Data were used from the phase III CAIRO study of the DCCG (Koopman et al, 2006 (link), 2007a (link)). In this study patients were randomised between sequential and combination treatment with capecitabine, irinotecan and oxaliplatin. Stratification parameters included WHO performance status, serum lactate dehydrogenase (LDH), prior adjuvant therapy, predominant localisation of metastases and participation institution. Assessment of tumour response was scheduled every three cycles (9 weeks) according to RECIST criteria (Therasse et al, 2000 (link)). Follow-up after completion of treatment was performed every 3 months until death. The primary endpoint was overall survival.
Patients were divided into synchronous and metachronous disease, with synchronous disease defined as distant metastases occurring within, and metachronous disease beyond 6 months of the primary diagnosis of CRC. For two reasons only patients in whom a resection of the primary tumour had been performed were included in the analysis. First, tissue of the primary tumour was required for histopathological review. Second, the arguments for non-resection may greatly vary from patients with an asymptomatic primary and excellent performance status to patients with a symptomatic primary with extensive metastases and poor performance status in whom a delay in systemic treatment is not warranted. These arguments are often not recorded in the patients’ files.
Patients were divided into synchronous and metachronous disease, with synchronous disease defined as distant metastases occurring within, and metachronous disease beyond 6 months of the primary diagnosis of CRC. For two reasons only patients in whom a resection of the primary tumour had been performed were included in the analysis. First, tissue of the primary tumour was required for histopathological review. Second, the arguments for non-resection may greatly vary from patients with an asymptomatic primary and excellent performance status to patients with a symptomatic primary with extensive metastases and poor performance status in whom a delay in systemic treatment is not warranted. These arguments are often not recorded in the patients’ files.
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