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Proposal 1907

Title of the Proposed Research

Critical characterization of the impact of clinical-pathological tumoral features on recurrence risk dynamics of NSCLS.

Lead Researcher

Tommaso De Pas

Affiliation

European institute of Oncology , Milan

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

13 September 2017

Lay Summary

Lung cancer is the leading cause of cancer death in the USA. Surgery is the initial treatment for patients with stage I to II(N0–N1). After surgery all patients had routine postsurgical surveillance with clinical assessment and imaging studies, including chest computed tomography, but frequency and choice of follow-up modality are not standardized. Indeed,no evidence from randomized trials is available to define optimal follow-up in treated stage I-III NSCLC patients. As a result,surveillance guidelines and practices vary greatly especially in imaging frequency and modality. Currently, experts can only extrapolate recommendations for follow-up strategies, either based on evidence from retrospective analysis of consecutive patients series treated in single insitution or follow-up policies in large published clinical trials The interpretation of previous retrospective studies is limited by their small sample sizes and by the heterogeneity of their surveillance methods used. Although some studies have suggested that surveillance CT scan is effective at detecting early second primary lung cancer, the data are less clear regarding efficacy of early detection of recurrence and the impact on patients survival. Furthermore,albeit available data show that the majority of recurrences are detected by scheduled surveillance CT scan, a not negligible percentage of recurrences are detected outside of the routine follow-up procedures, most commonly as a result of the development of new symptoms. This considerable high percentage of follow-up missed recurrences highlight the need to improve the follow-up strategies. A way to achieve this objective it may be represented by tailoring follow-up procedures and schedules on the specific distribution of the recurrence risk over time, according with the different clinical-pathological features of each tumor. So far,the reliable and consistent evidences available show that on average, a significant proportion(30%–60%) of patients who underwent resection for pathological stage IA–IIB NSCLC develop a locoregional or distant recurrence; that the hazard rate for disease recurrence is about 6%–7% per patient per year during the first 4 years, diminishing to2% per patient per year thereafter; and that, in addition, there is a smooth increase of the hazard rate for second primary cancer from 1% to 3% per patient per year during the first 3 years, which does not diminish over time. We have less evidences on whether and how the clinical-pathological features of tumors substantially modify the pattern of anatomical sites of recurrence as well as the distribution of the recurrence risk over time, as it has been largely proved in breast cancer. On the light of the limitations of the available data on the recurrences dynamics of NSCLCs that likely hamper the possibility of improve follow-up strategies, we propose to analyze the data of follow-up of patients enrolled in MAGRIT trial, to address specific questions.

Study Data Provided

GSK-109493: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3 positive Non-Small Cell Lung Cancer

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.