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
| Autor: | Harry Bleiberg, Philippe Rougier, Gilles Freyer, Patrice Herait, Lucile Awad, Dominique Mignard, Véronique Trillet-Lenoir, J.P. Droz, Stéphane Culine, Michel Marty, Roland Bugat |
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| Rok vydání: | 2000 |
| Předmět: |
Adult
Diarrhea Male Oncology Antimetabolites Antineoplastic Thiorphan Cancer Research medicine.medical_specialty Prognostic variable Neutropenia Colorectal cancer colorectal cancer Irinotecan survival Disease-Free Survival Clinical Trials Phase II as Topic Predictive Value of Tests Risk Factors Internal medicine Carcinoma medicine Humans Multicenter Studies as Topic Progression-free survival Neoplasm Metastasis Antidiarrheals Aged Randomized Controlled Trials as Topic Performance status business.industry prognostic factors toxicity Regular Article Middle Aged medicine.disease Antineoplastic Agents Phytogenic Surgery Drug Resistance Neoplasm Predictive value of tests Multivariate Analysis Camptothecin Female Fluorouracil Colorectal Neoplasms business medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| DOI: | 10.1054/bjoc.2000.1303 |
| Popis: | Our purpose was to determine, in patients with metastatic colorectal carcinoma treated with irinotecan single-agent after 5-FU failure, the most significant predictive parameters for tumour response, progression-free survival and toxicity. Between October 1992 and April 1995, 455 patients with 5-FU resistant metastatic colorectal carcinoma entered four consecutive phase II trials. The first two studies assessed tumour response, the other two were randomized studies which assessed the efficacy of racecadotril to prevent irinotecan-induced diarrhoea. Due to homogeneous main eligibility criterias, data from those studies could be pooled for statistical analysis. Potential clinical and biological predictive factors (PF) for toxicity, tumour growth control, e.g. response or stabilization and progression-free survival (PFS), were studied in multivariate analysis. 363 patients were evaluable for response, 432 were evaluable for PFS, 368 for neutropenia and 416 for delayed diarrhoea, respectively. Normal baseline haemoglobin level (Hb), time since diagnosis of colorectal carcinoma, grade 3 or 4 neutropenia or diarrhoea at first cycle and a low number of organs involved were the most PF for tumour growth control (P< 0.05). Significant prognostic variables for PFS were WHO Performance Status, liver and lymph-node involvement, time since diagnosis, age and CEA value (P≤ 0.02). Six groups of patients based on the number of unfavourable prognostic factors are presented. Baseline bilirubin, haemoglobin level, number of organs involved and time from diagnosis were PF for neutropenia; PS, serum creatinine, leukocyte count, time from 5-FU progression and prior abdominopelvic irradiation were PF for delayed diarrhoea (P≤ 0.05). These PF should help clinicians to anticipate for a given patient the probability to observe a response/stabilization or a toxicity. These results should also be prospectively confirmed in ongoing or future trials using irinotecan, both as a single agent and in combination with other drugs. © 2000 Cancer Research Campaign |
| Databáze: | OpenAIRE |
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