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Discussion | This pilot randomised clinical trial demonstrates that two different daily doses of 200 IU and 1000 IU of vitamin D for 4 months increase serum 25(OH)D concentration in a dose-response relationship in healthy young adults. No statistically significant relationship between BMI was found when comparing the intervention group with the control. Lower levels of total cholesterol, LDL-cholesterol and higher levels of HDL-cholesterol were evidenced in the intervention group. However, the decrease was statistically significant only in LDL-cholesterol levels in the intervention group when compared with the control group. | PMC9947753 | ||
Vitamin D and BMI | The relationship between vitamin D and BMI is mainly due to the participation of vitamin D as a pre-hormone and its ability to go to many specific tissues in the body | PMC9947753 | ||
Vitamin D and serum lipids | cardiovascular and metabolic conditionsIn | VITAMIN D DEFICIENCY | Various observational studies across the world indicate an association between vitamin D deficiency and low levels of high-density lipoproteins (HDL) and high triacylglycerols, as well as higher levels of apolipoprotein EOne of the strengths of our study was the quantification of the concentration of vitamin D in the blood, which made it possible to follow the intra-person variation in its metabolism. In addition, the analytical reliability of 25(OH)D in the quantification was monitored through DEQAS (the vitamin D External Quality Assessment Scheme), since the laboratory where the quantification was carried out could do it.Regarding limitations, we did not include a placebo group for ethical reasons. A smaller vitamin D dose of 200 IU/d was included to provide an adequate dose-response comparison with the higher dose. Another limitation is that being a pilot study the sample size was not optimal, and there was no evidence of significance in our findings on total cholesterol, HDL-cholesterol and triacylglycerols.Despite the lack of solid conclusions about the clinical benefits of vitamin D supplementation in published studies, achieving vitamin D sufficiency remains crucial in patients with cardiovascular and metabolic conditionsIn conclusion, we found that two different doses of vitamin D supplementation, 200 IU | PMC9947753 |
Acknowledgements | P. | The authors are grateful to all the participants for their willingness to realise the clinical trial.This work was financed by Minciencias (formerly COLCIENCIAS) with contract No. 774-2018. Project ‘Association between vitamin D status, excess weight and altered lipid profile in Colombian adolescents and young adults: challenges and opportunities in the early evaluation of cardiovascular risk’.Formulating the research question(s): N. C. S., E. M. G.-D. and D. C. Q.-L. Designing the study: N. C. S., E. M. G.-D., L. Z. R. and D. C. Q.-L. Carrying out the study: D. C. Q.-L., D. P. S., I. S. A., S. L. R. and M. F. Analysing the data: L. Z. R. Interpreting the findings and writing: N. C. S., E. M. G.-D., L. Z. R., M. F. and D. C. Q.-L. All authors have read and agreed to the published version of the manuscript.The authors declare no conflict of interest. | PMC9947753 | |
References | PMC9947753 | |||
Key Points | PMC10559177 | |||
Question | PROSTATE CANCER | What factors are associated with a shorter time interval to prostate-specific antigen (PSA) failure (PSA nadir plus 2 ng/mL or initiation of salvage therapies) in nonmetastatic unfavorable-risk prostate cancer? | PMC10559177 | |
Findings | SECONDARY | In this secondary analysis of a phase 3 clinical trial with 350 participants, significant factors associated with shorter time to PSA failure were younger than 70 years, a PSA of 10 ng/mL or more, and a Gleason score of 8 to 10. A high-risk group, defined by these 3 factors, had 43.8% risk of PSA failure at 3 years. | PMC10559177 | |
Meaning | PSA failure, prostate cancer | SECONDARY, PROSTATE CANCER | These findings suggest that males with unfavorable-risk prostate cancer who are at very high-risk for early PSA failure can be identified and may benefit from study in randomized treatment escalation studies.This secondary analysis of a randomized clinical trial evaluates the factors associated with a short interval to prostate-specific antigen failure among patients with prostate cancer. | PMC10559177 |
Importance | A shorter time interval to prostate-specific antigen (PSA) failure is associated with worse clinical outcomes; however, specific factors defining this state remain unknown. | PMC10559177 | ||
Objective | To evaluate the factors of a short time interval to PSA failure in order to identify patients for treatment escalation randomized clinical trials. | PMC10559177 | ||
Design, Setting, and Participants | prostate cancer, Cancer | SECONDARY, PROSTATE CANCER, CANCER | This secondary analysis of a randomized clinical trial was a secondary analysis of the Dana-Farber Cancer Institute 05-043 trial and included 350 patients with nonmetastatic unfavorable risk prostate cancer (PC). | PMC10559177 |
Interventions | Patients were randomized 1:1 to receive androgen deprivation therapy (ADT) and radiation therapy (RT) plus docetaxel vs ADT and RT. | PMC10559177 | ||
Main Outcomes and Measures | REGRESSION | Cumulative incidence rates curves of PSA failure, defined as PSA nadir plus 2 ng/mL or initiation of salvage therapies, and the Fine and Gray competing risks regression was used to assess the prognostic association between these factors and time to PSA failure. | PMC10559177 | |
Results | ONCOLOGY | The study included 350 males who primarily had a good performance status (330 [94.3%] with Eastern Cooperative Oncology Group score of 0), median (range) age of 66 (43-86) years, with 167 (46.6%) having Gleason scores of 8 to 10, and 195 (55.2%) presenting with a baseline PSA of more than 10 ng/mL. After a median (IQR) follow-up of 10.2 (8.0-11.4) years, having a PSA level of 10 ng/mL to 20 ng/mL (subdistribution hazard ratio [sHR], 1.98; 95% CI, 1.28-3.07; | PMC10559177 | |
Conclusions and Relevance | PSA failure | SECONDARY | In this secondary analysis of a randomized clinical trial of males with unfavorable risk PC, young age, PSA of 10 ng/mL or more, and a Gleason score of 8 to 10 estimated a shorter time to PSA failure. A subgroup of males at very high-risk for early PSA failure, as defined by our study, may benefit from treatment escalation with androgen receptor signaling inhibitors or cytotoxic chemotherapy and should be the subject of a prospective randomized clinical trial. | PMC10559177 |
Trial Registration | PMC10559177 | |||
Introduction | hormone-sensitive M0 prostate cancer | SECONDARY | Androgen-deprivation therapy (ADT) using a luteinizing hormone-releasing hormone agonist or antagonist is a component of treatment for advanced hormone-sensitive M0 prostate cancer (PC) as several prospective randomized clinical trials have demonstrated that the addition of ADT to radiation therapy (RT) prolongs PC-specific and overall survival (OS).The prognosis following prostate-specific antigen (PSA) failure in patients with localized PC treated with RT varies widely. In addition to PSA-based end points, such as PSA nadir or PSA doubling time, the shorter time interval from RT to PSA failure has been also found to be associated with worse clinical outcomes (eTable 1 in With the advent of more advanced treatments, such as AR-signaling inhibitors and docetaxel, an opportunity exists for treatment escalation, yet for whom treatment escalation is most needed remains unknown. In the current study, we present a secondary analysis of DFCI trial 05-043 using individual patient data, evaluating the factors of shorter time interval to PSA failure (ie, within 3 years) to identify patients for treatment escalation randomized clinical trials. | PMC10559177 |
Methods | Cancer | CANCER | This randomized clinical trial was approved by the institutional review board of the Dana-Farber/Harvard Cancer Center and registered with ClinicalTrials.gov. | PMC10559177 |
Patient Population and Treatment | T2c, adenocarcinoma of the prostate, Cancer | SEMINAL VESICLES, ONCOLOGY, ADENOCARCINOMA OF THE PROSTATE, CANCER | Between September 21, 2005, and January 13, 2015, 350 patients from both academic and community-based health centers in the United States, Australia, and New Zealand who has been diagnosed with the 2002 American Joint Commission on Cancer Clinical Stage T1b-T4N0M0 adenocarcinoma of the prostate with at least 1 unfavorable prognostic factor were included in this study. Unfavorable prognostic factors included (1) clinical T2c to T4 or (2) clinical T1b to T2b and 1 of the following: PSA level of more than 10 ng/mL (to convert to ug/L, multiply by 1.0), biopsy Gleason score of 4 + 3 or higher, tertiary grade 5 PC, biopsy Gleason score of 3 + 4 with at least 50% of biopsy cores positive, PSA velocity of more than 2 ng/mL/y, or biopsy or radiographic evidence of seminal vesicle invasion. Additional inclusion criteria included being 30 years or older, having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and having adequate hematologic function with a white blood cell count more than 3000/mmAs shown in | PMC10559177 |
CONSORT Diagram | ADT indicates androgen deprivation therapy; RT, radiation therapy. | PMC10559177 | ||
Follow-Up | death | After the end of treatment, males were followed up with every 6 months for the first 5 years and annually thereafter. A serum PSA was obtained at each follow-up. In addition to routine follow-up assessment, restating with a bone scan and pelvis magnetic resonance imaging or computed tomography were performed at the time of PSA failure. Salvage ADT was recommended when PSA levels rose to approximately 10 ng/mL. All patients were followed from the date of random assignment until death, and the cause of death was centrally reviewed. | PMC10559177 | |
Statistical Analysis | PSA failure, Deaths | REGRESSION, EVENTS, DISEASE, SECONDARY | The baseline characteristics of the study cohort at the time of randomization were presented using descriptive statistics in a tabular format. The primary end point was time to PSA failure, defined as time from randomization to earliest date of PSA nadir plus 2 ng/mL or the initiation of salvage therapies, such as ADT, brachytherapy, or radical prostatectomy, or censored at the date of last disease assessment for those alive and without PSA failure. Deaths from non-PC causes were counted as competing risk events.In this secondary analysis of a randomized clinical trial, the intent of the study was to assess the prognostic association between baseline clinical factors and time to PSA failure. Clinical factors evaluated included age (categorically defined as younger than 60 years vs 60 to 69 years vs 70 years or older), PSA (categorically defined as less than 4 ng/mL vs 4 to less than 10 ng/mL vs 10 to 20 ng/mL vs more than 20 ng/mL), biopsy Gleason score (categorically defined as 8 to 10 vs 7 vs 6 or less), clinical T-category (categorically defined as T3-4 vs T2 vs T1), ECOG performance status (categorically defined as 1 vs 0) and use of pelvic RT. To fulfill this objective, for each baseline factor of interest, graphical cumulative incidence rate (CIR) curves of PSA failure were produced, treating non-PC deaths as competing events. A Gray test was used to compare these curves for each baseline clinical factor of interest. Meanwhile, the CIR estimates of PSA failure at 3 and 5 years were provided with 95% CIs. Furthermore, to more quantitatively evaluate the association of baseline clinical factors of interest with PSA failure, a multivariable competing risk regression for the subdistribution hazard ratio (sHR) using the Fine and Gray model was applied. The model is stratified by regions (US-Northeast, US-West, US-other, Australia, and New Zealand), and randomization arm. Statistical significance was defined as | PMC10559177 |
Results | PMC10559177 | |||
Patient Characteristics | The study population included 350 males with a median (range) age of 66 (43-86) years and included 4 Asian males (1.1%), 9 Black males (2.6%), 271 White males (77.4%), and 66 males (18.9%) who selected other as their race. In total, 167 males (46.6%) had a Gleason score of 8 to 10 and 195 (55.2%) with baseline PSA of more than 10 ng/mL. Additionally, 330 males (94.3%) had a good performance status with an ECOG score of 0, as indicated in | PMC10559177 | ||
Baseline Clinical Characteristic of 350 Study Patients | ONCOLOGY | Abbreviations: ECOG, Eastern Cooperative Oncology Group; PSA, prostate-specific antigen.SI conversion factor: To convert PSA to μg/L, multiply by 1.0. | PMC10559177 | |
Factors of Time to PSA Failure | The CIRs of PSA failure at 3 and 5 years by clinical factors are shown in eTable 2 and illustrated in eFigure in | PMC10559177 | ||
Multivariable Competing Risk Regression Estimate of sHR for Biochemical Progression in Fine and Gray’s Model | ONCOLOGY | Abbreviations: ECOG, Eastern Cooperative Oncology Group; RT, PSA, prostate-specific antigen; radiation therapy; sHR, subdistribution hazard ratio.SI conversion factor: To convert ng/mL to μg/L, multiply by 1.0.The multivariable model is also stratified by regions (US-Northeast, US-West, US-Other, Australia, New Zealand) and randomization arm.Age was included in the model as a continuous variable; parameter and hazard ratios of age are shown in per 5-year increment.The 3 significant factors associated with time to PSA failure were used to divide patients into 2 categories. The high-risk category was defined as being younger than 70 years, having a PSA of 10 ng/mL or higher, and having a Gleason score of 8 to 10. Otherwise, it was defined as low risk. Among the males in the high risk category, CIRs of PSA failure at 3 years was 43.8% (95% CI, 31.8%-55.2%) (eTable 2 in | PMC10559177 | |
Cumulative Incidence Curves of PSA Failure by Risk Categories | High risk category is defined as age younger than 70 years, PSA 10 ng/mL or more, and a Gleason score of 8 to 10. | PMC10559177 | ||
Multivariable Competing Risk Regression Estimate of sHR for Biochemical Progression in Fine and Gray Model | ONCOLOGY | Abbreviations: ECOG, Eastern Cooperative Oncology Group; RT, radiation therapy; sHR, subdistribution hazard ratio.The multivariable model is also stratified by regions (US-Northeast, US-West, US-Other, Australia, New Zealand) and randomization arm.The high-risk category was defined as being younger than age 70 years, a prostate-specific antigen of 10 ng/mL or more, and a Gleason score of 8 to 10. | PMC10559177 | |
Discussion | SECONDARY | In this study, we examined a cohort of males who experienced PSA failure after ADT and RT with or without docetaxel for nonmetastatic unfavorable-risk PC in the context of a randomized clinical trial. We found 3 significant factors that were associated with a shorter time to PSA failure were being younger than 70 years, having a PSA of 10 ng/mL or more, and having a biopsy Gleason score of 8 to 10. By using these 3 factors, we defined a high-risk group with a 43.8% risk of PSA failure at 3 years. Of note, similar to a previously published randomized clinical trial,Time to PSA failure was investigated in other retrospective and secondary analyses of males who received RT alone or RT with ADT. In these studies, a shorter time to PSA failure associated with PC-specific mortality,Combination therapy of ADT and AR-signaling inhibitors leading to greater androgen suppression has been shown to improve clinical outcomes in males with nonmetastatic castrate-resistant PC (nmCRPC). The addition of enzalutamide to ADT was found to prolong OS in males with nmCRPC,Although the addition of docetaxel to ADT is currently not recommended for males with unfavorable-risk PC due to inconclusive results from previous randomized clinical trials,The use of molecular markers in risk stratification for PC is an active area of research with significant future potential. New tissue-based genomic tests, such as the Decipher, Prolaris, PTEN/TMPRSS2:ERG, Oncotype DX, ConfirmMDx, and ProMark, are being investigated to improve the detection and risk assessment of PC. | PMC10559177 | |
Limitations | comorbidity | SECONDARY | This study has limitations. First, it is a secondary subgroup analysis, and therefore these results are hypothesis-generating and should be evaluated in a new cohort study. Second, our observation of the significant factors associated with the shorter time to PSA failure may not be applicable in treatment settings outside the one used in this study. Therefore, the question remains whether these factors are maintained in the postoperative settings. Third, it is important to recognize that the high ECOG performance status observed in this cohort, which was a requirement for inclusion in the initial trial design, may limit the generalizability of our findings to populations with different performance status profiles. Fourth, it is important to acknowledge that the study cohort primarily consisted of non-Hispanic White men, which may limit the generalizability of our findings to more racially diverse populations. Fifth, the patient’s level of comorbidity may affect the survival benefit from the treatment intensification, and therefore future randomized clinical trials should consider prerandomization stratification by comorbidity level in addition to the high-risk group defined by our study. | PMC10559177 |
Conclusions | PSA failure | SECONDARY | In this secondary analysis of a randomized clinical trial of nonmetastatic unfavorable-risk PC, we found that being younger than 70 years, having a PSA of 10 ng/mL or more, and having a Gleason score of 8 to 10 could be used to estimate the shorter time to PSA failure following initial treatment with ADT and RT with or without docetaxel. These results support identifying males at very high risk for early PSA failure who may benefit from treatment escalation and could be studied in the setting of a prospective randomized clinical trial. | PMC10559177 |
Introduction | In 2021, there were 38.4 million people living with HIV (PLHIV) globally, of which 20.6 million (54%) were living in Eastern and Southern Africa. Longitudinal studies, inclusive of community randomized trials (CRTs), provide critical evidence to guide a broad range of health care interventions including HIV prevention. In this study, we have used an individual-level cohort study design to evaluate the association between sex and other baseline characteristics and participant retention in the HPTN 071 (PopART) trial in Zambia and South Africa. | PMC10294466 | ||
Methods | REGRESSION | HPTN 071 (PopART) was a community randomized trial (CRT) conducted from 2013 to 2018, in 21 communities. The primary outcome was measured in a randomly selected population cohort (PC), followed up over 3 to 4 years at annual rounds. PC retention was defined as completion of an annual follow-up questionnaire. Baseline characteristics were described by study arm and Poisson regression analyses used to measure the association between baseline factors and retention. In addition, we present a description of researcher-documented reasons for study withdrawal by PC participants. | PMC10294466 | |
Results | Of the 38,474 participants enrolled during the first round of the trial (PC0), most were women (27,139, 71%) and 73% completed at least one follow-up visit. Retention was lower in men (adj RR: 0.90; 95% CI: 0.88, 0.91) and higher among older participants (adj RR: 1.23; 95% CI 1.20, 1.26) when comparing ages 35–44 to 18–24 years. Retention was higher among individuals with high socioeconomic status (SES) (adj RR 1.16; 95% CI 1.14, 1.19) and medium SES (adj RR 1.12; 95% CI 1.09, 1.14) compared to low SES. The most common reasons for study withdrawal were study refusal (23%) and relocation outside the CRT catchment area (66%). | PMC10294466 | ||
Conclusion | Despite challenges, satisfactory retention outcomes were achieved in PopART with limited variability across study arms. In keeping with other studies, younger age, male sex, and lower SES were associated with lower levels of retention. Relocation outside of catchment area was the most common reason for non-retention in this CRT. | PMC10294466 | ||
Keywords | PMC10294466 | |||
Introduction | HIV infections | HIV INFECTIONS | In 2021, there were 38.4 million people living with HIV (PLHIV) globally, most of whom (20.6 million, 54%) were in Eastern and Southern Africa with 1.5 million new HIV infections globally [Participant retention outcomes vary across different types of longitudinal studies. Very high rates of loss to follow-up are routinely reported in observational cohort studies, commonly conducted within public health settings. For example, antiretroviral treatment (ART) cohort studies measuring programmatic outcomes in Africa report attrition rates of up to 50% at 1 year [Research into reasons for poor retention in longitudinal studies has focused primarily on cohort studies and RCTs with few data from CRTs. Factors influencing retention in longitudinal studies may be considered at the levels of participant characteristics and contextual factors. Participant characteristics associated with higher attrition include being male [There remains a paucity of conclusive data on factors contributing to and effective strategies toward retention in longitudinal studies, not least from CRTs in high burden settings. In this study, we aimed to evaluate the association between baseline characteristics and retention of research participants in the PopART population cohort (PC), implemented in urban and peri-urban communities in Zambia and South Africa. | PMC10294466 |
Methods | disability, primary retention | DISORDER, REGRESSION, SECONDARY, TUBERCULOSIS | HPTN 071 (PopART) was a three-arm CRT conducted from 2013 through 2018, in 21 urban or peri-urban communities in Zambia and South Africa [PC participants were recruited according to the following steps: (i) household census data were collected prior to PC0 to create a sampling frame; (ii) households in trial communities were randomly selected; (iii) research enumerators approached each selected household for enumeration of individual residents in the household using an electronic data capture device (EDC); (iv) from each enumerated household, one adult aged 18–44 years was randomly selected for invitation to participate in the PC, following eligibility determination; (v) if the randomly selected individual was willing to participate, an informed consent process was conducted. PC inclusion criteria included aged 18–44 years and the intention to remain in the study community for the trial duration. In contrast to facility-based studies, PopART follow-up visits were conducted in households and communities with extensive retention-focused activities. Scheduled retention activities included flexible household visit schedules in the form of household visits completed during weekday evenings and Saturdays, to reach individuals who were engaged in work or educational activities during the day [The primary objective of the current study was to evaluate characteristics associated with follow-up retention among participants enrolled at PC0. Our primary retention outcome was defined as the total number of annual visits where a participant completed a study questionnaire, with values ranging from 0 to 3. A secondary aim was to characterize retention during the study, including visit-level summaries of incomplete study visit outcomes (missed and withdrawal visits), as well as reasons for study withdrawal.PC survey data and laboratory outcomes were used in this analysis. Only data from participants enrolled at PC0 were included; participants enrolled at PC12 and PC24 were excluded from the analysis, to simplify the presentation and interpretation of results. A standardized electronic questionnaire (survey), completed at each annual round, included questions on demographic, socioeconomic, and biomedical factors. Questionnaires were administered by research enumerators who entered responses directly into the EDC which was programmed to include automated quality control steps. EDC data were uploaded in real time to the PC database managed by the HPTN data and statistical monitoring center (SCHARP). Data from laboratory test results were subsequently linked to questionnaire data in the database at SCHARP. Extensive iterative quality assurance processes were led by SCHARP with regular communication with site colleagues for resolution.Baseline variables providing a description of the research sample and hypothesized a priori to be related to retention, where data were available, were included in the analysis. Variable categories were chosen to align with those used for PopART primary and secondary analyses. We investigated the following variables: age (18–24, 25–34, 35–44); sex (male, female); marital status (married/living as married, never married, divorced/separated/widowed); nights spent away from home in the past 3 months (none, 1 to 7, 8 to 30, > 30); socioeconomic factors—education level (none to primary, partial or full secondary school, college/university), employment status (employed, student, unemployed), country-specific socioeconomic status (SES) level (low, medium, high, calculated using methods described in the supplementary materials); study factors—arm (arm A, arm B, arm C); behavioral factors—multiple sex partners in the past 12 months (yes, no), condom-less last sex (yes, no), alcohol use disorder identification test (AUDIT) score (categories low: 0–7 medium: 8–14, high: 15–40) [Combinations of longitudinal patterns of retention at the participant level were described in terms of retained visits (where a participant completed a study questionnaire) and not retained visits. Not retained visits were classified as either “missed visits” where follow-up was attempted at the next round or “withdrawal visits” where the participant was exited from the study. For each follow-up visit (PC12, PC24, PC36), we summarized the proportion of PC0 enrolled participants that were retained or had a missed or withdrawal visit, as well as reasons for study withdrawal. At PC36, all participants were considered retained or not retained, since it was the final study visit.We modeled retained visits using univariable and multivariable Poisson regression with robust Huber-White standard error estimates. All participants were assumed to have the same rate denominator of 3 possible follow-up visits. Our final multivariable model included sex as the primary exposure of interest. The following variables were hypothesized a priori to be related to retention: age, education, marital status, employment, country-specific SES, AUDIT score, and lab-confirmed HIV status. We additionally included the remaining variables (arm, nights spent away from home in the past 3 months, multiple sex partners in the past 12 months, condom-less last sex, recreational drug use, sick days taken off from work in past 3 months, disability status, self-reported HIV status and care, and self-report of ever told you have tuberculosis) if they showed a significant association (Ethical approval of the HPTN 071 (PopART) trial protocol was obtained from the ethics committees of the University of Zambia (HPTN071/PopART UNZA BREC REF: 011–11-12), Stellenbosch University (N12/11/074), and the London School of Hygiene and Tropical Medicine (6326). All participants included in this study have undergone a full informed consent process for PopART. | PMC10294466 |
Discussion | primary retention | Of participants enrolled at PC0, 73% had at least one follow-up visit completed (Table Retention in PopART was lower than that achieved in the Botswana Combination Prevention Project (BCPP). BCPP was a smaller CRT, conducted in a more rural setting (15 villages in Botswana) between 2013 and 2018 that evaluated the effect of enhanced provision of ART and voluntary male medical circumcision on population level HIV incidence. The CRT design in PopART and BCPP was comparable with study interventions provided community-wide and a cohort of community members randomly selected for more intensive follow-up for primary end point assessment. Study interventions were context specific and similar to PopART. In BCPP, 12,600 participants were followed up for HIV testing at 12 and approximately 29 months. Overall, > 95% of participants enrolled into the study cohort were successfully followed up at either 12 or 29 months [The association between HIV status and retention produced some interesting findings. Participants confirmed as HIV positive on baseline laboratory testing were significantly less likely to be retained. Far fewer participants self-reported HIV positive status at baseline than those confirmed on laboratory HIV testing. Participants self-reporting HIV positive at baseline were conversely more likely to be retained compared to those reporting “not knowing their status” or “never having tested.” The difference in frequency of HIV positive status between laboratory and self-report is likely to reflect a combination of “not knowing HIV status” and under-reporting of known HIV-positive status by participants, a trend supported by previously published data from the PC which showed that a considerable number of participants who were on ART self-reported they were HIV negative [Among participants defined as having permanently left the study (study “withdrawal”), the most common reason documented by the research team was “moving out of the study catchment” area (66%). This was despite “intention to remain in community over the 3-year period of study activities” being a study eligibility criterion. This suggests that participants who exited the community during the trial period were likely to have done so without prior long-term planning. In a separate PopART publication, social cohesion within study communities as the result of complex community dynamics (such as availability of social amenities, crime, poverty and drug use) was related to migration in and out of study communities. Where information is available, these factors should be considered in the choice of study communities and once the study is implemented a better understanding of these issues could assist to focus retention interventions [There has been extensive research into the effectiveness of retention strategies in longitudinal studies. A systematic review of 141 cohort studies from 28 countries [The need for disclosure by participants about study participation and support for participants within their households and communities is recognized as critical for retention [PopART has provided a unique opportunity to evaluate participant retention in the largest HIV prevention CRT to date. The community-based follow-up, over a long period of time (3–4 years), with inclusion of urban and peri-urban areas is also novel and contributes to the scientific relevance of this study. Standardized retention activities with active participant follow-up and careful documentation of these efforts, together with publications communicating associated outcomes from the study, have enabled us to complete a rigorous evaluation of participant retention. However, limitations for consideration exist. An approximately equal number of men and women were randomly selected for study enrolment. Men, however, were harder to access as they were often not present in the house and had higher rates of refusal to participate in the study. We unfortunately do not have systematic data on participants who refused to participate in the study. Men were more likely to be lost to follow-up and having more women in the cohort may therefore have increased overall retention. Similarly, reporter bias and “social desirability” among participants may have led to under-reporting of social activities such as alcohol and drug use which in turn affected the multivariable analysis. Conversely with the very large sample size, there becomes a high likelihood of statistically significant associations between independent variables and study outcomes even when differences in the proportions with the outcome are small across variable categories, and this should be considered when reviewing the multivariable analysis. Although the 21 communities in Zambia and South Africa included in PopART are representative of many high HIV burden communities, contextual factors (e.g., urban vs. peri-urban) likely play a significant role in determining participant retention. The findings of this study therefore need to be reviewed carefully when conducting similar studies in other settings. Our primary retention outcome was defined as the total number of annual visits where a study questionnaire was completed. For the participant visit to contribute to primary endpoint measurement laboratory-based HIV testing needed to be completed. There were a limited number of retained participants for whom no laboratory-based HIV testing was done for a variety of reasons including failure to complete phlebotomy and hemolyzed samples. Evaluation of this HIV testing pathway was outside the focus of this paper; however, challenges with testing should also be carefully considered by researchers implementing community-based trials. | PMC10294466 | |
Acknowledgements | AIDS | INFECTIOUS DISEASES, ALLERGY, AIDS, ABUSE, EMERGENCY | HPTN 071 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) under Cooperative Agreements UM1-AI068619, UM1-AI068617, and UM1-AI068613, with funding from the US President’s Emergency Plan for AIDS Relief (PEPFAR). Additional funding is provided through NIAID, the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), and the International Initiative for Impact Evaluation (3ie) with support from the Bill & Melinda Gates Foundation. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID, NIMH, NIDA, PEPFAR, 3ie, or the Bill & Melinda Gates Foundation. | PMC10294466 |
Authors’ contributions | NM and PB conceptualized the paper, EW and DS completed the analysis, and all authors participated in HPTN 071 and in the development of the manuscript. All authors have approved this final draft. | PMC10294466 | ||
Availability of data and materials | Hutchinson Cancer | Data used in this study will be available on request immediately after publication, with no end date. This includes de-identified participant data with a data dictionary. A data archive will be held at Fred Hutchinson Cancer Center, Seattle, WA, USA. Requests can be sent to HPTN-Data-Access@scharp.org. | PMC10294466 | |
Declarations | PMC10294466 | |||
Competing interests | The authors declare that they have no competing interests. | PMC10294466 | ||
References | PMC10294466 | |||
Background | metabolic syndrome, MetS | METABOLIC SYNDROME, SYNDROME | Despite the prior evidence of the impacts of sumac on glycemic indices, lipid profile and visceral fat, there is a lack of evidence regarding the efficacy of sumac in cases with metabolic syndrome (MetS). Therefore, we aimed to assess the effect of sumac supplementation on MetS markers among adults with this syndrome. | PMC10183306 |
Methods | MetS | In this triple-blinded randomized placebo-controlled cross-over clinical trial 47 adults with MetS were randomly assigned to receive 500 mg sumac or placebo (lactose) capsule, twice a day. Each phase took 6 weeks and there was a 2-week washout between phases. All clinical evaluations and laboratory tests were conducted before and after each phase. | PMC10183306 | |
Results | At the baseline of the study, mean (± SD) age, weight, and waist circumference of participants were respectively 58.7 (± 5.8) yr, 79.9 (± 14.3) kg, and 107.6 (± 10.8) cm. Intention to treat analysis (ITT) analyses revealed that sumac supplementation decreased systolic blood pressure by 5 mmHg (128.8 ± 21.4 at the baseline vs. 123.2 ± 17.6 after 6 weeks intervention, | PMC10183306 | ||
Conclusions | This cross-over trial revealed that sumac supplementation could reduce systolic blood pressure in men and women with MetS. Daily intake of 1000 mg sumac, as an adjuvant therapy, may be beneficial in management of MetS in adults. | PMC10183306 | ||
Keywords | PMC10183306 | |||
Methods | PMC10183306 | |||
Participants | MetS | A single-center triple-blind randomized placebo-controlled cross-over clinical trial was performed in Isfahan Endocrine and Metabolic Research Center (IEMRC) between November 2020 and June 2021. Individuals with MetS with the age range of 20 to 70 years who were willing to participate in the trial were included in the current analysis. According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP III) definition [ | PMC10183306 | |
Study design | Since the components of available sumac powder in the market might be non-standard, At the initial of study, participants were randomly assigned to one of 2 groups. In order to have appropriate randomization and blinding, an unaware person, who was not involved in the study, performed randomization through the website of “Participant flow diagram | PMC10183306 | ||
Measurements | fasting blood glucose | CREST | All clinical evaluations and laboratory tests were conducted before and after each phase. A trained nutritionist gathered the information about socio-demographic and medical history of participants through the face-to-face interview. Half way between the lower rib margin and the iliac crest was measured as waist circumference (WC), in centimeters. For weight measurement, individuals were weighed by a digital scale (OMRON, HN-286-E, Japan; with the accuracy of ± 100 g) without shoes, while wearing light clothes. Additionally, participants stood without shoes for height measurement, and a portable stadiometer (Seca, Hamburg, Germany, with accuracy of 0.5 cm) was used for this measurement. BMI was computed through weight (kg) divided by the square of the height (mSubjects were recommended to maintain their normal diet and lifestyle throughout all study phases. An expert nutritionist instructed individuals to complete a 3-day food record in each phase for assessment of energy and dietary intakes. Participants completed these records during a week in both phases (sumac and placebo arms) for two weekdays and 1 weekend day. Then, using the Iranian household measures, dietary intakes were converted to gram/day [A 12-h fasting blood sample was gathered from each participant, before and after of each study phase. After centrifuging blood samples for 10 min at room temperature, serum fasting blood glucose (FBG) concentration was assessed on the day of blood collection by enzymatic colorimetric method and through the use of the glucose oxidase (Pars Azmoon commercial kits, Tehran, Iran). Commercial kits were used for measurement of serum triglyceride, low density lipoprotein-cholesterol (LDL-c), HDL-c and total cholesterol concentrations by direct enzymatic colorimetric method (Pars Azmoon commercial kits, Tehran, Iran) and using a biochemical auto analyzer (Alpha Classic, Sanjesh Company, Iran). | PMC10183306 |
Statistical analysis | The normality of each variable distribution was examined by the use of Kolmogorov–Smirnov test. Descriptive statistics (means, SDs or SEs and range) were used to describe general characteristics of the study participants. For comparison of baseline characteristics between study groups, a paired t-test was applied. Changes in each variable in sumac and placebo arms were calculated by subsidizing baseline values from values of 6 | PMC10183306 | ||
Discussion | MetS, hypertension, steatohepatitis, MetS.Previous | NONALCOHOLIC FATTY LIVER, HYPERTENSION, STEATOHEPATITIS, OXIDATIVE STRESS | The current cross-over RCT revealed that sumac supplementation has significantly decreased systolic blood pressure among adults with MetS. Sumac supplementation might also prevent a significant rise in serum triglyceride among study subjects. This was the first cross-over trial that examined the effect of sumac supplementation on MetS markers in both men and women with MetS.Previous evidence has shown that having MetS is drastically related to increased risk of nonalcoholic fatty liver, steatohepatitis [Similar to our study, Asgary et al. [Previous studies suggested some pathways to explain the mechanisms for beneficial effects of sumac on MetS components. Sumac extract is a good source of natural antioxidants. Oxidative stress could lead to hypertension by two pathways including, increasing vascular contractile activity through damaging the endothelium [In the current investigation, there are some points that strengthen this RCT. The study was conducted on both male and female population. The cross-over design of the study resulted in independent relations from personal features or genetic variables. Moreover, performing ITT analysis helped us to include all subjects in the analysis. Additionally, triple-blinded design of the trial would decrease risk of bias. Nevertheless, some limitations must be kept in mind. High prevalence of covid-19 pandemic and the traffic restrictions for this pandemic during the study implementation increased loss to follow-up of participants. Furthermore, there was no biomarker to evaluate compliance of individuals to the sumac supplementation. Additionally, because of low number of participants we could not perform stratified analysis by gender. | PMC10183306 |
Conclusion | METABOLIC SYNDROME | This cross-over randomized controlled trial revealed that sumac supplementation could decrease systolic blood pressure and might prevent a rise in triglyceride concentration in men and women with metabolic syndrome. Daily intake of 1000 mg sumac, as an adjuvant therapy, could be beneficial in management of MetS in adults. | PMC10183306 | |
Acknowledgements | This study was extracted from an MS dissertation which was approved by Isfahan University of Medical Sciences. | PMC10183306 | ||
Authors’ contributions | FSM, ZH, MS and PS contributed in conception, design, data collection, data interpretation, manuscript drafting, approval of the final version of the manuscript, and agreed for all aspects of the work. The author(s) read and approved the final manuscript. | PMC10183306 | ||
Funding | The financial support for conception, design, data analysis and manuscript drafting comes from Isfahan University of Medical Sciences, Isfahan, Iran (no. 398797). | PMC10183306 | ||
Availability of data and materials | The data that support the findings of this study are available from the corresponding author (PS) upon reasonable request. | PMC10183306 | ||
Declarations | PMC10183306 | |||
Ethics approval and consent to participate | All participants provided an informed written consent. The study procedure was performed according to CONSORT 2010 checklist. The study protocol was ethically approved by the local Ethics Committee of Isfahan University of Medical Sciences. | PMC10183306 | ||
Consent for publication | All authors approved the final version of the manuscript, and agreed for all aspects of the work to be published. | PMC10183306 | ||
Competing interests | None of the authors had any personal or financial conflicts of interest. | PMC10183306 | ||
References | PMC10183306 | |||
Background | THYROID | Edited by: Andrea Frasoldati, Endocrine Unit ASMN, ItalyReviewed by: Adnan Işgör, Memorial Sisli Hospital, Türkiye; Demet Sengul, Giresun University, TürkiyeThis article was submitted to Thyroid Endocrinology, a section of the journal Frontiers in EndocrinologyThere is a cost advantage in using a needle without stylet over a needle with stylet in thyroid fine needle aspiration (FNA). This study aimed to elucidate the non-inferiority of thyroid FNA without a stylet (S-) to thyroid FNA with a stylet (S+) on specimen sampling. | PMC10076701 | |
Methods | MAY, THYROID NODULES | In this study, patients with thyroid nodules undergoing FNA were consecutively enrolled between May 2022 and July 2022. One experienced operator performed two punctures of each nodule with a stylet and without a stylet. Specimen adequacy was the primary outcome. Wald test was used for statistical analysis of the primary outcome. The difference in specimen adequacy between the two methods was expressed as a two-sided 95% confidence interval (CI). The S- method was considered non-inferior to the S+ method if the lower bound of the 95% CI of the S- minus S+ adequacy difference was greater than a predetermined non-inferiority margin of -10%. | PMC10076701 | |
Results | malignancy | A total of 149 patients (195 nodules) were enrolled in the study. A total of 167 of 195 nodules (85.64%) and 169 of 195 nodules (86.67%) were obtained adequate specimens using the S+ and S- methods, respectively. The difference in specimen adequacy (S- minus S+) between the two methods was 1.03% (95% CI, -5.83% to 7.88%). The lower bound 95% CI of the difference in specimen adequacy (-5.83%) was greater than the predetermined non-inferiority margin of -10%. The difference in the yield for malignancy was not significantly different between the two methods. | PMC10076701 | |
Conclusion | THYROID | Thyroid FNA without a stylet is non-inferior to thyroid FNA with a stylet on specimen sampling. | PMC10076701 | |
Introduction | DISEASES | Fine needle aspiration (FNA) is a simple, minimally invasive, and highly accurate method widely used in the diagnosis of many organ diseases, including thyroid (Furthermore, the value of the stylet has not been systematically evaluated in the FNA of the thyroid. Only one study evaluated the role of stylet using a few selected nodules (hypoechoic vascular type II nodules) ( | PMC10076701 | |
Materials and methods | PMC10076701 | |||
Study design | A single-center, prospective, randomized, controlled, non-inferiority trial was conducted at Fuyang People’s Hospital, a tertiary referral medical center. Written informed consent was obtained from all patients, and the study was approved by the Ethics Committee of Fuyang People’s Hospital (NO: 2022-80). | PMC10076701 | ||
Patients | cough | MAY, THYROID NODULES, THYROID NODULE | Patients with thyroid nodules who underwent FNA between May 2022 and July 2022 were prospectively enrolled in the study. The inclusion criteria were: (1) patients aged 18 years and above; (2) patients who provided written informed consent; and (3) patients who underwent ultrasound suggesting the presence of a thyroid nodule. The exclusion criteria were: (1) patients under anticoagulant therapy, such as aspirin and warfarin; (2) patients who could not cooperate with punctures, such as severe cough; and (3) those who could not provide written informed consent. | PMC10076701 |
Randomization | bleeding | BLEEDING | Each nodule was sampled for four passes (twice with a stylet (S+) and twice without a stylet (S-)). The nodules were randomly divided (1:1) into S+ (order of the four passes; S+→S-→S+→S-) and S- (order of the passes; S-→S+→S-→S+) to avoid the effect of bleeding from the previous pass on the later pass specimen. The order of S+ or S- first pass was determined by a preprinted random sequence that was kept in an opaque sealed envelope that the operator opened after the patients confirmed their enrollment. | PMC10076701 |
FNA procedure | THYROID, -20 | FNAs were performed under ultrasound (US) guidance by the same experienced operator. For patients with multiple nodules, FNA was performed on suspicious nodules, otherwise, the largest nodule was selected for sampling. For patients with mixed cystic-solid nodules, FNA was performed from the solid component. An US scanner (M9, Mindray, Shenzhen, China) was used for US with a 7.5-15 MHz linear array transducer. The medical record report contained the number, location, size, echogenicity, composition, vascularity, calcifications, depth, and Thyroid Imaging Reporting and Data System (TIRADS) categories of the punctured nodules. The passes were performed using a 25-gauge disposable puncture needle with a stylet (CCZA, Leapmed, Suzhou, China) without syringes. The stylet in the needle was kept during the puncture for S+ passes and removed before S- passes.The S+ pass was performed as follows: The patient was placed in a supine position with the neck slightly extended. The patient underwent local anesthesia using 0.1-0.3 ml of 2% lidocaine, and the skin was disinfected with iodophor. The stylet was removed after the needle tip puncture was put into the nodule under ultrasound guidance. The needle was pulled out when the needle was cut back and forth 15-20 times within the nodule or when the sample material was seen in the hub. Suction was not used in the process. The material in the needle lumen was expelled onto one clean glass slide using a 5 ml air-filled syringe after each pass. All the steps were the same for the S+ and S- pass, except for the stylet removal step that was avoided in S- pass.One slide specimen was made for each pass smear, and these slides were labeled as slides A1, B1, A2, and B2 in the order of pass. Sometimes slides A (A1 and A2) were two S+ specimens or two S- specimens since the choice of - the first pass was random to avoid bias of the pathologist. No on-site assessment was performed, where the specimens were air-dried, fixed in 95% alcohol, and stained with hematoxylin and eosin. | PMC10076701 | |
Cytological evaluation | THYROID | Five pathologists blinded to the stylet status of the passes evaluated cytology specimens. The same pathologist evaluated all specimens of one patient. Every thyroid FNA was first evaluated for specimen adequacy. Each specimen was classified as adequate or inadequate based on the Bethesda System for Reporting Thyroid Cytopathology (TBSRTC). Inadequate specimens (category I specimens in TBSRTC) were defined as specimens that did not meet the criteria for adequacy (presence of at least six groups of well-visualized follicular cells; each group containing at least 10 well-preserved epithelial cells).The two S+ specimens and two S- specimens of one nodule were evaluated as a separate whole with a separate cytologic result (specimens A1 and A2 as “nodule A” specimens and specimens B1 and B2 as “nodule B” specimens). The S+ and S- specimens of the nodule were considered inadequate when the two S+ specimens and two S- specimens were inadequate. | PMC10076701 | |
Outcome variables | malignancy | SECONDARY | Specimen adequacy was the primary outcome, while the yield for malignancy was the secondary outcome. Specimen adequacy was defined as the rate at which adequate specimens were obtained (proportion of non-TBSRTC category I specimens). The yield for malignancy was defined as a percentage of TBSRTC category VI specimens. | PMC10076701 |
Sample size estimation and statistical analysis | SECONDARY | Power Analysis and Sample Size (PASS) version 11 was used for sample size estimation. The sample size was determined based on data from a meta-analysis involving 25,000 patients, which claimed an overall specimen adequacy rate of 87.1% for thyroid FNA (For a patient with more than one nodule undergoing FNA, the nodules were considered independent observations for statistical analysis. Continuous variables were expressed as means and standard deviations. Categorical variables were expressed as frequencies and percentages. The primary outcome was analyzed using Wald test. The difference between the adequacy of the two methods was expressed as a two-sided 95% confidence interval (CI). The S- method was considered non-inferior to the S+ method if the lower bound of the two-sided 95% (equivalent to one-sided 97.5%) CI of the difference in specimen adequacy (S- minus S+) was greater than -10%. Chi-square tests were used to analyze the secondary outcomes. Statistical Package for Social Sciences (SPSS) version 23 and Statistical Analysis System (SAS) version 9.4 were used for all analyses. | PMC10076701 | |
Results | PMC10076701 | |||
Patients and nodules | MAY, THYROID NODULES | A total of 154 patients were enrolled from May 2022 to July 2022 (Flow diagram for 154 consecutive patients referred for thyroid nodules fine needle aspiration (FNA). | PMC10076701 | |
Cytological results | malignancy, follicular neoplasm | ATYPIA OF UNDETERMINED SIGNIFICANCE, FOLLICULAR NEOPLASM | The final cytological diagnosis was malignant (TBSRTC category VI) in 23 nodules (11.79%), suspicious for malignancy (TBSRTC category V) in 33 nodules (16.92%), follicular neoplasm or suspicious for a follicular neoplasm (TBSRTC category IV) in 5 nodules (2.56%), atypia of undetermined significance or follicular lesion of undetermined significance (TBSRTC category III) in 24 nodules (12.31%), benign (TBSRTC category II) in 91 nodules (46.67%), and inadequacy (TBSRTC category I) in 19 nodules (9.74%).The two S+ specimens and two S- specimens of each nodule were evaluated as a separate whole, and the cytological results are shown in Cytological results of specimens obtained with and without stylet. | PMC10076701 |
Specimen adequacy | The rates of obtaining adequate specimens were 167 of 195 nodes (85.64%) and 169 of 195 nodes (86.67%) for S+ and S- methods, respectively. The difference in specimen adequacy (S- minus S+) between the two methods was 1.03% (95% CI, -5.83% to 7.88%). The lower bound 95% CI of the difference in specimen adequacy (-5.83%) was greater than the predetermined non-inferiority margin of -10%, demonstrating the non-inferiority of the S- method to the S+ method.Analysis of each subgroup showed that the differences in specimen adequacy were not significantly different between the two methods (Subgroup analysis of specimen adequacy obtained with and without stylet. | PMC10076701 | ||
Yield for malignancy | malignancy | The yields for malignancy were 21 of 195 nodules (10.77%) and 20 of 195 nodules (10.26%) for S+ method and S- method, respectively ( | PMC10076701 | |
Adverse events | COMPLICATIONS | No complications or needle blockage were reported in this study. | PMC10076701 | |
Discussion | bleeding | BLEEDING, THYROID NODULES | Puncture needles with a stylet is widely used by many puncturers during thyroid FNA (Besides, there are limited data comparing thyroid FNA with and without a stylet. A published trial comparing the two techniques compared only a subset of selected thyroid nodules (hypoechoic vascular type II nodules) (However, a previous published study comparing thyroid FNA with and without a stylet showed that a stylet can improve specimen adequacy (Furthermore, only 480 of 2750 patients were screened in the study comparing thyroid FNA with and without a stylet (There is no doubt that the higher cost of puncture needles with a stylet than those without a stylet, such as an ordinary syringe needle, will significantly increase the puncture cost for patients. Therefore, its higher cost of puncture needles with stylet is unjustified if it does not improve specimen quality. Considering a large number of FNA examinations performed worldwide each year, the cost issue is not irrelevant. Our findings provide a reasonable basis for using low-cost puncture needles without a stylet can be used during thyroid FNA, which would reduce the average per-patient puncture cost and save health insurance funds.In this study, the patient population was representative of the typical patient population seen by most thyroid surgeons working in tertiary referral centers, with most being women and a wide age range. Therefore, the results may broadly apply to most patients with thyroid nodules. FNA is an operation-dependent procedure. Herein, only one experienced operator performed the procedures, thus excluding the influence of inter-operator differences. Furthermore, a non-inferiority design was used to ensure an adequate sample size. A randomized design was used for the order of S+ first or S- first puncture of each nodule to exclude the effect of bleeding from the first puncture on the adequacy of the second specimen. Patients using anticoagulant therapy, such as aspirin and warfarin, were excluded since these treatments affect specimen adequacy (This study has some limitations. First, the operator was not blinded to the stylet status of each puncture since this is logically impossible. Second, five cytopathologists interpreted the slides, and interobserver variation may have occurred during the interpretation. However, all slides from one patient were evaluated by the same cytopathologist. Third, only 25-gauge needles were used, and thus these results may not apply to other needle sizes. Finally, the sensitivity, specificity, and accuracy of the two techniques were not explored. | PMC10076701 |
Conclusions | In conclusion, this non-inferiority study demonstrated that the absence of a stylet during thyroid FNA is non-inferiority to using a stylet on specimen sampling. If other studies confirm these results, using a low-cost needle without a stylet during thyroid FNA is justified. This would make the whole process easier, as well as more cost-effective. | PMC10076701 | ||
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10076701 | ||
Ethics statement | This study was approved by the Ethics Committee of Fuyang People’s Hospital (NO: 2022-80). The patients/participants provided their written informed consent to participate in this study. | PMC10076701 | ||
Author contributions | All authors contributed to the study conception and design. PL, XM, and WM performed material preparation, data collection and analysis. PL wrote the first draft of the manuscript and all authors approved previous versions of the manuscript. All authors contributed to the article and approved the submitted version. | PMC10076701 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10076701 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10076701 | ||
References | PMC10076701 | |||
Abstract | PMC10075296 | |||
Background | DLBCL | LYMPHOMA, REMISSION | Diffuse large B‐cell lymphoma (DLBCL) is the most common (30%–35%) type of B‐cell lymphoma. Only about 60% of all newly diagnosed advanced‐stage DLBCL can be completely treated with x6 R‐CHOP. High‐dose chemotherapy (HDCT) followed by autologous hematopoietic stem cell transplantation in the first remission (upfront auto‐HSCT) can serve as an option to improve a prognosis in these patients. | PMC10075296 |
Aims | DLBCL | This trial aimed to improve prognosis in DLBCL by upfront auto‐HSCT. | PMC10075296 | |
Methods and Results | DLBCL | ONCOLOGY | A group of 105 patients: DLBCL NOS, age 18–65, stage IV, IPI ≥2, CR/PR after x6 R‐CHOP/DA‐EPOCH‐R from 2010 to 2019 at NMRC of Oncology named after N.N.Petrov of MoH of Russia was retrospectively analyzed. The HSCT group included patients with upfront HDCT followed by auto‐HSCT ( | PMC10075296 |
Conclusion | DLBCL | Upfront HDCT followed by auto‐HSCT can increase 3‐year OS and PFS and improve prognosis in DLBCL NOS, age 18–65, stage IV, IPI ≥2 patients.
| PMC10075296 |
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