Ren Z.,Fudan University |
Zhu K.,Sun Yat Sen University |
Kang H.,301 Military Hospital |
Lu M.,Sun Yat Sen University |
And 12 more authors.
Journal of Clinical Oncology | Year: 2015
Purpose: To assess whether urea-based cream (UBC) has prophylactic benefits on sorafenib-induced hand-foot skin reaction (HFSR) in patients with advanced hepatocellular carcinoma (HCC). Patients and Methods: In this randomized, open-label trial, 871 patients with advanced HCC throughout China were treated with 10% UBC three times per day plus best supportive care (BSC; n = 439) or BSC alone excluding all creams (n = 432), starting on day 1 of sorafenib treatment, for up to 12 weeks. HFSR was assessed every 2 weeks and at 14 weeks for patients completing the study. Once HFSR occurred, patients were allowed any cream, including a UBC. Results: The 12-week incidence of any grade HFSR was significantly lower in the UBC group versus the BSC-alone group (56.0% v 73.6%, respectively; odds ratio [OR], 0.457; 95% CI, 0.344 to 0.608; P < .001), as was the incidence of grade ≥ 2 HFSR (20.7% v 29.2%, respectively; OR, 0.635; 95% CI, 0.466 to 0.866; P = .004). Median time to first occurrence of HFSR was significantly longer in the UBC group than the BSC-alone group (84 v 34 days, respectively; hazard ratio, 0.658; 95% CI, 0.541 to 0.799; P < .001). Elevated AST was associated with increased risk of HFSR but did not alter the treatment effect of UBC. UBC plus BSC, compared with BSC alone, did not affect the sorafenib dose reduction or interruption rate (9.1% v 11.8%, respectively; P = .1937), response rate (11.1% v 10.1%, respectively; P = .6674), or disease control rate (98.8% v 98.2%, respectively; P = .5350) at week 12. Conclusion: UBC prophylaxis in patients with advanced HCC starting sorafenib reduced HFSR rates, extended the time to first occurrence of HFSR, and improved patient quality of life compared with BSC. Blinded, randomized, placebo-controlled trials to determine the role of UBC on the incidence and severity of HFSR are warranted. © 2015 by American Society of Clinical Oncology.
Gong J.,Peking University |
Hu B.,Anhui Provincial Hospital |
Zhang X.,Peking University |
Zhang F.,Suzhou Kowloon Hospital |
And 15 more authors.
Oncologist | Year: 2014
Background. The efficacy and toxicity of paclitaxel plus capecitabine (PX) as first-line treatment in advanced gastric cancer (AGC) was evaluated. Methods. Patients with previously untreated AGC were included. PX was given every 3 weeks until a maximum of six cycles or progression. Capecitabine monotherapy was continued for patients without disease progression. The primary endpoint was progression-free survival, and secondary endpoints were objective response rate, overall survival (OS), and safety. Results. Overall, 194 patients were treated per protocol and one patient was excluded because of allergy to paclitaxel. Response was evaluated in 175 patients, with an objective response rate of 34.8%. After a median follow-up of 33.2 months, disease progression was observed in 141 patients, 137 died, and 16 were lost to follow-up, with progression-free survival of 188 days and OS of 354 days. In multivariate Cox regression analysis, no factor remained an independent predictor of OS. Forty-five patients who received capecitabine monotherapy after PX had longer OS (531 days). Adverse events were mild (Fig. 1), and the most common grade 3-4 toxicities were leucopenia and neutropenia. Conclusion. PX as a first-line treatment has promising efficacy in AGC. Based on these data, a phase III study has been launched for further investigation. © AlphaMed Press 2014.
Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): A randomised, double-blind, placebo-controlled, phase 3 trial
Li J.,Fudan University |
Qin S.,Chinese People's Liberation Army |
Xu R.,Sun Yat Sen University |
Yau T.C.C.,University of Hong Kong |
And 16 more authors.
The Lancet Oncology | Year: 2015
Background: In the international randomised phase 3 CORRECT trial (. NCT01103323), regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer. Of the 760 patients in CORRECT, 111 were Asian (mostly Japanese). This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT. Methods: In this randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done in 25 hospitals in mainland China, Hong Kong, South Korea, Taiwan, and Vietnam, we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 3 months, and adequate bone marrow, liver, and renal function, without other uncontrolled medical disorders. We randomly allocated patients (2:1; with a computer-generated unicentric randomisation list [prepared by the study funder] and interactive voice response system; block size of six; stratified by metastatic site [single vs multiple organs] and time from diagnosis of metastatic disease [<18 months vs ≥18 months]) to receive oral regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle; patients in both groups were also to receive best supportive care. Participants, investigators, and the study funder were masked to treatment assignment. The primary endpoint was overall survival, and we analysed data on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01584830. Findings: Between April 29, 2012, and Feb 6, 2013, we screened 243 patients and randomly assigned 204 patients to receive either regorafenib (136 [67%]) or placebo (68 [33%]). After a median follow-up of 7·4 months (IQR 4·3-12·2), overall survival was significantly better with regorafenib than it was with placebo (hazard ratio 0·55, 95% CI 0·40-0·77, one-sided p=0·00016; median overall survival 8·8 months [95% CI 7·3-9·8] in the regorafenib group vs 6·3 months [4·8-7·6] in the placebo group). Drug-related adverse events occurred in 132 (97%) of 136 regorafenib recipients and 31 (46%) of 68 placebo recipients. The most frequent grade 3 or higher regorafenib-related adverse events were hand-foot skin reaction (22 [16%] of 136 patients in the regorafenib group vs none in the placebo group), hypertension (15 [11%] vs two [3%] of 68 patients in the placebo group), hyperbilirubinaemia (nine [7%] vs one [1%]), hypophosphataemia (nine [7%] vs none), alanine aminotransferase concentration increases (nine [7%] vs none), aspartate aminotransferase concentration increases (eight [6%] vs none), lipase concentration increases (six [4%] vs one [1%]), and maculopapular rash (six [4%] vs none). Drug-related serious adverse events occurred in 12 (9%) patients in the regorafenib group and three (4%) in the placebo group. Interpretation: This phase 3 trial is the second to show an overall survival benefit with regorafenib compared with placebo in patients with treatment-refractory metastatic colorectal cancer, substantiating the role of regorafenib as an important treatment option for patients whose disease has progressed after standard treatments. In this trial, preceding standard treatments did not necessarily include targeted treatments. Adverse events were generally consistent with the known safety profile of regorafenib in this setting. Funding: Bayer HealthCare Pharmaceuticals. © 2015 Elsevier Ltd.
Hoff P.M.,University of Sao Paulo |
Hoff P.M.,Hospital Sirio Libanes |
Hochhaus A.,Universitatsklinikum Jena |
Pestalozzi B.C.,University of Zürich |
And 12 more authors.
Journal of Clinical Oncology | Year: 2012
Purpose: Cediranib is a highly potent inhibitor of vascular endothelial growth factor (VEGF) signaling with activity against all three VEGF receptors. HORIZON II [Cediranib (AZD2171, RECENTIN) in Addition to Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer] assessed infusional fluorouracil, leucovorin, and oxaliplatin/ capecitabine and oxaliplatin (FOLFOX/CAPOX) with or without cediranib in patients with previously untreated metastatic colorectal cancer (mCRC). Patients and Methods: Eligible patients were initially randomly assigned 1:1:1 to receive cediranib (20 or 30 mg per day) or placebo plus FOLFOX/CAPOX. In an early analysis of this and two other cediranib studies (HORIZON I [Cediranib Plus FOLFOX6 Versus Bevacizumab Plus FOLFOX6 in Patients With Previously Treated Metastatic Colorectal Cancer] and HORIZON III [Cediranib Plus FOLFOX6 Versus Bevacizumab Plus FOLFOX6 in Patients With Untreated Metastatic Colorectal Cancer]), the 20-mg dose met the predefined criteria for continuation. Subsequent patients were randomly assigned 2:1 to the cediranib 20 mg or placebo arms. Progression-free survival (PFS) and overall survival (OS) were coprimary end points. Results: In all, 860 patients received cediranib 20 mg (n = 502) or placebo (n = 358). The addition of cediranib to FOLFOX/CAPOX resulted in PFS prolongation (hazard ratio [HR], 0.84; 95% CI, 0.73 to 0.98; P = .0121; median PFS, 8.6 months for cediranib v 8.3 months for placebo) but had no impact on OS (HR, 0.94; 95% CI, 0.79 to 1.12; P = .5707; median OS, 19.7 months for cediranib v 18.9 months for placebo). There were no significant differences in the secondary end points of objective response rate, duration of response, or liver resection rate. Median chemotherapy dose-intensity was decreased by approximately 10% in patients treated with cediranib. Adverse events (AEs) associated with cediranib were manageable. Conclusion: Addition of cediranib 20 mg to FOLFOX/CAPOX resulted in a modest PFS prolongation, but no significant difference in OS. The cediranib AE profile was consistent with those from previous studies. Because of the lack of improvement in OS, cediranib plus an oxaliplatin-based regimen cannot be recommended as a treatment for patients with mCRC. © 2012 by American Society of Clinical Oncology.
Mao F.,Shanghai JiaoTong University |
Zhang L.,Jilin Provincial Tumor Hospital |
Cai M.,Shanghai JiaoTong University |
Ding Z.,Shanghai JiaoTong University |
Shen-Tu Y.,Shanghai JiaoTong University
Chinese Journal of Lung Cancer | Year: 2014
Background and objective To discuss the clinical application of mediastinoscopy in the differential diagnosis and preoperative staging on lung cancer. Methods A total of 361 cases of patients were included in the study, of which 162 cases were undiagnosed mediastinal tumor patients before operation, and 199 patients were suspected or diagnosed with lung cancer or mediastinal lymph nodes enlargment(short diameter ≥1.0 cm). All patients underwent surgery, including 308 cases standard cervical mediastinoscopy (SCM), 53 cases parasternal mediastinoscopy (PM). Results Taking pathology diagnosis as the gold standard, the mediastinoscopy diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value are 98.11%, 97.62%, 100%, 100%, 91.67% and 98.28%, 98.03%, a 100%, 100%, 100% to mediastinal masses and mediastinal lymph node metastasis of lung cancer. Total seven cases suffered from complications of surgery-related, the complication rate was 1.93 percent (P<0.05). Conclusion The trauma of the mediastinoscopy is slight, which is safe, reliable, able to take in sufficient tissue quantities. Mediastinoscopy is highly helpful not only in diagnostic of mediastinal mass, but also in the differential diagnosis of lung cancer, and it's an important method and the gold standard of preoperative staging on lung cancer.
PubMed | Shanghai JiaoTong University and Jilin Provincial Tumor Hospital
Type: Evaluation Studies | Journal: Zhongguo fei ai za zhi = Chinese journal of lung cancer | Year: 2014
To discuss the clinical application of mediastinoscopy in the differential diagnosis and preoperative staging on lung cancer.A total of 361 cases of patients were included in the study, of which 162 cases were undiagnosed mediastinal tumor patients before operation, and 199 patients were suspected or diagnosed with lung cancer or mediastinal lymph nodes enlargment(short diameter 1.0 cm). All patients underwent surgery, including 308 cases standard cervical mediastinoscopy (SCM) , 53 cases parasternal mediastinoscopy (PM).Taking pathology diagnosis as the gold standard, the mediastinoscopy diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value are 98.11%, 97.62%, 100%, 100%, 91.67% and 98.28%, 98.03%, a 100%, 100%, 100% to mediastinal masses and mediastinal lymph node metastasis of lung cancer. Total seven cases suffered from complications of surgery-related, the complication rate was 1.93 percent (P<0.05).The trauma of the mediastinoscopy is slight, which is safe, reliable, able to take in sufficient tissue quantities. Mediastinoscopy is highly helpful not only in diagnostic of mediastinal mass, but also in the differential diagnosis of lung cancer, and its an important method and the gold standard of preoperative staging on lung cancer.
Wang Y.,Northeast Normal University |
Ju Z.,Northeast Normal University |
Ju Z.,University of Oklahoma |
Cao B.,University of Oklahoma |
And 8 more authors.
ACS Nano | Year: 2015
Candida albicans (C. albicans) infection causes high mortality rates within cancer patients. Due to the low sensitivity of the current diagnosis systems, a new sensitive detection method is needed for its diagnosis. Toward this end, here we exploited the capability of genetically displaying two functional peptides, one responsible for recognizing the biomarker for the infection (antisecreted aspartyl proteinase 2 IgG antibody) in the sera of cancer patients and another for binding magnetic nanoparticles (MNPs), on a single filamentous fd phage, a human-safe bacteria-specific virus. The resultant phage is first decorated with MNPs and then captures the biomarker from the sera. The phage-bound biomarker is then magnetically enriched and biochemically detected. This method greatly increases the sensitivity and specificity of the biomarker detection. The average detection time for each serum sample is only about 6 h, much shorter than the clinically used gold standard method, which takes about 1 week. The detection limit of our nanobiotechnological method is approximately 1.1 pg/mL, about 2 orders of magnitude lower than that of the traditional antigen-based method, opening up a new avenue to virus-based disease diagnosis. © 2015 American Chemical Society.
Liu Y.,Jilin Provincial Tumor Hospital |
Zuo X.,Jilin Provincial Tumor Hospital |
Zhang C.,Jilin Provincial Tumor Hospital |
Cheng Y.,Jilin Provincial Tumor Hospital
Chinese-German Journal of Clinical Oncology | Year: 2012
Objective: The aim of the study was to explore the effects and side effects of induction chemotherapy followed by chemoradiotherapy for limited-disease small cell lung cancer (LD-SCLC) patients with ipsilateral pleural effusion. Methods: From January 2005 to May 2009, 52 LD-SCLC patients with ipsilateral pleural effusion were treated with induction chemotherapy first. The regimen was taken as follows: etoposide 100 mg iv, d1-d5, cisplatin 25 mg/m 2 iv, d1-d3 or CBP AUC 4 iv, d1. Three-week therapy was a cycle. According to pleural effusion status after 2-4 cycles induction chemotherapy, patients got disappearance of pleural effusion after chemotherapy were underwent thoracic radiotherapy (TRT; 50 Gy/25 fraction) or same chemotherapy regimen; patients without disappearance or with increasing of pleural effusion after chemotherapy were given same chemotherapy regimen. Therapeutic effect was evaluated every two cycles according to RECIST 1.0 and side-effects were evaluated every cycle according to NCI-CTC AE Grades. All patients were followed up, and the median follow-up time was 26 months. Results: The response rate of patients was 80.7% (42/52) after induction chemotherapy and 34 patients got disappearance of pleural effusion. The median survival time, 1- and 2-year survival rates were 15.4 months, 76.9% (40 /52) and 38.5% (20 /52) respectively. The median survival time, 1- and 2-year survival rates of patients with pleural effusion remission received chest radiotherapy (A group, n = 20), patients with pleural effusion remission received chemotherapy (B group, n = 14) and patients without pleural effusion remission received chemotherapy (C group, n = 18) were 21.5 months, 14.4 months, 12.5 months, 80.0%, 64.3%, 55.6% and 35%, 21.4%, 11.1%, respectively. Main side effects were grades 1-2, including myelosuppression, fatigue, nausea and vomiting. No therapeutic related death was occurred. Conclusion: Induction chemotherapy plus chemoradiotherapy has shown better effect in prolonging survival of small cell lung cancer (SCLC) patients with ipsilateral pleural effusion than chemotherapy alone. The patients with decreased ipsilateral pleural effusion may receive benefit from subsequent TRT. © Huazhong University of Science and Technology and Springer-Verlag Berlin Heidelberg 2012.
Zhu J.,Jilin Provincial Tumor Hospital |
Ma L.,Jilin Provincial Tumor Hospital |
Cheng Y.,Jilin Provincial Tumor Hospital
Chinese-German Journal of Clinical Oncology | Year: 2010
Objective: This study was aimed to research the feasibility of ATP-bioluminescence assay (ATP-TCA) guiding the treatment on recurrent non-small cell lung cancer (NSCLC) combined with malignant pleural effusion. Methods: We collected 30 pleural fluid samples which were approved to be positive by cytology from recurrent NSCLC patients. These cells were cocultured with chemotherapy medicines, single agent or drugs combination. Five drug concentrations, two parallel holes were examined in vitro for 4 days, the results were measured by adding luciferase-fluorescein working system and luminescence analyzer. We applied chemotherapy medicines according to the results in vitro of ATP-TCA. Results: There were differences among drug sensitivities of individuals. All the samples could be evaluated. Effective single drugs included cisplatinum, mitomycin C, doxorubicin, and pemetrexed disodium; sensitive drugs in the combination therapy were gemcitabine plus cisplatin, vinorelbine plus cisplatin, paclitaxel plus cisplatin, docetaxel plus cisplatin, and mitomycin C, vindesine plus cisplatin, in which gemcitabine + cisplatin (GEM + DDP) in vitro was the most efficient program. Conclusion: ATP-TCA in vitro sensitivity assay is rapid, reliable, and simple to guide the treatment of recurrent NSCLC with malignant pleural effusion, and can help clinicians to make the individual chemotherapy program. © 2010 Springer-Verlag Berlin Heidelberg.
PubMed | Jilin Provincial Tumor Hospital
Type: Journal Article | Journal: Zhongguo fei ai za zhi = Chinese journal of lung cancer | Year: 2014
Small cell lung cancer accounts for about 15%-25% of lung cancer, although the new chemotherapy drugs and radiation technology are continuously progressing, but the prognosis is still poor. To explore the prognostic factor of small cell lung cancer (SCLC), we study the correlation between effect, prognosis and TNM stage, various treatment mode.We collected 91 Limited-disease-SCLC patients data From 2006 to 2012. The data were reviewed retrospectively and restaged as I, II, IIIa and IIIb stage groups according to the clinical staging in the seventh edition of the tumor. We compare the progression-free survival (FPS) and overall survival (OS). Survival analysis was evaluated by Kaplan-Meier and multivariate analysis was performed by Cox proportional hazards model.In the whole group, patients achieved complete response and partial response, exhibited an RR of 93.4%. The median PFS was 14.25 months of which, 22.03 months in patients in stage I, 15.97 months in stage II, 11.99 months in stage IIIa and 10.5 months in stage IIIb (P<0.05). The median overall survival (OS) was 19.56 months of which, 33.38 months in patients in stage I, 22.07 months in stage II, 16.0 months in stage IIIa and 15.52 months in stage IIIb (P<0.05). Patients of stage IIIa and IIIb have longer survival time in earlier radiation groups then that of later radiation groups. Univariate analysis indicate stage of TNM, the pattern of radiation therapy and chemotherapy cycles before radiation therapy were significantly related to the survival in SCLC. Multivariate analysis showed that stage of TNM, ECOG (Eastern Cooperative Oncology Group) performance status, pattern of radiation therapy and cycle numbers of chemotherapy before radiation were factors correlated with survival.The stage of TNM may become beneficial prognostic factors in the treatment of LD-SCLC. The time of radiation therapy in stage IIIa and IIIb is of worth further investigation.