scholarly journals Disease-free survival as a surrogate for overall survival in neoadjuvant trials of gastroesophageal adenocarcinoma: Pooled analysis of individual patient data from randomised controlled trials

2019 ◽  
Vol 123 ◽  
pp. 101-111 ◽  
Author(s):  
Ulrich Ronellenfitsch ◽  
Katrin Jensen ◽  
Svenja Seide ◽  
Meinhard Kieser ◽  
Matthias Schwarzbach ◽  
...  
Keyword(s):  
Overall Survival ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Disease Free Survival ◽  
Pooled Analysis ◽  
Controlled Trials ◽  
Free Survival ◽  
Gastroesophageal Adenocarcinoma ◽  
Randomised Controlled ◽  
Disease Free

scholarly journals Tumor PIK3CA Genotype and Prognosis in Early-Stage Breast Cancer: A Pooled Analysis of Individual Patient Data

2018 ◽  
Vol 36 (10) ◽  
pp. 981-990 ◽  
Author(s):  
Dimitrios Zardavas ◽  
Luc te Marvelde ◽  
Roger L. Milne ◽  
Debora Fumagalli ◽  
George Fountzilas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Individual Patient Data ◽  
Disease Free Survival ◽  
Pooled Analysis ◽  
Patient Data ◽  
Lower Grade ◽  
Free Survival ◽  
Pik3ca Mutations ◽  
Disease Free

Purpose Phosphatidylinositol-4, 5-bisphosphate 3-kinase catalytic subunit alpha ( PIK3CA) mutations are frequently observed in primary breast cancer. We evaluated their prognostic relevance by performing a pooled analysis of individual patient data. Patients and Methods Associations between PIK3CA status and clinicopathologic characteristics were tested by applying Cox regression models adjusted for age, tumor size, nodes, grade, estrogen receptor (ER) status, human epidermal growth factor receptor 2 (HER2) status, treatment, and study. Invasive disease-free survival (IDFS) was the primary end point; distant disease-free survival (DDFS) and overall survival (OS) were also assessed, overall and by breast cancer subtypes. Results Data from 10,319 patients from 19 studies were included (median OS follow-up, 6.9 years); 1,787 patients (17%) received chemotherapy, 4,036 (39%) received endocrine monotherapy, 3,583 (35%) received both, and 913 (9%) received none or their treatment was unknown. PIK3CA mutations occurred in 32% of patients, with significant associations with ER positivity, increasing age, lower grade, and smaller size (all P < .001). Prevalence of PIK3CA mutations was 18%, 22%, and 37% in the ER-negative/HER2-negative, HER2-positive, and ER-positive/HER2-negative subtypes, respectively. In univariable analysis, PIK3CA mutations were associated with better IDFS (HR, 0.77; 95% CI, 0.71 to 0.84; P < .001), with evidence for a stronger effect in the first years of follow-up (0 to 5 years: HR, 0.73; 95% CI, 0.66 to 0.81; P < .001; 5 to 10 years: HR, 0.82; 95% CI, 0.68 to 0.99; P = .037); > 10 years: (HR, 1.15; 95% CI, 0.84 to 1.58; P = .38; P heterogeneity = .02). In multivariable analysis, PIK3CA genotype remained significant for improved IDFS ( P = .043), but not for the DDFS and OS end points. Conclusion In this large pooled analysis, PIK3CA mutations were significantly associated with a better IDFS, DDFS, and OS, but had a lesser prognostic effect after adjustment for other prognostic factors.

scholarly journals The prognostic value of Immunoscore in patients with cancer: A pooled analysis of 10,328 patients

2020 ◽  
Vol 35 (3) ◽  
pp. 3-13 ◽  
Author(s):  
Xingxia Zhang ◽  
Jie Yang ◽  
Liang Du ◽  
Yong Zhou ◽  
Ka Li
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Prognostic Value ◽  
Disease Free Survival ◽  
Pooled Analysis ◽  
Disease Specific Survival ◽  
Free Survival ◽  
Patients With Cancer ◽  
Disease Free ◽  
Disease Specific

Objectives: Over the past decade, some publications have reported that Immunoscore was associated with the prognosis of several cancers. To better understand this issue, we conducted this pooled analysis. Methods: We systematically searched PubMed, Embase, Web of Science, and the Cochrane Library from their inceptions to 15 May 2019 to identify relevant articles. The pooled hazard ratio (HR) and 95% confidence interval (CI) was estimated for overall survival, disease-free survival, and disease-specific survival. Results: A total of 26 cohort studies with 10,328 patients involving eight cancer specialties were evaluated mainly by the consensus Immunoscore. The pooled analysis indicated that a lower Immunoscore was associated with a poor overall survival (HR 2.23, 95% CI 1.58, 2.70), disease-free survival (HR 2.40, 95% CI 1.96, 2.49), and disease-specific survival (HR 2.81, 95% CI 2.10, 3.77) for all cancers. The same convincing results were found in colorectal cancer, gastric cancer, and non-small cell lung cancer (especially the consensus Immunoscore for colon cancer). In five other types of cancer the results were similar, but the sample sizes were limited. Conclusions: These findings support that Immunoscore is significantly associated with the prognosis of patients with cancer. It provides a reliable estimate of the risk of recurrence in patients with colon cancer. However, more high-quality studies are necessary to assess the prognostic value of Immunoscore in non-colon cancers.

Estrogen Receptor Expression and Efficacy of Docetaxel-Containing Adjuvant Chemotherapy in Patients With Node-Positive Breast Cancer: Results From a Pooled Analysis

2008 ◽  
Vol 26 (16) ◽  
pp. 2636-2643 ◽  
Author(s):  
Fabrice Andre ◽  
Kristine Broglio ◽  
Henri Roche ◽  
Miguel Martin ◽  
John R. Mackey ◽  
...  
Keyword(s):  
Overall Survival ◽  
Estrogen Receptor ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Pooled Analysis ◽  
Free Survival ◽  
Er Positive ◽  
Disease Free ◽  
Er Expression ◽  
Er Status

PurposeSeveral adjuvant chemotherapy trials suggested that cytotoxic treatment is less effective in patients with estrogen receptor (ER) –positive breast cancers. The aim of the present study was to assess the efficacy of adjuvant docetaxel and anthracycline therapy according to ER expression in two randomized clinical trials.Patients and MethodsPooled data from two randomized trials, BCIRG001 and PACS01, were examined. Hazard ratios for recurrence and survival were estimated by Cox proportional hazards models and were adjusted for clinical variables. Interaction between docetaxel and ER expression was tested.ResultsER status was available for 3,329 patients (95% of all randomly assigned patients), of whom 75% (n = 2,493) were ER positive. Docetaxel therapy was associated with a 30% reduction in the risk of death (hazard ratio [HR] = 0.70; 95% CI, 0.54 to 0.91) in ER-positive patients and a 31% reduction (HR = 0.69; 95% CI, 0.52 to 0.94) in ER-negative patients. Docetaxel therapy was associated with a 21% reduction in the risk of recurrence (HR = 0.79; 95% CI, 0.66 to 0.93) in ER-positive patients and a 31% reduction (HR = 0.69; 95% CI, 0.54 to 0.97) in ER-negative patients. The interaction between docetaxel therapy and ER status was not statistically significant for either overall survival (P = .87) or disease-free survival (P = .30). ER expression was also not predictive for docetaxel efficacy when it was analyzed as a semi-continuous variable based on percent of positive cells by immunohistochemistry (test for heterogeneity, P = .56 and .86 for overall survival and disease-free survival, respectively).ConclusionIn the pooled analysis of these two trials, docetaxel did not have a statistically significantly different effect on the risk of recurrence or death in ER-positive and ER-negative patients.

Disease-Free Survival Versus Overall Survival As a Primary End Point for Adjuvant Colon Cancer Studies: Individual Patient Data From 20,898 Patients on 18 Randomized Trials

2005 ◽  
Vol 23 (34) ◽  
pp. 8664-8670 ◽  
Author(s):  
Daniel J. Sargent ◽  
Harry S. Wieand ◽  
Daniel G. Haller ◽  
Richard Gray ◽  
Jacqueline K. Benedetti ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Individual Patient Data ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Free Survival ◽  
End Point ◽  
Disease Free

Purpose A traditional end point for colon adjuvant clinical trials is overall survival (OS), with 5 years demonstrating adequate follow-up. A shorter-term end point providing convincing evidence to allow treatment comparisons could significantly speed the translation of advances into practice. Methods Individual patient data were pooled from 18 randomized phase III colon cancer adjuvant clinical trials. Trials included 43 arms, with a pooled sample size of 20,898 patients. The primary hypothesis was that disease-free survival (DFS), with 3 years of follow-up, is an appropriate primary end point to replace OS with 5 years of follow-up. Results The recurrence rates for years 1 through 5 were 12%, 14%, 8%, 5%, and 3%, respectively. Median time from recurrence to death was 12 months. Eighty percent of recurrences were in the first 3 years; 91% of patients with recurrence by 3 years died before 5 years. Correlation between 3-year DFS and 5-year OS was 0.89. Comparing control versus experimental arms within each trial, the correlation between hazard ratios for DFS and OS was 0.92. Within-trial log-rank testing using both DFS and OS provided the same conclusion in 23 (92%) of 25 cases. Formal measures of surrogacy were satisfied. Conclusion In patients treated on phase III adjuvant colon clinical trials, DFS and OS are highly correlated, both within patients and across trials. These results suggest that DFS after 3 years of median follow-up is an appropriate end point for adjuvant colon cancer clinical trials of fluorouracil-based regimens, although marginally significant DFS improvements may not translate into significant OS benefits.

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