VP31 Searching Non-English Literature For HTA Reports May Be Unnecessary

IntroductionCurrently, the Institute for Quality and Efficiency in Health Care (IQWiG) does not restrict literature searches by language. Given limited resources, it is unclear whether the effort put into screening and translating studies published in non-English and non-German (nEnG) languages yields much new information when compared to including only English and German literature. Therefore, we aimed to analyze the impact of nEnG literature on the conclusion of IQWiG's health technology assessments (HTAs).MethodsWe checked for seventy-two IQWiG HTAs (all non-drug intervention HTAs published until August 2018 and three additional HTAs on drugs) whether they included nEnG studies. For all HTAs including at least one nEnG study, we analyzed whether the statistical significance would have changed for any endpoint without the respective nEnG study(ies). If no endpoint was impacted by a nEnG study, we classified the study as non-relevant to the HTA's conclusion and specified a reason for this.ResultsOf seventy-two HTAs, twenty-nine (40 percent) included a total of eighty-three nEnG publications). Three HTAs were impacted by the inclusion of altogether seven Chinese publications. For one HTA on systemic therapy, five endpoints’ conclusions were changed; for the other two HTAs, the statistical significance would have changed for one endpoint each. The remaining seventy-six publications (included in sixty-nine HTAs) were judged as non-relevant to the HTA's conclusion, the most prominent reason being “meta-analysis would have had the same result without respective study” (44 percent of nEnG publications).ConclusionsOnly three of seventy-two HTAs (4 percent) were impacted by nEnG publications, the changes being minimal for two of these. When faced with limited time or personnel resources, searching only for English and German publications may be sufficient, especially when generalizability issues are a possible concern.

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Uncertainty in the impact of liver support systems in acute-on-chronic liver failure: a systematic review and network meta-analysis

Annals of Intensive Care ◽

10.1186/s13613-020-00795-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Klementina Ocskay ◽

Anna Kanjo ◽

Noémi Gede ◽

Zsolt Szakács ◽

Gabriella Pár ◽

...

Keyword(s):

Liver Failure ◽

Support Systems ◽

Meta Analysis ◽

Statistical Significance ◽

Bioartificial Liver ◽

Chronic Liver ◽

Chronic Liver Failure ◽

Liver Support ◽

Bioartificial Liver Support ◽

The Impact

Abstract Background The role of artificial and bioartificial liver support systems in acute-on-chronic liver failure (ACLF) is still controversial. We aimed to perform the first network meta-analysis comparing and ranking different liver support systems and standard medical therapy (SMT) in patients with ACLF. Methods The study protocol was registered with PROSPERO (CRD42020155850). A systematic search was conducted in five databases. We conducted a Bayesian network meta-analysis of randomized controlled trials assessing the effect of artificial or bioartificial liver support systems on survival in patients with ACLF. Ranking was performed by calculating the surface under cumulative ranking (SUCRA) curve values. The RoB2 tool and a modified GRADE approach were used for the assessment of the risk of bias and quality of evidence (QE). Results In the quantitative synthesis 16 trials were included, using MARS®, Prometheus®, ELAD®, plasma exchange (PE) and BioLogic-DT®. Overall (OS) and transplant-free (TFS) survival were assessed at 1 and 3 months. PE significantly improved 3-month OS compared to SMT (RR 0.74, CrI: 0.6–0.94) and ranked first on the cumulative ranking curves for both OS outcomes (SUCRA: 86% at 3 months; 77% at 1 month) and 3-month TFS (SUCRA: 87%) and second after ELAD for 1-month TFS (SUCRA: 76%). Other comparisons did not reach statistical significance. QE was moderate for PE concerning 1-month OS and both TFS outcomes. Other results were of very low certainty. Conclusion PE seems to be the best currently available liver support therapy in ACLF regarding 3-month OS. Based on the low QE, randomized trials are needed to confirm our findings for already existing options and to introduce new devices.

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Individual Resilience Interventions: A Systematic Review in Adult Population Samples over the Last Decade

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18147564 ◽

2021 ◽

Vol 18 (14) ◽

pp. 7564

Author(s):

Mafalda Ferreira ◽

António Marques ◽

Paulo Veloso Gomes

Keyword(s):

Systematic Review ◽

Methodological Quality ◽

Meta Analysis ◽

Statistical Significance ◽

Adult Population ◽

Well Being ◽

Eligibility Criteria ◽

Individual Resilience ◽

Literature Searches ◽

Great Heterogeneity

Resilience interventions have been gaining importance among researchers due to their potential to provide well-being and reduce the prevalence of mental disorders that are becoming an increasing concern, especially in Western countries, because of the costs associated. The purpose of this systematic review is to identify the intervention studies carried out in the last decade in adult population samples, evaluate their methodological quality and highlight the trends of these types of interventions. This review was performed using systematic literature searches in the following electronic databases: B-on, PubMed, PsycNet and Science Direct. The application of eligibility criteria resulted in the inclusion of 38 articles, of which 33 were randomized controlled trials and the other five were nonrandomized controlled studies. Although most studies showed statistical significance for their results, these were constrained by the great heterogeneity of the studies, the lack of power of the samples and their fair methodological quality. Therefore, it is important to consolidate the theoretical basis and standardize certain methodologies so that the effects of the interventions can be compared through a meta-analysis.

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Meta Analysis of Grade 3 and/or 4 Toxicities in Low-Grade Non-Hodgkin Lymphoma (LG-NHL) Patients Receiving Maintenance Rituximab (MR) Therapy: Impact of Schedule on Toxicity

Blood ◽

10.1182/blood.v118.21.2704.2704 ◽

2011 ◽

Vol 118 (21) ◽

pp. 2704-2704

Author(s):

Chadi Nabhan ◽

Dana Villines ◽

Tina V. Valdez ◽

Michele Ghielmini ◽

Shu-Fang Hsu Schmitz ◽

...

Keyword(s):

Clinical Trials ◽

Research Funding ◽

Meta Analysis ◽

Statistical Significance ◽

Comparative Trial ◽

Progression Free Survival ◽

Low Grade ◽

Front Line ◽

Grade 3 ◽

The Impact

Abstract Abstract 2704 Background: MR has improved the outcome and progression-free survival (PFS) in patients with follicular lymphoma (FL) in front-line and relapsed settings. However, maintenance schedules have been empirically designed based on either B-cell depletion kinetics or rituximab levels, with no consensus on the optimal regimen. Overall, toxicities have been predictable and tolerable but the impact of MR schedule on toxicities has not been previously reported and could influence selection of maintenance regimens. Methods: Using PubMed, prospective clinical trials employing MR were identified. Data presented in abstract form or at meetings were deemed incomplete and thus excluded. Data were analyzed from published manuscripts as percentages of subjects experiencing an adverse event (AE). Percentages were considered as the unit of analysis as this adjusted for the uneven sample sizes. Data were collected for overall Grade 3 and/or Grade 4 toxicity (AE reported at any phase of treatment) and was further categorized as AE occurring during initial treatment or during MR. Grade 1 and 2 toxicities were excluded from meta-analysis, given lack of consistent reporting. No grade 5 toxicities were reported. The incidence, severity, and type of toxicity was analyzed by type of induction (Rituximab (R) vs. R plus chemotherapy), histology (FL vs. FL plus other LG-NHL), setting (front-line vs. relapsed), and MR schedule (one dose every 2 months vs. one dose every 3 months vs. 4 doses every 6 months). Results: Nine clinical trials involving 1,928 patients were included in this Meta analysis (4 of which were randomized controlled in the MR phase). Of those, 1,004 patients received MR. The mean percentage of Grade 3/4 toxicities during any phase of treatment was 26% (95% CI = 0.12–51.88) but when restricted to the MR phase; it was 12.88% (95% CI = 6.50–19.26). Toxicities were numerically higher in patients receiving R induction plus chemotherapy versus R induction alone and in patients receiving MR for relapsed disease versus newly diagnosed patients, but did not reach statistical significance (P = 0.661 and 0.517, respectively). However, patients receiving MR every 2 months were significantly more likely to develop grade 3 and 4 toxicities compared to patients receiving MR every 6 months (P = 0.005). No statistical differences were demonstrated between the 2 vs. 3 months schedules or when comparing the 3 vs. 6 months schedules (P = 0.342 and 0.267, respectively) (Table 1). Statistically significant differences were also found in studies restricted to FL versus others allowing non-FL histologies (P = 0.025) with the FL patients experiencing more toxicity than others. The most frequently reported toxicities were neutropenia and infections. There were no treatment-related deaths in any of the arms. Conclusions: Approximately 13% of patients receiving MR experience grade 3 and/or 4 toxicities, mainly consisting of neutropenia and infections. MR given every 6 months appears to provide the least grade 3 and 4 toxicities. There is a suggestion of increased toxicity in FL histologies. It is important to note that this meta-analysis did not address efficacy and only a true comparative trial can definitively establish the relative risk/benefit ratios amongst MR schedules. Disclosures: Nabhan: Genentech: Research Funding, Speakers Bureau. Ghielmini:Roche: Consultancy, Honoraria, Research Funding, Speakers Bureau. Smith:Genentech: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

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Effect of number of computed tomography (CT) scans during follow-up (FUP) of patients with clinical stage I (CSI) seminoma: A trial-level meta-analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.6_suppl.564 ◽

2018 ◽

Vol 36 (6_suppl) ◽

pp. 564-564

Author(s):

Patrizia Giannatempo ◽

Daniele Raggi ◽

Elena Tagliabue ◽

Mario Catanzaro ◽

Davide Biasoni ◽

...

Keyword(s):

High Risk ◽

Meta Analysis ◽

Statistical Significance ◽

Clinical Stage ◽

Continuous Variable ◽

Ct Scans ◽

Occurrence Rate ◽

Prognostic Effect ◽

Level Data ◽

The Impact

564 Background: Despite the overall high cure-rate for patients (pts) with CSI seminoma (sem) regardless of the intervention used, huge discrepancy exists in the number of CT scans that are proposed to pts during FUP period, mainly during active surveillance (AS). The impact of such discrepancy in diagnosing pts with a high-risk relapse was assessed in published literature with a meta-analysis (MA). Methods: We searched for arms of studies of AS or active treatment (AT, adjuvant chemotherapy and radiotherapy) in pts with CSI sem. Meta-analytic techniques were used to pool and compare study level data of AS and AT groups and to study the impact of the number of CT scans (as a continuous variable) during FUP upon the % of pts with CSIII or with IGCCCG intermediate (int) prognosis sem at relapse. Results: 22 studies were analyzed (33 arms, n = 11025 pts). 39.6% had a high-risk sem, 38.8% (n = 4274) underwent AS vs 61.2% (n = 6751) AT. The number of CT scans ≤2y ranged 4-8, and 0-7 for AS and AT groups. Overall, 922 pts experienced a relapse (651 in AS and 271 in AT arms), 73.9% <2y and 22.3% at 2-5y FUP. Statistical modeling showed that the estimated rates of CSIII relapse (6% in AS, 32% in AT group, p = 0.0068) and int prognosis relapse (2% in AS, 11% in AT group, p = 0.0051), were divergent for the two groups. A higher number of CT scans in the first 2 years of FUP tended to reduce the occurrence rate of both endpoints, but failed to reach statistical significance in AS (p = 0.334 for CSIII, unidentifiable for int prognosis relapse), as well as in AT (p = 0.438, p = 0.103). The number of CT scans in 3-5y FUP had an even weaker prognostic effect. Similar trends were observed in AS cohort after adjusting for the CSI risk group. Conclusions: In this trial-level MA we did not find a statistically-significant association between the number of CT scans performed during FUP of CSI sem pts and the diagnosis of high-risk relapses. Huge discrepancy in the total number of CT scans was generally found between arms. In contrast, as expected, the pattern of relapse of CSI sem was different according to the treatment group. Based on these results, there is room for consistently reducing the number of CT scans during FUP of CSI sem pts undergoing AS.

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Influence of Pilot and Small Trials in Meta-Analyses of Behavioral Interventions: A Meta-epidemiological Study

10.21203/rs.3.rs-46722/v1 ◽

2020 ◽

Author(s):

Michael W. Beets ◽

R. Glenn Weaver ◽

John P.A. Ioannidis ◽

Alexis Jones ◽

Lauren von Klinggraeff ◽

...

Keyword(s):

Sample Size ◽

Behavioral Interventions ◽

Meta Analysis ◽

Statistical Significance ◽

Feasibility Studies ◽

Small Sample ◽

Effect Sizes ◽

Absolute Difference ◽

Meta Analyses ◽

The Impact

Abstract Background: Pilot/feasibility or studies with small sample sizes may be associated with inflated effects. This study explores the vibration of effect sizes (VoE) in meta-analyses when considering different inclusion criteria based upon sample size or pilot/feasibility status. Methods: Searches were conducted for meta-analyses of behavioral interventions on topics related to the prevention/treatment of childhood obesity from 01-2016 to 10-2019. The computed summary effect sizes (ES) were extracted from each meta-analysis. Individual studies included in the meta-analyses were classified into one of the following four categories: self-identified pilot/feasibility studies or based upon sample size (N≤100, N>100, and N>370 the upper 75th of sample size). The VoE was defined as the absolute difference (ABS) between the re-estimations of summary ES restricted to study classifications compared to the originally reported summary ES. Concordance (kappa) of statistical significance between summary ES was assessed. Fixed and random effects models and meta-regressions were estimated. Three case studies are presented to illustrate the impact of including pilot/feasibility and N≤100 studies on the estimated summary ES.Results: A total of 1,602 effect sizes, representing 145 reported summary ES, were extracted from 48 meta-analyses containing 603 unique studies (avg. 22 avg. meta-analysis, range 2-108) and included 227,217 participants. Pilot/feasibility and N≤100 studies comprised 22% (0-58%) and 21% (0-83%) of studies. Meta-regression indicated the ABS between the re-estimated and original summary ES where summary ES were comprised of ≥40% of N≤100 studies was 0.29. The ABS ES was 0.46 when summary ES comprised of >80% of both pilot/feasibility and N≤100 studies. Where ≤40% of the studies comprising a summary ES had N>370, the ABS ES ranged from 0.20-0.30. Concordance was low when removing both pilot/feasibility and N≤100 studies (kappa=0.53) and restricting analyses only to the largest studies (N>370, kappa=0.35), with 20% and 26% of the originally reported statistically significant ES rendered non-significant. Reanalysis of the three case study meta-analyses resulted in the re-estimated ES rendered either non-significant or half of the originally reported ES. Conclusions: When meta-analyses of behavioral interventions include a substantial proportion of both pilot/feasibility and N≤100 studies, summary ES can be affected markedly and should be interpreted with caution.

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Meta-Analysis of Oral Implant Fracture Incidence and Related Determinants

Journal of Oral Implants ◽

10.1155/2014/263925 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 6

Author(s):

Bernhard Pommer ◽

Lavinia Bucur ◽

Konstantin Zauza ◽

Gabor Tepper ◽

Markus Hof ◽

...

Keyword(s):

Systematic Review ◽

English Literature ◽

Rare Complication ◽

Meta Analysis ◽

Screw Loosening ◽

Prosthesis Failure ◽

Related Factors ◽

Oral Implant ◽

The Impact ◽

Short Implant

Dental implant fracture is a rare biomechanical complication, however, one of the most serious and frustating ones as it is generally associated with implant and prosthesis failure as well as the surgical hazards of explantation and reimplantation. To gain insights into implant fracture rates and the impact of patient-, surgery-, and prosthetic-related factors, systematic review and meta-analysis of the English literature were performed. Electronic and hand searches yielded 69 relevant publications reporting on 827 fractures out of 44521 implants investigated. The overall incidence of implant fractures was 1.6%. Mean patient age at the time of implant fracture was 54 ± 11 years, and 70% occurred in males. The vast majority (85%) occurred in posterior regions of the mouth (premolar or molar positions). No tendency of increased fracture rates could be noted for short implant lengths or narrow implant diameters. Implant fractures occurred after 4.1 ± 3.5 years of loading, on average, in most cases (88%) supporting fixed restorations; however, only 56% were preceded by screw loosening. Although further investigations are needed to fully explore the characteristics and causes of this rare complication, it can be concluded that no more than 2.8% of implants fracture is within a mean loading period of 8.3 years.

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Evaluation of the impact of patient input in health technology assessments at NICE

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462320002214 ◽

2021 ◽

Vol 37 ◽

Author(s):

Heidi Livingstone ◽

Vassilia Verdiel ◽

Helen Crosbie ◽

Sheela Upadhyaya ◽

Kevin Harris ◽

...

Keyword(s):

Decision Making ◽

Interventional Procedures ◽

Qualitative Data ◽

Health Technology ◽

Patient Experiences ◽

The Other ◽

Decision Making Process ◽

New Information ◽

The Impact ◽

New Evidence

Abstract Objective Accounts of patient experiences are increasingly used in health technology assessment (HTA) processes. However, we know little about their impact on the decision-making process. This study aims to assess the level and the type of impact of patient input to highly specialised technologies (HSTs) and interventional procedures (IPs) guidance at the National Institute for Health and Care Excellence (NICE). Methods A questionnaire was developed to capture quantitative and qualitative data on the amount and type of impact of patient input into NICE HTAs. It was completed by committee members of the guidance-producing programs after a discussion of the considered topics. The data were analyzed by topic and overall, for each program, and compared across programs. Results Patient input was assessed on ten pieces of HST guidance published between January 2015 and November 2019, and on twenty-six pieces of IP guidance scoped between February 2016 and October 2018. A total of 96 responses were collected for HST and 440 for IP. The level of impact of patient input was higher for HST than for IP. For HST, no respondents stated that it had no impact, whereas in IP, 35 percent of respondents did. The most common types of impact found for HST and IP were that it helped interpret the other evidence and that it provided new evidence. Conclusions The impact of patient input is not necessarily explicit in changing recommendations, but it provides context, reassurance, and new information to the committee for the decision-making process in HTAs.

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Case study of the comparison of data from conference abstracts and full-text articles in health technology assessment of rapidly evolving technologies: Does it make a difference?

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462306051166 ◽

2006 ◽

Vol 22 (3) ◽

pp. 288-294 ◽

Cited By ~ 5

Author(s):

Yenal Dundar ◽

Susanna Dodd ◽

Paula Williamson ◽

Rumona Dickson ◽

Tom Walley

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Full Text ◽

Methodological Quality ◽

Meta Analysis ◽

Statistical Significance ◽

Health Technology ◽

Sensitivity Analyses

Objectives: The aim of this study was to examine (i) the consistency of reporting research findings presented in conference abstracts and presentations and subsequent full publications, (ii) the ability to judge methodological quality of trials from conference abstracts and presentations, and (iii) the effect of inclusion or exclusion of data from these sources on the pooled effect estimates in a meta-analysis.Methods: This report is a case study of a selected health technology assessment review (TAR) of a rapidly evolving technology that had identified and included a meta-analysis of trial data from conference abstracts and presentations.Results: The overall quality of reporting in abstracts and presentations was poor, especially in abstracts. There was incomplete or inconsistent reporting of data in the abstract/presentations. Most often inconsistencies were between conference slide presentations and data reported in published full-text articles. Sensitivity analyses indicated that using data only from published papers would not have altered the direction of any of the results when compared with those using published and abstract data. However, the statistical significance of three of ten results would have changed. If conference abstracts and presentations were excluded from the early analysis, the direction of effect and statistical significance would have changed in one result. The overall conclusions of the original analysis would not have been altered.Conclusions: There are inconsistencies in data presented as conference abstracts/presentations and those reported in subsequent published reports. These inconsistencies could impact the final assessment results. Data discrepancies identified across sources included in TARs should be highlighted and their impact assessed and discussed. Sensitivity analyses should be carried out with and without abstract/presentation data included in the analysis. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials.

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Immunosuppression Impact on Head and Neck Cutaneous Squamous Cell Carcinoma: A Systematic Review with Meta-analysis

Otolaryngology ◽

10.1177/0194599818808511 ◽

2018 ◽

Vol 160 (3) ◽

pp. 439-446 ◽

Cited By ~ 4

Author(s):

Alhasan N. Elghouche ◽

Zachary E. Pflum ◽

Cecelia E. Schmalbach

Keyword(s):

Squamous Cell Carcinoma ◽

Cell Carcinoma ◽

Head And Neck ◽

Squamous Cell ◽

English Literature ◽

Meta Analysis ◽

Cutaneous Squamous Cell Carcinoma ◽

Hazard Ratios ◽

Staging Systems ◽

The Impact

Objective The primary objective was to define and quantify the relationship between immunosuppression and prognosis in patients with cutaneous squamous cell carcinoma of the head and neck. Data Sources Ovid/Medline, PubMed, Embase, and Scopus were searched from inception through June 5, 2017, with cross-referenced subject headings of squamous cell carcinoma, skin neoplasms, head and neck neoplasms, and prognosis. Additional gray literature was queried. Review Methods All prospective, retrospective, and cohort studies in the English literature investigating prognosis in patients with head and neck cutaneous squamous cell carcinoma were eligible for inclusion. Meta-analysis data were pooled using the fixed-effects model. The main outcome measures were hazard ratios detailing subgroup analysis between immunosuppressed and immunocompetent patients. Results Seventeen studies were eligible for inclusion; 317 of the 2886 patients were immunosuppressed. Meta-analysis with pooled hazard ratios was performed for all outcome variables with at least 3 reported hazard ratios. Immunosuppression portended a worse prognosis across all outcome variables of interest: locoregional recurrence (2.20; 95% confidence interval [CI], 1.45-3.36), disease-free survival (2.69; 95% CI, 1.60-4.51), disease-specific survival (3.61; 95% CI, 2.63-4.95), and overall survival (2.09; 95% CI, 1.64-2.67). Conclusion This is the largest investigation into the impact of immunosuppression on head and neck cutaneous squamous cell carcinoma. Immunosuppressed patients experience worse recurrence and survival outcomes compared to immunocompetent counterparts. The data support formal inclusion of immunosuppression in head and neck cutaneous squamous cell carcinoma staging systems.

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The impact of interval cytoreduction and age in advanced-stage ovarian cancer: A GOG ancillary study.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.5056 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 5056-5056

Author(s):

Stuart M. Lichtman ◽

James Java ◽

John L. Lovecchio ◽

Dennis Chi ◽

William P. Tew ◽

...

Keyword(s):

Ovarian Cancer ◽

Cox Regression ◽

Residual Disease ◽

Meta Analysis ◽

Statistical Significance ◽

Advanced Ovarian Cancer ◽

Progression Free Survival ◽

Ancillary Study ◽

Primary Surgery ◽

The Impact

5056 Background: To determine if an age group exists for which interval cytoreductive surgery (ICS) in patients with suboptimal residual disease at primary surgery influences progression free survival (PFS) and overall survival (OS) among women with advanced ovarian cancer treated on GOG 182. Methods: GOG 182 was a prospective, randomized trial of first-line chemotherapy in patients with advanced ovarian cancer. Patients with both optimal and suboptimal residual disease were included, and those with suboptimal residual were considered for ICS, with intent registered and stratified prior to randomization. Patients were randomized to one of five chemotherapy arms, employing combinations of either two or three agents delivered intravenously, with a control arm of paclitaxel and carboplatin. A retrospective analysis was approved by the GOG Ancillary Study Committee to investigate the influence of age on treatment and outcomes. In that analysis, Cox regression was used to identify independent prognostic factors and estimate their covariate effects on the adjusted PFS and OS of patients with suboptimal residual disease. Statistical significance was set at p<0.05. Results: Among the entire eligible study population, 28% (n=1,042) were registered with suboptimal residual disease (> 1 cm) and 109 of these patients elected to undergo ICS. Hazard ratios (HR) were determined for patients undergoing ICS with reference to patients with suboptimal disease not undergoing ICS. Based on the most current follow-up data, the HR for progression or death was not statistically different between the groups, but the HR of death alone was significant at 0.72 (95% CI: 0.57–0.92, p=0.008). There was no significant association of age with ICS in either the PFS or the OS model. Conclusions: In this trial, a patient’s age did not influence the effect of ICS on PFS or OS. There is no demonstrable benefit in PFS associated with ICS, but there was a statistically significant improvement in OS. To elucidate this finding, further study is warranted, likely in the form of a meta-analysis incorporating data from other prospective trials.

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