Baseline quality of life predicts survival in patients with advanced colorectal cancer
Introduction
Previous perceived lack of scientific value and practical difficulties contributed to skepticism surrounding the use of quality of life (QoL) data in oncology trials. However, it is now clear that high completion rates of QoL questionnaires are possible 1, 2, 3 and that QoL is a useful endpoint when measuring the impact of therapeutic manoeuvres. Its use in patients with colorectal cancer is no exception. Chemotherapy has been found to improve the QoL of patients as well as to prolong survival 4, 5. QoL measurements are of particular value in cancers with poor prognosis, as well as in the comparison of chemotherapy regimens that are unlikely to produce large differences in survival 6, 7, 8.
In addition to quantifying the impact of treatments, there is evidence to suggest that QoL data may also have a prognostic role. Baseline QoL has been demonstrated to predict survival in a number of cancer types including breast cancer 9, 10, lung cancer [11], melanoma [12] and in large cohorts of patients with varied malignancies 13, 14. A similar finding in patients with colorectal cancer would be of great value. Several poor prognostic factors in colorectal cancer have been identified, such as performance status, tumour burden, liver function and haematological parameters 15, 16, 17, 18, 19, but a simple prognostic model for these patients does not exist. Such a model may allow the stratification of trial patients, as well as the comparison of outcomes between studies.
The aim of this study was to examine the prognostic value of baseline QoL measurements in patients with locally advanced and metastatic colorectal cancer treated with systemic chemotherapy within the context of clinical trials.
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Patients
Between 1992 and 1998, four randomised clinical trials in advanced colorectal cancer were conducted at this institution. Details of these clinical trials have been presented elsewhere, but results are summarised in Table 1. Briefly, the COLO1 study randomised patients between protracted venous infusion (PVI) 5-fluorouracil (5-FU) with or without interferon [20]. The COLO2 study compared raltitrexed (Tomudex) with 5-FU, administered according to the Mayo schedule [21]. Patients in the Chromatic
Patient demographics
A total of 631 patients were recruited into the four studies from our centre. Of these, 501 patients completed the baseline QoL questionnaire (see Table 1). These form the cohort of the present study. Almost all patients (98%) received 5-FU-based chemotherapy, with only 2% receiving raltitrexed. The median age was 62 years (range 33–82), 63% of patients were male, 82% had metastatic disease and 98% of patients were of PS 0–2. The site of the primary was as follows: 28% in the right colon (up to
Discussion
We have found that baseline QoL measurements are significant independent prognostic indicators in patients with inoperable colorectal cancer receiving chemotherapy within the context of randomised phase III clinical trials. Patients with a high baseline global QoL have a 1-year survival that is almost double that of patients with a score below the median value (72.5% versus 38.3%, P<0.00001). The relationship between QoL and survival has been documented in other cancer types 9, 10, 11, 12, 13,
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