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Prospective Data Collection Initiative on Colorectal Cancer

ABSTRACT: Survival after colorectal cancer (CRC) diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. A combination of biochemical factors, histopathological features, genomic profile, environmental factors and other clinical factors are likely to influence prognosis and treatment effect, independent from tumor stage, but it is still unclear which, how, and to what extent these factors can influence tumor recurrence and mortality in both early stage (I-III) and late stage (IV) CRC. Although the results from prospective clinical trials will remain the backbone of evidence based medicine, this concerns a highly selected patient population since the large majority (85%-95%) of cancer patients do not participate in clinical trials for various reasons. It is unlikely that trial participation will significantly improve in the near future. This fact has the following implications: 1) It is highly desirable to validate the results from trials in the general patient population. However, this is complicated by the fact that the documentation of patients treated in general practice (i.e. outside the scope of clinical trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic characteristics and treatment parameters. 2) There is an increased availability of novel technologies that provide molecular markers with potential prognostic and/or predictive value. To test the clinical value of these markers large numbers of patients are required which greatly exceeds the number of patients who consent to participate in prospective clinical trials. 3) as a result of rapid technical developments, a range of new minimally invasive treatment options for CRC are entering the market. These interventions have the potential to be of great benefit for patients in terms of improved local control, higher probability of complete tumor removal, less damage to surrounding tissue, faster recovery and less short and long term side effects. Still, the interventions will have to prove their effectiveness, safety and superiority (or non-inferiority) to standard cancer treatments on a patient level. A prospective observational cohort study has the great opportunity to fill this gap.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2161372 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Purpose: The primary objective of the current study was to validate biomarkers to identify the 10% to 27% of patients with stage I and 35% of patients with stage IIA squamous cell carcinoma of lung (SC) who are likely to recur following surgical resection, so that these patients may be offered enrollment in clinical trials evaluating directed ACT. A secondary objective was to identify patients with stage IIB SC who are unlikely to develop recurrences and might thereby be spared the potential significant toxicity and expense of ACT. Methods: Two-stage validation used independent core laboratories, objective quality control standards, locked test parameters, and large multi-institutional specimen/data sets. First stage validation confirmed a signature’s ability to stratify patient survival. Second stage validation determined which signature(s) optimally improved risk discrimination when added to baseline clinical predictors. Participants were prospectively enrolled on institutional (Cohort I) or cooperative group (Cohort II) biospecimen/data collection protocols. All cases underwent central review of clinical, pathologic and biospecimen parameters using objective criteria to determine final inclusion (Cohort I: n=249; Cohort II: n=234). Primary selection required that a signature significantly predict 3-years survival after surgery in Cohort I. Signatures meeting this criterion were further tested in Cohort II, comparing risk prediction using baseline risk factors alone versus in combination with the signature. Results: Male sex, advanced age, and higher stage were associated with shorter survival in Cohort I and established a baseline clinical model. Of three signatures validated in Cohort I, one signature was validated in Cohort II and statistically significantly enhanced prognosis relative to the baseline model (C-index difference 0.122; p<0.05). Conclusions: These results represent the first rigorous validation of a test appropriate to direct adjuvant treatment or clinical trials for patients with lung squamous cell carcinoma.

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Prospective Data Collection Initiative on Colorectal Cancer

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