Following a meeting in Paris, France organized by Dr. These studies compared the same fluorouracil-based regimen versus surgery alone. In light of new therapies showing promise in adjuvant colon cancer studies in , the ACCENT database acquired a new cohort of six trials containing oral fluoropyrimidines, oxaliplatin, and irinotecan Table 2. How does Europe PMC derive its citations network? For example, ACCENT contains data from many different countries that must be solicited and combined, resulting in potential language issues, both in correspondence and within the data.
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Colorectal cancer is the fourth most common cancer worldwide, with a worldwide incidence on the order of 1 million cases per year resulting in on the order ofdeaths. The ACCENT database is the amalgamation of individual patient data from many of these trials, selected for their quality and importance.
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. RenfroQian Shiand Daniel J. Additionally, we provide an overview of the history, collaboration, construction, principles, and future of the ACCENT database, as it has set a precedent for multi-trial database creation in other types of cancer.
Each trial lead investigator may decline to allow the data from their trial to be used in any analysis, or voice a scientific objection. Inpatient-level data from the 24 trials contained in ACCENT were pooled to examine efficacy and toxicity outcomes by age, with young patients defined as age less than 40 years 5.
In a accet analysis motivated by newer therapies that had been found to prolong survival after recurrence, de Gramont et al. 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.
Mining the ACCENT database: a review and update
Other advanced statistical explorations have flourished with access to the ACCENT database, where complex multi-trial surrogacy evaluation methods and novel adaptive trial designs have been successfully motivated by actual data.
First, a number of investigators with ownership of afcent similar trials must be successfully encouraged to share data and to agree on policies guiding its sound scientific use.
In a subset of 9 trials demonstrating benefit in the experimental arm, the DFS benefit was similar by age. These requests are circulated to all participating ACCENT investigators including clinical oncologists as well as biostatisticians, who assess the plausibility, design, and likely impact of the proposed research.
Association between disease-free survival and overall survival when survival is prolonged after recurrence in patients receiving cytotoxic adjuvant chemotherapy for colon cancer: For example, ACCENT contains data from many different countries that must be solicited and combined, resulting in potential language issues, both in correspondence and within the data.
Ultimately, these insights gained by thoughtful examination of clinical trial data will facilitate timely assessment of new adjuvant therapies, with the overall objective of significantly improved outcomes for patients with colon cancer.
Martin Luther Universitaet, Berlin, Germany. Author manuscript; available in PMC Apr Of the 25, patients examined, obese and underweight patients showed worse OS than normal weight or overweight patients; however, this pattern was significant only for men. Following a meeting in Paris, France organized by Dr.
Underweight men and women showed acdent shorter TTR and reduced DFS, but this relationship was more significant in men than in women.
University Hospital Afcent, Gasthuisberg, Belgium. Adjuvant chemotherapy in elderly patients Historically, treatment of elderly patients with adjuvant chemotherapy following curative resection has been controversial, with limitations inherent to existing data obscuring or precluding practical guidelines.
Mining the ACCENT database: a review and update
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.
InSargent et al. Body mass index and overall survival While high body mass index BMI has been established as a strong risk factor in colon cancer, until recently, the prognostic and predictive impact of BMI on outcomes of patients treated with adjuvant therapy remained unclear.
Furthermore, the surrogacy association across trials was stronger for stage III than stage II disease, indicating that use of DFS as a surrogate is most appropriate in trials comprised mostly or entirely of stage III patients.
This is especially challenging when vastly different levels of detail may be supplied for any single item, or in some cases, the data is not supplied at all.
In a prospectively planned study, Dr. This interest in post-recurrence survival prompted the ACCENT group to explore factors influencing survival following recurrence.
These include but are not limited to: While the ACCENT group had thoroughly studied the relationships between disease recurrence, acvent therapy, and overall survival in the first axcent years after surgery, until this point, longer-term outcomes and implications had not yet been explored. At this stage, it is critical to have prospective and comprehensive data management, such that theoretically similar sources of information e.
Evidence for cure by adjuvant therapy in colon cancer: Overall, Sanoff et al.