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Clinical Trial
. 2000 May 6;355(9215):1588-96.

Comparison of Fluorouracil With Additional Levamisole, Higher-Dose Folinic Acid, or Both, as Adjuvant Chemotherapy for Colorectal Cancer: A Randomised Trial. QUASAR Collaborative Group

No authors listed
  • PMID: 10821362
Clinical Trial

Comparison of Fluorouracil With Additional Levamisole, Higher-Dose Folinic Acid, or Both, as Adjuvant Chemotherapy for Colorectal Cancer: A Randomised Trial. QUASAR Collaborative Group

No authors listed. Lancet. .

Abstract

Background: Standard adjuvant chemotherapy for colorectal cancer consists of fluorouracil with folinic acid or levamisole. The large QUASAR randomised trial aimed to investigate (in a two x two design) whether use of a higher dose of folinic acid or addition of levamisole to fluorouracil and folinic acid improved survival.

Methods: Patients with colorectal cancer, without evident residual disease, were randomly assigned fluorouracil (370 mg/m2) with high-dose (175 mg) or low-dose (25 mg) L-folinic acid and either active or placebo levamisole. The fluorouracil and folinic acid could be given either as six 5-day courses with 4 weeks between the start of the courses or as 30 once-weekly doses. Levamisole (50 mg) or placebo was given three times daily for 3 days repeated every 2 weeks for 12 courses. The primary endpoint was mortality from any cause. Analyses were by intention to treat.

Findings: Between 1994 and 1997, 4,927 patients were enrolled. 1,776 had recurrences and 1,576 died. Survival was similar with high-dose and low-dose folinic acid (70.1% vs 71.0% at 3 years; p=0-43), as were 3-year recurrence rates (36.0% vs 35.8%; p=0.94). Survival was worse with levamisole than with placebo (69.4% vs 71.5% at 3 years; p=0.06), and there were more recurrences with the active drug (37.0% vs 34.9% at 3 years; p=0.16).

Interpretation: The inclusion of levamisole in chemotherapy regimens for colorectal cancer does not delay recurrence or improve survival. Higher-dose folinic acid produced no extra benefit in these regimens over that from low-dose folinic acid. Trials of chemotherapy versus no chemotherapy will show whether these four treatments are equally effective or equally ineffective.

Comment in

  • Adjuvant chemotherapy.
    Waters JS, Cunningham D. Waters JS, et al. Lancet. 2000 Oct 7;356(9237):1276. doi: 10.1016/S0140-6736(05)73882-4. Lancet. 2000. PMID: 11072976 No abstract available.

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