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Factors predicting efficacy of oxaliplatin in combination with 5-fluorouracil (5-FU) ± folinic acid in a compassionate-use cohort of 481 5-FU-resistant advanced colorectal cancer patients

British Journal of Cancer volume 85, pages 509–517 (2001)Cite this article

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Abstract

A statistical analysis was performed on the patient data collected from two compassionate-use programmes using oxaliplatin (Eloxatin®) + 5-fluorouracil (5-FU) ± folinic acid (FA), to identify predictive factors for oxaliplatin-based salvage treatment in patients with 5-FU-resistant advanced colorectal cancer (ACRC). 481 5-FU-resistant ACRC patients, most with performance status ≤ 2, ≥ 3 involved sites, and ≥ 2 prior lines of chemotherapy, received oxaliplatin + 5-FU ± FA. Prognostic factors associated with overall response rate (ORR), time to progression (TTP) and overall survival (OS) were identified using univariate and multivariate logistic and/or Cox proportional hazards analyses. The ORR was 16% (95% CI: 13–20), the median TTP was 4.2 months (95% CI: 3.4–4.6), and the median OS was 9.6 months (95% CI: 8.6–10.6). The multivariate analysis indicated poor (≥ 2 WHO) performance status (PS), a large number of prior chemotherapy regimens (≥ 3), a low baseline haemoglobin level (< 10 g/dl), and a triweekly (vs biweekly) treatment administration schedule as significantly associated (P< 0.05) with a lower ORR. Sex (male), number of organs involved (≥3) and alkaline phosphatase (AP) level (≥ 2 × the upper limit of normal) were associated (P< 0.05) with shorter TTP. Poor PS, a large number of organs involved, and elevated AP were independently and significantly correlated with shorter OS. Our analysis identified a relationship between efficacy results of oxaliplatin + 5-FU ± FA treatment in 5-FU-resistant ACRC patients and baseline prognostic factors related to PS, extent of disease and number of prior regimens. © 2001 Cancer Research Campaign http://www.bjcancer.com

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  1. Cvitkovic et Associés Consultants, 18–20 rue Pasteur, Kremlin-Bicêtre, 94278

    M A Bensmaïne & E Cvitkovic

  2. Hôpital Saint-Louis, 1 avenue Claude Vellefaux, Paris, 75010

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  3. Hôpital Saint-Antoine, 184 rue du Fg St Antoine, Paris, 75012

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  4. Debioclinic, 2 rue du Nouveau Bercy, 94220 Charenton le Pont

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  5. Hôpital Paul Brousse, 14 avenue Paul Vaillant Couturier, Villejuif, 94805, Cedex

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  8. Centre Paul Papin, 2 rue du Moll, Angers, 49033, Cedex 01, France

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  9. Institut Jules Bordet, 1 rue Héger-Bordet, Brussels, 1000, Belgium

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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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Bensmaïne, M., Marty, M., Gramont, A. et al. Factors predicting efficacy of oxaliplatin in combination with 5-fluorouracil (5-FU) ± folinic acid in a compassionate-use cohort of 481 5-FU-resistant advanced colorectal cancer patients. Br J Cancer 85, 509–517 (2001). https://doi.org/10.1054/bjoc.2001.1953

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Keywords

  • clinical resistance
  • multivariate analysis
  • salvage chemotherapy

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