens from 100 newly diagnosed MM patients using real-time quantitative polymerase chain reaction,and the prognostic value of PRAME was determined through retrospective survival analysis.PRAME expression higher than the upper limit of normal bone marrow was defined as PRAME overexpression or PRAME (+).Results Sixty-two patients (62.0%) overexpressed PRAME.PRAME overexpression showed no prognostic significance to either overall survival (n=100) or progression-free survival (PFS,n=96,all P >0.05) of patients.The patients were also categorized according to regimens with or without bortezomib.PRAME overexpression tended to be associated with a lower two-year PFS rate in patients treated with non-bortezomib-containing regimens (53.5% vs.76.9%,P=0.071).By contrast,it was not associated with the two-year PFS rate in patients with bortezomib-containing regimens (77.5% vs.63.9%,P >0.05).When the patients were categorized into PRAME (+) and PRAME (-) groups,treatment with bortezomib-containing regimens predicted a higher two-year PFS rate in PRAME (+) patients (77.5% vs.53.5%,P=0.027) but showed no significant effect on two-year PFS rate in PRAME (-) patients (63.9% vs.76.9%,P >0.05).Conclusion PRAME overexpression might be an adverse prognostic factor of PFS in MM patients treated with non-bortezomib-containing regimens.Bortezomib improves PFS in patients overexpressing PRAME.展开更多
1文献来源Novello S, Kowalski DM, Luft A, et al.Pembrolizumab plus chemotherapy in squamous nonsmall-cell lung cancer:5-year update of the phaseⅢKEYNOTE-407 study[J]. J Clin Oncol,2023,41(11):1999-2006.2证据水平1b。3...1文献来源Novello S, Kowalski DM, Luft A, et al.Pembrolizumab plus chemotherapy in squamous nonsmall-cell lung cancer:5-year update of the phaseⅢKEYNOTE-407 study[J]. J Clin Oncol,2023,41(11):1999-2006.2证据水平1b。3背景对全球性随机Ⅲ期KEYNOTE-407研究的初步分析表明,与安慰剂联合化疗相比。展开更多
Objective: To examine the effect of a Chinese medicinal herbal formula (Feitai Capsule, 肺泰胶囊) on the quality of life (QOL) and progression-free survival (PFS) of patients with unresectable non-small cell lu...Objective: To examine the effect of a Chinese medicinal herbal formula (Feitai Capsule, 肺泰胶囊) on the quality of life (QOL) and progression-free survival (PFS) of patients with unresectable non-small cell lung cancer (NSCLC). Methods: Sixty-two patients were randomly divided into the treatment group (31 cases) and the control group (31 cases). For the treatment group, 4 capsules (1.2 g/capsule) of Feitai Capsule were administered 3 times a day after meals for 3 weeks; then no drug was administered for 1 week. This schedule was continued for at least 3 more cycles (12 weeks totally). If there were no obvious toxic reactions, the treatment was extended. The patients were evaluated at least once every 8 weeks until progressive dJsease (PD). For the control group, the regular follow-up and evaluation were performed at least once every 8 weeks until PD. Clinical symptoms, objective response, physical constitution and energy, QOL, and PFS were evaluated regularly. Analysis of variance (ANOVA), a non-parametric test, and analysis of covariance were used to compare clinical features, amelioration of clinical symptoms, physical constitution and energy, and QOL. Kaplan- Meier analysis was used to compare the two-group PFS. Results: Sixty patients finished the final evaluation, with 30 patients in each group. Baseline characters between groups were not significantly different (P〉0.05). The control group had a 36.7% improvement in clinical symptoms, while the treatment group had a 73.3% improvement. This difference was statistically significant (Z=-2.632, P=0.008). The control group had a 26.7% improvement in the Karnofsky performance status (KPS), while the treatment group had a 53.4% improvement. This was also significantly different (Z=-2.182, P=0.029). A comparative analysis indicated a positive correlation (r=0.917, P〈0.001). Compared with the control group, QOL in the treatment group was significantly improved, except in the social/family condition and doctor-patient relationship indicators. The PFS of the treatment group and control group were 6.23 months and 4.67 months, respectively (P=0.048). Conclusion: Feitai Capsule, a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients.展开更多
文摘BACKGROUND:Progression-free survival(PFS)has not been extensively investigated as a surrogate for survival in the firstline treatments of pancreatic cancer.The aim of this review was to evaluate PFS as a potential surrogate endpoint for overall survival(OS)in advanced pancreatic cancer in trials comparing poly-chemotherapy to gemcitabine alone.DATA SOURCES: A systematic literature search in PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials was conducted. The key words included randomized trial, first-line chemotherapy, pancreatic cancer, gemcitabine and poly-chemotherapy. Adjusted weighted linear regression was used to calculate Rs (Spearman's rank-order correlation coefficient) between PFS and post-progression survival (PPS) with OS (Rs) and between treatment effects on PFS and OS (RHR). RESUEFS: A total of 30 trials including 8467 patients met the inclusion criteria. Correlation between the treatment effects on PFS and OS (RHR=0.78) and between the endpoint PFS and OS was high across all studies (Rs=0.75). The slope of the re- gression line was 0.76±0.26, indicating that an agent produc- ing a 10% risk reduction for PFS will provide a 7.6%±2.6% risk reduction for OS. Correlation between PPS and OS was very strong (Rs=0.71) and accounted for more than 50% of the whole OS variability (R2=0.57). CONCLUSION: Because of the robust correlation with OS and the potential influence of PPS caused by the second line therapies, it may be justified to consider PFS as a surrogate endpoint in trials evaluating new cytotoxic agents when gemcitabine is the control arm.
基金Supported by M.P.Biotech Council,M.P.for financial assistance and BMHRC for infrastructural facilities,No.249
文摘Glioblastoma-multiforme(GBM), the most aggressive glial tumor, has a worldwide age-adjusted incidence ranging from 0.59-3.69/100000 persons. Despite current multimodal-treatment approach, median-survival time and progression-free survival(PFS) remains short. Glioblastomas display a variety of molecular alterations, which necessitates determining which of these have a prognostic significance. This is a case of a 45-yearold patient who presented with progressive slurring of speech and features of raised intracranial pressure. Computed tomography(CT) scan revealed a large heterogeneously enhancing lesion in the left front-temporalperisylvian region with solid, cystic areas, suggestive of malignant glioma. Partial tumor-excision was followed by concurrent chemo-radiotherapy. Histopathologically, the tumor was astrocytoma grade-IV. Patient had an extended PFS of 12 mo, with an overall survival of 26 mo. Primary-GBM was confirmed using molecular markers and the immunophenotypic signature was defined by evaluating systemic expression of human telomerase reverse transcriptase, interleukin-6, neutrophil-lymphocyte ratio, tissue inhibitor of metalloproteinases-1, human chitinase-3-like-protein-1(YKL-40) and high mobility group-A1. Current findings suggest that this signature can identify worst outcomes, independent of clinical criteria.
文摘目的:通过检测三阴性乳腺癌(triple-negative breast cancer,TNBC)组织中肿瘤相关中性粒细胞(tumor-associated neutrophils,TANs)浸润密度及程序性死亡配体-1(PD-L1)的表达情况来分析二者的相关性,并探究其临床意义。方法:选取141例我院三阴性乳腺癌患者组织标本,使用抗体CD66b作为TANs的标记物,通过免疫组织化学法检测TNBC肿瘤组织内TANs浸润和PD-L1表达的情况。采用Pearson积差相关或Spearman等级相关分别分析TANs浸润密度和PD-L1表达与临床病理特征的相关性,以及TNBC肿瘤组织内TANs浸润密度与PD-L1阳性表达之间的相关性;采用Kaplan-Meier曲线对TNBC患者进行生存分析。结果:TANs高浸润密度与高Ki67增殖指数、高组织学分级以及淋巴结转移均呈正相关(P<0.05)。PD-L1表达与高Ki67增殖指数及高组织学分级均呈正相关(P<0.05)。TNBC中TANs的浸润密度与PD-L1阳性表达呈正相关(P<0.05)。生存分析显示,TANs浸润密度和PD-L1表达均与TNBC患者的无进展生存期呈负相关(P<0.05)。结论:TNBC肿瘤组织内TANs浸润密度和PD-L1表达与多项临床病理特征以及不良预后密切相关,这提示TANs及PD-L1可作为TNBC预后评估的重要指标,并为探索TNBC免疫治疗潜在靶点提供研究依据。
文摘Interim Positron-Emission Tomography (int-PET) and the peripheral blood absolute lymphocyte/monocyte ratio at di- agnosis (ALC/AMC-DX) have been shown to be predictors for progression-free survival (PFS) and time to progression (TTP) in classical Hodgkin lymphoma (cHL). Therefore, we studied if the combination of ALC/AMC-DX and the (int-PET) can further stratified PFS and TTP in cHL patients. Patients were required to be diagnosed, treated, and followed with int-PET at Mayo Clinic, Rochester, Minnesota. From 2000 until 2008, 111 cHL patients qualified for the study. The median follow-up was 2.8 years (range: 0.3 - 10.4 years). Patients with a negative int-PET (N = 98) pre- sented with a higher ALC/AMC-DX (median of 2.32, range: 0.26 - 37.5) compared with patients with a positive int-PET (N = 13) (median of 0.9, range: 0.29 - 3.10), p 1.1. Group 1 experienced superior PFS and TTP in comparison with the other groups. In conclusion, the combination of ALC/AMC-DX and the int-PET provides a simple model to assess clinical outcomes in cHL.
文摘目的:分析扶正抑瘤方联合程序性死亡受体1(programmed cell death protein,PD-1)和配体1(programmed cell death protein ligand1,PD-L1)抑制剂对晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)不同证型治疗效果。方法:对入选的137例接受扶正抑瘤方联合PD-1/PD-L1抑制剂的NSCLC患者进行分型,并收集患者的临床资料,统计无进展生存期(Progression-free Survival,PFS),并通过功能状态(Karnofsky,KPS)评分和中医证候积分对患者治疗4周后功能状态和证候变化进行评估分析。结果:入选患者中肺脾气虚30例(21.74%),气虚痰湿证46例(33.33%),气血瘀滞证34例(24.64%),气阴两虚证28例(20.29%)。总体中位PFS(media Progressionfree Survival,mPFS)为6.0个月(95%CI:4.5~8.4)。其中气血瘀滞证mPFS最高为7.8个月(95%CI:5.5~10.0),气阴两虚证mPFS最低仅为4.5个月(95%CI:3.0~4.8)。不同证型之间mPFS差异有统计学意义(χ^(2)=15.527,P<0.01)。治疗4周后客观缓解率(Objective Response Rate,ORR)为23.66%,疾病控制率(Disease Control Rate,DCR)为62.6%。四个证型组的患者治疗4周期后KPS评分总改善有效率为63.36%,其中气血瘀滞证患者KPS改善率最高,为76.67%,其次为气虚痰湿72.73%;气阴两虚证患者KPS改善率最低,为35.71%。四证型组差异有统计学意义,气虚痰湿和气血瘀滞明显高于气阴两虚(P<0.01)。四个证型组的患者治疗满4周期后中医积分改善有效率为63.36%。其中肺脾气虚有效率为34.48%;气虚痰湿有效率为36.36%;气血瘀滞有效率为60%;气阴两虚有效率为25%。四个证型有效率对比差异有统计学意义,气血瘀滞证明显高于其他证型(P<0.05)。患者不良反应发生率为83.97%。主要包括疲劳,皮肤瘙痒、红肿、水泡,肺炎,肝、肾、甲状腺、心脏功能异常、消化道不良反应和骨髓抑制。结论:非小细胞肺癌主要可分为肺脾气虚证、气虚痰湿证、气血瘀滞证、气阴两虚证,扶正抑瘤方联合PD-1/PD-L1抑制剂对不同证型治疗效果不一,气阴两虚证治疗效果最差,可考虑更换方剂。
文摘Background Significant efforts have been made to identify factors that differentiate patients treated with novel therapies,such as bortezomib in multiple myeloma (MM).The exact expression pattern and prognostic value of the cancer/testis antigen preferentially expressed antigen of melanoma (PRAME) in MM are unknown and were explored in this study.Methods The transcript level of PRAME was detected in bone marrow specimens from 100 newly diagnosed MM patients using real-time quantitative polymerase chain reaction,and the prognostic value of PRAME was determined through retrospective survival analysis.PRAME expression higher than the upper limit of normal bone marrow was defined as PRAME overexpression or PRAME (+).Results Sixty-two patients (62.0%) overexpressed PRAME.PRAME overexpression showed no prognostic significance to either overall survival (n=100) or progression-free survival (PFS,n=96,all P >0.05) of patients.The patients were also categorized according to regimens with or without bortezomib.PRAME overexpression tended to be associated with a lower two-year PFS rate in patients treated with non-bortezomib-containing regimens (53.5% vs.76.9%,P=0.071).By contrast,it was not associated with the two-year PFS rate in patients with bortezomib-containing regimens (77.5% vs.63.9%,P >0.05).When the patients were categorized into PRAME (+) and PRAME (-) groups,treatment with bortezomib-containing regimens predicted a higher two-year PFS rate in PRAME (+) patients (77.5% vs.53.5%,P=0.027) but showed no significant effect on two-year PFS rate in PRAME (-) patients (63.9% vs.76.9%,P >0.05).Conclusion PRAME overexpression might be an adverse prognostic factor of PFS in MM patients treated with non-bortezomib-containing regimens.Bortezomib improves PFS in patients overexpressing PRAME.
文摘1文献来源Novello S, Kowalski DM, Luft A, et al.Pembrolizumab plus chemotherapy in squamous nonsmall-cell lung cancer:5-year update of the phaseⅢKEYNOTE-407 study[J]. J Clin Oncol,2023,41(11):1999-2006.2证据水平1b。3背景对全球性随机Ⅲ期KEYNOTE-407研究的初步分析表明,与安慰剂联合化疗相比。
基金Supported by the Key Subject of People's Liberation Army Eleventh-Five-Year Traditional Chinese Medicine Clinical Research Program(No.2006051002)
文摘Objective: To examine the effect of a Chinese medicinal herbal formula (Feitai Capsule, 肺泰胶囊) on the quality of life (QOL) and progression-free survival (PFS) of patients with unresectable non-small cell lung cancer (NSCLC). Methods: Sixty-two patients were randomly divided into the treatment group (31 cases) and the control group (31 cases). For the treatment group, 4 capsules (1.2 g/capsule) of Feitai Capsule were administered 3 times a day after meals for 3 weeks; then no drug was administered for 1 week. This schedule was continued for at least 3 more cycles (12 weeks totally). If there were no obvious toxic reactions, the treatment was extended. The patients were evaluated at least once every 8 weeks until progressive dJsease (PD). For the control group, the regular follow-up and evaluation were performed at least once every 8 weeks until PD. Clinical symptoms, objective response, physical constitution and energy, QOL, and PFS were evaluated regularly. Analysis of variance (ANOVA), a non-parametric test, and analysis of covariance were used to compare clinical features, amelioration of clinical symptoms, physical constitution and energy, and QOL. Kaplan- Meier analysis was used to compare the two-group PFS. Results: Sixty patients finished the final evaluation, with 30 patients in each group. Baseline characters between groups were not significantly different (P〉0.05). The control group had a 36.7% improvement in clinical symptoms, while the treatment group had a 73.3% improvement. This difference was statistically significant (Z=-2.632, P=0.008). The control group had a 26.7% improvement in the Karnofsky performance status (KPS), while the treatment group had a 53.4% improvement. This was also significantly different (Z=-2.182, P=0.029). A comparative analysis indicated a positive correlation (r=0.917, P〈0.001). Compared with the control group, QOL in the treatment group was significantly improved, except in the social/family condition and doctor-patient relationship indicators. The PFS of the treatment group and control group were 6.23 months and 4.67 months, respectively (P=0.048). Conclusion: Feitai Capsule, a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients.