FAQ – Fast Facts (New Endpoints)
Question: What are the current end points for research in adjuvant treatment of CRC?
Answer: An article by Punt et al discusses the efforts of a consensus panel to define appropriate end points for research in adjuvant therapy trials. A meta-analysis of 52 phase 3 trials in colon cancer care was completed, and appropriate end points were discussed, finalized, and defined as follows:
- Disease-free survival (DFS): time to any event, irrespective of cause. All events are included, except loss to follow-up.
- Relapse-free survival (RFS): time to any events, irrespective of cause, except for any second primary cancers. Events mean recurrence of or death from the same cancer and all treatment–related deaths or deaths from other causes. Second-primary same cancers and other primary cancers are ignored, and loss to follow-up is censored.
- Time to recurrence (TTR): time to any event related to the same cancer. All same-cancer recurrences and deaths from the same cancer are events. Second-primary same cancers and other primary cancers are ignored. Deaths from other cancers, non–cancer-related deaths, treatment-related deaths, and loss to follow-up are censored observations.
- Time to treatment failure (TTF): time to any event, except non–cancer-related death. All recurrences, treatment-related deaths, second same or other primary cancers, and deaths from other cancers are considered to be events. Loss to follow-up and non–cancer-related deaths are censored.
- Cancer-specific survival (CSS): time to death caused by the same cancer, whether due to the original tumor or to a second-primary same cancer. The only event is death from the same cancer, regardless of whether the death is caused by the primary tumor or a second same cancer. Locoregional recurrence, distant metastases, second-primary same cancers, and second other primary cancers are ignored. Deaths from other cancers, non–cancer-related deaths, treatment-related deaths, and loss to follow-up are censored.
- Overall survival (OS): time to death, irrespective of cause. There is no need to specify whether the death was due to cancer. Locoregional recurrence, distant metastases, second-primary CRCs, and second other primary cancers are ignored. Loss to follow-up is censored.
Based on their assessment of the meta-analysis, the consensus panel decided that DFS is the most appropriate primary end point for future trials of adjuvant therapy for colon cancer and any other type of cancer. The panel felt it was the most unbiased way of measuring results and that uniformity in research would help limit the variability with which research in this area is viewed. Although not all oncology nurses work with patients in clinical trials, they need to understand these key definitions, particularly when talking with patients about reasons for therapeutic choices. As oncology patients become more sophisticated regarding their care, their nurses must also become familiar with the most common terms related to survival and with rationales measuring treatment efficacy.
Punt CJA, Buyse M, Kohne CH, et al. Endpoints in adjuvant treatment trials: A systematic review of the literature in colon cancer and proposed definitions for future trials. J Natl Cancer Inst. 2007;99:998-1003. The full text free article is available at: http://jnci.oxfordjournals.org/cgi/reprint/99/13/998
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