524 Background: Guidelines recommend that oncology patients have the opportunity to participate in a clinical trial wherever possible. It is purported that as trial participants are often younger and fitter, data extrapolation from trial outcomes to patients seen in routine care may be difficult. We compared characteristics of patients with metastatic colorectal cancer (mCRC) participating in a first-line clinical trial with those treated in routine care. Methods: The TRACC (Treatment of Recurrent and Advanced Colorectal Cancer) database, a clinician-designed mCRC comprehensive database, was used to identify patients treated on a first-line trial compared with those receiving combination chemotherapy; single-agent therapy; or no chemotherapy. Data collection began in June 2009 and is ongoing at 15 Australian centres to date. Results: Of 671 patients, 49 (7.3%) participated in a first-line clinical trial. Patients on trial were significantly younger, with 49% (n=24) trial participants being under 60 years, compared with 33% (n=128) receiving combination chemotherapy off study (p=0.047), 13% (n=13) single-agent therapy (p<0.0001) and 10% (n=15) no treatment (p<0.0001). All trial participants were ECOG performance status 0-1, compared with 87% (n=335) of non-trial patients receiving combination chemotherapy (p<0.0001), 80% (n=82) receiving single-agent therapy (p<0.0001) and 52% (n=76) no treatment (p<0.0001). Similarly, Charlson comorbidity score was significantly lower in trial participants, with 88% (n=43) having a score 0-3 (less comorbidity) versus 71% (n=272) receiving combination chemotherapy, 39% (n=40) receiving single-agent therapy and 25% (n=36) no treatment. Preliminary analysis suggests significant overall survival benefit for the clinical trial cohort. Conclusions: Consistent with available literature, trial participants with mCRC are significantly younger, fitter and of better performance status than those who receive similar chemotherapy off-trial or no treatment. The impact of trial participation on survival may be thus subject to multiple factors biasing for a better outcome, including the contributing benefit of younger age and less comorbidity.
Safety and Feasibility of Additional Tumor Debulking to
First‐Line
Palliative Combination Chemotherapy for Patients with Multiorgan Metastatic Colorectal Cancer
