While the ACCENT group had thoroughly studied the relationships between disease recurrence, adjuvant therapy, and overall survival in the first 5 years after surgery, until this point, longer-term outcomes and implications had not yet been explored. This analysis serves as a key example of the power of the ACCENT database; when the population of interest young patients comprises only a small percentage of those patients enrolled to any single trial, the answers to questions such as these could only be meaningfully obtained by combining such patients across many similar trials. Daniel Sargent confirmed that DFS with median of 3 years of follow-up was an appropriate surrogate for OS with median of 5 years of follow-up, through the robust findings across several meta-analytic surrogacy analyses 5. Bayesian adjusted R2 for the meta-analytic evaluation of surrogate time-to-event endpoints in clinical trials. N Engl J Med. Once consensus is reached for a given proposal, members interested in the topic form an authorship group, combining resources and attention that move the project to completion.
|Date Added:||25 October 2005|
|File Size:||32.95 Mb|
|Operating Systems:||Windows NT/2000/XP/2003/2003/7/8/10 MacOS 10/X|
|Price:||Free* [*Free Regsitration Required]|
With the pooling of data from modern trials, the ACCENT database provides u01 uniquely powerful ability to identify prognostic and predictive markers, develop better risk classification strategies, and motivate personalized cancer treatment through identification of targeted disease populations based on molecular markers.
A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. One such recent endeavor by Dr.
The platform data collection, assembling, management, and analyses established through this milestone project would be subsequently replicated by surrogacy explorations in other disease settings. Author manuscript; available in PMC Apr See other articles in PMC that cite the published article.
In addition to facilitating large-scale predictive and prognostic clinical analyses in early stage colon cancer, the ACCENT database has served as an important resource for developing or testing aaccent multi-trial statistical analysis techniques. With organized and dedicated efforts such as those initiated and sustained by the Adjuvant Colon Cancer End Points ACCENT Group, the information yielded from individual studies may be combined to answer important disease questions that no single trial can address.
As co-morbidities were not known for ACCENT patients, but required for calculator entry, patients were assumed to have either “minor” or “average for age” co-morbidities. Also, each single trial typically yields many individual datasets, but each of these generally contains unique structure, format, or level of detail that is different from the datasets provided from any other trial.
When investigating outcome disparities between patients treated with identical therapies in the ACCENT trials, the authors found worsened overall survival and recurrence-free survival persisted among blacks when subsets defined by sex, age, and stage were explored, but no difference in recurrence-free interval existed between black and white patients.
Continued evaluation of data from clinical trials completed in order to define the optimal endpoint in varying settings is an ongoing process, which will require re-examination after each set of newly completed trials. Acent following recurrence The early s saw a lengthening of the time from patient recurrence to death. Overall, younger patients were found not to differ from older patients in terms of recurrence-free interval, but younger patients experienced improved OS and DFS relative to accentt patients.
Outcomes among black patients In a prospectively planned study, Dr. In reality, multiple clinical trials assessing similar treatments for a given disease are often conducted simultaneously, collectively including patients from slightly differing populations or from several different countries.
Gene Ontology GO Terms. Byformal efforts to solicit and pool data from additional adjuvant therapy trials in colon cancer yielded an additional 8 studies totaling more than 20, patients from 18 trials; these comprised the original ACCENT database and are listed in Table 1. Online is reasonably accurate overall for predicting outcomes in older trial patients with stage III colon cancer, though accuracy may differ between 5-year RFS and 5-year OS predictions when a fixed degree of co-morbidities is assumed.
Body mass index at diagnosis and survival among colon cancer patients enrolled in clinical trials of adjuvant chemotherapy. Since its flagship analysis of 3-year disease-free survival as a surrogate endpoint for 5-year overall survival inthe ACCENT group has produced many noteworthy scientific findings addressing a variety of clinical questions, which we describe here.
CitePeer Related Articles http: Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma.
Read Article at publisher’s site. Benefits and adverse events in younger versus older patients receiving adjuvant chemotherapy for colon cancer: Efficacy of adjuvant fluorouracil and folinic acid in B2 colon cancer. Additionally, we provide an overview of the history, collaboration, construction, principles, and future of the ACCENT database, as it accebt set a precedent for multi-trial database creation in other types of cancer.
Individual patient data from these trials was subsequently combined with data from two additional trials to conduct an analysis restricted to stage II patients 3. Today, the ACCENT database contains patient-level data from over 33, individuals enrolled onto 25 adjuvant colon cancer trials conducted between and Acxent or three year disease-free survival DFS as a primary end-point in stage III adjuvant colon cancer trials with fluoropyrimidines with or without oxaliplatin or irinotecan: Several unique challenges are inherent to this process, which may take years to complete.
Clinical trials are becoming more sophisticated in design and comprehensive in the information learned from patients, yet the knowledge to be gleaned from even the largest, most data-enriched trial remains limited. Underweight men and women showed a shorter TTR and reduced DFS, but this relationship was more significant in men than in women. The publisher’s final edited version of this article is available free at Chin Clin Oncol.
The frequent exclusion of elderly patients from chemotherapy trials by design and failure to offer chemotherapy to elderly patients due to health-related or perceived risks exacerbates this problem. DFS as endpoint for combination or u110 adjuvant therapy In light of new therapies showing promise in adjuvant colon cancer studies inthe ACCENT database acquired a new cohort of six trials containing oral fluoropyrimidines, oxaliplatin, and irinotecan Table 2.
These acecnt suggested that the disease process risk of recurrence did not differ by race, but that the poorer survival of black patients is most likely due to other factors.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.