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Annals of Oncology 13:1558-1567, 2002
© 2002 European Society for Medical Oncology

Original Paper

Antitumour activity of three second-line treatment combinations in patients with metastatic colorectal cancer after optimal 5-FU regimen failure: a randomised, multicentre phase II study

P. Rougier1,+, D. Lepille2, J. Bennouna3, A. Marre4, M. Ducreux5, L. Mignot6, A. Hua7 and D. Méry-Mignard7

1 Hôpital Ambroise Paré, Boulogne; 2 Clinique Pasteur, Evreux; 3 Centre Gauducheau, Nantes; 4 Hôpital, Rodez; 5 Institut Gustave Roussy, Villejuif; 6 Hôpital Foch, Suresnes; 7 Laboratoire Aventis, Paris, France

Received 7 November 2001; revised 28 March 2002; accepted 12 April 2002

Background:

We have investigated the efficacy, safety and quality of life profiles of three therapeutic combinations [irinotecan + leucovorin (LV)/5-fluorouracil (5-FU), oxaliplatin + LV/5-FU and irinotecan +oxaliplatin] in patients with metastatic colorectal cancer after failure of a 5-FU-based regimen, or whose disease had progressed within 6 months of the end of treatment.

Patients and methods:

One hundred and one patients were randomised to receive either: (i) irinotecan 180 mg/m2 on day 1 followed by an LV 200 mg/m2 infusion, before a 5-FU 400 mg/m2 bolus followed by a 5-FU 600 mg/m2 infusion (LV5FU2 regimen), on days 1 and 2 every 2 weeks; (ii) oxaliplatin 85 mg/m2 on day 1 followed by the LV5FU2 regimen on days 1 and 2 every 2 weeks; or (iii) oxaliplatin 85 mg/m2 followed by irinotecan 200 mg/m2, both on day 1 every 3 weeks. The primary end point was overall response rate (ORR).

Results:

The intention-to-treat ORRs were 11.4% [95% confidence interval (CI) 3.2–26.7), 21.2% (95% CI 9.0–38.9) and 15.2% (95% CI 5.1–31.9), respectively, in the three arms. Tumour growth control was >=60% for all three combinations and overall survivals were 12.2 months (95% CI 9.2–16.0), 11.5 months (95% CI 9.0–14.1) and 11.0 months (95% CI 8.1–12.2), respectively. All patients were evaluable for safety. Main grade 3–4 toxicity was neutropenia (33 to 39% of patients).

Conclusions:

Thus, second-line treatment with irinotecan/LV5FU2, oxaliplatin/LV5FU2 or irinotecan/oxaliplatin, provides good tumour growth control and survival coupled with an acceptable safety profile.

Key words: 5-fluorouracil, irinotecan, metastatic colorectal cancer, oxaliplatin, second-line chemotherapy


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