Prognostic factors for tumour response, progression-free survival and toxicity in metastatic colorectal cancer patients given irinotecan (CPT-11) as second-line chemotherapy after 5FU failure

摘要: Our purpose was to determine, in patients with metastatic colorectal carcinoma treated irinotecan single-agent after 5-FU failure, the most significant predictive parameters for tumour response, progression-free survival and toxicity. Between October 1992 April 1995, 455 resistant entered four consecutive phase II trials. The first two studies assessed other were randomized which efficacy of racecadotril prevent irinotecan-induced diarrhoea. Due homogeneous main eligibility criterias, data from those could be pooled statistical analysis. Potential clinical biological factors (PF) toxicity, growth control, e.g. response or stabilization (PFS), studied multivariate 363 evaluable 432 PFS, 368 neutropenia 416 delayed diarrhoea, respectively. Normal baseline haemoglobin level (Hb), time since diagnosis carcinoma, grade 3 4 diarrhoea at cycle a low number organs involved PF control (P< 0.05). Significant prognostic variables PFS WHO Performance Status, liver lymph-node involvement, diagnosis, age CEA value (P≤ 0.02). Six groups based on unfavourable are presented. Baseline bilirubin, level, neutropenia; PS, serum creatinine, leukocyte count, progression prior abdominopelvic irradiation These should help clinicians anticipate given patient probability observe response/stabilization results also prospectively confirmed ongoing future trials using irinotecan, both as single agent combination drugs. © 2000 Cancer Research Campaign