Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer
2005

Comparing Methotrexate and Leucovorin with 5-Fluorouracil in Colon Cancer Treatment

Sample size: 1945 publication 10 minutes Evidence: high

Author Information

Author(s): Sobrero A, Frassineti G, Falcone A, Dogliotti L, Rosso R, Costanzo F D, Bruzzi P

Primary Institution: Oncologia Medica Ospedale S Martino, Genova, Italy

Hypothesis

Does modulation of 5-fluorouracil by methotrexate improve survival compared to 5-fluorouracil plus leucovorin in colon cancer patients?

Conclusion

The study found that both treatment regimens produced similar survival outcomes in patients with stage II and III colon cancer.

Supporting Evidence

  • Survival rates were similar for both treatment groups at 5 years.
  • Both treatment regimens had comparable toxicity profiles.
  • Patients were followed for a median of 4.2 years.

Takeaway

Doctors wanted to see if a new way of giving medicine would help people with colon cancer live longer, but it turned out both ways worked the same.

Methodology

Patients were randomly assigned to receive either 6 monthly cycles of FU with LV or sequential MTX followed by FU and LV.

Potential Biases

The study design may have biases due to the lack of blinding and the potential for protocol violations.

Limitations

Some patient and tumor characteristics data were missing, which could affect the results.

Participant Demographics

The median age was 62 years, with 58.4% male and 41.6% female participants.

Statistical Information

P-Value

0.90

Confidence Interval

0.8–1.12 for relapse; 0.83–1.23 for overall mortality

Statistical Significance

p=0.90

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602276

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication