title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Methods | PMC10257092 | |||
Data Acquisition | SECONDARY | This quantile treatment effects study is a secondary analysis of pooled participant data. We obtained aggregate data through personal correspondence with the authors of Stone et al, | PMC10257092 | |
Statistical Analysis | PMC10257092 | |||
Data Quality Testing and Processing | depression | To test data completeness, we compared the counts of treatment-assigned and placebo-assigned participants in the aggregate data we received against the values reported by Stone et al.From the data obtained, we calculated 2 candidate measures of depression response since both percentage and absolute depression response ... | PMC10257092 | |
Testing Rank Similarity | depression | We separately tested for rank similarity using our 2 candidate measures of depression response. We used the rank similarity test of Frandsen and Lefgren | PMC10257092 | |
Quantile Treatment Effects | depression, QTE | We calculated each quantile of percentage depression response separately in the treatment and placebo arms, at quantiles from the 5th percentile to 95th percentile, in increments of 5%. The QTEs were calculated as the difference between percentage depression response in the treatment vs placebo arms at a given quantile... | PMC10257092 | |
Results | PMC10257092 | |||
Data Quality | depression | The aggregate data we received implied 71 393 participants, of whom 47 243 were assigned to drug and 24 150 to placebo. These values match the counts reported by Stone et al.There was a slight and statistically significant difference in mean baseline depression severity between drug and placebo arms equivalent to 0.15 ... | PMC10257092 | |
Testing Rank Similarity | depression | Since QTE analysis is most richly interpretable when rank similarity can be assumed, we tested whether our data and intended formulation were consistent with rank similarity. Following the method of Frandsen and Lefgren,Since there is not consensus in the literature about whether to define depression response as a perc... | PMC10257092 | |
Quantile Treatment Effects | depression | Next, we characterized the estimated distribution of antidepressant response. We calculated the depression response distribution separately in treatment and control conditions ( | PMC10257092 | |
Distribution of Percentage Depression Response | depression | The distribution of percentage change of depression severity from baseline to trial end is depicted for each treatment arm. Error bars represent 95% CIs. | PMC10257092 | |
Quantile Treatment Effects of Antidepressants Compared With Placebo | depression | For each quantile (τ) of depression response, the difference between the treatment arm and placebo arm depression response at that quantile is shown, expressed as a percentage, along with its bootstrapped 95% CI. | PMC10257092 | |
QTEs at Selected Quantiles | QTE | Abbreviation: QTE, quantile treatment effect. | PMC10257092 | |
Discussion | MDD, depression | SECONDARY | We conducted a secondary analysis of pooled IPD from 232 randomized clinical trials submitted to the FDA for antidepressant monotherapy for MDD to characterize the distribution of antidepressant response by depression severity. We observed that the population distribution of depression responses was strictly superior i... | PMC10257092 |
Strengths and Limitations | depression | ADVERSE EFFECTS | A strength of this study is its use of FDA data, which include both published and unpublished high-quality randomized clinical trials and their pooled IPD. Another strength is that the population-level findings do not depend on any special assumptions.One limitation of the study is that individual-level findings depend... | PMC10257092 |
Conclusions | MDD, depression | Among participants with baseline HAMD-17 scores of 20 or higher from 232 FDA trials for antidepressant monotherapy for MDD, all segments of the distribution of depression responses were more favorable with active treatment vs control. These findings suggest that if our statistical assumptions hold, then there is the po... | PMC10257092 | |
Purpose | above-the-knee, fractures | Different studies have shown that weightbearing is safe in stable transsyndesmotic, isolated lateral simple ankle fractures. Despite this evidence, AO guidelines still recommend immobilization with above-the-knee cast for 4–6 weeks for these fractures. The objective of this study was to compare the outcomes of mobiliza... | PMC10771350 | |
Methods | fracture | Fifty patients were randomly assigned to permissive weightbearing in a walking boot or non-weightbearing immobilization using a below-the-knee cast. Primary outcome was ankle functionality as scored by the Olerud-Molander Ankle Score (OMAS). Secondary outcomes were radiological displacement of fracture, range of motion... | PMC10771350 | |
Results | Ankle functionality after six and twelve weeks was significantly higher for the intervention group, with respectively 30 points ( | PMC10771350 | ||
Conclusion | fractures | Weightbearing and mobilization using a walking boot may be a safe treatment for patients with stable Weber B fractures. | PMC10771350 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00590-023-03651-6. | PMC10771350 | ||
Keywords | PMC10771350 | |||
Introduction | PMC10771350 | |||
Background and objectives | thrombosis, fractures, traumatic injuries | THROMBOSIS, ADVERSE EFFECTS | Ankle fractures are common traumatic injuries requiring adequate management. In the USA, approximately 673.214 ankle fractures occurred between 2012 and 2016, with an incidence of 4.22/10.000 person-years [When patients are restricted to a prolonged period of immobilization, adverse effects regarding recovery, increase... | PMC10771350 |
Patients and methods | PMC10771350 | |||
Trial design | ®, trauma | This randomized controlled trial was conducted in a high volume trauma center in [location blinded]. Interventional treatment consisted of six weeks of mobilization and weightbearing using a Rebound® walker, while the control group was designated to six weeks of immobilization and non-weightbearing with a below-the-kne... | PMC10771350 | |
Sample size calculation | We determined that a total of 46 patients would be required to provide a 80% power. With an effect size of 15 points of difference on the OMAS and a variance of 324 (square of SD in study by Dehghan et al.), 23 patients per group were required [ | PMC10771350 | ||
Participants | fracture, fractures, ankle injuries | HANSEN | From March 2018 to October 2019, patients aged ≥ 16 years old visiting the emergency department with an isolated Weber B fracture (Lauge Hansen supination-eversion stage 2-4A) were screened for eligibility. Patients were eligible for inclusion if non-weightbearing radiographs showed congruent ankle joint on mortise vie... | PMC10771350 |
Randomization | RS | After written consent was obtained, patients were randomly appointed to the control or intervention group (1:1 ratio) by the investigators (SF, RS) using an online randomization tool, provided by ‘Researchmanager’ [ | PMC10771350 | |
Interventions | plaster | A cast below the knee was applied by a trained plaster technician in the non-weightbearing group. The cast was applied from a few centimeters below the tuberositas tibiae to the base of the toes. The ankle was fixed in a plantigrade position. Patients assigned to cast group were specifically instructed not to bear weig... | PMC10771350 | |
Outcome measures | Primary outcome measure was the Olerud-Molander Ankle Score (OMAS; ordinal scale 0–100 with intervals of 5 points, whereas lower scores indicate worse outcome) after six weeks to compare ankle functionality in both groups. The OMAS is a frequently used ankle functionality score based on patient-reported measures [ | PMC10771350 | ||
Follow-up | trauma | Physical follow-up was planned at week 0, and 6 and 12 weeks after trauma. After these visits, patients were instructed to contact the primary investigator in case of medical complaints. Patient files were checked both 12 months and 24 months after randomization. Patients were randomized in week 0. Radiological imaging... | PMC10771350 | |
Statistical methods | All statistical analysis were performed using SPSS (IBM Corp. IBM SPSS Statistics for MacOS, Version 25.0, Armonk, NY, USA) and were conducted according to the intention-to-treat principle. In order to prevent type I errors, per-protocol analysis was also conducted. Every outcome measure was compared between the contro... | PMC10771350 | ||
Results | A total of 147 patients were eligible for inclusion. Fifty patients were randomized. Of these, 24 were randomized in the non-weightbearing group and 26 in the walking boot group. Weightbearing radiographs excluded 23 (15.6%) of 147 patients due to ankle joint instability. Twenty-two (14.9%) of 147 patients were not wil... | PMC10771350 | ||
Fracture healing | callus, posttraumatic, fracture, fractures, trauma | Radiologic follow-up after six weeks showed no fracture displacement in any patients. All fractures showed signs of callus bridging of the fracture site after 6 weeks. For illustration: Figure Radiographs taken posttraumatic and after six weeks of permissive weightbearing. Image 1a and b were obtained 2 days after trau... | PMC10771350 | |
SF-36 | No statistical differences between both treatment groups were observed at baseline. There was however a statistical significant difference after six week in the intervention group compared to the control group (Table | PMC10771350 | ||
Harms | fracture, posttraumatic complex regional pain, pain | ADVERSE EVENTS, EVENTS | No serious adverse events where observed. In five patients, unintended events were registered. Four events were related to contingency hospitalization due to pre-existent medical conditions. In one case, a patient randomized to the cast group developed posttraumatic complex regional pain syndrome. No delay of fracture ... | PMC10771350 |
Discussion | fracture, dislocation, pain, fractures, atrophy | ATROPHY | Permissive weightbearing using a walking boot resulted in both better ankle function and health-related quality of life after six weeks when compared to non-weightbearing immobilization using a below-the-knee cast.This study is not the first to compare mobilization and weightbearing to immobilization and non-weightbear... | PMC10771350 |
Conclusion | fractures | Permissive weightbearing using a walking boot seems a safe and viable treatment for patients with stable Weber B fractures with regard to ankle functionality. This study highlights the potential advantages of using a walking boot such as increased patient satisfaction, improved self-care, and faster return to work. | PMC10771350 | |
Author contributions | RVV | Conceptualization was done by SF and RVV; data curation was done by RCS, SF, and RVV; formal analysis was carried out by RCS, SF, and RVV; methodology was done by RCS and SF; supervision was done by RVV, EDL, BB, and BM; writing—original draft were done by RCS; writing—review and editing were done by RVV, BB, BM, and E... | PMC10771350 | |
Funding | No funding was acquired for this study. | PMC10771350 | ||
Data availability | Available upon request. | PMC10771350 | ||
Declarations | PMC10771350 | |||
Conflict of interest | The authors have no potential conflicts of interest. | PMC10771350 | ||
Ethical approval | This study was approved by the local medical ethical committee. | PMC10771350 | ||
Consent for publication | Consent for publication was given by the local medical ethical committee. | PMC10771350 | ||
References | PMC10771350 | |||
Abstract | advanced/metastatic, gastric/gastroesophageal junction cancer, GC/GEJC/esophageal adenocarcinoma | DISEASE | First‐line chemotherapy for advanced/metastatic human epidermal growth factor receptor 2 (HER2)‐negative gastric/gastroesophageal junction cancer (GC/GEJC) has poor median overall survival (OS; <1 year). We report efficacy and safety results from Chinese patients in the phase III global CheckMate 649 study of nivolumab... | PMC10092493 |
Abbreviations | death, Tumorstreatment‐related | ONCOLOGY | adverse eventblinded independent central reviewconfidence intervalcombined positive scoreduration of responseesophageal adenocarcinomaEastern Cooperative Oncology Group performance statusoxaliplatin, leucovorin and 5‐fluorouracilgastric cancergastroesophageal junction cancerhuman epidermal growth factor receptor 2hazar... | PMC10092493 |
INTRODUCTION | Gastric cancer, death, tumor, cancer, PD, tumors | GASTRIC CANCER, TUMOR, CANCER, CPS, TUMORS | Gastric cancer (GC) is the fifth most commonly diagnosed cancer and the fourth leading cause of cancer‐related death worldwide.CheckMate 649 is the largest, randomized phase III study of first‐line PD‐1 inhibitor‐based therapies in patients with unresectable advanced or metastatic, nonHER2‐positive GC/GEJC/EAC. In the ... | PMC10092493 |
METHODS | PMC10092493 | |||
Study design | cancer, tumor, PD‐L1 | ONCOLOGY, CANCER, TUMOR, CPS | This multicenter, open‐label, randomized phase III study enrolled patients at 175 hospitals and cancer centers in 29 countries, including 22 centers in China. Patients were initially randomized to receive nivolumab plus ipilimumab or chemotherapy alone at a 1:1 ratio. Amendments to the protocol resulted in randomizatio... | PMC10092493 |
Patients | Detailed methods were previously described. | PMC10092493 | ||
Treatments | Patients received nivolumab plus investigator's choice of XELOX (360 mg nivolumab day 1, 130 mg/m | PMC10092493 | ||
Endpoints | OS, PD‐L1 | CPS, SECONDARY | The dual primary endpoints for nivolumab plus chemotherapy vs chemotherapy in the global population were OS and PFS per blinded independent central review (BICR) in patients with PD‐L1 CPS ≥5. Hierarchically tested secondary endpoints included OS in patients with PD‐L1 CPS ≥1 and in all randomized patients. Other secon... | PMC10092493 |
Assessments | PD‐L1, death, tumor, Tumor, Treatment‐relatedness, Tumors, TRAEs, Cancer | ADVERSE EVENT, DISEASE PROGRESSION, TUMOR, TUMOR, ADVERSE EVENTS, TUMORS, CPS, EVENTS, CANCER | Incidence of death, treatment‐related adverse events (TRAEs), serious adverse events, TRAEs leading to discontinuation and TRAEs with potential immunologic etiology were assessed using the Medical Dictionary for Regulatory Activities version 23.0, and adverse events (AEs) were graded in severity using the National Canc... | PMC10092493 |
Statistical analyses | Statistical analyses were performed using SAS version 9.4 (Cary, NC). For the Chinese subgroup patient population, a two‐sided stratified log‐rank test was not performed for OS and PFS as described for the global population. | PMC10092493 | ||
RESULTS | PMC10092493 | |||
Patients | PD‐L1, death, esophageal adenocarcinoma, tumor | TUMOR, GASTROESOPHAGEAL JUNCTION CANCER, ESOPHAGEAL ADENOCARCINOMA, MAY, ONCOLOGY, CPS, GASTRIC CANCER | From April 2017 to May 2019, 357 Chinese patients were assessed for eligibility in CheckMate 649. Among these, 208 patients were randomized to receive nivolumab plus chemotherapy (n = 99) or chemotherapy alone (n = 109); 99 patients in the nivolumab plus chemotherapy group and 106 patients in the chemotherapy group rec... | PMC10092493 |
Efficacy | death, PD‐L1 | CPS, MAY | After a minimum follow‐up (time from concurrent randomization of the last patient to data cutoff [May 27, 2020]) of 12.1 months, Chinese patients with PD‐L1 CPS ≥5 in the nivolumab plus chemotherapy group had a 46% reduction in risk of death and a 5.9‐month improvement in median OS (15.5 months [95% CI: 11.9‐25.5] vs 9... | PMC10092493 |
Exposure and safety | Treatment‐relatedness, Cancer | ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, EVENTS, CANCER | Among all treated Chinese patients, the median (range) duration of treatment in the nivolumab plus chemotherapy group was 6.3 months (0.1‐32.6) for patients receiving nivolumab plus XELOX and 6.5 months (1.0‐30.0) for patients receiving nivolumab plus FOLFOX, while the median duration of treatment was 4.0 months (0.0‐2... | PMC10092493 |
DISCUSSION | death, TRAEs, PD‐L1 | PRIMARY TUMOR, ADVERSE EVENTS, CPS, SEPARATION, DISEASE CHARACTERISTIC | Chinese patients who received nivolumab plus chemotherapy experienced clinically meaningful improvements in OS and PFS per BICR vs chemotherapy alone in the PD‐L1 CPS ≥5 and PD‐L1 CPS ≥1 groups and in the all randomized population. There was early and sustained separation of OS and PFS curves and a higher percentage of... | PMC10092493 |
CONCLUSIONS | In this preplanned analysis of Chinese patients enrolled in CheckMate 649, nivolumab plus chemotherapy resulted in clinically meaningful improvements in OS, PFS, ORR and DOR compared with chemotherapy alone, and the safety profile was acceptable and showed no new safety signals, consistent with results from the global ... | PMC10092493 | ||
AUTHOR CONTRIBUTIONS | The work reported in the paper has been performed by the authors unless clearly specified in the text. Kohei Shitara, Mingshun Li and Ming Lei contributed to the conception and design of the study. Tianshu Liu, Yuxian Bai, Xiaoyan Lin, Wei Li, Jufeng Wang, Xiaochun Zhang, Hongming Pan, Chunmei Bai, Li Bai, Ying Cheng, ... | PMC10092493 | ||
CONFLICT OF INTEREST | cancer | CANCER | Kohei Shitara reports grants and personal fees from Astellas Pharma, Eli Lilly and Company, Ono Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical and Merck Pharmaceutical; grants from Dainippon Sumitomo Pharma, Chugai Pharma, Medi Science and Eisai; and personal fees from Bristol Myers Squibb, Takeda Pharmaceuticals... | PMC10092493 |
ETHICS STATEMENT | This study was conducted in accordance with the trial protocol and with Good Clinical Practice guidelines developed by the International Council for Harmonisation. Written informed consent was obtained from all patients per the Declaration of Helsinki principles. The study is registered at | PMC10092493 | ||
Supporting information |
Click here for additional data file. | PMC10092493 | ||
ACKNOWLEDGEMENTS | This study was supported by Bristol Myers Squibb and Ono Pharmaceutical Co. Ltd. We thank the patients and their families who made this study possible, the investigators and the clinical study teams at Bristol Myers Squibb (Princeton, NJ) and Ono Pharmaceutical Co. Ltd. (Osaka, Japan) and Dako (an Agilent Technologies ... | PMC10092493 | ||
DATA AVAILABILITY STATEMENT | Bristol Myers Squibb will honor legitimate requests for clinical trial data from qualified researchers. Data will be shared with external researchers whose proposed use of the data has been approved. Complete de‐identified patient data sets will be eligible for sharing 2 years after completion of the CheckMate 649 stud... | PMC10092493 | ||
REFERENCES | PMC10092493 | |||
Background | end-expiratory occlusion | SEPTIC SHOCK | An increase in cardiac index (CI) during an end-expiratory occlusion test (EEOt) predicts fluid responsiveness in ventilated patients. However, if CI monitoring is unavailable or the echocardiographic window is difficult, using the carotid Doppler (CD) could be a feasible alternative to track CI changes. This study inv... | PMC10116770 |
Methods | HEMODYNAMIC INSTABILITY | Prospective, single-center study in adults with hemodynamic instability. The CDPV and cFT on carotid artery Doppler and hemodynamic variables from the pulse contour analysis EV1000™ were recorded at baseline, during a 20-s EEOt, and after fluid challenge (500 mL). We defined responders as those who increased CI ≥ 15% a... | PMC10116770 | |
Results | arrhythmias, septic shock | ARRHYTHMIAS, SEPTIC SHOCK | We performed 44 measurements in 18 mechanically ventilated patients with septic shock and without arrhythmias. The fluid responsiveness rate was 43.2%. The changes in CDPV were significantly correlated with changes in CI during EEOt ( | PMC10116770 |
Conclusions | arrhythmias, septic shock | ARRHYTHMIAS, SEPTIC SHOCK | In septic shock patients without arrhythmias, an increase in CDPV greater than 10.5% during a 20-s EEOt predicted fluid responsiveness with > 95% specificity. Carotid Doppler combined with EEOt may help optimize preload when invasive hemodynamic monitoring is unavailable. However, the 61% gray zone is a major limitatio... | PMC10116770 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13054-023-04422-9. | PMC10116770 | ||
Keywords | PMC10116770 | |||
Background | preload-responsive, stroke, EEOt, increases cardiac preload | STROKE, SEPTIC SHOCK | Fluid responsiveness is defined as an increase in cardiac index (CI) in response to an increase in preload [Several functional hemodynamic tests for assessing fluid responsiveness have been introduced in clinical practice in the last few years [The EEOt is based on an interruption of mechanical ventilation at the end o... | PMC10116770 |
Methods | PMC10116770 | |||
Patient population | tachycardia, hypotension, septic shock, carotid artery stenosis, heart failure | PERIPHERAL ARTERIAL DISEASE, VALVULAR HEART DISEASE, CARDIAC ARRHYTHMIA, SEPTIC SHOCK, CAROTID ARTERY STENOSIS, HEART FAILURE | The institutional review board of Policlinico Agostino Gemelli University Hospital approved the present study (Prot. N. 0048329/18 ID 1677) retrospectively registered on ClinicalTrials.gov NCT04470856 on July 14, 2020. All patients or their legal representatives gave their written informed consent to participate.All ad... | PMC10116770 |
Carotid Doppler | One investigator (SD'A) with previous formal training in critical care ultrasound insonated the common carotid artery in a longitudinal view approximately 1–2 cm before the bifurcation using a 5–10-MHz linear array transducer (Vivid™ iq, General Electric Healthcare, Chicago, Illinois, USA) and performed a pulse-wave Do... | PMC10116770 | ||
Study endpoints | The primary endpoint of this study was the correlation between changes in CDPV and CI during an EEOt. Secondary endpoints were the correlations between changes in CDPV and CI after the fluid challenge and between changes in cFT and CI during EEOt and after fluid challenge. We also explored the ability of changes in CDP... | PMC10116770 | ||
Statistical analysis | BROWN | The distribution of continuous variables was assessed with the Kolmogorov–Smirnov test. Data are expressed as mean ± standard deviation (SD) or median (interquartile range), as appropriate. Categorical variables are reported as fractions and percentages (%). Differences between parametric variables were evaluated with ... | PMC10116770 | |
Results | We performed 44 measurements on 18 patients. Their characteristics are shown in Table Patient characteristicsData are expressed as median [IQR], mean ± standard deviation, or n (%)PEEP, positive end-expiratory pressure; SAPS, Simplified Acute Physiology Score; and SOFA, Sequential Organ Failure AssessmentThe overall ra... | PMC10116770 | ||
Hemodynamic effects of EEOt | During the EEOt, the CI increased by 10.9% (from 2.2 ± 0.6 to 2.5 ± 0.8 L/min/mChanges in cardiac index in responders (FR) and non-responders (NFR) during EEOt and after fluid challengeChanges in carotid Doppler peak velocity (CDPV) in responders (FR) and non-responders (NFR) during EEOt and after fluid challenge | PMC10116770 | ||
Hemodynamic effects of fluid challenge | After the 500-mL fluid challenge, in fluid responders, the CI increased by 22.2% (from 2.2 ± 0.6 to 2.8 ± 0.9 L/min/mThe mean values of MAP, HR, SVV, CVP, and SVRI did not change significantly during EEOt and after the fluid challenge. | PMC10116770 | ||
Correlation between changes in carotid Doppler and in cardiac output measurements | The linear correlation coefficient r between the percentage changes in CDPV and CI during EEOt was 0.52 [0.26–0.71]. A significant but lower correlation was found for cFT (On rmcorr, the percentage changes in CDPV vs. the percentage changes in CI were significantly correlated across EEOt and fluid challenge in responde... | PMC10116770 | ||
Discussion | critically ill, end-inspiratory occlusion maneuver, EEOt, septic shock, arrhythmias | CARDIAC FAILURE, CRITICALLY ILL, FLUID OVERLOAD, FRANK, SEPTIC SHOCK, ATRIAL FIBRILLATION, ARRHYTHMIAS | Our results showed a significant correlation between changes in CPDV during EEOt and changes in CI during the subsequent fluid challenge. An increase in CDPV greater than 10.5% during an EEOt predicted fluid responsiveness in ICU patients with septic shock with high specificity. This may allow clinicians to non-invasiv... | PMC10116770 |
Conclusions | arrhythmias | ARRHYTHMIAS, SEPTIC SHOCK | Our study showed that in adult patients with septic shock, the changes in CPDV and cFT during EEOt on carotid Doppler are correlated with the changes in CI that occur after a fluid challenge, and that an increase in CDPV greater than 10.5% during a 20-s EEOt predicted fluid responsiveness with > 95% specificity. Caroti... | PMC10116770 |
Author contributions | AMD | SD'A, AMD, and CS contributed to conception and design of the work. SD'A, AMD, SC, and CP were involved in enrollment and data acquisition. CS, SD'A, AMD, and AM contributed to interpretation of data. SD'A, CS, AMD, and AM were involved in manuscript writing. CS and MA contributed to revision and senior contribution. A... | PMC10116770 | |
Funding | DEL | This study was funded by a finalized grant from Università Cattolica del Sacro Cuore Linea D1/2018. | PMC10116770 | |
Availability of data and materials | All data generated or analyzed during this study are included in this article. The dataset used and/or analyzed during the study is available from the corresponding author on request. | PMC10116770 | ||
Declarations | PMC10116770 | |||
Ethics approval and consent to participate | This study was approved by the institutional review board (Prot. N. 0048329/18 ID 1677) of the Fondazione Policlinico Universitario A. Gemelli- IRCCS and carried out in accordance with the principles outlined in the Declaration of Helsinki. All patients or their legal representatives gave their written informed consent... | PMC10116770 | ||
Consent to publication | Not applicable. | PMC10116770 | ||
Competing interests | On behalf of all authors, the corresponding author states that there is no conflict of interest. | PMC10116770 | ||
References | PMC10116770 | |||
Subject terms | Nasopharyngeal Carcinoma | SOLID TUMOUR, DISEASE, SOLID TUMORS, NASOPHARYNGEAL CARCINOMA, SECONDARY, NASOPHARYNGEAL CARCINOMA | Immunotherapy combined with antiangiogenic targeted therapy has improved the treatment of certain solid tumors, but effective regimens remain elusive for refractory recurrent/metastatic nasopharyngeal carcinoma (RM-NPC). We conducted a phase 2 trial to evaluate the safety and activity of camrelizumab plus apatinib in p... | PMC10425437 |
Introduction | NPC | NASOPHARYNGEAL CARCINOMA, DISEASE | Nasopharyngeal carcinoma (NPC) has unique geographical, etiological and biological characteristics that set it apart from other head and neck tumorsThe combination of a PD-1/PD-L1 inhibitor with an anti-angiogenesis antibody has shown efficacy in many malignanciesIn this phase 2 trial presented here, we report the resu... | PMC10425437 |
Results | PMC10425437 | |||
Patients | Between 8 September 2020, and 7 January 2021, 66 patients were screened, of whom 52 were enrolled in the study, with 27 in cohort 1 and 25 in cohort 2, all of whom were included in the full and safety analysis set. On Jan. 31, 2021, the protocol was amended to include 13 additional patients in the cohort 1 and 7 in the... | PMC10425437 |
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