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1.
Cancer Med ; 13(10): e7203, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38769930

RESUMO

OBJECTIVE: To explore the efficacy of serplulimab plus chemotherapy in esophageal squamous cell carcinoma (ESCC) patients with liver metastases. METHODS: A post hoc exploratory analysis of ASTRUM-007 study was performed, focusing on the association between the liver metastases status and the clinical outcomes. A systematic literature search of electronic databases was conducted to identify eligible randomized controlled trials for the meta-analysis. Study-level pooled analyses of hazard ratios (HRs) for PFS according to liver metastases were performed. RESULTS: The post hoc analysis of ASTRUM-007 showed that although patients with liver metastases had a worse prognosis comparing with the non-liver metastases patients in both treatment arms (serplulimab plus chemotherapy arm: median PFS, 5.7 vs. 6.6 months, HR 1.57 [95% CI, 1.15-2.13]; median OS, 13.7 vs. 15.3 months, HR 1.48 [95% CI, 1.09-1.98]; placebo plus chemotherapy arm: median PFS, 4.3 vs. 5.5 months, HR 1.58 [95% CI, 1.01-2.39]; median OS, 10.3 vs. 11.2 months, HR 1.32 [95% CI, 0.84-2.00]), OS and PFS benefits derived from serplulimab plus chemotherapy versus placebo plus chemotherapy in this study were observed in both patients with liver metastases (HR of PFS: 0.60; 95% CI, 0.37-0.97; HR of OS: 0.68; 95% CI, 0.43-1.11) and the non-liver metastases patients (HR of PFS: 0.62; 95% CI, 0.49-0.80; HR of OS: 0.69; 95% CI, 0.55-0.87) with similar magnitude. Three randomized controlled trials were included in the meta-analysis. Pooled HRs demonstrated that the addition of anti-PD-1 antibodies significantly improved PFS compared to chemotherapy alone regardless of liver metastases status. CONCLUSIONS: This study reveals that the presence of liver metastases is a poor prognostic factor but does not affect the improvements in both PFS and OS brought by adding PD-1 blockade to chemotherapy in ESCC patients. Predictive biomarkers for survival in these patients warrant further investigation.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Esofágicas , Carcinoma de Células Escamosas do Esôfago , Neoplasias Hepáticas , Humanos , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/mortalidade , Carcinoma de Células Escamosas do Esôfago/tratamento farmacológico , Carcinoma de Células Escamosas do Esôfago/secundário , Carcinoma de Células Escamosas do Esôfago/mortalidade , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Esofágicas/tratamento farmacológico , Neoplasias Esofágicas/patologia , Neoplasias Esofágicas/mortalidade , Masculino , Inibidores de Checkpoint Imunológico/uso terapêutico , Feminino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Idoso , Resultado do Tratamento , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/administração & dosagem
2.
Nat Med ; 29(2): 473-482, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36732627

RESUMO

First-line systemic therapeutic options for advanced esophageal squamous cell carcinoma (ESCC) are limited. In this multicenter, double-blind phase 3 trial, a total of 551 patients with previously untreated, locally advanced or metastatic ESCC and PD-L1 combined positive score of ≥1 were randomized (2:1) to receive serplulimab (an anti-PD-1 antibody; 3 mg/kg) or placebo (on day 1), plus cisplatin (50 mg/m2) (on day 1) and continuous infusion of 5-fluorouracil (1,200 mg/m2) (on days 1 and 2), once every 2 weeks. The study met the primary endpoints. At the prespecified final analysis of progression-free survival (PFS) assessed by the blinded independent radiological review committee, serplulimab plus chemotherapy significantly improved PFS compared with placebo plus chemotherapy (median PFS of 5.8 months and 5.3 months, respectively; hazard ratio, 0.60; 95% confidence interval, 0.48-0.75; P < 0.0001). At the prespecified interim analysis of overall survival (OS), serplulimab plus chemotherapy also significantly prolonged OS compared with placebo plus chemotherapy (median OS of 15.3 months and 11.8 months, respectively; hazard ratio, 0.68; 95% confidence interval, 0.53-0.87; P = 0.0020). Grade 3 or higher treatment-related adverse events occurred in 201 (53%) and 81 (48%) patients in the serplulimab plus chemotherapy group and the placebo plus chemotherapy group, respectively. Serplulimab plus chemotherapy administered every 2 weeks significantly improved PFS and OS in patients with previously untreated, PD-L1-positive advanced ESCC, with a manageable safety profile. This study is registered with ClinicalTrials.gov ( NCT03958890 ).


Assuntos
Neoplasias Esofágicas , Carcinoma de Células Escamosas do Esôfago , Humanos , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Antígeno B7-H1/uso terapêutico , Cisplatino , Método Duplo-Cego , Carcinoma de Células Escamosas do Esôfago/induzido quimicamente , Carcinoma de Células Escamosas do Esôfago/tratamento farmacológico
3.
Cell Rep Med ; 4(12): 101301, 2023 12 19.
Artigo em Inglês | MEDLINE | ID: mdl-38016482

RESUMO

We report a multicenter, phase 2 study evaluating the efficacy of pucotenlimab, an anti-PD-1 antibody, in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, and potential biomarkers for response. Overall, 100 patients with previously treated, advanced solid tumors centrally confirmed as dMMR or MSI-H received pucotenlimab at 200 mg every 3 weeks. The most common cancer type is colorectal cancer (n = 71). With a median follow-up of 22.5 months, the objective response rate is 49.0% (95% confidence interval 38.86%-59.20%) as assessed by the independent review committee, while the median progression-free survival and overall survival have not been reached. Grade ≥3 treatment-related adverse events were observed in 18 patients. For the biomarker analysis, responders are enriched in patients with mutations in the KMT2D gene. Pucotenlimab is an effective treatment option for previously treated advanced dMMR/MSI-H solid tumors, and the predictive value of KMT2D mutation warrants further research. This study is registered with ClinicalTrials.gov: NCT03704246.


Assuntos
Neoplasias Colorretais , Instabilidade de Microssatélites , Humanos , Reparo de Erro de Pareamento de DNA/genética , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/genética , Resultado do Tratamento
4.
Zhonghua Zhong Liu Za Zhi ; 33(10): 783-6, 2011 Oct.
Artigo em Zh | MEDLINE | ID: mdl-22335913

RESUMO

OBJECTIVE: The aim of this study was to analyze the clinical characteristics and prognostic factors in patients with cancer of unknown primary site (CUP). METHODS: The clinical and follow-up data of 68 CUP patients (46 adenocarcinoma patients, 22 squamous cell carcinoma patients), were retrospectively analyzed. Univariate and multivariate analysis were conducted to determine the correlation of survival with clinical features, tumor markers, blood test, liver function and so on. RESULTS: The median survival time of the 68 CUP patients was 123 days. The results from univariate Cox regression analysis showed that the prognostic factors were related to a performance status, presence or absence of liver metastases, the number of metastatic sites, carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH), hypoalbuminemia, hypohemoglobinemia and lymphocyte count. Multivariate Cox regression analysis of the clinical factors identified that a performance status (PS) ≥ 2, liver metastasis, elevated serum carcinoembryonic antigen (CEA) and lactate dehydrogenase (LDH) levels, hypoalbuminemia (< 35 g/L) and lymphopenia (≤ 0.7 × 10(9)/L) were significant independent unfavorable predictive factors. Based on the number of the unfavorable predictive factors, we divided all the patients into three subgroups: subgroup involving 0-1 unfavorable factor, subgroup involving 2 - 3 unfavorable factors and subgroup involving 4 - 6 unfavorable factors. The median survival time was 390 days, 138 days and 77 days, respectively, in the 3 subgroups. Compared with the other two groups, the survival of the subgroup involving 0 - 1 unfavorable factor was significantly longer (P < 0.05), the survival between the subgroup involving 2 - 3 unfavorable factors and subgroup involving 4 - 6 unfavorable factors was not significantly different (P > 0.05). CONCLUSIONS: A performance status ≥ 2, liver metastasis, elevated serum carcinoembryonic antigen and lactate dehydrogenase levels, hypoalbuminemia and lymphopenia are independent unfavorable prognostic factors in patients with cancer of unknown primary site. The patients who had more than 2 unfavorable prognostic factors have a worse prognosis.


Assuntos
Adenocarcinoma/secundário , Carcinoma de Células Escamosas/secundário , Neoplasias Hepáticas/secundário , Neoplasias Primárias Desconhecidas , Adenocarcinoma/sangue , Adenocarcinoma/patologia , Adenocarcinoma/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antígeno Carcinoembrionário/sangue , Carcinoma de Células Escamosas/sangue , Carcinoma de Células Escamosas/patologia , Carcinoma de Células Escamosas/terapia , Feminino , Seguimentos , Humanos , L-Lactato Desidrogenase/sangue , Contagem de Leucócitos , Neoplasias Pulmonares/secundário , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Neoplasias Primárias Desconhecidas/sangue , Neoplasias Primárias Desconhecidas/patologia , Neoplasias Primárias Desconhecidas/terapia , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Albumina Sérica/metabolismo , Análise de Sobrevida , Adulto Jovem
5.
J Immunother Cancer ; 8(2)2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33060149

RESUMO

BACKGROUND: Irinotecan is used as second-line treatment in advanced gastric or gastroesophageal junction (G/GEJ) cancer. The role of anti-programmed death-1 (PD-1) antibody plus irinotecan, in this setting and population is unclear. METHODS: This multicenter, open-label, single-arm, phase II trial was conducted in 11 Chinese hospitals. Eligible patients had histologically confirmed advanced G/GEJ cancer that refractory to, or intolerant of, first-line chemotherapy with a platinum and/or fluoropyrimidine. Subjects received HX008 200 mg intravenously every 3 weeks plus irinotecan 160 mg/m2 intravenously every 2 weeks until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) as assessed according to Response Evaluation Criteria In Solid Tumors V.1.1. RESULTS: Between October 2018 and September 2019, a total of 58 patients with advanced G/GEJ cancer were enrolled in this study. Median follow-up was 10.5 months (range 7.4-18.9) months. Confirmed ORR was observed in 16 patients, for an ORR of 27.6% (95% CI 16.1% to 39.1%); 19 patients experienced stable disease, leading to a disease control rate of 60.3% (95% CI 46.4% to 73.0%). ORR in patients with PD-ligand 1 (L1) positive (Combined Positive Score (CPS) ≥1) and negative (CPS<1) tumors was 38.5% (5/13) and 37.5% (3/8), respectively. Median duration of response was 8.0 months (range 1.5-12.5), 6 of 16 (37.5%) responses were ongoing. Median progression-free survival (PFS) was 4.2 months (95% CI 2.2 to 5.5). Median overall survival (OS) was not reached (NR) (95% CI 8.7 to NR). Patients with PD-L1 positive tumors tended to have longer OS than those with PD-L1 negative tumors, but the difference was not statistically significant (NR vs 8.7 months, p=0.1858).The most common treatment-related adverse events of grade 3 or 4 included neutropenia (32.8%), leukopenia (31.0%), anemia (17.2%), decreased appetite (8.6%), vomit (6.9%), nausea (6.9%) and fatigue (5.2%). There were no treatment-related deaths. CONCLUSION: The combination of HX008 and irinotecan demonstrated promising activity and manageable safety as second-line treatment in patients with advanced G/GEJ cancer, which warrants further study. TRIAL REGISTRATION NUMBER: NCT03704246.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Neoplasias Esofágicas/tratamento farmacológico , Junção Esofagogástrica/patologia , Irinotecano/uso terapêutico , Neoplasias Gástricas/tratamento farmacológico , Adulto , Idoso , Anticorpos Monoclonais Humanizados/farmacologia , Feminino , Humanos , Irinotecano/farmacologia , Masculino , Pessoa de Meia-Idade
7.
Chin J Integr Med ; 12(3): 175-9, 2006 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-17005076

RESUMO

OBJECTIVE: To explore the effect and possible mechanism of traditional Chinese medicine (TCM) on survival and quality of life (QOL) in patients with esophageal carcinoma after esophagectomy. METHODS: Adopting prospective controlled method of study, the authors had 128 post-esophagectomy patients, hospitalized from February 2001 to February 2002, randomly divided into 3 groups: the TCM group, treated with TCM drugs alone; the chemotherapy group, with chemotherapy alone applied; and the synthetic group, treated with chemotherapy combined with Chinese medicine. Their survival rate and QOL were compared. RESULTS: In the TCM group, the chemotherapy group and the synthetic group, the respective 3-year relapse and remote metastasis rate were 71.4%, 76.7%, 53.4%, respectively (chi(2) = 6.53, P < 0.05); the 1-year survival rate 42.9%, 46.5%, 72.1%; 2-year survival rate 28.6%, 27.9%, 55.8%, and 3-year survival rate 26.2%, 23.1%, 37.2%, respectively. And the QOL improving rate was 69.0%, 37.2%, 58.1%, respectively, all showing significant difference among them (chi(2) = 6.10, all P < 0.05). Moreover, immune function was increased in the TCM and the synthetic groups. CONCLUSION: Integrative Chinese and Western medicinal treatment was the beneficial choice for post-operational patients with esophageal carcinoma. However, long time use of simple Chinese medicine was also advisable, especially for those in poverty.


Assuntos
Medicamentos de Ervas Chinesas/administração & dosagem , Neoplasias Esofágicas , Esofagectomia , Qualidade de Vida , Adulto , Idoso , Medicamentos de Ervas Chinesas/efeitos adversos , Neoplasias Esofágicas/tratamento farmacológico , Neoplasias Esofágicas/mortalidade , Neoplasias Esofágicas/cirurgia , Feminino , Seguimentos , Humanos , Sistema Imunitário/efeitos dos fármacos , Imunoglobulinas/sangue , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/mortalidade , Estudos Prospectivos , Taxa de Sobrevida , Subpopulações de Linfócitos T
8.
J Cancer Res Ther ; 10 Suppl 1: 46-51, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25207891

RESUMO

OBJECTIVE: To evaluate the clinical efficacy of Kanglaite (KLT) injection combined with chemotherapy versus chemotherapy alone in the treatment of advanced non-small cell lung carcinoma (NSCLC) by meta-analysis. MATERIALS AND METHODS: Electronic search of PubMed, EMBASE, Chinese National Knowledge Infrastructure (CNKI) and Wanfang databases was conducted to select studies about KLT injection combined with chemotherapy versus chemotherapy alone in the treatment of advanced NSCLC. The pooled risk ratio (RR) and its 95% confidence interval (95% CI) for objective response rate (ORR), Karnofsky (KPS) score improvement and nausea and vomiting were calculated by Stata11.0 statistical software. RESULT: Finally, we included 34 clinical trials in this meta-analysis. The pooled results suggested that KLT injection combined with systematic chemotherapy can significantly increase the objective response rate (ORR) [RR = 1.35, 95% CI: 1.23-1.48, (Z = 6.43, P = 0.000)], the quality of patients' life (KSP improvement) [RR = 2.04, 95% CI: 1.79-2.33, (Z = 10.57, P = 0.000)] and decrease the risk ratio of gastrointestinal reaction [RR = 0.53, 95% CI: 0.42-0.66, (Z = 5.53, P = 0.000)] compared with chemotherapy alone. CONCLUSION: KLT injection combined with chemotherapy can improve the short-term efficacy, performance status and decrease the risk of gastrointestinal reaction compared with systematic chemotherapy alone.


Assuntos
Antineoplásicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma Pulmonar de Células não Pequenas/patologia , Tratamento Farmacológico , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Avaliação de Estado de Karnofsky , Estadiamento de Neoplasias , PubMed
9.
Artigo em Inglês | MEDLINE | ID: mdl-24146487

RESUMO

We studied the in vitro anti-tumor activity of Bidens Bipinnata L. extract. MTT assay was used to investigate the inhibitory effect of different concentrations of the extracts on human hepatocellular carcinoma (HepG2) cell lines and human cervical carcinoma (Hela) cell lines, and the IC50 values were calculated. The Bidens Bipinnata L. extract had different degrees of inhibitory effects on these two cells, and when exposure time was 48 h, the inhibition rate reached its peak, with IC50 values of 14.80 µg/mL and 13.50 µg/mL respectively. The Bidens Bipinnata L. extract had a good inhibitory effect on human HepG2 cell lines and Hela cell lines, and thus has certain development prospects.


Assuntos
Antineoplásicos Fitogênicos/uso terapêutico , Bidens , Hepatoblastoma/tratamento farmacológico , Neoplasias Hepáticas/tratamento farmacológico , Fitoterapia , Extratos Vegetais/uso terapêutico , Neoplasias do Colo do Útero/tratamento farmacológico , Antineoplásicos Fitogênicos/farmacologia , Feminino , Células HeLa , Células Hep G2 , Humanos , Concentração Inibidora 50 , Extratos Vegetais/farmacologia
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