scholarly journals Disease-free survival is not a surrogate endpoint for overall survival in adjuvant trials of pancreatic cancer: a systematic review of randomized trials

HPB ◽  
2017 ◽  
Vol 19 (11) ◽  
pp. 944-950 ◽  
Author(s):  
Fausto Petrelli ◽  
Gianluca Tomasello ◽  
Michele Ghidini ◽  
Veronica Lonati ◽  
Rodolfo Passalacqua ◽  
...  
Keyword(s):  
Systematic Review ◽  
Pancreatic Cancer ◽  
Overall Survival ◽  
Randomized Trials ◽  
Disease Free Survival ◽  
Surrogate Endpoint ◽  
Free Survival ◽  
Disease Free

Predictive Prognostic Value of Tissue-Based MicroRNA Expression in Oral Squamous Cell Carcinoma: A Systematic Review and Meta-analysis

2018 ◽  
Vol 97 (7) ◽  
pp. 759-766 ◽  
Author(s):  
G. Troiano ◽  
F. Mastrangelo ◽  
V.C.A. Caponio ◽  
L. Laino ◽  
N. Cirillo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Oral Squamous Cell Carcinoma ◽  
Mirna Expression ◽  
Prognostic Value ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Free Survival ◽  
Disease Free

Oral squamous cell carcinoma (OSCC) is a common type of cancer characterized by a low survival rate, mostly due to local recurrence and metastasis. In view of the importance of predicting tumor behavior in the choice of treatment strategies for OSCC, several studies have attempted to investigate the prognostic value of tissue biomarkers, including microRNA (miRNA). The purpose of this study was to perform a systematic review and meta-analysis to evaluate the relationship between miRNA expression and survival of OSCC patients. Studies were identified by searching on MEDLINE/PubMed, SCOPUS, Web of Science, and Google Scholar. Quality assessment of studies was performed with the Newcastle-Ottawa Scale. Data were collected from cohort studies comparing disease-free survival and overall survival in patients with high miRNA expression compared to those with low expression. A total of 15 studies featuring 1,200 OSCC samples, predominantly from Asia, met the inclusion criteria and were included in the meta-analysis. Poor prognosis correlated with upregulation of 9 miRNAs (miR-21, miR-455-5p, miiR-155-5p, miR-372, miR-373, miR-29b, miR-1246, miR-196a, and miR-181) and downregulation of 7 miRNAs (miR-204, miR-101, miR-32, miR-20a, miR-16, miR-17, and miR-125b). The pooled hazard ratio values (95% confidence interval) related to different miRNA expression for overall survival and disease-free survival were 2.65 (2.07–3.39) and 1.95 (1.28–2.98), respectively. The results of this meta-analysis revealed that the expression levels of specific miRNAs can robustly predict prognosis of OSCC patients.

TP1.2.3Oncological Outcomes of Organ Preservation Strategies - Local Excision Procedures and ‘Watchful Waiting’ In Management of Low Rectal Cancers – A Systematic Review And Meta-Analysis

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
A R Aspari ◽  
V Ramesh ◽  
G Kumar ◽  
S N Narayanasamy ◽  
A O Gumber ◽  
...  
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Local Recurrence ◽  
Organ Preservation ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Distant Metastases ◽  
Free Survival ◽  
Rectal Cancers ◽  
Disease Free

Abstract Objective To evaluate local recurrence, metastases, and survival outcomes of `wait and watch’ (WW) strategy and local excision (LE) of tumours, in comparison to the present standard practice of total mesorectal excision (TME) for locally advanced rectal cancers. Data Sources MEDLINE, EMBASE, PubMed databases, and sources of Grey literature. Study Selection Randomised and non-randomised prospective studies, retrospective studies with propensity-score-matched analyses. Data Extraction and Synthesis These were carried out independently by two reviewers. A random-effects methodology was used for meta-analyses. Data was presented keeping with the 27-item PRISMA checklist. Main Outcomes The primary outcomes of interest were local recurrence, distant metastases, disease-free-survival and overall-survival, which were assessed in comparison to those associated with radical surgeries (TME). Results 7 of the 16 studies in the systematic review were included for the quantitative synthesis and meta-analysis. Local recurrence rates were comparable amongst patients in WW group and LE group to those undergoing TME. [Risk ratio (RR) 3.07/1.41; 95% Confidence Interval (CI) 0.86-10.95/0.66-3.01; P = 0.08/P=0.89 respectively]. Rates of distant metastases in the WW group and LE group were comparable to those undergoing TME [RR = 0.71/0.94; 95% CI 0.22-2.30/0.55-1.61; P = 0.56/ P = 0.83 respectively]. The median 3-year disease-free survival among patients undergoing WW, LE procedure, and TME were 88%, 80%, and 78.2% respectively; and the median 3-year overall survival among the three groups were 96%, 93%, and 89.5% respectively. Conclusions and Relevance Organ-preservation strategies appear to be a viable treatment option in the management of rectal-cancers. Further research is warranted to provide stronger levels of evidence on organ-preservation strategies.

Re-Evaluating Disease-Free Survival as an Endpoint vs Overall Survival in Stage III Adjuvant Colon Cancer Trials

2021 ◽  
Author(s):  
Jun Yin ◽  
Mohamed E Salem ◽  
Jesse G Dixon ◽  
Zhaohui Jin ◽  
Romain Cohen ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Surrogate Endpoint ◽  
Free Survival ◽  
A Value ◽  
Deficient Mismatch Repair ◽  
Disease Free

Abstract Background Disease-free survival with a 3-year median follow-up (3-year DFS) was validated as a surrogate for overall survival with a 5-year median follow-up (5-year OS) in adjuvant chemotherapy colon cancer (CC) trials. Recent data show further improvements in OS and survival after recurrence, in patients who received adjuvant FOLFOX. Hence, re-evaluation of the association between DFS and OS and determination of the optimal follow-up duration of OS to aid its utility in future adjuvant trials are needed. Methods Individual patient data from nine randomized studies conducted between 1998 and 2009 were included; three trials tested biologics. Trial-level surrogacy examining the correlation of treatment effect estimates of 3-year DFS with 5 to 6.5-year OS was evaluated using both linear regression (R2WLS) and Copula bivariate (R2Copula) models and reported with 95% confidence intervals (CIs). For R2, a value closer to 1 indicates a stronger correlation. Results Data from a total of 18,396 patients were analyzed (median age = 59 years; 54.0% male), with 54.1% having low-risk tumors (pT1-3 & pN1), 31.6% KRAS mutated, 12.3% BRAF mutated, and 12.4% microsatellite instability high/deficient mismatch repair tumors. Trial level correlation between 3-year DFS and 5-year OS remained strong (R2 =0.82, 95% CI = 0.67 to 0.98; R2 =0.92, 95% CI = 0.83 to 1.00) and increased as the median follow-up of OS extended. Analyses limited to trials that tested biologics showed consistent results. Conclusion Three-year DFS remains a validated surrogate endpoint for 5-year OS in adjuvant CC trials. The correlation was likely strengthened with 6 years of follow-up for OS.

Endpoints in adjuvant trials: A systematic review of the literature in colon cancer and proposed definitions for future trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4018-4018
Author(s):  
M. E. Buyse ◽  
K. J. Punt ◽  
C. H. Köhne ◽  
P. Hohenberger ◽  
R. Labianca ◽  
...  
Keyword(s):  
Systematic Review ◽  
Colon Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Review Of The Literature ◽  
Free Survival ◽  
Medical Oncologists ◽  
Starting Point ◽  
Definition Of ◽  
Disease Free

4018 Background: Disease-free survival (DFS) is the primary endpoint of most trials testing adjuvant treatments. However many other endpoints are used. There is much confusion about these endpoints since different definitions were used among trials, or no definitions were provided at all. Moreover there is no consensus on either the definition of each endpoint or on the most relevant among these endpoints. This creates difficulties when comparing the results of various trials. Methods: Adjuvant trials in colon cancer were used as a model. A systematic review was performed on published adjuvant studies in colon cancer from 1997–2006, and the definitions of endpoints other than overall survival (OS) were recorded. A panel of medical oncologists, surgical oncologists, and a statistician, all with expertise in randomised trials in colorectal cancer, aimed to reach consensus on the definition of the various endpoints as well as to select the most relevant among these. Results: A total of 52 studies were identified. In addition to overall survival 8 other endpoints were used, and both the definition of these endpoints as well as the starting point differed considerably among these studies. No definition was provided for the endpoint in 19 (37%) studies and for the starting point in 30 (58%) studies. The panel reached consensus on the definition of each endpoint ( table ), and agreed that DFS, defined as the time from randomisation to any event irrespective of cause was considered to be the most relevant endpoint for adjuvant studies. The date of randomisation was considered to be the most appropriate starting point. Conclusions: The proposed guideline will help in the design of future adjuvant studies in colon cancer, and will achieve the uniformity required to facilitate cross-study comparisons. It may serve as a model for adjuvant studies in other solid tumors. [Table: see text] No significant financial relationships to disclose.

Adjuvant Therapy for Stage II Colon Cancer: A Systematic Review From the Cancer Care Ontario Program in Evidence-Based Care’s Gastrointestinal Cancer Disease Site Group

2004 ◽  
Vol 22 (16) ◽  
pp. 3395-3407 ◽  
Author(s):  
Alvaro Figueredo ◽  
Manya L. Charette ◽  
Jean Maroun ◽  
Melissa C. Brouwers ◽  
Lisa Zuraw
Keyword(s):  
Systematic Review ◽  
Colon Cancer ◽  
Overall Survival ◽  
Adjuvant Therapy ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Stage Ii ◽  
Free Survival ◽  
Stage Ii Colon Cancer ◽  
Disease Free

Purpose To develop a systematic review that would address the following question: Should patients with stage II colon cancer receive adjuvant therapy? Methods A systematic review was undertaken to locate randomized controlled trials comparing adjuvant therapy to observation. Results Thirty-seven trials and 11 meta-analyses were included. The evidence for stage II colon cancer comes primarily from a trial of fluorouracil plus levamisole and a meta-analysis of 1,016 patients comparing fluorouracil plus folinic acid versus observation. Neither detected an improvement in disease-free or overall survival for adjuvant therapy. A recent pooled analysis of data from seven trials observed a benefit for adjuvant therapy in a multivariate analysis for both disease-free and overall survival. The disease-free survival benefits appeared to extend to stage II patients; however, no P values were provided. A meta-analysis of chemotherapy by portal vein infusion has also shown a benefit in disease-free and overall survival for stage II patients. A meta-analysis was conducted using data on stage II patients where data were available (n = 4,187). The mortality risk ratio was 0.87 (95% CI, 0.75 to 1.01; P = .07). Conclusion There is preliminary evidence indicating that adjuvant therapy is associated with a disease-free survival benefit for patients with stage II colon cancer. These benefits are small and not necessarily associated with improved overall survival. Patients should be made aware of these results and encouraged to participate in active clinical trials. Additional investigation of newer therapies and more mature data from the presently available trials should be pursued.

A Systematic Review of Prognosis and Therapy of Anal Malignant Melanoma: A Plea for More Precise Reporting of Location and Thickness

2012 ◽  
Vol 78 (1) ◽  
pp. 28-35 ◽  
Author(s):  
Ziad Kanaan ◽  
Aaron Mulhall ◽  
Suhal Mahid ◽  
Marla L. Torres ◽  
Michael McCafferty ◽  
...  
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Malignant Melanoma ◽  
Median Survival ◽  
Disease Free Survival ◽  
Lymph Node Status ◽  
Free Survival ◽  
Node Status ◽  
The Mean ◽  
Disease Free

Anal malignant melanoma (AMM) is a rare tumor with poor prognosis. We performed a systematic review of reports on wide local excision (WLE) and abdominoperineal resection (APR) for treatment of AMM in an attempt to define a precise set of reporting measures for outcomes of treatment of AMM. A systematic review of the literature was performed. Demographic data, surgical treatment, pathology, and survival rates were recorded. We compared WLE versus APR in terms of the overall survival time, the disease-free survival, and overall survival at 60 months. Twenty-one reports met the inclusion criteria. Notably, of these, 10 did not specify thickness of the primary melanoma. Interestingly, groin lymph node status was described in 19 of 21 reports, whereas location was specified in only 12 papers and thickness (depth in mm) in only 11. The median survival times of patients undergoing WLE (n = 324) and those undergoing APR (n = 369) are comparable (20 and 21 months, respectively). The mean median survival at 60 months was 15 per cent for WLE and 14 per cent for APR. The mean disease-free survival at 60 months was found to be 10 per cent for WLE and 6 per cent for APR. Patient selection for such a rare neoplasm yields very similar outcomes for both conservative and radical treatments. There is a wide variation in the reporting of both clinical and treatment outcomes. More uniformity of reporting of pathologic features and node status is essential before rational assessment of results can be done.

scholarly journals The Significance of SIX1 as a Prognostic Biomarker for Survival Outcome in Various Cancer Patients: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Guang Zhu ◽  
Ying Liu ◽  
Lei Zhao ◽  
Zhenhua Lin ◽  
Yingshi Piao
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Cancer Patients ◽  
Human Cancer ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Cancer Type ◽  
Free Survival ◽  
Cancer Types ◽  
Disease Free

Sine Oculis Homeobox Homolog 1 (SIX1) is reported to promote cancer initiation and progression in many preclinical models and is demonstrated in human cancer tissues. However, the correlation between SIX1 and cancer patients’ prognosis has not yet been systematically evaluated. Therefore, we performed a systematic review and meta-analysis in various human cancer types and extracted some data from TCGA datasets for further verification and perfection. We constructed 27 studies and estimated the association between SIX1 expression in various cancer patients’ overall survival and verified with TCGA datasets. Twenty-seven studies with 4899 patients are include in the analysis of overall, and disease-free survival, most of them were retrospective. The pooled hazard ratios (HRs) for overall and disease-free survival in high SIX1 expression patients were 1.54 (95% CI: 1.32-1.80, P<0.00001) and 1.83 (95% CI: 1.31-2.55, P=0.0004) respectively. On subgroup analysis classified in cancer type, high SIX1 expression was associated with poor overall survival in patients with hepatocellular carcinoma (HR 1.50; 95% CI: 1.17-1.93, P =0.001), breast cancer (HR 1.31; 95% CI: 1.10-1.55, P =0.002) and esophageal squamous cell carcinoma (HR 1.89; 95% CI: 1.42-2.52, P<0.0001). Next, we utilized TCGA online datasets, and the consistent results were verified in various cancer types. SIX1 expression indicated its potential to serve as a cancer biomarker and deliver prognostic information in various cancer patients. More works still need to improve the understandings of SIX1 expression and prognosis in different cancer types.

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