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Two different first-line 5-fluorouracil regimens with or without oxaliplatin in patients with metastatic colorectal cancer

Journal Article


Abstract


  • Background: Oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (LV) are standard first-line treatments for patients with metastatic colorectal cancer (mCRC). The aim of this multicentre, open-label, phase IIIb study was to assess the addition of oxaliplatin to two different 5-FU regimens.

    Patients and methods: Patients with previously untreated mCRC were randomised to arm A [two-weekly oxaliplatin 85 mg/m(2) + either continuous intravenous infusion (CIV) of 5-FU without LV or two-weekly bolus and CIV 5-FU + LV (LV5FU2)] or arm B (5-FU CIV or LV5FU2 alone). Irinotecan monotherapy was planned on progression.

    Results: A total of 725 patients were enrolled. After a fixed follow-up of 2 years for each patient, 2-year survival rates were 27.3% and 24.8% in arms A and B, respectively (hazard ratio 0.93; 95% confidence interval 0.78-1.10). The addition of oxaliplatin significantly improved response rates (54.1 versus 29.8%; P < 0.0001) and median progression-free survival (7.9 versus 5.9 months; P < 0.0001). The most common grade 3-4 toxic effects were neutropenia (arm A, 33%; arm B, 5%), diarrhoea (arm A, 14%; arm B, 8%), and fatigue (arm A, 9%; arm B, 8%).

    Conclusions: Despite improved rates of tumour control, these results failed to demonstrate a survival benefit from the addition of oxaliplatin to infused 5-FU and lend further support to the use of sequential monotherapy in some patients with mCRC.

Authors


  •   Cunningham, D (external author)
  •   Sirohi, B (external author)
  •   Pluzanska, A (external author)
  •   Utracka-Hutka, B (external author)
  •   Zaluski, J (external author)
  •   Glynne-Jones, R (external author)
  •   Koralewski, P (external author)
  •   Bridgewater, John (external author)
  •   Mainwaring, P (external author)
  •   Wasan, H (external author)
  •   Wang, Jiazhao
  •   Szczylik, C (external author)
  •   Clingan, Phillip R.
  •   Chan, R T T (external author)
  •   Tabah-Fisch, Isabelle (external author)
  •   Cassidy, J (external author)

Publication Date


  • 2009

Citation


  • Cunningham, D., Sirohi, B., Pluzanska, A., Utracka-Hutka, B., Zaluski, J., Glynne-Jones, R., Koralewski, P., Bridgewater, J., Mainwaring, P., Wasan, H., Wang, J., Szczylik, C., Clingan, P. R., Chan, R. T., Tabah-Fisch, I. & Cassidy, J. (2009). Two different first-line 5-fluorouracil regimens with or without oxaliplatin in patients with metastatic colorectal cancer. Annals of Oncology, 20 (2), 244-250.

Scopus Eid


  • 2-s2.0-60649088752

Ro Metadata Url


  • http://ro.uow.edu.au/scipapers/4994

Number Of Pages


  • 6

Start Page


  • 244

End Page


  • 250

Volume


  • 20

Issue


  • 2

Abstract


  • Background: Oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (LV) are standard first-line treatments for patients with metastatic colorectal cancer (mCRC). The aim of this multicentre, open-label, phase IIIb study was to assess the addition of oxaliplatin to two different 5-FU regimens.

    Patients and methods: Patients with previously untreated mCRC were randomised to arm A [two-weekly oxaliplatin 85 mg/m(2) + either continuous intravenous infusion (CIV) of 5-FU without LV or two-weekly bolus and CIV 5-FU + LV (LV5FU2)] or arm B (5-FU CIV or LV5FU2 alone). Irinotecan monotherapy was planned on progression.

    Results: A total of 725 patients were enrolled. After a fixed follow-up of 2 years for each patient, 2-year survival rates were 27.3% and 24.8% in arms A and B, respectively (hazard ratio 0.93; 95% confidence interval 0.78-1.10). The addition of oxaliplatin significantly improved response rates (54.1 versus 29.8%; P < 0.0001) and median progression-free survival (7.9 versus 5.9 months; P < 0.0001). The most common grade 3-4 toxic effects were neutropenia (arm A, 33%; arm B, 5%), diarrhoea (arm A, 14%; arm B, 8%), and fatigue (arm A, 9%; arm B, 8%).

    Conclusions: Despite improved rates of tumour control, these results failed to demonstrate a survival benefit from the addition of oxaliplatin to infused 5-FU and lend further support to the use of sequential monotherapy in some patients with mCRC.

Authors


  •   Cunningham, D (external author)
  •   Sirohi, B (external author)
  •   Pluzanska, A (external author)
  •   Utracka-Hutka, B (external author)
  •   Zaluski, J (external author)
  •   Glynne-Jones, R (external author)
  •   Koralewski, P (external author)
  •   Bridgewater, John (external author)
  •   Mainwaring, P (external author)
  •   Wasan, H (external author)
  •   Wang, Jiazhao
  •   Szczylik, C (external author)
  •   Clingan, Phillip R.
  •   Chan, R T T (external author)
  •   Tabah-Fisch, Isabelle (external author)
  •   Cassidy, J (external author)

Publication Date


  • 2009

Citation


  • Cunningham, D., Sirohi, B., Pluzanska, A., Utracka-Hutka, B., Zaluski, J., Glynne-Jones, R., Koralewski, P., Bridgewater, J., Mainwaring, P., Wasan, H., Wang, J., Szczylik, C., Clingan, P. R., Chan, R. T., Tabah-Fisch, I. & Cassidy, J. (2009). Two different first-line 5-fluorouracil regimens with or without oxaliplatin in patients with metastatic colorectal cancer. Annals of Oncology, 20 (2), 244-250.

Scopus Eid


  • 2-s2.0-60649088752

Ro Metadata Url


  • http://ro.uow.edu.au/scipapers/4994

Number Of Pages


  • 6

Start Page


  • 244

End Page


  • 250

Volume


  • 20

Issue


  • 2