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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

British Journal of Cancer volume 83, pages 431–437 (2000)Cite this article

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Abstract

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

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    This paper was modified 12 months after initial publication to switch to Creative Commons licence terms, as noted at publication

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Author information

Affiliations

  1. Medical Oncology Unit and EA 643, Centre Hospitalier Lyon-Sud, 69495, Pierre-Bénite Cedex, Lyon, France

    G Freyer & V Trillet-Lenoir

  2. Institut Gustave Roussy, Villejuif and Hôpital Ambroise Paré, Boulogne, France

    P Rougier

  3. Institut Claudius Regaud, Toulouse, France

    R Bugat

  4. Centre Léon Bérard, Lyon, France

    J-P Droz

  5. Hôpital Saint-Louis, Paris, France

    M Marty

  6. Institut Jules Bordet, Brussels, Belgium

    H Bleiberg

  7. Rhone-Poulenc Rorer, Antony, France

    D Mignard, L Awad & P Herait

  8. Centre Anticancéreux du Val d'Aurelle, Montpellier, France

    S Culine

Authors
  1. G Freyer
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  2. P Rougier
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  3. R Bugat
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  4. J-P Droz
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  9. P Herait
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  10. S Culine
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  11. V Trillet-Lenoir
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Consortia

the CPT-11 F205, F220, F221 and V222 study groups

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From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/

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Freyer, G., Rougier, P., Bugat, R. et al. 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. Br J Cancer 83, 431–437 (2000). https://doi.org/10.1054/bjoc.2000.1303

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Keywords

  • irinotecan
  • colorectal cancer
  • prognostic factors
  • survival
  • toxicity

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