Abstract

BackgroundIn cancer research the selection and definitions of survival endpoints are important and yet they are not used consistently. The aim of this study was to compare different survival endpoints in patients with primary colorectal cancer (CRC) and to understand the effect of second primary other cancer on disease-free survival (DFS) calculations.MethodsA population-based cohort of 415 patients with CRC, 332 of whom were treated with curative intention between the years 2000-2003, was analysed. Events such as locoregional recurrence, distant metastases, second primary cancers, death, cause of death and loss to follow-up were recorded. Different survival endpoints, including DFS, overall survival, cancer-specific survival, relapse-free survival, time to treatment failure and time to recurrence were compared and DFS was calculated with and without inclusion of second primary other cancers.ResultsThe events that occurred most often in patients treated with curative intention were non-cancer-related death (n = 74), distant metastases (n = 66) and death from CRC (n = 59). DFS was the survival endpoint with most events (n = 170) followed by overall survival (n = 144) and relapse-free survival (n = 139). Fewer events were seen for time to treatment failure (n = 80), time to recurrence (n = 68) and cancer-specific survival (n = 59). Second primary other cancer occurred in 26 patients and its inclusion as an event in DFS calculations had a detrimental effect on the survival. The DFS for patients with stage I-III disease was 62% after 5 years if second primary other cancer was not included as an event, compared with 58% if it was. However, the difference was larger for stage II (68 vs 60%) than for stage III (49 vs 47%).ConclusionsThe inclusion of second primary other cancer as an endpoint in DFS analyses significantly alters the DFS for patients with CRC. Researchers and journals must clearly define survival endpoints in all trial protocols and published manuscripts.

Highlights

  • In cancer research the selection and definitions of survival endpoints are important and yet they are not used consistently

  • The present study reveals that inclusion of second primary other cancers affects the results of disease-free survival (DFS) in patients with colorectal cancer (CRC)

  • Second primary other cancers generate a significant number of events during follow-up of patients with CRC, which causes worse DFS when the second primary other cancers are included as an event in the calculations

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Summary

Introduction

In cancer research the selection and definitions of survival endpoints are important and yet they are not used consistently. In cancer research the selection and definition of survival endpoints are important and among the central issues discussed in the Consolidated Standards of Reporting Trials (CONSORT) statement [1,2]. Meta-analyses will not be reliable when studies with different endpoint definitions are being compared. It is central in the quest for improved cancer treatment that we minimize problems related to study analyses. It was an excellent initiative to publish a consensus report on the definitions of endpoints used in adjuvant treatment trials in CRC (Table 1) [4]

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