Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer - PubMed (original) (raw)

Clinical Trial

. 1998 Oct 31;352(9138):1407-12.

doi: 10.1016/S0140-6736(98)03085-2.

E Van Cutsem, E Bajetta, N Niederle, K Possinger, R Labianca, M Navarro, R Morant, H Bleiberg, J Wils, L Awad, P Herait, C Jacques

Affiliations

• PMID: 9807986
• DOI: 10.1016/S0140-6736(98)03085-2

Clinical Trial

Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer

P Rougier et al. Lancet. 1998.

Erratum in

• Lancet 1998 Nov 14;352(9140):1634

Abstract

Background: In phase II trials, irinotecan is active in patients with advanced colorectal cancer, but the survival and clinical benefit of irinotecan compared with second-line fluorouracil by continuous infusion is not known.

Methods: 267 patients who had failed to respond to first-line fluorouracil, or whose disease had progressed after treatment with first-line fluorouracil were randomly allocated irinotecan 300-350 mg/m2 infused once every 3 weeks or fluorouracil by continuous infusion. Treatment was given until disease progression, unacceptable toxic effects, or the patient refused to continue treatment. The primary endpoint was survival, while progression-free survival, response rate, symptom-free survival, adverse events, and quality of life (QoL) were secondary endpoints.

Findings: 133 patients were randomly allocated irinotecan and 134 were allocated fluorouracil by continuous infusion. Patients treated with irinotecan lived for significantly longer than patients on fluorouracil (p=0.035). Survival at 1 year was increased from 32% in the fluorouracil group to 45% in the irinotecan group. Median survival was 10.8 months in the irinotecan group and 8.5 months in the fluorouracil group. Median progression-free survival was longer with irinotecan (4.2 vs 2.9 months for irinotecan vs fluorouracil, respectively; p=0.030). The median pain-free survival was 10.3 months and 8.5 months (p=0.06) for irinotecan and fluorouracil, respectively. Both treatments were equally well tolerated. QoL was similar in both groups.

Interpretation: Compared with fluorouracil by continuous infusion second-line irinotecan significantly improved survival in patients with advanced colorectal cancer.

PubMed Disclaimer

Comment in

• Irinotecan for colorectal cancer: a small step forward.
  O'Connell MJ. O'Connell MJ. Lancet. 1998 Oct 31;352(9138):1402. doi: 10.1016/S0140-6736(98)00051-8. Lancet. 1998. PMID: 9807982 No abstract available.
• Optimum doses of irinotecan.
  Erlichman C, Goldberg RM, Pitot HC, O'Connell MJ. Erlichman C, et al. Lancet. 1999 Apr 10;353(9160):1275-6. doi: 10.1016/s0140-6736(05)75197-7. Lancet. 1999. PMID: 10217115 No abstract available.

Similar articles

• Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer.
  Cunningham D, Pyrhönen S, James RD, Punt CJ, Hickish TF, Heikkila R, Johannesen TB, Starkhammar H, Topham CA, Awad L, Jacques C, Herait P. Cunningham D, et al. Lancet. 1998 Oct 31;352(9138):1413-8. doi: 10.1016/S0140-6736(98)02309-5. Lancet. 1998. PMID: 9807987 Clinical Trial.
• [Second-line irinotecan chemotherapy in the treatment of metastatic colorectal cancers: phase III trials].
  Mitry E, Ducreux M, Rougier P. Mitry E, et al. Bull Cancer. 1998 Dec;Spec No:38-42. Bull Cancer. 1998. PMID: 9932083 Review. French.
• Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial.
  Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Douillard JY, et al. Lancet. 2000 Mar 25;355(9209):1041-7. doi: 10.1016/s0140-6736(00)02034-1. Lancet. 2000. PMID: 10744089 Clinical Trial.
• [Irinotecan monotherapy in the treatment of colorectal cancers: results of phase II trials].
  Van Cutsem E, Peeters M. Van Cutsem E, et al. Bull Cancer. 1998 Dec;Spec No:33-7. Bull Cancer. 1998. PMID: 9932082 Review. French.

Cited by

• Molecular Insights of Drug Resistance in Epilepsy: Multi-omics Unveil.
  Dhureja M, Chaturvedi P, Choudhary A, Kumar P, Munshi A. Dhureja M, et al. Mol Neurobiol. 2024 May 16. doi: 10.1007/s12035-024-04220-6. Online ahead of print. Mol Neurobiol. 2024. PMID: 38753128 Review.
• Camptothesome-based combination nanotherapeutic regimen for improved colorectal cancer immunochemotherapy.
  Wang Z, Li W, Jiang Y, Tran TB, Chung J, Kim M, Scott AJ, Lu J. Wang Z, et al. Biomaterials. 2024 Apr;306:122477. doi: 10.1016/j.biomaterials.2024.122477. Epub 2024 Jan 18. Biomaterials. 2024. PMID: 38309054 Free PMC article.
• Pucotenlimab in patients with advanced mismatch repair-deficient or microsatellite instability-high solid tumors: A multicenter phase 2 study.
  Zhang B, Song Y, Luo S, Yin X, Li E, Wang H, He Y, Liu Z, Fan Q, Liang X, Shu Y, Liu Y, Xu N, Zhang S, Zhuang Z, Zhang J, Kou X, Wang F, Zhu X, Zeng S, Wang K, Zhong H, Li S, Bai Y, Yu J, Dou Y, Ma T, Liu Q, Huang J. Zhang B, et al. Cell Rep Med. 2023 Dec 19;4(12):101301. doi: 10.1016/j.xcrm.2023.101301. Epub 2023 Nov 27. Cell Rep Med. 2023. PMID: 38016482 Free PMC article. Clinical Trial.
• Real-World Outcomes in Patients with Metastatic Colorectal Cancer in Spain: The RWD-ACROSS Study.
  Pericay C, Fernández Montes A, Alonso Orduña V, Macias Declara I, Asensio Martínez E, Rodríguez Salas N, Torres E, Cacho Lavín D, Rodríguez Alonso RM, Falcó E, Oliva JC, Cirera L. Pericay C, et al. Cancers (Basel). 2023 Sep 17;15(18):4603. doi: 10.3390/cancers15184603. Cancers (Basel). 2023. PMID: 37760572 Free PMC article.
• Irinotecan-Induced Toxicity: A Pharmacogenetic Study Beyond UGT1A1.
  de With M, van Doorn L, Kloet E, van Veggel A, Matic M, de Neijs MJ, Oomen-de Hoop E, van Meerten E, van Schaik RHN, Mathijssen RHJ, Bins S. de With M, et al. Clin Pharmacokinet. 2023 Nov;62(11):1589-1597. doi: 10.1007/s40262-023-01279-7. Epub 2023 Sep 16. Clin Pharmacokinet. 2023. PMID: 37715926 Free PMC article.

Publication types

MeSH terms

Substances

LinkOut - more resources

• Full Text Sources

  • Elsevier Science
  • Ovid Technologies, Inc.

• Other Literature Sources

  • The Lens - Patent Citations

• Medical

  • MedlinePlus Health Information