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1.
N Engl J Med ; 381(12): 1124-1135, 2019 09 19.
Artigo em Inglês | MEDLINE | ID: mdl-31150573

RESUMO

BACKGROUND: Platinum-based concurrent chemoradiotherapy is the standard of care for patients with locoregionally advanced nasopharyngeal carcinoma. Additional gemcitabine and cisplatin induction chemotherapy has shown promising efficacy in phase 2 trials. METHODS: In a parallel-group, multicenter, randomized, controlled, phase 3 trial, we compared gemcitabine and cisplatin as induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone. Patients with locoregionally advanced nasopharyngeal carcinoma were randomly assigned in a 1:1 ratio to receive gemcitabine (at a dose of 1 g per square meter of body-surface area on days 1 and 8) plus cisplatin (80 mg per square meter on day 1), administered every 3 weeks for three cycles, plus chemoradiotherapy (concurrent cisplatin at a dose of 100 mg per square meter every 3 weeks for three cycles plus intensity-modulated radiotherapy) or chemoradiotherapy alone. The primary end point was recurrence-free survival (i.e., freedom from disease recurrence [distant metastasis or locoregional recurrence] or death from any cause) in the intention-to-treat population. Secondary end points included overall survival, treatment adherence, and safety. RESULTS: A total of 480 patients were included in the trial (242 patients in the induction chemotherapy group and 238 in the standard-therapy group). At a median follow-up of 42.7 months, the 3-year recurrence-free survival was 85.3% in the induction chemotherapy group and 76.5% in the standard-therapy group (stratified hazard ratio for recurrence or death, 0.51; 95% confidence interval [CI], 0.34 to 0.77; P = 0.001). Overall survival at 3 years was 94.6% and 90.3%, respectively (stratified hazard ratio for death, 0.43; 95% CI, 0.24 to 0.77). A total of 96.7% of the patients completed three cycles of induction chemotherapy. The incidence of acute adverse events of grade 3 or 4 was 75.7% in the induction chemotherapy group and 55.7% in the standard-therapy group, with a higher incidence of neutropenia, thrombocytopenia, anemia, nausea, and vomiting in the induction chemotherapy group. The incidence of grade 3 or 4 late toxic effects was 9.2% in the induction chemotherapy group and 11.4% in the standard-therapy group. CONCLUSIONS: Induction chemotherapy added to chemoradiotherapy significantly improved recurrence-free survival and overall survival, as compared with chemoradiotherapy alone, among patients with locoregionally advanced nasopharyngeal carcinoma. (Funded by the Innovation Team Development Plan of the Ministry of Education and others; ClinicalTrials.gov number, NCT01872962.).


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimiorradioterapia , Cisplatino/administração & dosagem , Desoxicitidina/análogos & derivados , Quimioterapia de Indução , Carcinoma Nasofaríngeo/tratamento farmacológico , Adolescente , Adulto , Cisplatino/efeitos adversos , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Feminino , Humanos , Quimioterapia de Indução/efeitos adversos , Leucopenia/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Carcinoma Nasofaríngeo/terapia , Análise de Sobrevida , Adulto Jovem
2.
Chin J Cancer ; 36(1): 98, 2017 Dec 29.
Artigo em Inglês | MEDLINE | ID: mdl-29284539

RESUMO

BACKGROUND: According to the 7th edition of the American Joint Committee on Cancer (AJCC) staging system, over 50% of patients with nasopharyngeal carcinoma (NPC) have N1 disease at initial diagnosis. However, patients with N1 NPC are relatively under-researched, and the metastasis risk of this group is not well-stratified. This study aimed to evaluate the prognostic values of gross tumor volume of metastatic regional lymph node (GTVnd) and pretreatment serum copy number of Epstein-Barr virus (EBV) DNA in predicting distant metastasis of patients with N1 NPC, and to develop an integrated prognostic model that incorporates GTVnd and EBV DNA copy number for this group of patients. METHODS: The medical records of 787 newly diagnosed patients with nonmetastatic, histologically proven N1 NPC who were treated at Sun Yat-sen University Cancer Center between November 2009 and February 2012 were analyzed. Computed tomography-derived GTVnd was measured using the summation-of-area technique. Blood samples were collected before treatment to quantify plasma EBV DNA. The receiver operating characteristic (ROC) curve analysis was used to evaluate the cut-off point for GTVnd, and the area under the ROC curve was used to assess the predicted validity of GTVnd. The survival rates were assessed by Kaplan-Meier analysis, and the survival curves were compared using a log-rank test. Multivariate analysis was conducted using the Cox proportional hazard regression model. RESULTS: The 5-year distant metastasis-free survival (DMFS) rates for patients with GTVnd > 18.9 vs. ≤ 18.9 mL were 82.2% vs. 93.2% (P < 0.001), and for patients with EBV DNA copy number > 4000 vs. ≤ 4000 copies/mL were 83.5% vs. 93.9% (P < 0.001). After adjusting for GTVnd, EBV DNA copy number, and T category in the Cox regression model, both GTVnd > 18.9 mL and EBV DNA copy number > 4000 copies/mL were significantly associated with poor prognosis (both P < 0.05). According to combination of GTVnd and EBV DNA copy number, all patients were divided into low-, moderate-, and high-risk groups, with the 5-year DMFS rates of 96.1, 87.4, and 73.8%, respectively (P < 0.001). Multivariate analysis confirmed the prognostic value of this model for distant metastatic risk stratification (hazard ratio [HR], 4.17; 95% confidence interval [CI] 2.34-7.59; P < 0.001). CONCLUSIONS: GTVnd and serum EBV DNA copy number are independent prognostic factors for predicting distant metastasis in NPC patients with N1 disease. The prognostic model incorporating GTVnd and EBV DNA copy number may improve metastatic risk stratification for this group of patients.

3.
Tumour Biol ; 39(7): 1010428317717843, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28671052

RESUMO

Distant metastasis has become the predominant model of treatment failures in patients with locoregionally advanced nasopharyngeal carcinoma. Effort should therefore be made to stratify locoregionally advanced nasopharyngeal carcinoma patients into different groups based on the risk of metastasis to improve prognosis and tailor individualized treatments. This study aims to assess the value of primary gross tumor volume and the maximum standardized uptake value for predicting distant metastasis-free survival of patients with locoregionally advanced nasopharyngeal carcinoma. A total of 294 locoregionally advanced nasopharyngeal carcinoma patients who were identified from prospectively maintained database and underwent fluor-18-fluorodeoxyglucose positron emission tomography/computed tomography imaging before treatment were included. The maximum standardized uptake value was recorded for the primary tumor (SUVmax-P) and neck lymph nodes (SUVmax-N). Computed tomography-derived primary gross tumor volume was measured using the summation-of-area technique. At 5 years, the distant metastasis-free survival rate was 83.7%. The cut-off of the SUVmax-P, SUVmax-N, and primary gross tumor volume for distant metastasis-free survival was 8.95, 5.75, and 31.3 mL, respectively, by receiver operating characteristic curve. In univariate analysis, only SUVmax-N (hazard ratio: 7.01; 95% confidence interval: 1.70-28.87; p < 0.01) and clinical stage (hazard ratio: 3.03; 95% confidence interval: 1.67-5.47; p = 0.007) were confirmed as independent predictors of distant metastasis-free survival. A prognostic model was derived by SUVmax-N and clinical stage: low risk (SUVmax-N < 5.75 regardless of clinical stage), medium risk (stage III and SUVmax-N ≥ 5.75), and high risk (stage IV and SUVmax-N ≥ 5.75). Multivariate analysis revealed that SUVmax-N and the prognostic model remained independent prognostic factors for distant metastasis-free survival (p = 0.023 and p < 0.001, respectively), but the clinical stage became insignificant (p = 0.133). Furthermore, the adjusted hazard ratios for the prognostic model were higher than SUVmax-N (hazard ratio = 6.27 vs 5.21, respectively). In summary, compared with SUVmax-P, SUVmax-N may be a better predictor of distant metastasis-free survival for patients with locoregionally advanced nasopharyngeal carcinoma. Combining SUVmax-N with clinical stage gives a more precise picture in predicting distant metastasis.


Assuntos
Carcinoma/patologia , Neoplasias Nasofaríngeas/patologia , Metástase Neoplásica/patologia , Recidiva Local de Neoplasia/patologia , Prognóstico , Adulto , Idoso , Carcinoma/diagnóstico por imagem , Intervalo Livre de Doença , Feminino , Fluordesoxiglucose F18/administração & dosagem , Humanos , Linfonodos/diagnóstico por imagem , Linfonodos/patologia , Masculino , Pessoa de Meia-Idade , Carcinoma Nasofaríngeo , Neoplasias Nasofaríngeas/diagnóstico por imagem , Metástase Neoplásica/diagnóstico por imagem , Recidiva Local de Neoplasia/diagnóstico por imagem , Tomografia por Emissão de Pósitrons , Modelos de Riscos Proporcionais , Tomografia Computadorizada por Raios X , Carga Tumoral
4.
Cancer Sci ; 108(8): 1640-1647, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28603915

RESUMO

Epstein-Barr virus (EBV) is closely associated with nasopharyngeal carcinoma (NPC). Serum IgA antibodies against early antigen (EA-IgA) and viral capsid antigen (VCA-IgA) are the most commonly used to screen for NPC in endemic areas. However, the prognostic value of serum EA-IgA and VCA-IgA in patients with NPC is less clear. We hypothesize that serum EA-IgA and VCA-IgA levels have prognostic impact for survival outcomes in NPC patients with undetectable pretreatment EBV (pEBV) DNA. In this series, 334 patients with non-metastatic NPC and undetectable pEBV DNA were included. Serum EA-IgA and VCA-IgA were determined by ELISA. After analysis, serum EA-IgA and VCA-IgA loads correlated positively with T, N, and overall stage (all P < 0.05). Serum EA-IgA was not associated with survival outcome in univariable analyses. But patients with serum VCA-IgA >1:120 had significantly inferior 5-year progression-free survival (80.4% vs 89.6%, P = 0.025), distant metastasis-free survival (88.4% vs 94.8%, P = 0.050), and locoregional relapse-free survival (88.4% vs 95.6%, P = 0.023; log-rank test). Multivariable analyses revealed that N stage was the only independent prognostic factor (all P < 0.05), but the VCA-IgA became insignificant. Further analyses revealed that serum VCA-IgA was not an independent prognostic factor in early N (N0-1) or advanced N (N2-3) stage NPC. In summary, although both EA-IgA and VCA-IgA correlate strongly with TNM stage, our analyses do not suggest that these antibodies are prognostic biomarkers in patients with NPC and undetectable pEBV DNA.


Assuntos
Anticorpos Antivirais/sangue , Proteínas do Capsídeo/imunologia , Carcinoma/patologia , Infecções por Vírus Epstein-Barr/diagnóstico , Herpesvirus Humano 4/imunologia , Neoplasias Nasofaríngeas/patologia , Adolescente , Adulto , Idoso , Carcinoma/imunologia , Carcinoma/radioterapia , Carcinoma/virologia , Infecções por Vírus Epstein-Barr/imunologia , Infecções por Vírus Epstein-Barr/radioterapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Carcinoma Nasofaríngeo , Neoplasias Nasofaríngeas/imunologia , Neoplasias Nasofaríngeas/radioterapia , Neoplasias Nasofaríngeas/virologia , Estadiamento de Neoplasias , Prognóstico , Análise de Sobrevida , Adulto Jovem
5.
Transl Oncol ; 10(4): 527-534, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28570869

RESUMO

PURPOSE: To assess the effect of adding neoadjuvant chemotherapy (NACT) to concurrent chemoradiotherapy (CCRT) in patients with locoregionally advanced nasopharyngeal carcinoma (NPC) and undetectable pretreatment Epstein-Barr virus (pEBV) DNA. MATERIALS AND METHODS: We enrolled 639 NPC patients with stage II to IVB and undetectable pEBV DNA to receive CCRT with or without NACT. Radiotherapy was 2.0 to 2.27 Gy per fraction with five daily fractions per week for 6 to 7 weeks to the primary tumor and 62 to 70 Gy to the involved neck area. NACT was cisplatin (80-100 mg/m2day 1) and 5-fluorouracil (800-1000 mg/m2, 120-hour continuous intravenous infusion) every 3 weeks for two or three cycles. CCRT was cisplatin (80-100 mg/m2day 1) every 3 weeks for three cycles. RESULTS: For all patients, the 5-year overall survival (OS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS), and progression-free survival (PFS) rates were 91.9%, 92.2%, 95.0%, and 86.4%, respectively. There was no significant difference in OS (5-year OS 90.8% [NACT + CCRT group] vs 92.7% [CCRT alone]; hazard ratio [HR] 1.24; P=.486), LRFS (HR 1.13, 95% confidence interval [CI] 0.59-2.14, P=.715), DMFS (HR 0.78, 95% CI 0.34-1.78, P=.554), or PFS (HR 1.21, 95% CI 0.75-1.95, P=.472). CONCLUSION: CCRT with or without NACT produced a good treatment outcome in patients with locoregionally advanced NPC and undetectable pEBV DNA, but NACT before CCRT did not significantly improve survival rates.

6.
Eur J Cancer ; 75: 150-158, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-28235726

RESUMO

AIM OF THE STUDY: Previous results from our trial showed that adjuvant cisplatin and fluorouracil chemotherapy did not significantly improve survival after concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) at 2 years. Here, we present the data of long-term survival and late toxicities to further assess the ultimate therapeutic index of adjuvant chemotherapy (AC). METHODS: Patients with stage III-IVB (except T3-4N0) NPC were randomly assigned to receive CCRT plus AC or CCRT only at seven institutions in China. Patients in both groups received cisplatin 40 mg/m2 weekly up to 7 weeks concurrently with radiotherapy. The CCRT plus AC group subsequently received adjuvant cisplatin 80 mg/m2 and fluorouracil 800 mg/m2/d for 120 h every 4 weeks for three cycles. The primary end-point was failure-free survival. RESULTS: Two hundred and fifty-one patients were randomised to the CCRT plus AC group and 257 to the CCRT only group. After a median follow-up of 68.4 months, estimated 5-year failure-free survival rate was 75% in the CCRT plus AC group and 71% in the CCRT only group (hazard ratio 0.88, 95% confidence interval 0.64-1.22; p = 0.45). 66 (27%) of 249 patients in the CCRT plus AC group and 53 (21%) of 254 patients in the CCRT only group developed one or more late grade 3-4 toxicities (p = 0.14). CONCLUSION: Adjuvant cisplatin and fluorouracil chemotherapy still failed to demonstrate significant survival benefit after CCRT in locoregionally advanced NPC based on the long-term follow-up data, and addition of adjuvant cisplatin and fluorouracil did not significantly increase late toxicities. REGISTRATION NUMBER: NCT00677118.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma/terapia , Neoplasias Nasofaríngeas/terapia , Adolescente , Adulto , Idoso , Carcinoma/mortalidade , Quimiorradioterapia/métodos , Quimiorradioterapia/mortalidade , Quimioterapia Adjuvante/métodos , Quimioterapia Adjuvante/mortalidade , China/epidemiologia , Cisplatino/administração & dosagem , Intervalo Livre de Doença , Feminino , Fluoruracila/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Carcinoma Nasofaríngeo , Neoplasias Nasofaríngeas/mortalidade , Resultado do Tratamento , Adulto Jovem
7.
Infect Dis Poverty ; 5(1): 98, 2016 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-27604628

RESUMO

BACKGROUND: Following the decline of malaria transmission in many countries and regions, serological parameters have become particularly useful for estimating malaria transmission in low-intensity areas. This study evaluated a novel serological marker, Malaria Random Constructed Antigen-1 (M.RCAg-1), which contains 11 epitopes from eight Plasmodium falciparum antigens, as a tool for assessing malaria transmission intensity along the border area of China-Myanmar. METHOD: Serum from Plasmodium falciparum and P. vivax patients was used to detect the properties of M.RCAg-1 and antibody responses. Cross-sectional surveys were conducted at the China-Myanmar border and in Hainan province in 2012 and 2013 using cluster sampling. Filter blood spot papers were collected from all participants. Antibodies against M.RCAg-1 were detected using indirect ELISA. The Mann-Whitney test and Spearman's rank correlation test were performed to analyze antibody data. P. falciparum malaria transmission intensity was estimated using a catalytic conversion model based on the maximum likelihood of generating a community seroconversion rate (SCR). RESULTS: M.RCAg-1 was well-recognized by the naturally acquired anti-malaria antibodies in P. falciparum patients and had very limited cross-reactivity with P. vivax infection. The total amount of IgG antibodies was decreased with the decrease in parasitemia after taking medication and lasted several weeks. In a population survey, the antibody levels were higher in residents living close to the China-Myanmar border than those living in non-epidemic areas (P < 0.0001), but no significant difference was observed between residents from Hainan and non-epidemic areas. The calculated SCR was 0.0128 for Jieyangka, 0.004 for Susuzhai, 0.0047 for Qiushan, and 0.043 for Kayahe. The estimated exposure rate obtained from the anti-M.RCAg-1 antibody level correlated with traditional measures of transmission intensity derived from altitude. CONCLUSION: Our study demonstrates that M.RCAg-1 is potentially useful as a serological indicator of exposure to P. falciparum malaria, especially for malaria surveillance in low transmission areas.


Assuntos
Anticorpos Antiprotozoários/sangue , Antígenos de Protozoários/metabolismo , Epitopos/imunologia , Malária Falciparum/epidemiologia , Plasmodium falciparum/imunologia , Estudos Soroepidemiológicos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , China/epidemiologia , Estudos Transversais , Feminino , Humanos , Malária Falciparum/parasitologia , Malária Falciparum/transmissão , Masculino , Pessoa de Meia-Idade , Mianmar/epidemiologia , Adulto Jovem
8.
Ther Adv Med Oncol ; 8(3): 153-9, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-27239233

RESUMO

PURPOSE: No standard salvage regimen has been established for patients with recurrent and metastatic nasopharyngeal carcinoma (NPC) and disease progression after prior platinum-based chemotherapy. This phase II study was designed to evaluate the efficacy and safety of gemcitabine plus S-1 (GS) chemotherapy as a remedial regimen in this setting. METHODS: In this multicenter phase II study, 49 patients with recurrent and metastatic NPC who failed previous platinum-based chemotherapy received gemcitabine (1.0 g/m(2) on days 1 and 8) plus oral S-1 chemotherapy (twice daily from day 1 to 14). Each cycle was repeated every 3 weeks for two cycles at least. The dose of S-1 was determined according to the body surface area (BSA): 40 mg twice a day for BSA <1.25 m(2); 50 mg twice a day for 1.25 m(2) ⩽ BSA <1.5 m(2); and 60 mg twice a day for BSA ⩾1.5 m(2). RESULTS: Treatment was generally well-tolerated. A total of seven patients (14.3%) had grade 3 toxicities and the main toxicity was myelosuppression, whereas the nonhematology adverse events were minimal. There were 3 complete responses (6.4%), 17 partial responses (36.2%), and the overall response rate was 42.6% (95% confidence interval: 27.3-61.2). Median time to progression was 5.8 months and median survival was 14.8 months. The 1- and 2-year survival rates were 64% and 30%, respectively. CONCLUSIONS: Gemcitabine plus S-1 offers a satisfactory clinical activity and an acceptable safety profile for recurrent and metastatic NPC patients after failure of platinum-based chemotherapy.

9.
Artigo em Chinês | MEDLINE | ID: mdl-30148292

RESUMO

The capture and ligation probe-PCR(CLIP-PCR) with pooling strategy method and microscopy were applied on 100 clinical samples(7 positive and 93 negative samples) from the malaria reference laboratory in Yunnan Province. By calculating the detection rate, sensitivity, specificity, detection time and detection cost, the efficacy of the CLIP-PCR with pooling strategy method in detecting Plasmodium spp. was evaluated. The CLIP-PCR with matrix pooling strategy successfully detected Plasmodium spp. in all the 7 positive samples. Its sensitivity and specificity relative to the microscopy as a gold standard were both 100%. The detection time for all the samples by CLIP-PCR was 5.0 h, 85.0% shorter than that by microscopy(33.3 h), and the detection cost was 300 yuan, 75.0% less than that by microscopy (1 000 yuan).


Assuntos
Plasmodium , China , DNA de Protozoário , Humanos , Malária , Microscopia , Reação em Cadeia da Polimerase
10.
Drug Des Devel Ther ; 9: 6401-5, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26677316

RESUMO

PURPOSE: This Phase II trial was designed to evaluate the efficacy and safety of docetaxel combined with nedaplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma. METHODS: In this multicenter Phase II trial, the patients were treated with intravenous docetaxel (75 mg/m(2), day 1) and nedaplatin (80 mg/m(2), day 1), each cycle repeated every 3 weeks for two cycles at least. RESULTS: From January 2010 to November 2013, a total of 78 patients were recruited in this trial. Among them, 73 patients were assessable for response. The treatment was well tolerated. The main hematological adverse event was neutropenia. A total of 12 patients (15.4%) had grade 3 or grade 4 neutropenia. Grade 3 anemia was observed in six patients (7.7%) and no grade 3/4 thrombocytopenia was observed. No Grade 3/4 non-hematological toxicity was observed. There were five complete response (6.8%), 43 partial responses (58.9%), and the overall response rate was 65.8% (95% confidence interval [CI], 48.7%-81.2%). With a median follow-up period of 18.6 months, the median time to progression was 7.9 months (95% CI, 4.2-10.8 months), median overall survival was 15.7 months (95% CI, 11.6-18.5 months). CONCLUSION: Docetaxel combined with nedaplatin offers a satisfactory clinical activity and an acceptable safety profile as first-line chemotherapy for patients with recurrent and metastatic nasopharyngeal carcinoma.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Nasofaríngeas/tratamento farmacológico , Neoplasias Nasofaríngeas/secundário , Recidiva Local de Neoplasia/tratamento farmacológico , Compostos Organoplatínicos/uso terapêutico , Taxoides/administração & dosagem , Taxoides/uso terapêutico , Adolescente , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/química , Carcinoma , Docetaxel , Desenho de Drogas , Feminino , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Carcinoma Nasofaríngeo , Compostos Organoplatínicos/administração & dosagem , Compostos Organoplatínicos/química , Taxoides/química , Adulto Jovem
11.
J Cancer ; 6(6): 502-10, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26000040

RESUMO

PURPOSE: To investigate prognostic impact of chemoradiotherapy-induced hemoglobin (Hb) decrease on treatment outcomes of endemic nasopharyngeal carcinoma (NPC). MATERIALS AND METHODS: Eight hundred and fifteen non-metastatic NPC, receiving neoadjuvant chemotherapy followed by radiotherapy (NACT+RT group) or concomitant chemoradiotherapy (CCRT group), were enrolled in this study, who were regrouped according to pre-radiotherapy Hb (pre-RT Hb), post-radiotherapy Hb (post-RT Hb) and individual Hb decrease through radiotherapy or CCRT (△Hb), respectively. Survival curves were estimated using Kaplan-Meier method and compared by log-rank test. Multivariate analysis was performed using the COX proportional hazard model and binary logistic regression model. RESULTS: A poorer 5-year disease-free survival (DFS) was observed when pre-RT Hb<130.00 g/L. However, post-RT Hb<130.00 g/L was associated with significantly poorer 5-year locoregional recurrence-free survival (LRFS) (P=0.010) and disease specific survival (DSS) (P=0.008). Multivariate analysis with the COX proportional hazard model identified post-RT Hb<130.00 g/L as an independent negative prognostic factor for both LRFS (hazard ratio [HR], 1.896; 95% confidence interval [CI], 1.158-3.106; P=0.011) and DSS (HR, 1.767; 95% CI, 1.152-2.711; P=0.009). Similarly, △Hb <-15.00 g/L also predicted poorer 5-year LRFS (P=0.024) and DSS (P=0.015), which was confirmed in multivariate analysis as an independent adverse prognostic factor for LRFS (HR, 1.586; 95% CI, 1.058-2.377; P=0.026) and DSS (HR, 1.556; 95% CI, 1.087-2.227; P=0.016), respectively. Multivariate analysis with binary logistic regression model indicated that CCRT was a significantly independent predictor for post-RT Hb <130.00 g/L and △Hb < -15.00 g/L. CONCLUSIONS: Chemoradiotherapy-induced decreased Hb levels have negative influence on locoregional control and survival, and might counteract the benefit of neoadjuvant/concomitant chemotherapy. Further studies on supportive care to maintain sufficient Hb level during chemo-radiotherapy are warranted.

12.
Radiother Oncol ; 114(2): 161-6, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25497558

RESUMO

PURPOSE: The objective of this study was to evaluate the efficacy and safety of Endostar combined with concurrent chemoradiotherapy (CCRT) in patients with stage III non-small-cell lung cancer (NSCLC). METHODS: Patients with unresectable stage III NSCLC were treated with Endostar (7.5mg/m(2)/d) for 7days at weeks 1, 3, 5, and 7, while two cycles of docetaxel (65mg/m(2)) and cisplatin (65mg/m(2)) were administered on days 8 and 36, with concurrent thoracic radiation to a dose of 60-66Gy. Primary end points were short-term efficacy and treatment-related toxicity. RESULTS: Fifty patients were enrolled into the study, and 48 were assessable. Of the 48 patients, 83% had stage IIIB and 65% had N3 disease. Median follow-up was 25.0months. Overall response rate was 77%. The estimated median progression-free survival (PFS) was 9.9months, and the estimated median overall survival (OS) was 24.0months. The 1-, 2-, and 3-year local control rates were 75%, 67%, and 51%, PFS rates were 48%, 27%, and 16%, and OS rates were 81%, 50%, and 30%, respectively. All toxicities were tolerable with proper treatment. CONCLUSIONS: The combination of Endostar with CCRT for locally advanced NSCLC patients was feasible and showed promising survival and local control rates.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/radioterapia , Adulto , Idoso , Carcinoma Pulmonar de Células não Pequenas/patologia , Quimiorradioterapia , Cisplatino/administração & dosagem , Intervalo Livre de Doença , Docetaxel , Endostatinas/administração & dosagem , Feminino , Humanos , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Prospectivos , Taxa de Sobrevida , Taxoides/administração & dosagem
13.
Zhonghua Kou Qiang Yi Xue Za Zhi ; 48(1): 3-6, 2013 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-23534512

RESUMO

OBJECTIVE: To detect the plasma leptin levels in patients with aggressive periodontitis (AgP) and to analyze the relationship between circulating leptin level and periodontal condition. METHODS: A total of 97 patients with AgP and 44 healthy controls were recruited. Detailed clinical examinations were conducted and clinical parameters such as bleeding index (BI), probing depth (PD), attachment loss (AL) were recorded. Plasma leptin level was measured by enzyme-linked immunosorbent assay. RESULTS: The plasma leptin level in AgP group was significantly higher than that of control subjects [(20.0 ± 4.3) µg/L vs. (7.5 ± 1.3) µg/L, P < 0.01)]. The plasma leptin level was positively related to BI, PD and AL, and the r values were 0.647, 0.596 and 0.632 respectively (P < 0.01). CONCLUSIONS: Plasma leptin concentration in AgP patients was significantly elevated compared with healthy controls. Circulating leptin level was positively related to periodontal parameters including BI, PD and AL.


Assuntos
Periodontite Agressiva/sangue , Leptina/sangue , Adolescente , Adulto , Periodontite Agressiva/diagnóstico , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Perda da Inserção Periodontal/sangue , Perda da Inserção Periodontal/diagnóstico , Índice Periodontal , Plasma/metabolismo , Adulto Jovem
14.
J Cell Biochem ; 113(7): 2268-78, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22334501

RESUMO

Early diagnosis and treatment is known to improve prognosis for nasopharyngeal carcinoma (NPC). The study determined the specific peptide profiles by comparing the serum differences between NPC patients and healthy controls, and provided the basis for the diagnostic model and identification of specific biomarkers of NPC. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS) can be used to detect the molecular mass of peptides. Mass spectra of peptides were generated after extracting and purification of 40 NPC samples in the training set, 21 in the single center validation set and 99 in the multicenter validation set using weak cationic-exchanger magnetic beads. The spectra were analyzed statistically using FlexAnalysis™ and ClinProt™ bioinformatics software. The four most significant peaks were selected out to train a genetic algorithm model to diagnose NPC. The diagnostic sensitivity and specificity were 100% and 100% in the training set, 90.5% and 88.9% in the single center validation set, 91.9% and 83.3% in the multicenter validation set, and the false positive rate (FPR) and false negative rate (FNR) were obviously lower in the NPC group (FPR, 16.7%; FNR, 8.1%) than in the other cancer group (FPR, 39%; FNR, 61%), respectively. So, the diagnostic model including four peptides can be suitable for NPC but not for other cancers. FGA peptide fragments identified may serve as tumor-associated biomarkers for NPC.


Assuntos
Biomarcadores Tumorais/sangue , Fibrinogênio/análise , Neoplasias Nasofaríngeas/diagnóstico , Peptídeos/sangue , Adulto , Sequência de Aminoácidos , Carcinoma , Feminino , Humanos , Fenômenos Magnéticos , Nanopartículas de Magnetita , Masculino , Pessoa de Meia-Idade , Carcinoma Nasofaríngeo , Proteômica/métodos , Espectrometria de Massas por Ionização e Dessorção a Laser Assistida por Matriz/métodos
15.
Lancet Oncol ; 13(2): 163-71, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22154591

RESUMO

BACKGROUND: The effect of the addition of adjuvant chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. We aimed to assess the contribution of adjuvant chemotherapy to concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone. METHODS: We did an open-label phase 3 multicentre randomised controlled trial at seven institutions in China. Randomisation was by a computer-generated random number code. Patients were stratified by treatment centre and randomly assigned in blocks of four. Treatment allocation was not masked. We randomly assigned patients with non-metastatic stage III or IV (except T3-4N0) nasopharyngeal carcinoma to receive concurrent chemoradiotherapy plus adjuvant chemotherapy or concurrent chemoradiotherapy alone. Patients in both groups received 40 mg/m(2) cisplatin weekly up to 7 weeks, concurrently with radiotherapy. Radiotherapy was given as 2·0-2·27 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumour and 60-66 Gy to the involved neck area. The concurrent chemoradiotherapy plus adjuvant chemotherapy group subsequently received 80 mg/m(2) adjuvant cisplatin and 800 mg/m(2) per day fluorouracil for 120 h every 4 weeks for three cycles. Our primary endpoint was failure-free survival. We did efficacy analyses in our intention-to-treat population. Our trial is ongoing; in this report we present the 2 year survival results and acute toxic effects. This trial is registered with ClinicalTrials.gov, number NCT00677118. FINDINGS: 251 patients were assigned to the concurrent chemoradiotherapy plus adjuvant chemotherapy group and 257 to the concurrent chemoradiotherapy alone group. After a median follow-up of 37·8 months (range 1·3-61·0), the estimated 2 year failure-free survival rate was 86% (95% CI 81-90) in the concurrent chemoradiotherapy plus adjuvant chemotherapy group and 84% (78-88) in concurrent chemoradiotherapy only group (hazard ratio 0·74, 95% CI 0·49-1·10; p=0·13). Stomatitis was the most commonly reported grade 3 or 4 adverse event during both radiotherapy (76 of 249 patients in the concurrent chemoradiotherapy plus adjuvant chemotherapy group and 82 of 254 in the concurrent chemoradiotherapy alone group) and adjuvant chemotherapy (43 [21%] of 205 patients treated with adjuvant chemotherapy). INTERPRETATION: Adjuvant cisplatin and fluorouracil chemotherapy did not significantly improve failure-free survival after concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma. Longer follow-up is needed to fully assess survival and late toxic effects, but such regimens should not, at present, be used outside well-designed clinical trials. FUNDING: Sun Yat-sen University Clinical Research 5010 Programme (No 2007037), Science Foundation of Key Hospital Clinical Programme of Ministry of Health PR China (No 2010-178), and Guangdong Province Universities and Colleges Pearl River Scholar Funded Scheme (2010).


Assuntos
Quimiorradioterapia/métodos , Quimioterapia Adjuvante/métodos , Neoplasias Nasofaríngeas/epidemiologia , Neoplasias Nasofaríngeas/terapia , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica , Carcinoma , China , Cisplatino/administração & dosagem , Cisplatino/efeitos adversos , Intervalo Livre de Doença , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Carcinoma Nasofaríngeo , Estadiamento de Neoplasias , Adulto Jovem
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