Clinical trial enrollment, patient characteristics, and survival differences in prospectively registered metastatic colorectal cancer patients

Abstract

BACKGROUND: Trial accrual patterns were examined to determine whether metastatic colorectal cancer (mCRC) patients enrolled in trials are representative of a general cancer population concerning patient characteristics and survival. METHODS: A total of 760 mCRC patients referred for their first oncological consideration at 3 hospitals in Scandinavia covering defined populations were registered consecutively during 2003 to 2006. Clinical trial enrollment, patient characteristics, and treatment were recorded prospectively, and the follow‐up was complete. RESULTS: Palliative chemotherapy was initiated in 61% of the patients. Approximately one‒third (36%) of patients receiving chemotherapy were included in a trial. The main reason for nonparticipation was failed eligibility criteria (69%). The median survival after chemotherapy was 15.8 months for all patients, and 18 months after combination chemotherapy. Trial patients had better prognostic characteristics and significantly longer survival than nontrial patients: 21.3 months versus 15.2 months when receiving combination chemotherapy. Poor performance status was the main reason for giving best supportive care only, and the median survival was then only 2.1 months. The median survival for all 760 nonresectable mCRC patients was 10.7 months. CONCLUSIONS: mCRC patients enrolled into clinical trials differ in characteristics from patients receiving chemotherapy outside protocol and have better survival, even when given the same treatment. Although trial patients have a median survival close to 2 years, survival is lower for all patients receiving chemotherapy and much lower for all patients diagnosed with mCRC. Studies that better accept the heterogeneity of the population with mCRC are needed. Cancer 2009. © 2009 American Cancer Society.

Survival improvements associated with access to biological agents: Results from the South Australian (SA) metastatic colorectal cancer (mCRC) registry

“…Biological therapy was also identified to be an independent favorable prognostic factor for OS on the multivariate Cox proportional hazard model. A more than fivemonth difference in mCRC survival outcome between patients treated on and outside of clinical trials, even when given the same treatment, was previously shown by Sorbye et al [18]. This highlights the utility of population-based databases, such as the SA mCRC registry, in assessing clinical benefit of new treatment in heterogenous mCRC population in a community setting.…”

Oncological treatment and outcome of colorectal cancer in Greenland

“…The present study indicates that 5-year survival was similar in Greenland and Denmark for both colon cancer (48% vs. 49%) and rectum cancer (53% vs. 50%) [16]. Among patients with metastatic CRC, median survival in Greenland was similar to patients in Scandinavia: 17 vs. 15.8 months for patients treated with chemotherapy and 2 vs. 2.8 months for patients receiving best supportive care alone [20]. Despite a previous study in Greenland suggesting a significant diagnostic delay for patients living in remote areas outside Nuuk [6], and international research reporting on significant disparities in cancer-related outcomes in rural and remote areas [10–13], we found no significant difference in stage distribution or survival rates between patients from Nuuk and patients living along the coastline outside Nuuk.…”

“…A high percentage of CRC patients with Stage III disease received adjuvant therapy, 79% compared to 69% in Denmark [19]. Palliative chemotherapy for metastatic CRC was initiated as often in Greenland as in Scandinavia, 61% vs. 61% received palliative treatment [20]. The present study indicates that 5-year survival was similar in Greenland and Denmark for both colon cancer (48% vs. 49%) and rectum cancer (53% vs. 50%) [16].…”

Impact of early disease progression and surgical complications on adjuvant chemotherapy completion rates and survival in patients undergoing the surgery first approach for resectable pancreatic ductal adenocarcinoma – A population-based cohort study

“…Some multicentre studies included good performance status patients with strict tumour biology inclusion criteria, such as low Ca 19-9 levels, that also may explain the better five-years survival than in our population-based study [18]. Furthermore, population based studies generally reveal lower OS compared to selected randomised study cohorts [40].…”